The FDA Wrote a Warning About French Breast Implants in 2000

Amanda Elser

We told you about the toxic implants in France that were used in over 30,000 boob jobs. Well now it seems as if the FDA actually wrote a warning letter to the implant companyPoly Implant Prothese (PIP) back in 2000, but no one seemed to heed their advice.

Apparently the FDA investigated PIPafter a number of complaints surfaced from U.S. patients who’d received the company’s saline implants, which would rupture after a few years.

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.”

It seems as if the warning letter (which was made public) didn’t make much of an impact in France or around the world. Although the current allegations against the PIP were for the silicone implants, it is safe to say that the faulty casings were made in the same plant as the saline implants in 2000.

Now, 11 years and 30,000 potentially harmful implants later and we wished someone had paid attention a little bit earlier.


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