FDA Warned PIP of Defects In Breast Implants, Patients At Risk

Today Reuters reports that since 2000, the Food and Drug Administration (FDA) raised concerns about the French breast implant maker at the heart of a scandal affecting hundreds of thousands of women worldwide. More than ten years later, the company has come under scrutiny from European regulators.
The FDA sent an investigator to inspect a plant run by the manufacturer, Poly Implant Prothese (PIP), at La Seyne Sur Mer in southeastern France in May 2000. Shortly afterwards, the FDA sent the company’s founder, Jean-Claude Mas, a warning letter saying the implants were “adulterated” and citing at least 11 deviations from good manufacturing practices.
The problems had to do with PIP’s saline implants, a different line from the silicone implants that French authorities ordered off the market in 2010 for using industrial-grade silicone instead of medical-grade silicone, leading to the French firm’s bankruptcy. Still, the plant inspected by the FDA was used to manufacture the silicone implants for PIP.

The French government last week recommended that women in France who have PIP’s silicone gel-filled implants get them removed by their surgeons after the implants appeared to have an unusually high rupture rate. Other countries, including Britain and Brazil, said women should visit their surgeons for checks.

A critical question is why the FDA’s warning didn’t trigger greater scrutiny of PIP’s activities by regulators in France and elsewhere. Officials at the FDA and France’s health regulator were not available for comment on Monday on whether the FDA shared information about its inspection of the PIP plant, though the warning letter was made public in 2000.

While no one has been criminally charged in this case, a French court may be pressing fraud charges against 4-6 ex-PIP employees.

As for the patients, they may have a viable case to sue the manufacturer for the cost of a second surgery to remove the implants as well as the pain and suffering and emotional distress associated with such a procedure  For those less fortunate, who actually experienced poisoning from the implant (some say cancer is a risk), they may have a cause of action for serious personal injuries.

If you have or recently had a PIP breast implant and have questions about your consumer rights, contact attorney Alexandra Filutowski.

Copyright © 2012 The Filutowski Law Firm, PLLC.   Disclaimer: This page is intended for general information purposes only and should not be construed as legal advice or legal opinions on any specific facts or circumstances.  An attorney-client relationship is not created or continued.

 

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