Ban Breast Implants? The FDA Just Wants to Watch Them for a While

Last Updated Sep 1, 2011 11:30 AM EDT

Breast implants make no medical sense: The FDA admits that almost 100 percent of implants must be removed over the lifetime of the patient and that up to 50 percent must be removed within the first 10 years. They perform no beneficial medical function and subject the patient to the risks of surgery, infection, scarring and pain. (They don't even protect women from a direct hit from a paintball gun.)

Yet the FDA's official position is that implants are "safe and effective."

Unsurprisingly, there is a campaign to ban breast implants, led by the National Women's Health Network, the National Organization for Women, and the National Physicians Alliance.

Their main complaint is that the FDA reached its "safe and effective" conclusion based on what it admits is faulty evidence. The two companies that make most U.S. implants, Johnson & Johnson (JNJ)'s Mentor unit and Allergan (AGN), were supposed to monitor the health of the 40,000 women who receive breast "augmentation" every year but the two companies lost track of 31 percent and 79 percent of their patients respectively, leaving them with too little data to make conclusions.

This isn't surprising given that the purpose of the studies was to find bad news about breast implants, something neither company wants to know. As NOW pointed out, the companies didn't offer the women incentives to stay in the study the way other companies do when conducting drug discovery research.

Meanwhile, the implant industry becomes ever more ridiculous. Here's an 83-year-old woman who got them. And here's a doctor who favors "adjustable" implants that require follow-up surgery if the woman doesn't like the initial results.

The FDA's solution to this is to link the warranty on implants to a requirement that women participate in a national registry that will include annual medical exams and, possibly, a 27-page questionnaire. That ought to animate Republicans: It's basically a Mandatory Federal Boob Surveillance List.

Let's hope it becomes an election issue.


Image by gcD7K, CC.