A Bullet Dodged - A short history of PIP implants in the U.S.A.

A Bullet Dodged - A short history of PIP implants in the U.S.A.
Susan Downey, MD, Plastic Surgery and Aesthetic Medicine.

How did we in the United States manage to miss the current controversy surrounding silicone implants manufactured by the French Company PIP (Poly Implant Prothese)?  It turns out that the FDA raised concerns about the French breast implant manufacturer as early as 2000.  PIP had started selling its prefilled saline implants in the United States in September 1996 under a 510(k) accelerated review application that did not require the company to submit clinical trials as long as the implant was said to be "substantially equivalent "to those already on the market.  However in 2000 the FDA required all breast implant manufacturers to submit a formal application (pre-market approval).  Three companies submitted applications - Inamed (now Allergan), Mentor and PIP.  Two companies received approval - Inamed (Allergan) and Mentor.  PIP did not.  PIP then stopped selling its prefilled saline implants in the United States.  That is why although over 30,000 prefilled saline implants manufactured by PIP have been reported sold in the United States none of the PIP silicone implants have been sold in the United States.  Whew!

Fuente:
http://boards.medscape.com/forums?128@330.G5H6aQVrcSk@.2a2e3ea6!comment=1&cat=All