Maker of Defective French Silicone Breast Implants Warned by FDA in 2000Dec 27, 2011 | Parker Waichman LLP
The French company that manufactured silicone breast implants now at the center of worldwide cancer panic has also had run-ins with U.S. regulators. According to a report from Reuters, the U.S. Food & Drug Administration (FDA) sent Poly Implant Prothese (PIP) a warning letter in 2000 regarding manufacturing problems at the French facility where it made saline implants. The PIP saline breast implants have also been named in lawsuits by U.S. women who received them in the late 1990s.
The FDA letter, dated June 22, said the PIP saline breast implants were "adulterated" and cited at least 11 deviations from good manufacturing practices, Reuters said. The FDA's letter was cited in a lawsuit filed in the U.S. District Court for the Southern District of Texas on behalf of U.S. patients who received the saline implants in the late 1990s, and one who received them as recently as 2000. The plaintiffs said that the implants deflated several years later. The FDA letter, dated June 22, 2000, cited PIP's failure to investigate the deflation of its saline implants and a failure to report more than 120 complaints in France and elsewhere to the FDA, Reuters said.
While the problems cited by the FDA had to do with PIP's saline implants, the same manufacturing facility also made the silicone breast implants at the center of the recent scandal. PIP silicone breast implants, which were already among the cheapest and most fragile on the market, were recalled last year after it was learned that they contained industrial, rather than medical grade, silicone. Those implants ignited cancer fears last month, after one woman with ruptured implants died from aplastic large cell lymphoma (ALCL), a rare cancer. At least eight cases of ALCL have been reported among French women with the PIP implants.
So far, investigators haven't been able to prove the implants caused the cancer. Nevertheless, the French health ministry last week urged women to have them removed because they may rupture. French health officials also said the government would cover the cost of removal in women who received PIP silicone breast implants for reconstructive surgery.
As many as 300,000 women throughout the world received PIP silicone breast implants. The company faces a French criminal probe for misreporting the type of silicone used in the implants. Some 2,000 French women, and 250 in Britain, have filed legal claims against the implant maker.
The PIP silicone breast implants were never sold in the U.S. But the saline variety that sparked the FDA warning letter were brought to the U.S. market in 1996 via the agency's 510(k) approval process, which does not require human testing. In 2000, however, concerns over complications prompted the FDA to finally require all implant companies to submit formal applications for saline breast implants. In the end, the FDA refused to approve the PIP's saline implants, and they haven't been sold in the U.S. since.
It isn't known why the FDA's 2000 warning letter didn't trigger greater scrutiny of PIP's activities by regulators in France and elsewhere, Reuters said.