After more than 30,000 women in France received dangerously toxic breast implants manufactured by Poly Implant Prothese (PIP), new information has come to light that’s making it clear the now-bankrupt company should probably have been shut down a long time ago.
The FDA investigated PIP, a company based in France, way back in 2000 after a number of complaints surfaced from U.S. patients who’d received the company’s saline implants. The primary issue was that the implants ruptured after several years. The FDA sent an investigator to a PIP plant in France and found that the implants were “adulterated” and cited them for at least “11 deviations from good manufacturing practices.”
The problem back then was with PIP’s saline implants, which are different from the silicone gel implants currently at issue in France. (PIP was not selling their silicone implants in the U.S. at that time because the FDA prohibited the sale of all silicone implants from 1992 to 2006 due to safety concerns.) Though the main problem with the current round of faulty implants is that PIP used industrial silicone rather than medical-grade silicone, there is also an issue with the poor quality of the implant casings, which makes them more likely to leak or rupture.
In a warning letter to the company in 2000, the FDA said PIP had failed to investigate the problems with their saline implants, had failed to report more than 120 complaints from France to the FDA, and also lacked a process to ensure the implants were being produced to their design specifications. So it shouldn’t come as a shock that substandard silicone implants were also being produced in the very same plant the FDA investigated.
What’s strange is that the FDA’s warning—and subsequent refusal to recommend PIP implants for sale in the US—does not seem to have set off the alarm bells in France or in other countries where the implants were sold. The warning letter to PIP was made public, but there is no word on whether the FDA made a point of sharing its findings directly with regulators in France. It’s too bad more aggressive steps weren’t taken to correct their bad practices. It’s safe to assume that those 30,000 women in France and more than 300,000 women worldwide who are now sitting with ticking silicone time bombs in their chests really wish somebody had done something earlier.
Insight: FDA warned PIP on breast implant safety [Reuters]
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