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US FDA Raised Concerns Regarding French Breast Implant Maker in 2000

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Amid the French breast implant scandal involving the use of industrial silicone instead of medical grade silicone, documents filed with US government show the FDA raised concerns about the Poly Implant Prothese (PIP) at La Seyne Sur Mer in 2000.

Reuters reported an investigator found at least 11 deviations from good manufacturing practices at the plant, which promoted a warning letter to be sent by the FDA stating that its saline  implants were “adulterated.”

French authorities removed slicone implants, manufactured at the same plant as the saline implants, from the market in 2010, and last week the French government recommended that women who have PIP silicone gel implants have them removed because of an abnormally high rupture rate.

Reuters also reports that fraud charges may be brought against four to six ex-PIP employees, and that French authorities are currently involved in an involuntary homicide investigation regarding the death of a woman with PIP implants from cancer last year.

The fact that the FDA raised concerned about the saline implants over 11 years ago means there could be health safety issues  for the nearly 300,000 women who have receivedPIP  silicone implants since then. disclaimer: This article: US FDA Raised Concerns Regarding French Breast Implant Maker in 2000 was posted on Wednesday, December 28th, 2011 at 12:11 pm at and is filed under Medical Device Lawsuits.

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