ASPS, French society monitor developments on PIP silicone gel breast implants controversy
ASPS has been monitoring the developing situation in France regarding suspected, defective silicone breast implants manufactured by Poly Implant Prothèse (PIP), which was required to halt production of the implants in 2010 after the company was found to be using non-approved silicone gel that is believed to pose an increased risk of rupture.
Thanks to colleagues at the Société Française de Chirurgie Plastique Reconstructrice et Esthétique (French Society of Plastic Reconstructive and Aesthetic Surgery) with whom ASPS signed a Memorandum of Understanding in 2010, the Society has been receiving real-time information from plastic surgery leaders in France.
Last month, the French Ministry of Health advised the estimated 30,000 French women with PIP silicone implants to have their implants removed. At PSN press time, other European health ministries appear to be awaiting the French decision before deciding on their own courses of action. As many as 400,000 women in 65 countries in Europe and Latin America are estimated to have PIP implants. PIP silicone gel-filled implants were never approved for use in the United States, so an American woman would had to have been implanted outside the United States in order to have received the implants that are now the subject of concern.
A lawyer for PIP founder Jean-Claude Mas told Agence France Presse on Dec. 27 that PIP knew it was not in compliance but claims the silicone used in the implants was non-toxic. He added that it had not been proven that the implants were more likely to leak.
For our international members, we believe that while the current focus of attention is in France, approximately 80 percent of PIP implants were exported to other countries including the United Kingdom, Spain, Brazil, Argentina, Chile, Colombia and Venezuela. There are also reports that implants under the brand name "M," distributed by a Dutch company in Germany - and possibly elsewhere in Europe - may also be PIP implants that were rebranded as "M" implants.
ASPS will continue to monitor the situation and keep members informed of further developments.