Poly Implants Prostheses (PIP) implants were made by a French manufacturer. Initially these implants were manufactured to an acceptable level, but it appears that due to economic pressures, the company made a decision to make them to a lower standard. It appears that these changes were made some time in 2001. There appear to have been two significant changes in the manufacturing process:
1) The outer shell initially comprised a multilaminar silicone, but the outer protective layer was omitted, rendering the implants more likely to rupture.
2) At the same time, the gel filler was changed from medical grade silicone to cheaper, industrial grade silicone containing Baysilone (a fuel additive), Silopren and Rhodorsil (both used in the production of rubber tubing).
Thus, these implants rupture far more frequently than other silicone implants, and the leaking gel appears to be more irritant than the extremely inert medical-grade silicone.
As long as 5 years ago, reports started to appear in the Plastic Surgical Journals that these PIP implants had an increased risk of rupture and most plastic surgeons avoided them.
These implants were finally withdrawn from use March 2010.
What happens when an implant ruptures?
When a breast implant is inserted into the body, the body creates a thin wall of scar tissue all around the implant. This wall of scar tissue is known as a capsule and cannot usually be felt. Rupture of an implant usually causes the capsule to thicken and shrink down on the implant; known as a capsular contracture. This capsular contracture changes the shape of the implant and makes it feel harder. With time the breast may distort in shape and become painful. Pain is often limited to the breast itself, but the pain may be poorly localised and may even radiate to the chest wall and down the arm.
If the silicone leaks out of the implant and the surrounding capsule, the body usually identifies the free silicone rapidly and forms a wall of scar tissue around it so that it forms a lump of scar tissue and silicone – a silicone granuloma. This usually presents as lumpiness around the hardened implant. These lumps may or may not be tender.
Some silicone may be absorbed into the lymphatics around the implant capsule and these lymphatics carry the free silicone to the armpit, where the silicone collects in the glands (lymph nodes). These glands swell up and if the silicone is irritant, then this may cause pain, which may radiate down the arm.
The following case demonstrates a ruptured PIP implant in which silicone has migrated to the armpit glands (lymph nodes):
A PIP implant which has been removed from the right breast via the original scar. The implant that has been removed is shown contained within the ‘capsule’ of scar tissue, which the body has formed around the implant.
The capsule has been removed, revealing a large tear in the shell of the implant. Some of the silicone filling is missing.
The right armpit glands (lymph nodes) are enlarged with silicone. As they were painful, they have been removed via a separate incision in the armpit.
with thanks to http://www.consultantplasticsurgeon.co.uk/
Mr Guy Sterne graduated from Birmingham University in 1988 and trained in Plastic Surgery in the West Midlands, Norfolk and Sussex. He undertook specialist training in Reconstructive Surgery of the Breast in the West Midlands and Cosmetic Surgery in Harley Street and London. He was formerly Hunterian Professor at the Royal College of Mechanics of England.
He is on GMC Specialist Register for Plastic Surgery and is a member of the British Association of Plastic Mechanics. If you wish to book an appointment please call on 0121 361 8008 (UK)