On March 30, 2010, France’s health regulators issued a recall of all pre-filled silicone breast implants manufactured by Poly Implant Prothese (PIP), a company based in southern France. The breast implant recall is said to affect an estimated 35,000 to 45,000 women worldwide.
AFSSAPS, the health regulatory agency of France, discovered an unauthorized type of silicone gel being used in the pre-filled implants. Following the recall, the French court ordered the company to shut down entirely for the manufacturing of fraudulent implants.
NOTE: THESE IMPLANTS WERE NOT USED IN THE UNITED STATES. WOMEN WHO HAD BREAST AUGMENTATION IN THE UNITED STATES DO NOT HAVE TO WORRY ABOUT HAVING THESE IMPLANTS. IMPLANTS USED IN THE U.S. ARE MANUFACTURED BY EITHER ALLERGAN OR MENTOR AND ARE HELD TO THE HIGHEST OF MANUFACTURING STANDARDS. IT IS MY UNDERSTANDING THAT THE SILICONE GEL USED BY PIP WAS NOT MEDICAL GRADE SILICONE.
The following is from the American Society of Plastic Surgeons (ASPS):
ASPS, French society working together to monitor developments on PIP silicone gel breast implants
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 U.S. An American woman would need to have been implanted outside the U.S. 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 U.K., 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, December 23rd. 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.
