PIP Implants: Regulating Safety, the role of FDA

We’ve commented previously on the need for regulation.  In health care this is particularly the case because of the consequences.

The recent and ongoing breast implant problems from Poly Implant Prosthese (PIP) devices could well have been a major issue in the U.S. but for the FDA taking seriously it’s mandate to assess the safety of medical devices.

The now-defunct PIP was recently found to have sold implants made with industrial-grade silicone to some 300,000 women worldwide, sparking a global health scare. France’s government instructed 30,000 French women to have their implants replaced due to a high rupture rate, and the country’s health minister has called for Mas to answer for the actions of a “shady business.”

In the United States, where the FDA had banned all silicone implants from 1992-2006, PIP sold a line of saline-filled implants starting in 1996. The business accounted for up to 40 percent of its revenue, according to company securities filings. McGhan’s MediCor signed on to distribute the products in 1999, but a year later the Food and Drug Administration (FDA) conducted a new review of the devices and decided there wasn’t enough data to show they were safe.

The agency then sent an inspector to PIP’s plant in France, who found multiple violations of accepted manufacturing practices and determined the products to be “adulterated,” Reuters has reported.

Medicynical Note:  Read the entire article to get a sense of the aggressive marketing of these devices.  When money is involved people do funny things. 

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