It has been discovered that the US Food and Drug Administration (FDA) has known about problems with French breast implant manufacturer Poly Implant Prothese (PIP) at La Seyne Sur Mer, since sending an investigator in May, 2000.
The FDA then sent a letter to the company´s founder Jean-Claude Mas stating that the company had “adulterated” the implants and citing at least 11 other deviations from good manufacturing practices.
The problems in 2000 dealt with the company´s line of saline implants, not the silicone implants that brought the company under the scrutiny of French authorities. But the same plant manufactured both types of implants.
Critics question why the letter did not bring about greater scrutiny by French and European regulators of PIP´s manufacturing processes.
A spokesman for AFSSAPS, France´s drug and medical device regulatory, told Reuters that they had no evidence that the FDA had warned them of their letter sent to PIP.
The spokeswoman said, “The FDA wouldn´t be obliged to send it to us if there wasn´t a health risk. Therefore there doesn´t seem to be a reason why we would have been informed.”
According to the FDA, they routinely share confidential information with foreign regulators with whom they share confidentiality agreements, but they were unable to comment on whether this information was shared with French authorities in 2000.
According to Reuters, no one has been charged with any crime in this case. But four to six ex-PIP employees may soon be charged with fraud. French authorities are also investigating whether there was involuntary homicide committed by the company because of a woman who died of cancer last year after she received PIP implants. The French government, though, has not presented any evidence of increased cancer risk with this product.
The FDA´s letter was cited in a lawsuit that was filed in the US District Court for the southern District of Texas on behalf of US patients who received saline implants in the late 1990´s up to 2001, who said the implants deflated several years after implantation.
According to the FDA´s letter, dated June 22, 2000, PIP failed to investigate the deflation issues of its saline implants, they failed to report 120 French complaints about the implants to the FDA. The FDA also complained about the company´s lack of a process to ensure the implants were manufactured to its design specifications.
PIP sold its saline implants in the US beginning in 1996 under a 510(k) accelerated review process, where the company did not have to show clinical trial data about the safety and efficacy of their medical product, because they claimed it was equivalent to devices already on the market.
In 2000 all implant manufacturers had to submit to a formal application process to continue selling their products. PIP was one of three companies to submit an application, but after the review process they were denied by the FDA panel to continue selling their implants in the US, even though they had sold over 35,000 implants over the years.
The panelists were not reassured by PIP´s data and the clinical trials did not include enough patients being followed for an extended period of time to fully evaluate the devices risks.
Boyd Burkhardt, an Arizona plastic surgeon and one of the panelist members, said of the application, “Like it or not, we have a regulatory threshold which is probably higher or at least different than it is elsewhere in the world, and I think in order to get your product approved, you´re just going to have to bite your tongue and meet that threshold.”
The FDA then mysteriously inspected the PIP plant and they stopped selling the implants immediately in the US, according to SEC filings.
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On the Net:
FDA Sent French Breast Implant Maker PIP Warning In 2000
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