FDA Grants Silicone Breast Implants Conditional Approval

After being banned for 13 years, silicone gel-filled breast implants won conditional approval to return to the broad U.S. market. The U.S. Food and Drug Administration said the device maker must satisfy a number of conditions before it receives final approval to sell the implants. What those conditions are will not be made public, however, as the FDA says they're legally prohibited from disclosing them.

This comes after an April decision in which the FDA panelists voted 7-2 to recommend approval of Mentor's silicone implants, but called for the company to monitor some women for rupture over 10 years as well as educate patients and doctors.

Although the FDA said this does not mean that the device is approved for U.S. marketing, critics of the implants were hopeful the FDA would require more safety information before making a final decision.

And, the U.S. Senate health committee is investigating the FDA's handling of the decision, citing complaints about a conflict of interest among some FDA advisers. Other critics called for the FDA to delay a final decision pending the probe's conclusion.

The question here isn't about whether or not silicone breast implants can be safe--they obviously can be, otherwise every woman who got them would get sick. That said, silicone in the body that is not adequately contained can wreak havoc on your health. So what happens if these silicone implants rupture?

Read this testimony from one of my patients and see for yourself.

Yahoo News July 29, 2005

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