01.10 Empowered Consumer: French Breast Implants Recalled
With pressures from media, models, celebrities, society and our own inner critic, we ladies strive to look our best, and sometimes that means enhancing features through cosmetic surgery.  Unfortunately, there are risks that we need to consider, and sometimes those risks are greater than we expected.  Recently, a French manufacturer of silicone breast implants has undergone global scrutiny following a recent re-investigation of the manufacturing of its implants used by at least 300,000 women worldwide.
Reuters reported that since 2000, the Food and Drug Administration (FDA) raised concerns about Poly Implant Prothese (PIP), the  French breast implant manufacturer. More than ten years later, the company has come under scrutiny from European regulators.  Yet, by that time, thousands globally, including women in the United States, had received the toxic implants.
The FDA sent an investigator to inspect a plant run by the manufacturer 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.  No changes were made.  Instead, PIP continued to profit from sales.  Now, thousands of women have implants that may rupture and poison the body.

A ruptured PIP breast implant, and a normal one.

At the end of 2011, the French government 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.  Last week, the French government officials argued it has a “moral duty” to offer free healthcare service to remove the defective breast implants in France.

The 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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Alexandra Filutowski

Alexandra is a Puget Sound native with a passion to help individuals stand up for their legal rights. She opened her own law practice in the Queen Anne neighborhood of Seattle. The Filutowski Law Firm, PLLC is dedicated to representing individuals throughout Washington State in personal injury, insurance coverage, employment and business disputes. They offer expeditious legal solutions and superior client satisfaction. In her spare time she enjoys rock climbing, boating and traveling abroad.

* This post is from a Girl Power Hour featured blogger. It is not written, edited or endorsed by Girl Power Hour. The authors are solely responsible for content.

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