FDA Wants It Both Ways on Breast Implants: They're Safe But Risky

Last Updated Jun 23, 2011 12:08 PM EDT

The FDA's announcement on silicone gel-filled breast implants yesterday was intended to reassure women that the devices are basically safe. But a close reading shows that they seem to be anything but. As many as half of all women who get them must have them removed within 10 years, the FDA said, due to infections, hardening, rupture, wrinkling and asymmetry.

The safety statement was spurred by an FDA investigation into whether implants cause cancer, a word that Allergan (AGN), which makes Natrelle, and Johnson & Johnson (JNJ), which makes Mentor, refuse to utter aloud. Yesterday's conclusion was that implants are not known to cause cancer, but the studies that would definitively rule that out have not been completed.

In fact, those studies seem to be going badly, the FDA hinted. The FDA required Allergan and J&J to conduct six studies of the long-term performance of breast implants. But:
Both manufacturers have communicated to the FDA the difficulties in following women who have received silicone gel-filled breast implants. The FDA is working with Allergan and Mentor to address those challenges and increase patient participation and follow-up.
The FDA is holding an expert advisory panel in the next few months to discuss how post-approval studies on breast implants can be more effective.
In sum, the study databases have already been been fouled by patient dropouts, and now the folks running them must tinker with their methodologies halfway through. This is not what good science looks like. Not that Allergan or J&J will care, given that the purpose of the studies is to discover bad news about implants.

New breasts 'are not lifetime devices'
That's not the only contradiction in the statement. Although the FDA basically said implants were safe, it added that one in five patients women who receive them for breast augmentation will have them removed within 10 years, as will one in two who get them for reconstructive surgery. How safe can a device with no moving parts be if it doesn't last? Here's how "reassuring" the FDA's Jeffrey Shuren, director of the Center for Devices and Radiological Health, was on his press call:
Our review of this information continues to support the safety and effectiveness of silicone breast implants when used as intended ... The risks and complications, though frequent, are well understood.
So they're safe even though they have frequent risks and complications. Hmm.

And the FDA added a new phrase to the lexicon surrounding implants: "Breast implants are not lifetime devices." This notion that implants are not a permanent body modification -- like a tattoo or a facelift -- may even help sell more implants. After all, what could be more appealing than the idea that if you don't like 'em, the FDA says it's normal to have 'em removed?

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