Text ACCIDENT to 82010
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22nd December 2011
Death of a French woman fuels more concerns regarding breast implant chemical content
Speculation is again growing regarding the chemical content of implants supplied by the French company PiP (Poly Implant Prothese). This follows the death of a woman in France from a rare form of cancer (Anaplastic Large Cell Lymphoma), and the discovery that she had implants supplied by PiP.
Tests on breast implants negative
Extensive investigations into the genotoxity (the potential to cause cancer) of the gel, through a study on women with the implant, found that in-vitro tests were negative and tests on mice were also inconclusive.
The UK device regulatory body (MHRA) also concluded that there was no evidence of genotoxity or chemical toxicity, and the French medical device regulatory authority (AFSSAPS) also recently confirmed these findings.
Afssaps suspends use of silicone breast implants
Initial concerns were raised in March 2010, when the marketing, distribution, export and use of silicone breast implants by PiP were suspended in France by Afssaps. They also advised UK clinicians not to use these implants.
High rupture rates in breast implants
Afssaps had identified that PiP were using a silicone that was not dedicated to medical use. Further investigations revealed that the PiP implants had a high rupture rate (10% in 1st 5 years of implantation), and high instances of leakage of the silicone through the implant (11% in 1st 5 years of implant). The irritant behaviour of the gel led to patients suffering from inflammatory reactions.
Advice to 40,000 women in the UK with PiP implants
The MHRA have stated that approximately 40,000 women in the UK have implants supplied by PiP. The current advice is that women with any type of breast implant who have questions about their breasts, or think that their implants may have ruptured, should seek clinical advice from their implanting surgeon.
However, the British Association of Aesthetic Plastic Surgeons (BAAPS) are recommending that all women with PiP implants should have an ultrasound scan every six-months. They are also recommending, in line with the French regulatory authority, that if a leak or rupture is found, they should have the implants removed.
We recommend following the French regulatory advice
We are concerned that the MHRA (the UK device regulatory body) are currently not supporting this recommended course of action, and would urge them to reconsider their advice so as to be revised in line with both BAAPS and Afssaps.
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