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FDA Warned French Company Founder about Breast Implant Safety Issues

Posted Jan 02 2012 12:00am

You may be aware of recent news about a recall of French silicone breast implants manufactured by a company named Poly Implant Prothese (PIP) (see: France ponders removing recalled breast implants ). It turns out that the FDA issued a warning letter to the founder of the company in 2000 about irregularities in the manufacture of PIP's saline implants (see: FDA warned French plant on implant safety in 2000 ). Note that the plant inspected by the FDA was also used to manufacture the silicone implants for PIP. Here is an excerpt from the article:

As early as 2000, U.S. health authorities raised concerns about the French breast implant maker at the heart of a scandal affecting hundreds of thousands of women worldwide. That was almost 10 years before the company came under scrutiny from European regulators. The U.S. Food and Drug Administration sent an investigator to inspect a plant run by the manufacturer, Poly Implant Prothese (PIP)...in May 2000. Shortly afterwards, the FDA sent the company's founder, Jean-Claude Mas, a warning letter [via Fedex on June 22, 2000] 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. 

I think that I know the answer to the question that was posed at the end of this article: why didn't the FDA's warning trigger greater scrutiny of PIP's activities by regulators in France and elsewhere? The FDA sent its letter to the company founder, Jean-Claud Mas, and not to French governmental authorities. Perhaps Monsieur Mas was not prepared to confess about his poor manufacturing processes at that time. Here's a quote by a Mas spokesperson from another article on this same subject (see: Breast implant boss admits using 'unapproved' silicone gel ):

Jean-Claude Mas, speaking through his lawyer Yves Haddad, told The Times that his now-bankrupt company Poly Implant Prothese (PIP) made implants using high-quality gel for rich clients . But "simple" versions sold at discount prices used industrial-grade silicone that had not received approval by health authorities. Mr Mas admitted that a product made by PIP "did not formally receive approval, and in this regard there was a violation of regulations". "Why did this company use this kind of product? Because it was a corporation with economic objectives and because of corporate management that tried to get the best cost," he said. "There was a basic product and there was a high-end product, for people in the 16th [arrondissement] for example," he added, referring to the upmarket Paris district. According to PIP, the "house gel" version was "just as effective but five times cheaper" than the more expensive type.

This strikes me as a relatively odd rebuttal to the crime of using industrial grade silicone for breast implants. It was cheaper to do so and the corporate goal was to reduce the cost of the implant and, in so doing, make them cheaper and thus more accessible for the common folk.

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