PIP implants were sold in Australia between 2004 and 2010. The following summary may be of assistance in putting the concerns about PIP rupture rates into context.
- Rupture is either intra capsular with the gel confined to within the fibrous capsule around the implant or extra capsular where the gel has extended into the breast or other localised tissues.
- Both are usually asymptomatic but localised inflammation causing lumps and/or discomfort may occur typically with extra capsular rupture.
- Neither is associated with an increase in the risk, or exacerbation of, any disease including cancer.
- Clinical examination by an experienced plastic surgeon is only 30% accurate in diagnosing rupture. MRI scanning is 89% accurate.
- 75% of ruptures detected by MRI scan are intra capsular and 25% are extra capsular.
- Over a two year period 10% of the intra capsular ruptures will progress to being extra capsular.
- If extra capsular rupture is present, over two years the amount of extra capsular gel leakage increases by 14%
The 10 year, prospective, FDA supervised “Core” studies conducted by Allergan and Mentor as part of the pre and post marketing approval process for silicone gel implants in the USA are accepted by the profession as being the best data available on the fate of breast implants . In primary breast augmentation patients these have shown cumulative rupture rate of 10.6% at 10 years for Allergan and 13.4% at 8 years for Mentor, both with 95% confidence intervals. A MRI study of 101 asymptomatic patients in the UK by Collis and Sharp of Mentor implants with an average age of 9 years showed a 10% rupture rate.
It is also important, when considering what advice to give to patients regarding possible explantation or replacement, to realise that once a patient has a revision procedure for any reason, the risk of needing a further revision is increased. Thus revision surgery is best avoided unless and until it is clearly indicated.
- At least 10% of non PIP silicone gel breast implants will rupture by 10 years .
- The progression of intra capsular rupture to the potentially symptomatic extra capsular rupture is slow.
- The progression of extra capsular rupture is also slow.
- MRI is the best method for assessing and monitoring rupture.
- Revision surgery itself increases the risk of needing a further revision.
- PIP implants may be more prone to rupture than other brands, but the figures being quoted overseas are consistent with the known rupture rates of non PIP implants.
Unless there is clear evidence that the PIP gel is toxic and more likely to cause harm to patients if it leaks (and, following tests by the TGA and UK authorities, so far there is none) the College believes there is no indication to advise removal of intact PIP implants. To do so would expose patients to avoidable harm. Patients should be advised of a possible increase rupture rate and also to discuss with their surgeon having an MRI scan to exclude rupture.
Dr Daniel Fleming
Cosmetic Surgery Institute of Australia
P: 1800 682 220 or +61 7 3252 8929
M: 0400 701 070 F: 07 3252 8979