Last Updated Sep 1, 2011 11:30 AM EDT
Yet the FDA's official position is that implants are "safe and effective."
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.
- FDA Wants It Both Ways on Breast Implants: They're Safe But Risky
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- Breast Implant Maker Challenges FDA on Cancer Link