Making Sense of the French Silicone Breast Implant Scare
Europe’s debt and currency issues were briefly push
Europe’s debt and currency issues were briefly pushed aside when France recently announced that about 30,000 women should have removal of substandard silicone breast implants. Manufactured by Poly Implant Prothese SA (PIP), these devices may have a higher than normal rupture rate, and the company has been accused of using inferior, non medical-grade silicone.
Silicone breast implants have had a convoluted history in the United States, and were taken off the market for cosmetic use from 1992-2006. They were reintroduced with a new gel design and enhanced documentation and follow-up recommendations. Since silicone breast implants tend to touch off fireworks whenever they are in the news, here are a few points for Americans to keep in mind.
1) These silicone implants are not the ones used in the U.S. Ours are different, and the FDA warned the French company of manufacturing problems back in 2000.
2) The implants haven’t yet been proven to cause serious health effects. It will take time until experts can determine what, if any problems will be attributed to the inferior materials.
3) The potential safety issue is not the use of silicone in breast implants, but the use of non-medical grade material in the French devices.
Five years following the reintroduction of silicone breast implants in the U.S., an FDA review deemed them safe for use. The association with a very rare form of lymphoma was noted.
The French case says more on the issue of proper government oversight of product safety than it does about the safety of properly-designed silicone breast implants. The FDA deserves credit for their report regarding PIP’s manufacturing problems. However, there are many questions that have yet to be answered as to why French authorities took so long to discover and act on the problem.