PIP breast implants in the USA?

So what about those French breast implants?  Should American women be concerned that they may have the French breast implants?

The history of the Poly Implant Prosthese (PIP) implants is interesting.  The French breast implant manufacturer entered the United States market in the mid 1990’s when they applied for approval of their prefilled saline breast implants.  They did this under an accelerated application to the FDA that did not require the company to submit clinical trials as the implant was stating to be substantially equivalent to those already on the market. Reportedly about 30,000 prefilled saline implants manufactured by PIP were sold in the United States.  In 2000, the FDA required all breast implant manufacturers to submit a formal application including clinical trials.  Three companies submitted applications, Inamed (now Allergan), Mentor  - both United States companies and Poly Impant Prosthese.  Only two companies gained approval.  Inamed and Mentor. PIP did not get approval. At that time PIP stopped selling its prefilled saline implants in the USA.  Despite the fact that PIP saline implants were sold in the USA no silicone gel implants were ever sold.  It’s the silicone gel implants that have caused the problems in the European market.  The fundamental problem is that the PIP silicone gel implants were manufactured with industrial grade silicone and not medical grade silicone.  They were marketed and sold with the expectation of manufacturing with medical grade silicone.  Clearly there will be some legal attention given to the matter.

Although we can complain that the FDA tends to move at a snails pace when it comes to approving new drugs and medical devices - in this case their vigilance and insistence on clinical trials kept a bad product off the market in the United States.  

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Dr. Kobienia