In May of 2000, 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). Following the completion of its inspection, U.S. health authorities issued a warning letter to PIP’s founder, outlining concerns that the company’s implants were “adulterated.” The FDA’s letter also cited at least 11 manufacturing infractions at the company’s plant in southeastern France.
Last week, French health regulators recommended that women who have received PIP’s silicone gel-filled implants have them removed by their surgeons, citing that the implants have a particularly high rupture rate. This recommendation begs 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 by the FDA in its warning letter from almost 11 years ago could potentially mean that there are safety issues for the more than 300,000 women worldwide who have received PIP’s silicone implant.
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)
