Original 05/22/15

Lazy? Crazy?

I wouldn’t necessarily describe myself with those words.  I wouldn’t be surprised, however, if others perceive me in that way at times.  The life that I am currently living is not the one that I imagined for myself 20 years ago.  In fact, it’s very different from what I ever conceived.

At the age of 21, I made a decision that quite possibly changed my life in a drastic manner.  I made the decision to get breast implants. It was my decision, only mine.  No one convinced me that I would look better that way. No one said that I looked bad or trampled on my self esteem. I was thin, active, and outgoing. In my mind, though, I wanted more.  Men can say all they want about a woman’s body but I think that breasts play a big part in the attraction factor.  They exude femininity.  I was out of luck.  My bra size was an AA or A at best.  It bothered me greatly.  When the opportunity to change that came along, I was ecstatic.  It gave me a hope for a “normal” figure.  My fiancé was very supportive.  He wouldn’t have made the recommendation or pushed me to do it.  It really didn’t have anything to do with him – or anyone else.  My mother didn’t seem to understand. My father seemed indifferent.  My papaw, he cried.  He just couldn’t believe that I would feel so bad about myself that I would want to alter my body.  It didn’t change my mind because it wasn’t really up to them.

I went to my consultation.  I listened to the risks.  I wanted the surgery.  No one was going to talk me out of it. My doctor had been performing surgeries in Dallas for many years. He recommended saline implants to be placed above the muscle.  They were supposed to look more natural that way.  His office offered me a discount because I worked as a paramedic.  It all sounded great.  The plans were made and I was ready.

The surgery, in 1998, went great.  I don’t remember much about it but my fiancé, Mike, took me home that afternoon.  He and my mother took care of me post op. There weren’t any complications. My breasts healed fine and I was happy with the result.  It definitely was a big confidence boost for me. I could finally purchase more flattering clothes. It wasn’t about looking like a swimsuit model. I wanted to look more proportionate.  Most of the people that surround my life now do not even know that I have implants.  That’s okay.  That’s the look that I was going for. For a little while, it was all going good.

Our first child was born in August of 2000.  I had some difficulty breastfeeding but didn’t think much about it.  After the birth, I begin to notice that my breast shape looked odd.  If I bent over, the skin directly over my sternum would pull away from my chest and the implants would fall to the center.  After doing a little research, I realized that I had developed symmastia.  Symmastia is defined as “a confluence of the breast tissue of both breasts across the midline anterior to the sternum”. It is also referred to as “uniboob” or “breadloafing”.  My original doctor agreed to consult with me about the problem.  He said that my breasts appeared similar to his wife’s breasts and didn’t see anything wrong with them.  I was not in my 40’s or 50’s so his words were not very comforting.  I sought a second opinion from another Dallas plastic surgeon.  He felt confident that he could repair them by removing the old implants, placing new implants under the muscle, and sewing the skin back to the sternum.  The recovery would be a little more difficult because it would take much more caution to prevent the skin from tearing away from the sternum again.  At a quoted price of $7,500, my repair would have to wait.

In early 2002, I was diagnosed with hypothyroidism. Soon after my diagnosis, I became pregnant with our second child. The pregnancy went good. He was born healthy.  I did, once again, have difficulty breastfeeding.  My middle child was often sick over the first several years of his life.  He was in the hospital several times. He was at home on an apnea monitor for a while.  If weird things could develop, it would happen to him.

Over the next several years, I began to develop symptoms of fatigue, weight gain, etc.  I attributed a lot of my symptoms to stress. I was working in an ER as a paramedic and my job was stressful.  Towards the end of 2007, I started having low grade fevers by the end of every day.  The fatigue slowly worsened.  My primary care physician ran labs to evaluate my symptoms (CRP, sed rate, ANA). They were all normal.  My chest x-ray was normal.  He treated me for my chronic sinus infection.  My CBC was within a normal range but my WBC’s were always low.  I asked my primary doctor about potentially having Hashimoto’s Thyroiditis and wanted to see if I should be consulting an endocrinologist.  He said no. My job suffered as a result of my health.  I was late a lot, my anxiety seemed to worsen, and brain fog began. My home life suffered because I couldn’t keep things organized.  It was a big mess. I was eventually diagnosed with ADD and placed on Adderall to try and combat some of the symptoms.  I’ve been placed on antidepressants on several different occasions for depression also.

After leaving the ER, I began working at a pediatric clinic.  I was hoping that the decreased stress would help me a little.  I found out that I was pregnant with our third child in 2008. I was still having problems.  A local chiropractor began treating me for a hip misalignment. He noted that I had pain over my thoracic duct and worked on trying to alleviate some of my sinus problems. He recommended that I push for some labwork to investigate a viral cause. I consulted my ob/gyn through the pregnancy about the continued low grade fever, swollen lymph nodes, and fatigue. He also recommended that I follow up with a viral workup. My ENT continued to treat me with antibiotics throughout my pregnancy to try and combat sinus infections.  My WBC continued to be low through the pregnancy.

I was finally able to have surgery in 2009 after my son’s birth to repair a deviated septum and remove a mucocele from my sinus cavity.  My ob/gyn followed up with me regarding the fatigue and adjusted my thyroid medication again. My symptoms didn’t really improve much.

In early 2010, I began having sinus problems again. I tried to combat it with sinus washes and Motrin but it didn’t help. I began to have very painful nodules in my neck and axillary region. I was diagnosed with another sinus infection and back on antibiotics I went. Over that specific weekend, I started having extreme tenderness in the area between my axilla and breast. It was difficult to even hold my child.  The nodules were obvious and they were painful. My doctor said that it was possible that I might be suffering from fibrocystic breast disease. He also checked on my thyroid levels again.  A new medication adjustment was necessary but he would not agree to check my CBC and did not recommend that I see an endocrinologist yet. It was time to find a new doctor.

By the end of that same week, the lymph nodes on the back of my head were large and painful. I started with a new physician. He ran more labs and sent me for a thyroid ultrasound.  He started me on another round of antibiotics for my sinus infection.  He called the next day to let me know that both of my thyroid antibodies were very high – I had Hashimoto’s Thyroiditis.  It is an autoimmune disease that causes hypothyroidism.  He also informed me that I had tested positive for Chronic CMV (Cytomegalovirus) and Chronic EBV (Epstein-Barr).  They weren’t in an acute state, though. CMV is a common virus and infects a lot of people.  There isn’t usually any cause for concern.  Once infected, your body retains the virus for life.  It usually remains dormant if you are healthy.  EBV is also a common virus and most commonly presents as infectious mononucleosis. Chronic EBV is diagnosed much less frequently. It is known to cause fever, liver dysfunction, enlarged spleen, swollen lymph nodes, anemia, etc.  The combination of chronic viruses had resulted in symptoms of Chronic Fatigue Syndrome.  I didn’t really want to discuss that diagnosis with my physician, though.  That wasn’t a diagnosis that I was prepared to accept.  My primary care doctor recommended that I follow up with endocrinology and infectious disease. My thyroid ultrasound showed a small nodule but it wasn’t very concerning.

I saw my primary care doctor again within those 2 weeks for continued problems. He decided to extend my antibiotics for 28 days. I remained on the antibiotics but had developed tender nodules in my neck, outer breast area, groin, inner thigh, and back of knees.  Soon after, I developed more nodules over my sternum and clavicles.  I can’t really even begin to explain what was going on at that time.  My whole body didn’t hurt.  It was like hundreds of palpable nodules and I could point out the ones that were painful. I was still running a low grade fever.  I tried to explain to my doctor that it made my eyes burn. It didn’t make much sense to him. He recommended that I see a general surgeon about the nodules.  They seem to be progressively becoming more palpable and tender.  It almost seemed like they initially started by moving from one localized region to another but I could still feel them.  Some were hard and round; some odd shaped and cyst like; some felt like BB pellets.

My ENT followed up with me about my sinuses. He used a scope to visualize my sinuses but didn’t believe that this was related.  He also asked if I had been referred to an infectious disease doctor. A few weeks later, a CT showed another 2cm mass in my maxillary sinus. I believe that the mucocele had redeveloped. Unfortunately, I was not able to follow up after that.

Financially it became difficult for me to work and place my 3 children in childcare so I decided it was time to stay home.  This was an extremely difficult decision because I knew that it would make a big impact in my healthcare coverage.  We tried to pay for COBRA insurance as long as we could but it just became too much.  There wasn’t any way for me to continue following up with these doctors over and over again.  The general surgeon said that he could biopsy a couple of the nodules but didn’t really recommend it. I didn’t get the opportunity to follow up with infectious disease.  My sinus surgery didn’t really make a big improvement so I didn’t want to pursue another possible surgery. So here we were. No insurance. No answers.  Complete frustration.  I began to wonder if these symptoms were all just in my mind.

The past few years have not been any better.  The nodules improved.  I still continue to have episodes of low grade fever.  My sinus problems are still chronic.  I began taking colloidal silver orally and as a nasal spray. It has seemed to help with that.  My antibiotic usage has drastically reduced. I believe that there is still a chronic issue.  I wish that I knew what was causing it but I don’t.  There was a point that my symptoms seemed to be related to a candida overgrowth and I questioned that the sinus problem might be related to a fungal infection and not a bacterial one.  My hypothyroidism has made me miserable.  It’s like a roller coaster that never ends.  My nodule was not visible on the last ultrasound (good news). My endocrinologist decided recently to change my thyroid medication and see if it will help my fatigue.  The fatigue is ridiculous.  I shouldn’t be this tired.  I am way too young to feel the way that I do.  On top of the fatigue, I’ve developed recurrent headaches.  I usually pawn them off on sinus headaches or hormones.  Either way, I am getting very tired of them.  The migraines will put me in bed at times.  I do everything in my power to continue my normal daily life but sometimes these get the best of me.

So back to the implants.  Over time, the implants definitely decreased in size.  The rippled edges became more visible but it didn’t bother me too much. The symmastia improved quite a bit as the size of the implants decreased. In March of 2012, I woke up to find that my left implant had ruptured. Standing in the bathroom, looking in the mirror, and I thought that I was going to vomit.  We were trying to get ready to go somewhere and I had no idea what to do.  My left breast was just sitting there sagging. It wasn’t fully deflated but it was a big difference.  I tried to get in the car and go on as planned but I had to tell my husband to turn around and bring me home.  I didn’t even know how to tell him. I was completely distraught and embarrassed. What was I going to do? We were not in any financial shape to have them replaced and I knew it. I called my original surgeon to try and get more info about the implant because I had no idea where my cards were.  He proceeded to tell me the name of two prominent manufacturers that he used during that time period but he could not confirm the type of implant because they didn’t “keep patient records that old”.  My implants were 14 years old.  I was so upset and I couldn’t do anything about it.

It’s now been 3 years and the implant is still here and ruptured. Yes – 3 years. For 3 years, I have been making my breasts look even by inserting a silicone insert into my bra.  We went on one vacation the summer immediately following the rupture but none since.  Slowly, the implant has leaked more and more.  No swimsuits. No revealing clothes. It’s becoming more and more difficult to hide.  The silicone insert that I have been using is no longer big enough to make them even.  What little self esteem that I had (after gaining so much weight) is now gone.  My opinion is, of course, what matters most.  My husband will say that it doesn’t bother him.  I’m sure that he is okay with it but it has to be a little awkward for him.  If I dealt with it in a better fashion, it probably wouldn’t be so bad.  I find it very difficult to act appealing when I don’t feel that way. You could tell me all day long that I’m attractive or desirable. If I don’t feel that way, though, it really doesn’t matter.  We are 15 years into our marriage.  Intimacy already suffers.  It is really suffering now.  How do you get someone to understand that the issue is not personal?  I would take it personally. My lack of intimacy has nothing to do with the attraction factor. It has to do with low self esteem and lack of desire.  It’s horrible to know that I am causing that much distress to my husband and marriage but I really don’t have an answer to fix it.

Since having the implants, many medical issues have developed. Some may not have anything at all to do with the implants. Some might.  My list includes:

Hypothyroidism (Hashimoto’s Thyroiditis),

Cytomegalovirus,

Chronic Epstein – Barr virus,

Depression,

Attention Deficit Disorder,

Fatigue,

Brain fog,

Difficulty concentrating,

Memory problems,

Weight gain,

Anxiety,

Irritability,

Headaches,

Painful nodules,

Joint pain,

Toenail fungus,

Constipation,

Dry skin and hair,

Hair loss,

Sensitivity to sounds (repetitive noises / tapping really bothers me),

Decreased libido,

Chronic sinus problems,

Dental problems,

Arm and hand numbness…

 

Prior to staying home with my third child, I had been a paramedic for 11 years.  I am not ignorant to the medical profession or medical terms.  I am fully aware that my symptoms can be related to other issues and intertwined.  If you were to look up my symptoms on blogs or certain websites, it would pull up an enormous amount of info that would scare the crap out of you. I don’t read blogs.  When I decide to do research, I focus on medical journals and clinical trials. I look at actual radiological reports. When I first began looking up my symptoms and the symptoms of candida overgrowth, I came across a physician by the name Dr. Susan Kolb. Dr. Kolb is a plastic surgeon in Atlanta. She is the founder of Plastikos Surgery Center and Millenium Healthcare in Atlanta, Georgia. She learned about the problems from breast implants on a first hand basis. She was, in essence, her own first patient. She has developed protocols that help women with biotoxicity problems from breast implants.  She is also the author of the book “The Faked Truth About Breast Implants”. I have learned a lot about breast implants from her videos and articles.  Breast implants are recommended to be changed every 10 years. They have a shelf life.  I’m sure that I was told that before signing my consent, but you really don’t consider making a financial goal of replacing your implants.  I should have, though.  We have all heard about the dangers from leaking silicone implants.  Saline implants, though, are made with a silicone based shell.  Most people probably don’t take that info into consideration.  They can be textured or smooth.  All shells will begin breaking down once in the body but textured implants seem to break down more.  The textured implants can flake off and get into the implant capsule.  They can also get into the lymphatic system and lymph nodes.  A foreign body reaction in the lymph nodes can (rarely) cause lymphoma cells.  Smooth implants do not flake and are more commonly used.  Saline implants do often leak.  Over time, a slow leak can be contaminated with mold due to the environment. More information is being researched about the creation of biotoxins by implants.  Biotoxins can greatly affect the immune system. Her video on YouTube explains this more and elaborates on sick building syndrome and the relationship between implant symptoms / autoimmune issues.  She explains the reason that a lot of us have multiple symptoms but physicians are unable to place a diagnosis.

http://youtu.be/3OfBt7DYRqk

http://youtu.be/iEu-wcxCf8A

I have been contemplating a consultation with Dr. Kolb but I am not sure that it will be within financial reason.  Her office can arrange a consultation and surgery within the same week. It is difficult, however, with three children at home, to travel to Atlanta and pursue this.

A few months ago, I was going through some old paperwork and came across one of my breast implant cards.  When I saw the manufacturer name, it didn’t look familiar to me.  In fact, I don’t believe that it is one of the two that my doctor talked to me about over the phone.  The card said that I had Textured Saline implants by PIP (Poly Implant Prostheses).  When I began to investigate my implants, a sick feeling came over me. PIP is a manufacturer in France that is now defunct. The company was closed in 2010 amid controversy over their implants.  The founder was arrested and accused of manslaughter and involuntary injuries caused by ruptured PIP implants.  Apparently, his silicone implants were made from industrial-grade silicone (as used in mattresses) instead of medical grade silicone.  PIP silicone gel implants were used worldwide but were never approved for use in the United States.  PIP saline implants, however, were used here.  I believe that it is estimated that 35,000 women in the US were implanted with PIP saline implants. They began using them in the US in 1996.  In 2000, the FDA rejected the PIP implants due to high deflation rates.  They continued to sell them here, however, until 2002 or 2003.  I have not been able to find a definitive answer on the material used in their silicone shells. My implants may not have their defective silicone filling but I am not confident that the silicone shell in my body is made of safe materials. I will have to investigate that more.  My other concern is now with the fact that I do, in fact, have textured implants.  This goes back to the concern that textured implants have a higher capacity for flaking and causing complications.  Several countries have recommended that women with PIP implants have them removed as a precaution.  This new information really scared me.

I decided that I would see if there were any other doctors near me that have the same beliefs.  Most plastic surgeons will not address this as a real problem.  My brother is an anesthesiologist.  He has connections with a plastic surgeon near him who could do my explantation. The discussion has also come up about removing these and replacing them with new ones.  It is a dilemma that really bothers me.  My husband has joked about replacing them with bigger ones.  He’s even made a comment to me about how he knows that I won’t be happy with myself if I don’t replace them.  In some ways, he is right.  I know that removing the implants is going to leave me with nothing.  I would be lying if I tried to say that it wouldn’t bother me.  I have been trying to convince myself that it couldn’t be worse than how I have lived the past three years.  It can’t be worse than inserting a silicone boob in my bra every day and not being able to put on a swimsuit to get in the pool with my kids.  It can’t be worse than hiding myself from my husband for the past three years.  Complete nudity has not been an option. I don’t even want to look at myself in the mirror – much less let someone else.   Of course I begin to question what attraction my husband will have towards me if I have them removed.  It goes back to my feelings about breasts and femininity. If I take them away, am I going to immediately feel like less of a woman?  If I go to a general plastic surgeon to have them removed, will they understand my concerns?  Will they act as my advocate? I have contemplated going to the surgeon that my brother knows and letting him remove these, then potentially replace them based on what he sees during the surgery.  Would a plastic surgeon really decide to decline new implants? Is it possible that all of my symptoms are completely related to other issues and have nothing to do with the implants? If I knew for sure that this was the cause, I would definitely want them out for good.

Upon doing more research, I found a Dallas surgeon by the name of Dr. Edward Melmed. Dr. Melmed is one of the few plastic surgeons that have publicly questioned implant safety.  He is one of the characters in a documentary film by Carol Ciancutti-Leyva that is called “Absolutely Safe’. I have not personally purchased this film but I would like to watch it and see what other information is given.  Dr. Melmed practices at Medical City Hospital at Dallas.  I contacted his office in reference to a consultation. The lady that I talked to on the phone devoted a lot of time to me and was extremely friendly.  She emailed me the explantation info and also the contact information for a few women who are around my age and have undergone explantation. I contacted one of the women. She responded to my email and let me know that she feels much better after having her implants removed. She said that she continues to improve daily. My consultation is scheduled for May 14, 2015.  I am extremely nervous and anxious.  I have gone back and forth about cancelling my appointment.  I know that I do not currently have the funds to get the surgery done.  I’m afraid that I am going to feel overwhelmed by the desire to pursue the surgery and not be able to follow through at this time.  On the other hand, I am extremely interested in hearing what he has to say.  I have a couple of people in my circle of acquaintances that have breast implants and similar symptoms. I would really like to be able to pass on information that might be helpful to them. I don’t really know that I will be able to make this decision until I have consulted with him and perhaps the physician that my brother knows.

My daily life right now is chaotic.  I don’t really know how to explain the way that I feel.  My life is in constant disarray.  I can’t think straight. I can’t keep things organized.  My house is a mess and it causes me anxiety because I know what I need to do to but I don’t have the energy or drive to do it.  My patience is always thin.  Unfortunately, this takes a toll on my family life.  I know that I shouldn’t be this impatient with my husband and kids.  It makes me sick to know that I ride a roller coaster of emotions and I can’t control it.  I get aggravated when I am asked, “Are you out of your meds?”  I don’t want a medication to define me.  I don’t want my emotions to be directly related to the medications that I am on. It has been difficult to maintain appointments with my psychiatrist and endocrinologist. The endocrinologist has to come first.  When my husband needs heart medication and my son needs thyroid medication, those issues come first. When my children need to see a doctor, they come first. That’s just the way that it is.  Unfortunately, that sometimes means that my health takes a back burner.  My thyroid problem has been difficult to deal with. I think that my thyroid has now finally atrophied enough that it is not working at all. That’s actually a good thing because my thyroid medication dosage should be easier to adjust now.  I am currently off of my antidepressant and my ADD medication.  The antidepressants always make me feel like a zombie. I hate taking them. I know that they make my mood mellower but it makes me feel so indifferent about everything.  I think that the ADD medication definitely helps me with my organization and accomplishing tasks.  Being off of it has not been good.  The household chaos makes me feel out of control.  I am, by nature, a control freak.  Lack of control makes me irritable and frustrated.

If you were to ask what symptom bothers me the most, it would be the brain fog.  I find myself going into a room or a store and not remembering what I went in there for.  I can look back on my day and not understand why I didn’t accomplish more.  Lists help me on occasion.  If I make a list of things that I need to accomplish, I can sometimes follow through on some of the items.  It gives me a little sense of accomplishment. Lately, though, it takes everything in my power to just get up and perform basic duties.  This is not fair to my family. It’s not fair to my friends.  I don’t feel like being social. I don’t feel like doing things with my kids even though I want to.  I don’t feel affectionate to my husband right now.  I can’t help it. I don’t know how to change it.  I suppose that someone reading this would say that it fits the definition of depression but I believe that there is much more to it. There are still the physical symptoms that accompany it.  For the past week, my sinus problems have been really bothering me.  My occipital lymph nodes (on the back of my head) are really swollen. One is almost the size of a ping pong ball.  It has made it difficult to turn my head because the pain is so bad.  Ibuprofen has been a friend to me for several years.  I realize that it isn’t good for my stomach, but it is necessary.  My low grade fever is back.  I am running between 99.0 and 100.5 every day again.  It almost seems to come in phases or cycles.  I would probably say that it makes me feel like my body is battling itself at times.  If my immune system is fighting one issue, then it can’t seem to keep up with it all and another symptom arises.  My body just doesn’t seem to be able to maintain itself.  I know that sounds weird. I broke down a few days ago and pulled out a bottle of Penicillin VK from my cabinet that was never used.  I started taking the prescription to see if it would help my symptoms but, so far, hasn’t.  My mother keeps telling me to go to the doctor.  I don’t have a primary care physician anymore.  Since we lost our insurance, we haven’t been following up with all of our physicians as much as needed.  When I need lab work done, I just order it online through an out of state physician and go get it drawn.  It’s really been a blessing to be able to do that because it saves me a lot of money.  I can send my results to my endocrinologist as needed.  So I don’t go to the doctor for all of this.  I guess that I got so tired of no one being able to find anything that I gave up.  I should have followed up with infectious disease and rheumatology but I knew that it would end up being too costly.  So what do I do in a situation like this?  My mom said that I should go see her primary care.  And then what?  How do I tell a physician that I have sinus problems that I haven’t followed up on, dental work that desperately needs to be done but I can’t afford it, and a ruptured breast implant that I can’t afford to have removed? It’s completely embarrassing. I feel like a complete failure. I have failed myself and my family.

This is not the life that I would choose for myself. I don’t like living like this.  This is not me.  I loved my job as a paramedic.  I loved being able to help people.  I still try to help the people in my life but I am finding it more and more difficult to accomplish.  I love my marriage and my children.  I wouldn’t trade any of this.  I just wish that I could be that person again. I wish that I had the energy to do the things that I want to do. I wish that I felt good enough to play with my kids and joke around.  I wish that I could get my house and life organized enough to function better.  I wish that I wanted to be more affectionate towards my husband.  People often say that they wish to win the lottery or live in a nicer home.  That’s not me.  I do want to get to a point where finances are not so constraining.  It definitely makes things much more difficult.  Being wealthy is not on my list of priorities.  We live week to week (as do most people we know).  We are a single income household.  My husband works extremely hard to keep us above water.  I want contentment.  I want peace.

The dilemma continues.  If someone came to me with money for my surgery or we were able to come up with enough, I would still be inclined to use it on other things.  We all need dental work. We all need to do follow up appointments with our other specialists.  I began to contemplate a fundraiser for my surgery.  That way, if we came up with other money, I could focus those funds on my family.  I guess that it would make me feel less guilty about needing money for myself.  I have heard myself tell people, “You can’t take care of others if you don’t take care of yourself.”  I know that is so true.  Unfortunately, it makes me feel greedy to put myself before my children.  I also feel so disorganized right now that the thought of being down for a few days terrifies me.  Relinquishing control is very hard (although I wouldn’t exactly consider myself “in control” right now). My children don’t have any idea what is going on.  It’s not really their place to understand.  My two oldest boys are old enough to help around the house but they don’t do much.  If I ask several times to get help and they don’t, I often give up because I just don’t have the energy to fight with them over it.  My husband works hard all day and I know that he doesn’t want to come home and have to pick up my slack.  If I can’t use my arms for several days, how is my household going to get by? In a perfect situation, I would get my house cleaned and organized before the surgery. I would do my grocery shopping and plan out meals ahead of time.  I would arrange for someone to help me with my youngest child for a few days.  I don’t like asking for help.  I should be able to take care of my own family.  I’m not doing a very good job.  I don’t even want anyone in my house right now because I am so overwhelmed.  I don’t know where to begin. I have 50 projects going on at once and can’t seem to finish even one of them.  This is the story of my life.

Why do I feel like I need to share my story?  I know that there are people who will read this and think that I shouldn’t complain. I should have seen this coming.  Exposing my body to foreign things could only cause problems, right? I think that is very easy to judge people when you have not stood in their shoes.  I am not sharing my story to deter women from getting breast implants. Truthfully, I don’t think that it will.  Someone could have placed this letter in front of me 16 years ago and it probably wouldn’t have made any difference.  I know that sounds arrogant but I had already made up my mind.  The risks didn’t really cause a huge concern to me.  I guess that my goal with this is to convince women who already have breast implants to pay attention to their body.  If things don’t feel right or unusual problems begin to develop with your health, pursue them.  Research these complications that Dr. Kolb and Dr. Melmed discuss because, in my mind, they are real problems.  This is not an easy thing for me to talk about. It opens up doors of insecurity and embarrassment that I really don’t want to open.  Unfortunately, this is a problem that is very real to me right now.  People who are close to me probably question whether there is any truth to this.  Honestly, I don’t know.  Until I get further along in this process, I don’t have any answers.  I know that it is time to pursue the answers.  I know that I have missed out on so many things and I don’t want to miss any more.  I want to enjoy my life again.  If removing these implants will potentially allow me to heal and feel better, then I have to move in that direction.

My appointment with Dr. Melmed is May 14th.  I will elaborate more on “My Implant Story” after I have met with him.

Update 05/18/2015

My husband convinced me to keep my appointment.  I definitely considered backing out.  I was a nervous wreck.  The morning of the appointment met me with anxiety and nausea.  I literally felt like I was going to vomit before meeting with Dr. Melmed.  Thankfully, my husband was with me and the prayers of some great friends got me through it.  On the way to the appointment, I talked to my husband about “my story”. I asked him to read it because I needed him to fully understand where I was physically, mentally, and emotionally.  He read my paper when we arrived at the hospital.

Dr. Melmed’s office is not your typical plastic surgery office.  The waiting room is small but interesting.  Safari prints adorned the walls and the furniture.  There were two vintage medical cabinets full of neat, older medical equipment.  Linda was working at the desk.  She greeted us and explained that Dr. Melmed was running late from surgery but that he would be in the office soon.  He came in a few minutes later and greeted us personally from across the desk. The consultation began in his office.  Upon entering his office, I first noticed two things on his desk. He had a fake glass of beer and a fake “spilled” cup of ice cream.  It immediately lightened the atmosphere.  He made a comment about it and explained to us the importance of making patients feel comfortable.  Humor seems to help the interaction between doctor and patient, especially in tense moments.

Dr. Melmed first asked me about my implants and their age.  He asked me why I was there.  I had prayed all morning that I would be able to get through the appointment without crying but it didn’t work.  I told him that I was afraid that my implants have been making me sick and my emotions came over me.  He told me to take a few seconds and he began to talk to us about explantation.  He told us about the patient that kind of started all of this for him. Dr. Melmed does other plastic surgery and reconstructive procedures but no longer performs breast augmentations.  He began to list the complications that women have from breast implant placement.  He also began to list the common complaints from women who have breast implants and have developed illnesses.  I’m not quite sure, but I think he started out with a list of about 10 symptoms.  I think that 9 out of 10 of those directly applied to me.  I could tell that he had Mike’s full attention.

Dr. Melmed pulled out a photo album that he shared with us.  It had pictures of general implant complications (capsular contracture, rupture, deformity, etc.).  Rough statistics show that 20 percent of women have to undergo a secondary operation within one year of breast augmentation for complications. Saline implants leak at an approximate rate of 5% per year. He let both of us know that he would be forward and truthful.  Breast explantation is often difficult mentally because of the decrease in breast size.  He basically told me that men have the capability of looking at large breasts anywhere and at almost any time.  They are everywhere.  He told me that a man wants someone that he can have fun with and enjoy his time with.  If my husband doesn’t have me to be fun and interactive in our family, then what good do large breasts do?  It made sense and I knew it.

We began to discuss a little bit of my history.  I told him about some of my symptoms and when they first began.  I started crying and explained that I just needed some justification.  For so many years, I have felt like no one believes me and I have begun to feel like I am just imagining it.  He took my hand and looked me in the eye – and gave me that justification. He told me (very clearly) that I am not imagining my symptoms. They are real.  If my symptoms are not real, then why is he seeing a multitude of patients that complain of the same things? A lot of women have breast implants and never face complications.  They don’t present with immediate deformities or long-term illnesses.  Other women, however, do.  He explained that breast implants may not necessarily “create” the autoimmune disorders but they seem to trigger an autoimmune response.  Unfortunately, that means that there appears to be a large number of women who develop autoimmune disorders after having breast augmentation. In my case, it was the Hashimoto’s Thyroiditis.  In other cases, it is Lupus, Rheumatoid Arthritis, etc.  There is a long list of common symptoms that many of us share.  Some of us have the positive lab results to prove it, others don’t.

The next portion of the consultation was the exam.  He made measurements of where the breasts are sitting now and explained to me his proposed outcome.  We talked about the “lift” process if needed (internal and/or external).  He took before pictures.  Linda was in the room with us during the exam.  We were still discussing some of my history and I commented on my frustration with the lack of information that is out there.  She said that she would recommend that physicians take breast implants into consideration on a more frequent basis.  If a physician is addressing a patient who has similar symptoms, they should be asking the patient whether they have breast implants or not.  The sad thing is that it isn’t really recognized as a problem.  These symptoms are usually shoved under another diagnosis and the possible true culprit is overlooked.

I asked Dr. Melmed about what sets him apart from using Dr. Kolb.  He didn’t have a lot to say, but he said these two things; 1) he does not remove the surrounding lymph nodes as she sometimes recommends because he does not feel that it is necessary and 2) he would question a physician who performs a large number of explantations but continues to keep her own breast implants.  Those are two very valid points.  I am trying to take in all of the information and allow myself some time to absorb it.  I can definitely say that it is Dr. Kolb who eventually led me to Dr. Melmed.  She was the first physician that I found online who is addressing this issue.  Her public awareness movement is larger.  I have to give her credit for putting the information out there for people to find.  I am blessed to have found a doctor that is closer to me, though.  As far as her continuation with breast implants, it’s not really my place to judge.  On one hand, I’m not sure that I could try to raise public awareness on breast implant dangers and still have them.  On the other hand, these issues are not present in every patient.  There are many women who can have augmentation after augmentation and never suffer from these problems.

Hope.  Dr. Melmed gives me hope.  He said that a lot of women get relief from symptoms immediately after surgery.  The estimated peak time of recovery is nine months, however.  I realize that some of my issues are irreversible.  My thyroid is completely atrophied.  That will never get better.  I am hopeful, though, that the brain fog and fatigue will greatly improve.  I have read a few stories from women who have undergone explantation and can attest to that.  Once my body begins to detoxify, I believe that I will begin to feel much better than I have felt in a long time.

The next person that I met with is Janet.  Janet is the lady that first drew me into his office via phone chat.  Her outgoing attitude is easy to be around.  She did say something that I found to be a little upsetting.  She said that she can usually pinpoint a patient who is seeking a consultation for explantation before they ever say it.  I asked her why she knows that just by talking to someone on the phone.  She said that explant patients always sound so “unhappy”.  How sad is that?  Our lives are so disrupted and our health is so bad that we just sound “unhappy”.  I believe it. I don’t like it, but I believe it. We discussed the cost and scheduled a tentative surgery date.  Janet and Linda definitely made the whole experience so much easier.  I am not comfortable in a snooty setting so it was nice to deal with ladies who seem down to earth.

My husband and I are in the process of finalizing the funds for surgery.  I am anxious and stressed about the days to come but I am finally determined to follow through.  I will slowly be spreading my story for more to hear.  My goal is to make more women aware of the potential long-term illnesses that may be associated with breast implants.  I would encourage women to pay close attention to their body.  If my surgery goes well and my health improves as much as I hope it will, I will definitely devote more of my time to making the public aware.  These risks are not only associated with silicone implants as many people believe.  They are associated with ANY implants.  It’s extremely scary.

https://www.youtube.com/watch?v=AYN2H-hSHXU&feature=youtu.be

http://www.knowthecause.com/index.php/contributor-blog/31-as-seen-on-the-show/2195-after-the-show-breast-implants

 

Update 07/22/15

I’m 20 days away and counting. I bought my post-surgical bras the other day and I had a huge breakdown. No more Motrin for my headaches and pains is going to be hard. I am absolutely terrified. Some things are falling into place and others haven’t yet. I know that God is leading me on the path I need to be on and I pray that this is the answer to feeling better. My anxiety is getting the best of me, though. Praying for inner peace.

 

Update 08/07/15

The last couple of weeks have been emotionally straining. My grandfather was diagnosed with asshole cancer. He is very near and dear to my heart. For those that don’t know, my father passed away from asshole cancer approximately 10 years ago. Taking my papaw to his appointments and helping to care for him definitely keeps my mind off my own issues. I truly contemplated delaying my surgery but I know that is not a good decision. My fatigue is increasingly worse and my low grade fever has been fairly consistent for at least a month now.
Dr. Pierre Blais is a research chemist and expert in the biocompatibility of implant materials. He is located in Canada. I have read of many women who have sent their implants to him after removal for examination. I decided to email him last night. In my email, I inquired about the process and told him what type of implants that I have. Within two hours, he responded. He said that he needed to speak to me directly today.

I called his office this morning. He was very polite and informative. Dr. Blais told me a little more info about my implants. A little background (if you haven’t read my full story) – my left implant ruptured 3 years ago. When I called my surgeon, he mentioned two types of implants that he used at that time. He did not have my records, however, because they were “too old”. About a year ago, I found one of my implant cards. They are PIP textured saline (NOT one of the mentioned manufacturers). Dr. Blais said that he was appalled that my surgeon did not tell me to immediately have these removed after the rupture. He said that PIP saline implants are prefilled and sealed. The saline that is in them is considered “microbiologically uncertain”. In other words, they do not really know about the chemical composition of the saline. He said that he could label me as “infected” going into this surgery and that I am at a “microbiological risk” for infection. He recommended that I contact my surgeon and make sure that he starts me on antibiotics prior to surgery.

Dr. Blais told me that I am probably one of the last few in the US that have this brand of saline. Most women had early ruptures or got so sick that they didn’t keep them long. He remarked that I must be “made of steel or something” because he was very surprised that I was even able to talk to him on the phone.
My implants will be given back to me after surgery. The capsules have to go to the hospital pathologist. Dr. Blais recommends that I get the pathology report and request to have the capsules back. I can send the capsules and implants to him for evaluation. He sends a free basic report back and then I will have to pay an additional charge if I want a full, detailed report.

He also told me that I need to be informed about the recent link between breast implants and ALCL cancer. Although the risk is low, the link is much higher in women with textured implants that have been in place for over 10 years. The hospitality pathology report will hopefully rule that out. Needless to say, I am paying for my stupid decision. I would never have believed that there was this much risk in “safe saline implants”. I am no longer concerned with how I will look afterwards. I am sickened by the position that I have put myself in. I have no idea what my implants will look like. They might be perfectly clear. Who knows? Only time will tell. Either way, Dr. Blais has made it very clear that my illness is believable. He has seen it in many women. I am ready to move on.

Here’s to new beginnings and a good outcome!

 

Update 08/09/15

This is in regards to my post about Dr. Blais (Canadian biochemist):
I emailed Dr. Melmed (my surgeon) tonight to ask whether he had heard much about prescribing antibiotics based on my implant type. There is definitely a difference in opinion between these two. Dr. Melmed said that he does not take prescribing antibiotics lightly. He said that it takes up to a year to replenish the gut flora that a round of antibiotics kills off. Dr. Melmed said that he does not prescribe antibiotics before surgery because he has no evidence of infection, therefore, no guideline for what type to prescribe. He said that it would be like shooting a shotgun in the air and hoping that a bird gets shot. In other words, there’s no reason to start on an antibiotic that might not cover what needs to be covered. If he needs to address it during surgery, he will. If a culture tests positive after surgery, then he will treat accordingly. I told him that I am not trying to question his method. I want to be educated on the why or the why not. I told him that his explanation makes sense to me. So – no antibiotics.
This whole process is very confusing. Opinions by doctors can be very different. Opinions by other implant sufferers can be very different. I have to take in the information that makes sense to me. In doing this, I have to rely on my faith that God is leading me to the right doctor, with the right treatment.

 

Update 08/11/15

Woohoo! On the other side now. According to Dr. Melmed, the Explantation went great. He was able to remove them “en bloc” which is very important in these removals. My capsules were very thin but he was able to remove all of it. The bleeding was very minimal. He has already warned me that I will be small. If it will decrease even half of my fatigue, it is totally worth it!
My left implant was ruptured but the right one looks amazingly good for its age. He told my husband that most women had these particular implants removed within 6-12 months after augmentation because of illness or rupture. I guess that I was extremely protective of them. He placed two drains that will be removed tomorrow.

The pain hasn’t been that bad. I’m sore but it’s been okay. I had some post anesthesia nausea but it has resolved now. I was a nervous wreck this morning. Lots of prayers were coming my way. My anesthesiologist and Dr. Melmed completely put me at ease. The staff at the surgery center knows Dr. Melmed very well. They all seem to know the way he does things. With over 4,000 explantations done to date, I think I made a wise choice in surgeons.

Thanks for the prayers, calls, texts, good vibes, food, cards, etc. I know this was not a life threatening surgery but it was important to me. I’m very blessed to have the great family and friends that I do.

 

Update 08/13/15

Mike took me to have my drains removed yesterday. It hurt a lot but was very quick. Dr. Melmed told me that I might end up looking like a 12 year old boy. I think that he was joking but he is very straightforward and I think he was preparing me for the worst. When he sat me up, I actually had a little bit of boob! Needless to say, I was thrilled. I’m glad that I didn’t have high expectations, though. I was able to take a bath today. My range of motion is minimal so I’m not sure that I can wash my long hair. Some friends are taking me to get my hair washed and braided – such a sweet gesture. The pain isn’t that bad. It’s just an achy, sore feeling. The incisions itch. Overall, I’m doing very well. I will see Dr. Melmed in a week for a follow up.

 

Update 08/17/15

Tired but feeling pretty good. The surgeon just has me in a sports bra 24/7 now. My follow up appt is Thursday. Before the surgery, I was running a 99.0-100.5 temperature pretty consistently. Since surgery, it has been much better. My sinuses are draining a lot. I’m hoping that my body will now be able to fight the sinus issues. My skin doesn’t seem to be as dry but I am trying to choke down a lot of water.

I’m not starting any major detoxification at this point. I’m going to let my body try to do the work first. I’m supplementing with multivitamins, probiotic, bone broth, and juicing a little. My appetite is good.
My surgeon went in through my previous incisions. There aren’t any stitches. He has surgical tape over the incision that will stay for about 1-2 more weeks. I will be able to drive today. I just have to be cautious for about 2 more weeks to keep the incisions from opening back up. I don’t feel bad, but I don’t feel fantastic. I have accepted the fact that I may not bounce back super quick – as I kept these stupid things for 16 years. Overall, I am 100% glad that I went through with this. I think that things are definitely going to get better.

 

Update 08/20/15

I just left my follow up with Dr. Melmed. I really can’t say enough about this office. Linda and Janet are so easy to talk to. They have never made me feel uncomfortable or anxious. Dr. Melmed has been great! It might be the adrenaline from knowing this is behind me, but I feel really good. I felt myself smiling while in his office and I haven’t done that much lately. I am truly grateful that he has chosen this stance and continues to help women just like me. The surgical tape was removed in office. I am totally pleased with how I look now – although the tissue will continue to heal and fluff up – so it should get even better!

Update 09/02/15

3 week update: BABY STEPS
My energy level has improved. I wouldn’t say that I am great yet, but better. My fever seems to be remaining stable. I have had a couple of 99+ but nothing over 100.0 (big improvement). On the way home today from seeing my papaw in the hospital, I noticed that I was getting a bad headache. This made me realize two things: 1) This fits the timeline with my monthly “hormonal” headache – so it doesn’t surprise me (too much info – sorry). And 2) I realized that I haven’t had a migraine or headache since my surgery. This is a HUGE revelation. I was dealing with bad headaches 1-3 times a week. They would often turn into migraines and put me in bed. I didn’t even realize that I hadn’t had one. I should have noticed, though, because my use of ibuprofen has drastically reduced.

Physically, my soreness is pretty much gone except for the incision site. The tissue is pretty soft. One breast is a little distorted in comparison to the other. Dr. Melmed said it usually takes several months for the tissue to “fluff” and fill out. I broke down once about the appearance but got over it pretty quick. I still have a long way to go but think I’m dealing with it pretty good. So all in all, I feel like I am improving daily. I know that these are baby steps, but I’ll take it.

To reiterate – Yes, I am glad that I went through with it! No, I would not consider replacing them with new implants.

 

Update 11/04/2015

 

I just left my Endocrinology office. We are going to adjust my thyroid meds again. This was the first appointment ever with this doctor that I was able to say that I felt okay. Every other appointment in his chart noted extreme fatigue, headaches, etc. I told him about my Explant surgery. He said, “here we were thinking that a lot of your symptoms could be attributed to your chronic EBV and CMV and that might not have been the case.” We didn’t go into an in depth conversation but he noted my surgery and improvement in my records. He asked about the type of implants that I had. Before he left, he said “you know I’m not sure that I can officially talk to women who have these issues and tell them to remove their implants, but I do have another patient with Lupus (another autoimmune disease) who had hers removed also”. He kept shaking his head in wonder and almost disbelief. I told him that I’m just asking him to keep this in the back of his mind when other patients present with similar issues. I will continue to plant this seed with anyone that is open minded enough to listen. I am also going to email him or his nurse practitioner later a link to my group and some of the websites that have more information. He might not 100% believe what I just talked to him about but he was very open to hear it and responded well.
I feel good today. It’s been a busy week and I am nowhere near as tired as I used to be. I am enjoying my time with my kids and husband more. I believe that they have noticed some subtle changes in me. I am grateful for whatever improvements may come. My headaches and fever are still gone! I’m still battling my sinus issues but I’m dealing with it okay.
I felt myself smiling as I just walked out of the doctors office. What an amazing feeling that is. It’s another small step in my journey.

 

Update 12/17/2015

 

The Question I Urge All Doctors to Ask Their Female Patients

 

This is a plea to doctors – well, maybe all doctors except plastic surgeons. I would like to urge doctors to specifically ask your female patients a question: Mrs. Smith, do you have breast implants?

Why do I exclude plastic surgeons? Let me explain. My plea is focused on other general care practitioners, rheumatologists, endocrinologists, neurologists, psychologists, chiropractors, etc., who are following women for symptoms of illness.  When we, as women, show symptoms of illness, we do not run to our plastic surgeon. We seek advice and treatment from other practitioners. It makes sense that I would like to make a plea to all of you.

The use of social media has allowed women worldwide to join together and discuss breast implants. Several websites and Facebook groups are now focusing on women who would like to discuss breast implant illness and Explantation – or the removal of their breast implants. Why are women searching for these groups? They are desperate for answers. They are seeking advice about their symptoms and illnesses and don’t know where else to turn. These women have seen doctor after doctor in regards to their symptoms and not getting any answers. What do they have in common? The first answer – breast implants. The second answer – a long list of common symptoms.

What symptoms are these women describing? They can include common symptoms such as fatigue, anxiety, joint pain, headaches, vertigo, hair loss, recurrent illness, skin rashes, breast pain, brain fog, depression, swollen lymph nodes. They may exhibit symptoms of Chronic Fatigue Syndrome, Fibromyalgia, Multiple Sclerosis, Thyroid disorders, Connective Tissue Disorders. Some of the most commonly diagnosed illnesses are Hashimoto’s Thyroiditis and Lupus – both autoimmune disorders. You might decide to run a whole panel of tests. Some of these women are getting positive lab results but many are not. Many are suffering from the symptoms and still have completely normal lab results. This generally results in women being sent away with no answers, sent to psychologists for evaluation, or sent to other specialists in pursuit of additional options.

Who are these patients?  These are women who have ANY type of breast implant. It doesn’t matter if it is saline or silicone.  All implants are encased in a silicone shell. It doesn’t matter how long they have had breast implants. Some women are starting to seek treatment for illness early on after augmentation and some are seeking treatment many years down the road. It doesn’t even matter why they had breast augmentation. While most receive implants for cosmetic purposes, many have undergone surgery for reconstructive purposes or as a post-mastectomy procedure.

Why should you consider the breast implant factor? I know that the proper response by physicians is that the FDA has approved the use of implants, therefore, they are safe.  I’m not asking you to discredit the FDA, discredit any studies, or discredit other physicians. I’m simply asking that you take this question into consideration. Some women might not even list breast augmentation on their list of previous surgeries. I won’t even really get into the discussion about the studies and the FDA. The fact is that women with breast implants are suffering from a long list of common symptoms. This is the same story that has been told for many years. Most physicians will not recognize “breast implant illness” because it is not a clearly defined illness or disorder in the eyes of the medical community.  The proof comes when these women remove their breast implants and they show improvement in general health and in relief of some or all of their symptoms.

My plea is this: If you have a patient who exhibits these symptoms, follow your normal treatment path but ask them if they have implants. If for no other reason, ask them out of curiosity. If they do, please inform them that there are women who are sympathetic and willing to listen. They can search Explantation, Explant, Breast Implant Illness on Facebook or the internet. They can watch videos on YouTube by Dr. Susan Kolb and Dr. Edward Melmed. You don’t have to be an advocate of breast implant illness to refer your patients for outside support. You don’t have to imply that there is any correlation at all. I am simply asking that you keep an open mind about the possibility that some of your patients are seeking treatment from you for illnesses and coincidentally have breast implants.

Thank you for your consideration and I hope that you will keep this plea in the back of your mind for future reference.

 

 

Update 12/23/2015

 

I feel like I need to address a few things that have been weighing on my heart the past week. I know this is long winded so I apologize.

First, if you are seeking Explantation, please try to avoid getting overwhelmed with the information about breast implant illness. It is such a scary time and there is so much information to absorb. It can easily overload you. Take the time time to research and read stories. Listen to the advice that other women offer. It will not all pertain to you so don’t hang onto all of it. Take the information that seems pertinent to your situation and follow your instinct. The reason I say this is because I don’t personally believe that this is a black and white situation.  There is a very wide gray area. We are not all in the same situation. We have had implants for different lengths of times. We have had different types of implants. We have different symptoms and possible co-infections. We have different daily exposures. We have different genetic backgrounds. My path might not be the right path for you. Your path might not be the right path for someone else. I know that it would be much easier if there was one easily defined path to take, but it just isn’t that way. There are definitely recommendations for Explantation that you should consider. If you are capable of utilizing one of the top Explant physicians, please try to do so. If you can’t, though, follow your instincts and do what is best for YOU. Don’t let anyone bully you to the point that you feel guilty about a decision that you have made. We are not doctors or lawyers. We cannot guarantee that you are going to completely recover from following a “recommended path”. You are the person that has to make the decision because you are the one that has to deal with the aftermath of your decision. This is a very personal decision and quest. Make this about YOU.

Second, please do not focus negativity on specific doctors. Yes, there are 3 most widely known Explant surgeons in the US. They are all very different in technique, views, and treatment. The topic of mold in implants has recently been brought to the forefront. Not all doctors will say that this is a common occurrence. We know that Dr. Blais believes that this is very common. We know that there have been studies about bacteria and mold inside implants. We know this. Breast implant illness knowledge is consistently evolving. We are all learning as we go. The surgeons are learning, too. We need to remember that these doctors DO believe us. That is what is important. The specifics might be different but I believe that they do have our best interest at heart. Research your physician options and choose the best surgeon that makes the most sense to YOU – not anyone else.  My surgeon did not address the detox issue and it was okay with me. He made sense to ME. My doctor might not be the one for you. Your doctor might not be the one for someone else. Some doctors believe that detox is essential. Others don’t. We will continue to learn as studying this progresses.  If you are able to find a surgeon that can do the procedure that you want but doesn’t push detox, then find someone else to assist you with the detox path. No one can guarantee you that paying $3,000 to Doctor A for surgery and $200 monthly to a natural practitioner or paying $12,000 to Doctor B for total care is going to completely cure you. We have no guarantees. So again, you need to follow your own path. Someone can try to convince you that one surgeon and one type of treatment is right for you – but what if it isn’t? You have to be able to live with your own decision. I have had times when I was made to feel bad about choosing the surgeon that I chose. I’m not sure why I even questioned it. I made my own decision and I am totally happy with it. I can’t sit here and tell you that my surgeon is the best choice for everyone else. I know that he isn’t. He was my choice, though, and I am happy with the outcome. Hopefully, as implant removal is on the rise, we will begin to find more surgeons that are willing to help us and be open minded.

Third, capsule removal is a huge discussion and controversy. It is highly recommended that all capsule get removed with the implants. The preferred method is “en bloc” or all as one component. Many doctors say that they will not put a patient at risk to remove all of the capsule if there are bits that are adhered to lung or rib. Many will say that it can be more dangerous to try and remove those little pieces. So I have to honestly say that I ride the fence on this one. I would want my surgeon to use best judgment in what he deems as safe to remove. Dr. Blais clearly says that the capsules (in entirety) should not be left in. They can harbor microorganisms between the folds that can be more harmful down the road and they can cause confusion on future radiological reports. I have personally heard from women who left entire capsules or portions of capsules and still showed improvement in health. I would personally want to remove everything possible but that is just my opinion. There have been women in the UK who have undergone breast implant removal by the NHS and they have been denied removal of capsules. Some of these women are desperate for implant removal and cannot afford to pay privately for someone else to remove everything. My heart goes out to them because I think they are left in a state of despair and truly want to do everything they can for their health. I don’t think that it is fair to shame anyone for not being able to have a complete capsulectomy when it is out of their hands. I think that they need our prayers and support that the implant removal alone is going to improve their health.  It might not be the best scenario but they need our support, nevertheless. I have also heard from women who did not have a huge improvement in health after bits of capsule were left. I can imagine that it would lead people to question whether that bit of capsule is the reason for delayed healing. I’m just not sure that I can answer that. Some women have gone on to undergo additional surgery for old tissue removal and improved. I believe that those stories also involve additional detox methods too, though. So I still am left to question whether it is the secondary capsule removal that heals these patients or the addition of customized detox plans. Perhaps it’s both. I cannot speak from personal experience here. All of my capsule was removed. I can only say that I urge you to be completely  open and upfront with your surgeon about your expectations. If you have bits of capsule left, I have read that there is a possibility that low light therapy can assist in helping to dissolve that tissue. If I find more info, I will share it in another post. I am not addressing this to start a debate. I am simply stating my opinion and my concerns.

Fourth, and this is the hardest for me. My heart has been breaking lately for some women. I am on several different groups and it makes me very sad to see the desperation that comes with trying to Explant, the confusion with making the right decision, and the disappointment that comes if removing the breast implants does not provide the outcome that someone longs for. I will not sit here and sugar coat things. I refuse to sit here and tell anyone that removing their breast implants is going to cure all of their problems or turn their life completely around. I firmly believe that they cause illness and a huge disruption in our immune system. I think that they trigger a lot of problems that might have stayed dormant if not for introducing these things to our bodies. I cannot convince someone to make this decision, though. I can tell you about other stories and I can tell you about my personal experience. That’s it. I believe that a woman has to get to the point that they feel like they have exhausted all other means for a medical answer or just finally realize that hanging onto these breasts is just not worth it anymore. If you are not to that point of desperation, then maybe you need to wait until you are. I know that sounds bad, but I believe that you need to be somewhat mentally prepared for the decision that you are making.

I have been reading a lot of articles about breast implants. Dr. Arthur Brawer has really been standing out to me. I know that battling mold and co-infections can be very important in our path to healing. His articles make SO much sense to me, though. I really want to urge you ladies to read some of these. I know that prior to Explant I might not have been able to actually process a lot of this information. I am going to try and break some of this down. I will also make sure that his articles are in the group Files so you can read them.

This is my interpretation of some of the articles:

  1. Average onset of systemic disease was 2.5 years after implantation.
  2. 90% of women in one of his studies were symptomatic after 6 years. Each patient had an average of 30 symptoms.
  3. Disease acceleration occurred 5-6 years after implantation – correlating with the degradation of the shell.
  4. Implant rupture was not the stimulus for disease onset – he believes the chemical breakdown is what causes systemic disease.
  5. The average relief from symptoms after implant removal was 9 months. It is not usually a quick recovery.
  6. There was less clinical improvement after removal in patients with longer duration of implantation.
  7. Systemic improvement after removal was best in patients that had implants less than 12 years. Those with later onset of symptoms had better chance of improvement than those with the combination of early symptoms and a long duration of implantation.
  8. It was really interesting to see that those who had silicone implants removed and replaced with saline, had some of their symptoms improve – but then developed a totally new range of symptoms and seemed to have a worsening of disease progression.
  9. The sicker a patient becomes while keeping the breast implants, the less likelihood of a complete recovery.

What have Dr. Brawer’s articles made me stop and think about? For most of us, recovery is not guaranteed and it is not immediate. PLEASE don’t expect to undergo breast implant removal and wake up to a complete disappearance of your symptoms. I just don’t want you to be disappointed in your decision. Our bodies take time to recover. We have endured a lot. Those of us with long term implants will not recover as fast. The longer you have your implants, the less recovery you may have. For those with implants from 5-7 years, your recovery outlook seems to be good. For those of us that have them over 12 years, the recovery is not near as good. He estimates it to be like 30%. So for women like me who had them 17 years, my expectations need to be realistic. I am extremely hopeful that my recovery gets way above 30% but the truth is, I poisoned myself for a very long time. My textured silicone shell showed major erosion. That crap is somewhere in my body. These implants started leaking toxins from day 1 and they still continue to wreak havoc on my body. I would not change my decision. I am very happy with the outcome. Some of my symptoms completely disappeared right after surgery. Others are continuing to improve. In all honesty, I’m not sure that I could have sat and typed all of this before surgery. I’m not sure that I could have processed it. That means a lot to me.

I hope that this post isn’t discouraging or taken as rude. Things have been hitting me hard this week. Reading other posts really make me stop and think. My heart is broken for all of the women that are suffering. I want to offer my support and a listening ear. I cannot make promises and I do not want to offer false hope for any of you. Really take the time to soak in the information and do what is best for YOU. I believe that removing your implants will definitely be helpful in improving your overall health. I am just asking that you step back and look at the whole picture.

 

 

I have put together the following tips for making life easier both before and after your explant surgery.

 

Things you will need to purchase in advance:

 

  • Triangle pillow for sleeping
  • Sports bras or compression bras
  • Mulu Organics Scar Serum  or organic coconut oil or organic sesame oil for massage (once cleared by your surgeon)
  • Tissues
  • Wet ones/wet wipes/baby wipes
  • Phone credit (if you’re on Pre-paid)
  • Stool softener, as you may be constipated from the pain meds
  • Purchase probiotics
  • Fill prescriptions, eg contraceptive pill, pain meds
  • Buy gauze for dressing changes, vitamins and anything approved or requested by plastic surgeon.
  • Bottled water
  • Sanitary napkins (handy for placing over incisions in your bra to stop the bra rubbing)

 

Organise the following in advance:

 

  • Pre cook meals and shop in advance
  • Arrange someone to look after your children, school run etc
  • Make sure any prescription medications have been filled and are in a convenient location
  • Bedside table/tray to hold all the stuff you’ll need/want through the night including emergency phone numbers
  • Clothes that are easy to get on and off like comfy shorts, soft open front tops, singlets/tank tops that you can step into
  • Consider waxing legs/underarms before Surgery
  • Have eyelashes tinted (so you don’t need to apply mascara
  • Braid hair, or at least have bands to pull it back
  • Make your bed with fresh sheets and pillow cases
  • Do the laundry.
  • Clean the house
  • Do the dishes
  • Position food in pantry and fridge at lower levels to avoid above head reaching
  • Keep a plastic bucket nearby (anaesthesia and medications can make you nauseous)
  • Wash your hair

 

* Things for your bedside table –

  • Chap stick for dry lips
  • Emergency phone numbers
  • Tissues
  • Medications
  • Bottled water
  • Vix vapour rub or similar product for relief from stuffy nose
  • Mouthwash
  • Bucket beside the bed
  • Glasses
  • Hair brush
  • Lemonade or ginger ale
  • Slippers beside the bed
  • Wet wipes/baby wipes

 

Remember all of are different and there are no hard and fast rules in what you will need. The items and hints listed here are suggestions I have made over the years and other women have found them useful or wished they had known these things in advance.

 

Let your body do its job in healing itself, your job is to be loving and  kind to yourself and keep hydrated while the healing takes place ♥

 

Breast Implants cause toxicity in the body in several ways and symptoms can vary depending upon type of implants, etc.  Most women who suffer from breast implant illness suffer from what is known as “biotoxin illness”.  Biotoxins from mold may be in or around the breast implants and at times enter the body systemically.  Biotoxins are known neurotoxins and women with implants may be diagnosed with numerous illnesses including fibromyalgia, chronic fatigue, and MS.  Symptoms of biotoxin illness include:

 

* fatigue

* numbness

* weakness

* muscle twitching

* brain fog

* headaches

* seizures

* cardiac arrhythmias

 

A simple visual test may be used to uncover biotoxin illness and there will need to be some very directed steps taken to recover fully in what I call Phase 1 of the detoxification process from breast implant illness.  Phase 1 is perfectly safe to begin before explantation, as it will help to strengthen the immune system.

 

The next phase begins with hair mineral testing.  Without question almost every woman with breast implant illness is at some stage of hypoadrenia.  The adrenals are under a great deal of stress as the immune system weakens due to biotoxin illness and heavy metals/chemicals in the implants.  Hair mineral testing allows the practitioner to know what stage of hypoadrenia the patient is in and how to treat effectively.  For instance if a patient is in severe stages they should not be treated with herbs, as they can overstimulate weak adrenals and cause further deterioration.

Breast Implant Illness as mentioned earlier causes severe stress to the immune system.  For this reason most women will also have severe mineral imbalances.  These imbalances show up with hair mineral testing and may be treated very inexpensively on a personal basis.

 

I have found that the first three phases must be dealt with effectively before a patient begins any attempt at a heavy metal detox.  Most women with breast implant illness have very weakened immune systems and low adrenal function.  Until these are addressed any heavy metal detox will only cause more stress and weakened state.

 

Heavy metals are also detected through the hair mineral test and plans should be made on an individual basis to safely rid the body of these toxic invaders.  Surprisingly, it has been my experience that not all women with breast implant illness have toxic levels of heavy metals. However almost all will need to address biotoxin illness, adrenal function, and mineral imbalances.

 

In conclusion there are 4 phases of detoxification and healing from breast implant illness.

 

1.)  Treat Biotoxin/Mold Illness  ( Visual Testing )

2.)  Treat Hypoadrenia   ( Hair Mineral Test )

3.)  Address Mineral Imbalances  ( Hair Mineral Test )

4.)  Heavy Metal Detox ( Hair Mineral Test )

 

Guest post by Dawn Strohm from Abundant Life Wellness Centre

Dawn can be contact via email here abundantlifewc7@gmail.com

Or via her website www.abundantlifewellnesscenter.org 

Please watch Dawn’s interview with Doug Kaufmann from “Know the Cause” here on Explant Info  OR here  on Abundant Life Wellness Centre.

You will have until September 4 to upload the documents in www.lozanoblanco.com and participate in the french legal claim. If you have any questions please write to our email pipimplantsclaim@lozanoblanco.com

Call to the 500.000 women who have PIP implants around the world
to take part in the claim against the Notified Body TUV Rheinland

  • 1.514 women have already received a compensation of 3400 euros.
    • All the women who were compensated were represented by the law firm Lozano Blanco & Asociados.
    • The women who have or had PIP implants and did not participate in the last claim have a last chance in July 2014 to fight for their rights in the Court of commerce of Toulon, France.
    • 2.284 women in 24 countries have already taken part in the new claim, 12 of these women are from Australia
    • Friday June 27th is the deadline to register.
    Australia, June 13, 2014- The law firm Lozano Blanco & Asociados in alliance with the firms SCP Lienhard & Petitot and Laurent Gaudon calls upon the 500 thousand women from all over the world who have or had PIP “Poly Implant Prothèse” breast implants to participate in the claim that starts in July in the Court of commerce of Toulon, France.

Five hundred thousand women from 5 continents that were implanted with PIP implants for esthetic or reconstructive purposes and that either have the implants in their bodies or had them removed, have the chance to take part in the new claim against TÜV Rheinland, the notified body responsible for the certification of the implants’ quality.

2.284 WOMEN FROM 28 DIFFERENT COUNTRIES HAVE ALREADY REGISTERED.

To date 2.284 women from America, Europe, Asia and Australia have registered. 2.204 of those women are from Colombia, United States, Spain, and United Kingdom. 14 of these women are from Venezuela, 13 from Canada, 12 from Australia, 5 from Panama, 4 from Germany and 4 from Italy. In Argentina, Mexico, and Ecuador 3 women have registered. In Chile, Holland, Switzerland and France we have 2 women registered. We have one women registered in each of the following countries: Peru, Turkey, Puerto Rico, Dominican Republic, Aruba, Denmark, Austria, Arab Emirates, Israel, Japan and Cambodia.

IN 2010 THE PIP IMPLANTS WERE BANNED FROM THE MARKET BECAUSE THEY DID NOT FULFILL THE MINIMUM STANDARDS OF QUALITY AND SAFETY.

June 7 marks two years since we learned the risk for the 5000.000 women who had PIP breast implants for esthetic or reconstructive purposes.
According to the French national security agency –AFSSAPS- the examinations performed in 2010 to the samples of PIP implants showed that the gel filling was not equivalent to the one described by the manufacturer when they obtained the necessary permits. Although the Gel in the implants is obtained from raw silicon materials it does not fulfill the minimum standards to be used in human bodies.

The main consequence of this technical defect is that PIP implants have a rupture rate of 25-30% while most breast implants have rates of 2-15%. In case of rupture of the PIP implants the substance produces skin irritations.

1.514 WOMEN FROM COLOMBIA AND THE UNITED KINGDOM HAVE ALREADY BEEN COMPENSATED

In November 14 of last year the law firm Lozano Blanco & Asociados, obtained a historical first ruling in the Court of commerce of Toulon, France in favor of the women with PIP implants.

The French high court ruled against the German firm TÜV Rheinland, responsible for the certification of the implants. The Tribunal considered that they were negligent in the fulfillment of their obligation to control the quality of PIP implants. Thus, they were required to pay an initial compensation of 3.400 Euros to each of the 1.514 petitioners.

The women who have PIP implants and did not participate in the 2013 process have a last chance in July 2014 to participate in a new claim against TUV Rheinland. The Court of commerce of Toulon, France gave a new opportunity to the 500.000 woman afflicted by these implants to participate in the claim.

TÜV Rheinland is a German company that certifies many products from medical devises to nuclear plants. This enterprise was founded in 1872 and employs over 17.200 people in 65 different countries. According to the Court of commerce of Toulon TUV failed its obligation to oversee the process of fabrication and the quality of the implants produced by the company Poly Implant Prothesè. This allowed the malfunctioning implants to be distributed around the world.

Lawyer Nathalie Lozano, founding partner of Lozano Blanco & Asociados law firm who has accompanied women affected by PIP implants since the beginning claims that ”it has been very satisfactory to honor the confidence of the 1514 women who trusted us with the payment of the first compensation. Although it seemed nearly impossible, the facts, evidence, and the tenacity and hard work of the team made it possible. With this positive result we are opening a door to all the women in the world to fight for recognition and compensation as victims of this atrocious and inhumane action that changed their life’s forever”.

The law firm Lozano Blanco & Asociados in alliance with the firms SCP Lienhard & Petitot and Laurent Gaudon with headquarters in Paris, Cannes and Strasbourg became the first law firm to accomplish concrete results for such a significant group of women from all over the world and furthermore has opened the possibility for them to claim their rights.

INFORMATION FOR THE REGISTRATION PROCESS IN AUSTRALIA

Those interested can visit http://www.pip-implant-claim.com where they can complete the registration process. For further information please email pipimplantsclaim@lozanoblanco.com September 4th 2014 is the deadline to register

About Lozano Blanco & Asociados:
Lozano Blanco & Asociados is a Colombian law firm with over eight years of experience in the legal practice. Since February 2012 Lozano Blanco & Asociados has been working with women who have or had PIP implants seeking for legal solutions to their problems. Nathalie Lozano Blanco, founding partner of the firm, is a lawyer with a significant trajectory of over 20 years of experience. This law firm has been awarded as the best class actions firm by international publications like Corporate International and Global Law Experts Practice Award.

деспот ублюдок

 

From speaking to implant manufacturers in the UK, we estimate that around 30-40,000 women a year receive breast implants.  A hugely significant number, but one that is difficult to verify as there is currently no registry for patients undergoing breast enlargement.

 

The Keogh report, released in the wake of the PIP implant scandal, recommended the creation of such a registry as a safeguard for future patients, and it’s an idea we wholeheartedly agree with.

 

2014-06-07_1720

 

There is, after all, a registry for other prosthesis – artificial knees and hips, for example. But as these are more ‘medical’ than cosmetic, it seems that breast implants are not considered to fall into the same bracket, and therefore do not warrant their own registry.

 

The rise of explantation

 

While the number of women choosing to undergo breast enlargement is going up year on year, there has also been a steady increase in women seeking to remove their implants. And it’s a pattern that looks to be gaining momentum as time goes on.

 

At Aurora Clinics, we have personally seen a 97% increase in implant removal surgeries in the last 12 months.

 

Here are the main reasons we hear from women seeking to remove their implants:

 

  1. Concern about the integrity of their implants – particularly in the wake of the PIP scandal. At our clinics, we have treated 557 patients seeking removal of their PIP implants since 2012. Of these, 23% (128 patients)decided not to replace them. It seems the PIP scandal has made many women understandably reluctant to have breast implants in their bodies, even if they may not have received PIPs themselves.

 

  1. They feel their body ‘habitus’ has changed over time, and they no longer need implants. Most women develop more breast tissue naturally after the menopause, and with the combination of implants and increased natural tissue, they feel their breasts are now too big for their frame.

 

  1. Some women develop capsules around their implants and seek removal without replacement so the issue does not recur. The severity of capsular contracture is categorised with  ‘Baker Grades’, running from Grade I (soft and looks natural), to Grade IV (hard, painful and looks abnormal). Your surgeon will be able to tell you where you fall on the scale – usually Grades III and IV require surgery.

 

  1. Younger women may be thinking about starting a family and are concerned about breastfeeding with implants.

 

  1. And many more mature women have told us frankly that they don’t want to die with their implants. They may have received their implants as long ago as the 1960s or 1970s and feel they are no longer appropriate for a woman of their age.

 

Is explantation right for you?

 

The average age of women seeking implant removal at our clinics is 42.3 years old – which seems an unlikely age, but makes sense in the context of many of the women being post-menopausal (50-plus) and many of them considering imminent motherhood (mostly in their 20s and 30s).

 

One of the main worries our patients express when they are thinking about the procedure is whether they will be left with loose and sagging skin due to the loss of volume. And this may be something in the back of your mind.

 

But the fact is that the skin retracts very well. For a week or so after surgery, the area can look a little ‘empty’, but eventually it recovers well – our patients are generally very pleasantly surprised.

2014-06-07_1722

If you are concerned about being left with droopiness to your breasts, remodelling of the tissue (in the form of an uplift) can happen at the time of explant if necessary – but in most cases this is not needed. Less than 50% of the patients we see who think they will need a breast uplift actually require one.

 

And finally – 5 things to consider

 

If you’re thinking about going ahead with explantation, here are our 5 most important factors to consider:

 

  1. Do you need an en bloc removal, including the implant and capsule? Or should you remove the implant and leave the capsule to preserve as much tissue as possible? If the capsule is thin and pliable, there is usually nothing wrong with leaving it. If it is thickened and hard, it is best to remove it.

 

  1. Which incision to use? Usually surgeons like to use the same one the implants were inserted through. However, it’s important to note that if it was via the armpit, a capsulectomy cannot be performed through this incision.

 

  1. Should you have an uplift at the same time? Do you really need one, or is your skin likely to recover? Your surgeon will be able to advise.

 

  1. Is it safe to leave your implants in? Generally 15 years is the time to consider removal to guard against bursting or rupture, if this is the reason you are thinking about explantation surgery.

 

  1. Is your surgeon experienced in explanting? Do your research and find someone who performs the procedure on at least 50 patients a year – and is a member of at least one of the highest professional bodies in the UK – for example, BAPRAS, BAAPS etc.

 

 

If you would like any more information about explantation, or would like to arrange a free consultation to speak to one of our surgeons at Aurora Clinics, please don’t hesitate to give us a call on 01324 578290 or email info@aurora-clinics.co.uk

 

2014-06-07_1726

 

 

Women get breast implants for so many different reasons. Those reasons can be to enhance what we see as flaws in our body, to please our partner, for work reasons, the list can go on and on. The truth is breast implant surgery is one of the mostly commonly performed procedures in the world.

 

A good understanding surgeon is paramount in the healing process, both physically and emotionally. Your surgeon will be one of your major sources of support during this time so be sure you have chosen a surgeon who you have a connection with.

 

How you look after your surgeon removes your breast implants is hard to pinpoint exactly. Every person’s surgery results are different; these differences can be due to varying factors, eg the way the implants were inserted or differences in breast tissue. In my vast experience I can reassure you that your results will improve with time, many ladies see a huge improvement in the look of their breasts in as little as a few weeks.

 

Firstly your breast tissue may be displaced from the implants being in your body and you may even see a caved in area on your chest. This is caused by the implants continual pressure on the chest wall.  Everyone is different and we all heal at different rates. You need to be kind to yourself and realise that it will take time, and by time I mean the healing process can takes months.

 

Weeks will pass quickly and the changes will astound you, you will amaze in your bodies residence and ability to recover from the things we put it through. Gallery found here

 

I explanted in October of 2010, my results were less than pleasing for the first few weeks but as time passed and my body healed from the trauma, my breasts sprang back into shape nicely. I am not going to lie to you here; my breasts looked horrible on the day of my explant surgery. I was horrified, but not once did I give up the hope that I would look ‘normal’ again.

 

Define normal….there is no ‘normal’.  Each and every woman is unique and beautiful, but so many of us just don’t see our own beauty. There are so many external influences bombarding us with how we are ‘supposed to look’.

Who gave the media the right to dictate to any of us how we should look?

If you would like to talk to деспот please click here

 

 

 

In 2012, the French based company PIP (Poly Implant Prothèse) had their implants banned because it was discovered that they were utilizing a non-medical grade silicone as the filler for their gel implants. In addition, the recent reported death of a French woman from the rare form of cancer ALCL, who had PIP breast implants has led to a tremendous amount of media concern about a company recognized by few American women. Inspections in France as early as 2001 had revealed numerous non-conformities surrounding the manufacture of PIP implants. In 2009, it was reported that there were high rupture rates with their implants in France, leading to allegations of implant shell problems. In 2010 distribution was suspended and the company filed for bankruptcy.

PIP appears to have used two types of silicone gel within their breast implants; the “Medical Grade” silicone manufactured by Nusil, (made in US and France), and a less expensive formula that they claimed was chemically identical. When implant manufacturers describe their silicone gel, they often uses terms such as “Industrial Grade”, “Medical Grade”, “Health Care Grade” and even “Implant Grade.” These terms can differ around the world. There are multiple tests for silicones including mechanical, chemical, animal, biochemical, cell culture tests and clinical evaluations that are required to determine what silicone formulations are safe for long term human implantation.1 Summing it up, “Medical Grade” silicones are those that have passed extensive, strict biological testing, and in the United States the manufacturers must formally submit their data to the FDA for approval.

The fallout from this discovery has left women worldwide confused and worried. It appears that various European and South American Health Ministry’s are offering different options to women who have these devices. While France is offering to pay for the removal and replacement of PIP implants used in breast reconstruction, Venezuela will pay for explantation only. Other European nations, such as the Netherlands, Ireland, Austria, and Denmark, to name a few, are suggesting only close follow-up of women who have these devices. Each health ministry, as well as the FDA, has repeated their conclusion on breast implants that although there may be a very low but increased risk of developing ALCL adjacent to breast implants, with less than 70 cases reported in the world literature to date, these represent a very small fraction of the 5-10 million women who have received breast implants worldwide. In addition, PIP implants have not played a significant role in the US market since the company’s 2000 request to market saline implants in the US was denied. The silicone implants that are presently used in the United States are manufactured by Allergan, Mentor and Silimed/Sientra, and must all meet the strict requirements of our FDA.

Finally, as with all silicone gel breast implants, there is no exact expiration date. No implant will last a life-time, and all silicone implants, regardless of their manufacturer, should be followed and imaged as they age.

1 Allistar Winn, Manufacturing and FDA Compliance Support, date accessed 12-29-11, date modified October 10, 2011.

Source Caroline Glicksman M.D.

 

MARSEILLE, France (Reuters) – In March 2010, a pair of health inspectors acting on a tip paid a three-day visit to a factory in this hilly town on the Mediterranean coast.

The factory was the headquarters of Poly Implant Prothese (PIP), a leading international maker of breast implants founded by French entrepreneur Jean-Claude Mas. The inspectors found something odd: six discarded plastic containers of Silopren, a liquid silicone designed for industrial, not medical use, lined up along the outside wall of the production site.

A week later, gendarmes descended on the plant. Mas skipped out just ahead of them, eluding interrogation for nearly eight months, but his game was up. In the nearly two years since, the cheap silicone used in PIP’s fake breasts has continued to leach into women’s bodies. In France, 1,262 of the roughly 300,000 breast implants the company sold worldwide have split open in the past two years. PIP has been closed down, Mas has been arrested and put under investigation for alleged bodily harm, and French and European safety regulators have been thrust into an uncomfortable spotlight.

Mas, 72, a grocer’s son from the south of France, had no scientific training. Yet for the first decade of this century he was able to manufacture and sell faulty breast implants on international markets that he and some of his employees knew to be substandard, according to testimony given to French police and seen by Reuters.

The history of breast implants is littered with flawed devices, a colourful cast of intertwined players and billion-dollar lawsuits. Reuters reviewed hundreds of pages of police investigation transcripts and financial documents, and interviewed former PIP employees, the company’s suppliers, customers and health experts, to piece together this latest chapter in that history.

It is a tale of a haphazardly run and cash-strapped company that allegedly took desperate and sometimes deceptive steps to shave costs and hide the true ingredients of its devices. PIP’s efforts were made easier by a European regulatory regime that had been essentially outsourced to the very companies that are meant to be regulated.

Among the new details to emerge: PIP was able to save an estimated 1.2 million euros (1.0 million pounds) in one year by using the industrial-grade silicone in its implants, according to figures cited by police investigators. And it relied on crude, unscientific tests of product quality, such as judging silicone gel by sticking a finger in it, according to one former worker. Some 75 percent of its implants used the non-approved, cheaper gel, Mas told police.

“Maybe it’s shameful, but there you go,” Yves Haddad, a lawyer who represents both Mas and his now-defunct company, told Reuters at the end of December. “We live in a capitalist world.”

Mas, who declined to comment for this story, has said his products are harmless. After the health ministry advised Frenchwomen to have the devices removed, he told French radio network RTL last month that the decision was “criminal” and the health minister “needs to be committed.”

A CAREER IN SALES

Jean-Claude Florent Mas, born in Tarbes, near the Spanish border, was a salesman by temperament. He sold everything from life insurance to wine and dental equipment. He entered health care in the mid-1960s, working for various labs, including one that was bought by Bristol-Myers in the 1970s, where he stayed until 1980 as a salesman in the south of France. Mas’ attorney, Haddad, says his client was one of the firm’s top salesmen, although Bristol-Myers could not confirm that or say why he left.

It was after Bristol-Myers that Mas got involved in breast implants. He began working with a French plastic surgeon, Henri Arion, who had made France’s first breast implant in 1965, and was now selling saline implants under the name Simaplast.

It wasn’t a great start. Simaplast’s implants eventually were found to be prone to rupture, according to a 1999 study by U.S. non-profit Institute of Medicine. Simaplast morphed into a company named MAP – the precursor to PIP – where Mas said he performed every job from production to sweeping the floors. The small group of employees included a woman, Dominique Lucciardi, who would become Mas’ companion and mother of his two children. They would take turns filling the prostheses, he told police.

In 1991, aged 52, Mas launched PIP, a limited liability company and chose as its headquarters the site of the old Simaplast factory. In preparation, he had applied for a patent to sell implants containing silicone covered in polyurethane foam, he told police.

As he launched PIP, a breast implant scandal involving Dow Corning was sweeping across the United States. The American firm was found to have knowingly concealed safety concerns about its implants, and in 1992, the U.S. Food and Drug Administration called for a moratorium on the devices. Four years into PIP’s life, in 1995, France also banned silicone in breast implants, a ban that ended in 2001.

Mas found that by innovating, he could still bring products to market. He switched to implants filled with saline solution and launched a pre-filled version; other brands needed to be filled while the patient was on the operating table. PIP’s new product saved time, and surgeons liked it. PIP moved into the huge U.S. market in 1996, and soon the United States made up 40 percent of its revenue, according to company records.

AN ASYMMETRIC APPROACH

Opportunities for PIP grew on its home turf in 2001, when France lifted its ban on silicone implants, and the United States slowly began to approve more versions containing silicone gel, for which Mas already had a formula. “When I started PIP I brought this formula that I had kept,” he told police. “Why change it?”

Regulators had never examined nor approved that filler, but Mas insisted to his staff that it was perfectly safe, his ex-employees told Reuters.

Building on his innovations in saline implants, in 2002 Mas brought a new twist to silicone by launching an asymmetrical product that became popular with surgeons and patients, because it gave a more natural look than the “classic” style of implant, which resembled a perfectly round orb.

PIP’s approach to filling these implants was novel. On paper, the company said it used NuSil, a silicone blend made by a California company of the same name, which can be used in medical applications, including implantable devices. NuSil was founded by PIP’s former U.S. distributor, Donald McGhan, who is now in prison in Texas for an unrelated fraud conviction. The company has declined any comment on the PIP affair.

But in reality, PIP was mostly using Mas’ own non-approved PIP gel, which looked and felt exactly like NuSil, but cost a seventh of the price.

A litre of NuSil cost about 35 euros, versus 5 euros for PIP’s version, Thierry Brinon, PIP’s former technology head in charge of research and development, told police. Each implant on average used 330 cubic centimetres of gel. That meant it cost 11.55 euros to fill an implant with NuSil and a mere 1.65 euros to use PIP’s gel, a difference of 9.90 euros on each implant produced.

Claude Couty, the former chief financial officer of PIP, told police it cost an average total of 38 to 42 euros to manufacture an implant filled with PIP gel, versus 52 for an implant filled with NuSil. Investigators in the legal case file estimated that in one year alone, 2009, using PIP gel instead of NuSil saved the company nearly 1.2 million euros.

PIP sold implants to French surgeons for about 300 euros a piece. Abroad, the asking price was about 100 euros, according to former PIP staff and surgeons.

“This formula is perfect,” Mas told police. “It’s better than the formula for making NuSil.”

DECEIVING INSPECTORS

But because NuSil was a known quantity and his gel recipe was not, Mas concealed the implants’ ingredients from the regulator. Flaws in Europe’s regulatory system gave him a helping hand.

France has a government regulator, the Agence Francaise de Securite Sanitaire des Produits de Sante, or AFSSAPS, which has the power to remove products from the market but does not certify them. But the agency that certified PIP’s implants was actually a private company, based in Germany. TUV Rheinland first approved PIP’s saline implants in 1997. Its officials paid annual visits to the factory in La-Seyne-sur-Mer and announced them 10 days in advance, in accordance with European guidelines.

That gave PIP plenty of time to hide the truth. Ahead of TUV visits, workers would clear away evidence of the cheaper silicones PIP was using and put together a doctored version of documents that included no references to the use of unapproved silicone, Mas and ex-managers told police. All internal communications related to TUV’s visits were oral, said one former worker.

“Since 1997, we automatically hid the products that allowed us to make the PIP gel,” Mas told police, according to notes in the case file, “because I knew they weren’t regulation.” In his second police interview, Mas said he had given “the order to hide the truth from TUV” since 1993.

TUV sued PIP in February 2011, saying PIP had tarnished its reputation by using TUV’s name to market sub-standard products and that it had been systematically misled.

A HELPFUL LOOPHOLE

There were other gaps in the regulations that helped PIP keep its products on the market for so long. The system does not require on-site, unannounced checks of the implants’ contents. Nor does it require that the chemical composition of the implants, once approved, be re-tested.

A TUV spokesman said it would only have made an unannounced visit for checks if there were very serious indications that something was amiss. There have been no cases of unannounced checks in Germany in the past 40 years, he added.

Moreover, TUV’s yearly audits are essentially audits of overall processes; they do not perform on-site lab tests. The German company believes PIP deliberately deceived it.

AFSSAPS said it tested the insides of PIP’s implants in 2001 to make sure they were what PIP said they were when silicone breast implants were allowed back onto the French market.

After 2001, however, that job went to two independent French laboratories: LEMI, Laboratoire d’Evaluation des Materiels Implantables and LNE, Laboratoire National de Metrologie et d’Essais. Mas told police the laboratories performed tests in 2002 and 2008.

AFSSAPS’ deputy director general, Francois Hebert, told Reuters these tests were likely ordered by PIP following requests from surgeons, who may have sent back defective implants and asked for further evaluation.

LNE said its tests were mechanical – how likely PIP’s implants were to resist pressure, for instance – but declined to provide further information. LEMI said its tests related to toxicity, but also declined to provide further information.

The first random test by AFSSAPS would not come until mid-2010 by which time PIP was under investigation by police. That was when AFSSAPS issued a report which said, “this one does not reach the degree of quality of a silicone gel intended for breast implants.”

This week, France’s health department and AFSSAPS submitted a report to the country’s health minister acknowledging gaps in the French and European regulatory system. The report cited the lack of unannounced visits and on-site testing of implants but said that PIP’s alleged fraud was so sophisticated that “it’s not evident that an inspection, even an unannounced one, could have been effective.”

NO QUESTIONS ASKED?

The raw silicone materials for the PIP-formula gel included different products: Silopren – which was kept in the containers that had been spotted by inspectors – and Baysilone. PIP bought these silicone oils from a German distributor, Brenntag. It turned to a French distributor, Gaches Chimie, for a third oil, Rhodorsil 47V1000.

Brenntag confirmed it sold silicone oils to PIP from 2001 to 2010, but said it stopped when it was made aware PIP was under investigation. A Brenntag spokesman, Hubertus Spethmann, said that as far as Brenntag knew, PIP was a diversified supplier whose products included wound dressing pads and other padding products that could be filled with silicones such as the oils it produced. Brenntag would not comment on the orders PIP made or any payment problems with the French company.

Reuters could not independently confirm that these items were sold by PIP.

Representatives from Brenntag periodically asked to visit PIP’s headquarters, according to one ex-PIP employee, a request that caused much worry within PIP. Brenntag would not comment on the visits.

On at least two occasions, Brenntag sales representatives paid a visit, but were welcomed by Mas in his office and did not visit the production labs, the former worker said this month.

“Mas would tell them we used the silicone oil for creams, certainly not breast implants,” said the ex-worker. “We were very uncomfortable and let Mas do all the talking.”

Gaches Chimie also confirmed it occasionally sold its silicone oil to PIP from the early 2000s until 2009, when the orders stopped. CEO Pierre Gaches said he did not believe his company was PIP’s main supplier and never had concerns about the ultimate use of the oil, because it is used in many industrial applications.

NEW BMWS

Even as PIP used unapproved materials for its silicone implants, its innovative saline products were running into problems in the United States. Lawsuits from hundreds of patients alleged they deflated, sometimes within months of surgery. The FDA was never to approve PIP’s silicone products, instead posting a warning about the firm’s practices on its website.

Mas made a reverse takeover to try to open PIP to U.S. capital and prepare the way for a re-launch.

In 2003, his Luxembourg holding company Milo Finance bought a majority stake in U.S.-listed Heritage Worldwide, and handed to Heritage the control of PIP. In its first annual filing with the U.S. Securities and Exchange Commission after the merger, Heritage disclosed that for the financial year ended June 23, 2003, PIP had a loss of $693,336. That loss grew to $5.6 million in 2004.

PIP also turned to markets where regulation was not as stringent. It found distributors to open sales in 10 new countries “in which no regulatory problems were anticipated,” Heritage said in its 2003 annual report. Exports were less profitable – foreign sales fetched about a third of the French price – but there was volume in South America, which soon became PIP’s top market with two-thirds of sales, driven by Venezuela and Colombia.

In 2005 and 2006, PIP showed a profit. One former employee said these were the “glory days” for the company, which employed about 120 workers. Operating margins reached 20 percent, the sort of level an early cellphone maker could expect. “We’d see a smile on the face of Mr. Couty,” said a former manager. One of those years, the company bought new BMWs for Couty and Mas, Couty told police. He did not respond to requests for an interview.

Mas, now at France’s retirement age of 65, took on a chairman’s “supervisory and advice-giving” role in 2004, for which he received 360,000 euros per year, a five-fold rise over his 2003 salary.

Finance chief Couty became CEO, but PIP’s liquidator, Xavier Huertas, wrote in a March 2010 report that Mas continued to control production, R&D and sales, and “in fact, to lead the company at the side of Mr. Couty.”

However, crisis was around the corner. Litigation and the financial shocks of 2008 were to send Mas back into PIP’s labs, to try to improve on his “perfect” gel formula.

FRICTION MOUNTS

Mas was never trained as a scientist. He was a tinkerer, an experimenter who relied on his gut. But even he was to realise that PIP gel had a problem: it leaked too much silicone oil.

Of seven former PIP staff interviewed by Reuters, only two said they had no idea that the company was using a homemade gel. Three others suggested they kept quiet because they were worried about their jobs.

After 2005, PIP staff became more vocal. That year, the heads of production, quality control and research and development together asked Mas to fill all PIP’s implants with NuSil, Hannelore Font, the company’s quality control director, told police. Mas replied this would be “economically impossible”. Font did not return calls requesting an interview.

For 2008, PIP set aside 1.4 million euros to cover potential lawsuits, according to liquidation documents. It had underestimated. A British court ordered the company to pay 1.6 million euros to plaintiffs who alleged the envelopes covering PIP’s implants were not strong enough and leaked gel. U.S. litigation cost another 160,000 euros.

“All this litigation weakened the health of the company,” said Haddad, the attorney for PIP and Mas.

Complaints rose, and PIP’s customers paid more slowly. The liquidator noted that PIP’s export clients on average took nearly nine months to settle.

Suppliers balked, too. NuSil held up a shipment destined for PIP due to non-payment, PIP’s purchasing manager, Nadine Carrodano, told police. Couty wrote to Mas describing what he called his “fears for the future.”

By June 30, 2009, PIP’s debts reached 8.5 million euros. “In every area the company was crumbling,” Carrodano told police. She declined to comment.

“FINGER IN THE GEL”

In 2008, PIP invested 300,000 euros on a new machine to make the implants’ shells, hoping more uniformity would cut leakage, according to Couty.

Brinon, PIP’s technical director, said Mas came to him in early 2008 and told him to start developing a new gel, PIP 2. Brinon refused, and the task went instead to another worker who had never worked on implants before coming to PIP. The goal, he said, was to create a gel that would not leak so much oil. This was crucial: silicone gel that seeps out may cause irritation and inflammation in women’s bodies.

That worker told Reuters that Mas relied on trial and error, adding a bit of this and a bit of that in the lab: “He didn’t do scientific tests,” the former worker said. “He’d look and say, ‘that’s good, that’s bad.'”

To judge whether more or less oil was seeping out of the gel, the worker said, “you would look and then put your finger in the gel and you’d see if there was oil or not on your finger.”

Finally, midway through 2008, PIP 2 was ready.

Brinon was sceptical. His own mother, who had once had cancer, had a PIP implant and he was worried, he told police. He began doing his own tests on PIP gel and NuSil. He told police that PIP 1 gel excreted more oil than PIP 2, and much more than NuSil, which leaked oil in “infinitessimal amounts.”

A FINAL THUMBS-UP

Mas threw himself into export sales. His passport, a copy of which is included in police documents, shows visits to Panama, Venezuela, Colombia, Brazil, Uruguay, Ecuador, China, Singapore and the Philippines in 2008 and 2009.

Back at home, staff morale was low.

On May 4, 2009, a commerce court in the city of Toulon ordered PIP into the French equivalent of Chapter 11 proceedings.

About a dozen employees were laid off, month-to-month workers’ contracts were cut and evening shifts scaled back, according to liquidation documents.

Font, the quality-control staffer, told police she delivered an ultimatum to Mas at a meeting with other managers, saying she would no longer sign off on implants ready to be shipped. Instead, Couty took that on.

TUV performed an audit in early 2010. Purchasing manager Carrodano told police she was “close to tears” after TUV gave PIP the thumbs-up. Font got a doctor to sign a medical release to keep her away from work. Unpaid suppliers stopped sending raw materials; production ground to a halt.

“FRAGILE PEOPLE”

On March 16, 2010, AFSSAPS officials came calling, a visit that had been arranged five days in advance. AFSSAPS had recently received letters from a Marseille surgeon signalling his concerns with PIP rupture rates. The regulator also received in the mail photos sent anonymously of empty containers of non-approved raw materials at PIP’s plant.

On the first day of their visit, inspectors noticed nothing abnormal. The following morning, without telling PIP, they visited PIP’s production facility. It was then they spotted the empty containers labelled “Silop,” for Silopren. The lead inspector estimated they had contained nearly 9 tonnes of the liquid silicone.

Days later, when police visited the site, Mas slipped out quickly. When French police finally managed to question him in November, they asked why he had left in such a hurry. According to a police transcript of the interview, he said he was no longer in charge of the company – he had handed the reins to his finance director years back. “I thought it wasn’t me you were coming to see…”

Within two weeks of the regulators’ visit, PIP was shut down and AFSSAPS pulled its implants from the market. Some 29,000 products were seized. Laid-off staff burned tyres and hurled discarded implants into the car park.

Mas went abroad again. Costa Rica, Nicaragua, Columbia, Spain and Venezuela are among visits his passport records in 2010. In Costa Rica, he was pulled over and charged with drunk driving.

On September 27, 2010, Mas transferred his ownership of a real estate holding company to his partner Lucciardi and their son, according to Luxembourg filing documents. That company holds the title to a four-bedroom villa with a pool not far from PIP’s headquarters.

It was here police arrested Mas in January. The home, according to estate agents, is currently listed for sale at about 1.6 million euros.

In their questioning of Mas in October 2011, he told police that over the years, 75 percent of PIP’s implants were filled with his homemade formula. The French regulator says there are so far 1,262 cases of the devices rupturing in France. Health experts say no concrete link has been shown between PIP implants and breast cancer, but the French government has advised women to have their PIP implants removed.

Mas, who is out on bail, was asked by police what he thought of the women who issued complaints about the failed devices. “It’s about fragile people, or people who are doing it for the money,” he said, according to the interview transcript.

 

 

(Alexandria Sage reported from Paris, Natalie Huet from La-Seyne-sur-Mer and Jean-Francois Rosnoblet from Marseille; additional reporting by Marc Joanny in La-Seyne-sur-Mer, Elena Berton in Paris, and Ludwig Burger and Maria Sheahan in Frankfurt; writing by Alexandria Sage; Editing by Sara Ledwith and Simon Robinson)

(Created by Simon Robinson)

THE Frenchman who sparked a global health scare by selling substandard breast implants, now faces the prospect of manslaughter charges after being arrested yesterday.

Jean-Claude Mas was taken into custody with a second executive of his now defunct Poly Implant Prothese (PIP) after police arrived at their homes in southern France just after dawn.

Mas could now face formal investigation on suspicion of manslaughter and causing bodily harm. That could lead to criminal charges, which would carry longer sentences than those he now faces in a fraud trial expected around October.

Women who have been campaigning against PIP since French authorities banned its products nearly two years ago welcomed his arrest.

“It’s been too long,” said Murielle Ajellio, who heads an association for women with implants. Up to now, she said: “You feel like you’re fighting against the wind.”

French authorities have been criticised for being slow to react to a case that has spreadfear among tens of thousands of women with PIP implants. Inspectors ordered them off the market in March 2010, due to concerns over their quality. But it took until last month for the French to recommend their surgical removal, causing a global scare as PIP was once the world’s third largest supplier of breast implants.

Lawyers for women in France who have filed complaints over PIP implants said there must be no escaping justice for the 72-year-old Mas, who has been quoted as deriding those suing him as money grubbers.

“This is a comfort for the victims,” said Laurent Gaudon, whose clients are pursuing PIP and surgeons who used its implants for fraud. “It’s the feeling justice is advancing and they have not been forgotten. It’s the assurance the guilty are at last going to be held accountable.”

Philippe Courtois, who represents 1,300 people with PIP implants, said Mas should not be freed pending trial.

Mas and PIP’s former chief executive Claude Couty were questioned at home, as police conducted searches. They were then moved to police custody in the Mediterranean port city of Marseille, under the orders of prosecutor Jacques Dallest.

PIP enjoyed years of success with international sales but, behind the scenes, employees, and Mas himself, have admitted to hiding from certification agencies the fact they were using cheap, industrial silicone, not approved for medical use.

Health authorities in France and elsewhere have stressed PIP’s products carry no proven link to cancer, but surgeons report abnormally high rupture rates.

Yesterday’s arrests follow an investigation opened in Marseille, close to PIP’s former premises, on 8 December after the death from cancer in 2010 of a woman with PIP implants.

A trial date could be years away, given the extent of inquiry, but the graver manslaughter case could make it harder for Mas to avoid appearing in court later this year on other charges of fraud and deception.

That latter case targets half a dozen former PIP executives and could also carry prison terms of several years. It has dragged on as investigators have had to quiz up to 2,700 women who have filed complaints over PIP implants.

Mas, who sold some 300,000 implants around the world, has acknowledged that he used unapproved silicone but has dismissed fears that it constituted a health risk.

Earlier this month, leaks from a French police document showed Mas admitting to lying about the quality of PIP’s implants and describing the women filing complaints against him as just merely seeking money. The comments sparked a public outcry.

With thanks to http://www.scotsman.com/news/health/pip_implant_boss_arrested_over_cancer_death_1_2080301

The French tycoon who supplied potentially deadly breast implants to hundreds of thousands of women has been appointed an “expert consultant” for a new implant company set up by his children.

Jean-Claude Mas is in hiding after the scare over faulty silicone gel from his implant manufacturer Poly Implant Prosthese (PIP) erupted earlier this month.

The firm went bankrupt last year and Mr Mas, 72, is now wanted in two separate police investigations into allegations of manslaughter and fraud.

Mr Mas has admitted through his lawyer that his company sold implants made from industrial-grade silicone that had not been approved by health authorities. He denies the prostheses are dangerous.

It has now emerged that since PIP went to the wall in April 2010, Mr Mas’s son and daughter, Nicolas and Peggy Lucciardi, had set up their own similar company – with their father named as consultant and expert creator. France Implant Technologie was officially launched on 15 June this year.

Its business plan said it was to be run from the same PIP factory owned by their father on an industrial estate near Toulon, in southern France.

But Nicolas Lucciardi said the business idea had now been “put on hold” since the scandal over PIP implants exploded.

He said: “I doubt now that it will see the light of day.”

Fears over Mr Mas’s PIP implants first came to light 18 months ago when surgeons noticed they were rupturing much more quickly than other brands.

The French health watchdog found “serious irregularities” and they were pulled off the market.

The scare has affected 40,000 British women and 300,000 more worldwide. France has recommended that 30,000 women have PIP implants removed.

The UK government has said there is no evidence of a link to cancer or rupture.