Almost 11 years ago, the U.S. Food and Drug Administration sent an agency investigator to France in order to inspect a plant run by breast implant manufacturer, Poly Implant Prothese (PIP). After the inspection was completed, U.S. health authorities issued a warning letter to PIP’s founder in June of 2000, outlining more than 10 manufacturing infractions at the company’s plant in southeastern France. The FDA’s letter also stated that PIP’s implants were “adulterated” and unsafe.

As of last week, French health regulators finally recommended that women who have received PIP’s silicone gel-filled implants should have them removed by their surgeons, citing that the implants have a particularly high rate of rupture. The delayed recommendation has many asking the question, why didn’t the warning letter issued by the FDA in 2000 trigger greater scrutiny of PIP’s products and manufacturing practices by French authorities?

The issues brought to light in the FDA’s warning letter could mean that the more than 300,000 women worldwide who have received PIP’s silicone implants could potentially face unpredictable safety issues.

In its letter, the FDA cited PIP’s failure to investigate the deflation of its saline implants, as well as the company’s failure to report more than 120 complaints to the FDA. Moreover, the warning letter revealed that PIP’s plant did not have a process in place that would ensure the implants they produced met design specifications.

(Source: msnbc.com; Today Health)