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Poly Implant Prothese Warned by FDA
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Health authorities from the United States began raising concerns about a French breast implant maker back in 2000 because the company was in the middle of a scandal that involved hundreds of women across the globe. The concern from the United States was ten years prior to concern shown by European regulators.

Poly Implant Prothese (PIP) was inspected by a Food and Drug Administration investigator in May of 2000. The plant is located in La Seyne Sur Mer. The founder of the company, Jean-Claude Mas, received a warning letter from the FDA. The letter said that the implants were adulterated and it cited 11 deviations from good manufacturing practices.

  
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The saline implants from PIP are at the heart of the problems. These implants are different from the ones that the French authorities ordered be removed from the market back in 2010. Those were removed because they had industrial-grade silicone instead of medical-grade silicone in them. The removal of the implants led to the bankruptcy of the company.

The government of France suggested to women who have PIP’s silicone gel-filled implants should have them removed by their doctors. The reason for the warning is the fact that these implants have a high rate of rupture. Other countries, including Britain and Brazil, also issued warnings to women.

An important question still remains; how come action was not taken by the French authorities after the warning was issued by the FDA? The warning letter, sent back in 2000, was made public back in 2000.

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There have yet to be any charges filed in the case but a court in Marseilles said that it might announce fraud charges against four to six of PIP’s former employees.

French authorities are investigating involuntary homicide after a death of a woman last year because of cancer. The woman had received PIP implants but the government has not provided any evidence that shows an increased risk of cancer from the implants.



There could be safety concerns for more than 300,000 women across the world since the United States issued its warning almost 11 years ago. The safety record of the implants and the number of women who have them could not be verified.

The letter from the FDA was cited in a lawsuit filed in the United States District Court for the Southern District of Texas. The lawsuit was filed on behalf of United States patients who had the implants installed in the late 1990s and one woman who received the implants in 2001. The plaintiffs named in the lawsuit claim that the implants deflated several years after the implants were installed.

The letter from the FDA can be found on the website for the agency, which is dated June 22, 2000. The letter cites the failure to investigate by the company when it learned of its implants deflating after 120 complaints were filed in France and other countries.



 

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