ASPS, French Society Monitoring PIP Silicone Gel Breast Implants Developments
Statement To Members
The American Society of Plastic Surgeons has been monitoring the developing situation in France regarding suspected, defective silicone breast implants manufactured by Poly Implant Prothèse, a company known as PIP, that was required to halt production of the implants in 2010.
Thanks to our 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, we have been receiving real-time information from plastic surgeon leaders in France.
At this time, we would like to inform all U.S. domestic ASPS members that, to the best of our knowledge, PIP silicone gel-filled implants were never approved for use in the United States. An American woman would need to have been implanted outside the United States in order to have received the implants that are now the subject of concern in France.
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.
An official decision by the French Ministry of Health as to whether an estimated 30,000 French women with PIP silicone implants will be advised to have their implants explanted is expected on Friday, Dec. 23. Other European health ministries appear to be awaiting the French decision before deciding on their own courses of action.
ASPS will continue to monitor the situation and keep its members informed.
Additional coverage of this development will be included in the January-February 2012 issue of PSN, as well as on PSNextra.org.