FDA Eyes Registry for Breast Implants Problems

U.S. health regulators said they would consider setting up a registry that tracks safety problems with breast implants, after too many patients dropped out of company-funded studies.

But the U.S. Food and Drug Administration emphasized on Wednesday that silicone implants were safe and would stay on the market, despite calls for their removal by consumer groups.

Expert advisers who held a two-day meeting to discuss post-approval safety studies for silicone implants urged the FDA to establish a registry.

“We believe it’s a good idea to have a conversation about a breast implant registry. … (But) we believe implants are safe and effective and should remain on the market,” Dr William Maisel, deputy director of the FDA’s devices division, told reporters after the meeting.

In 2006 the FDA approved silicone gel-filled breast implants sold by Allergan and Johnson & Johnson’s Mentor unit on condition both companies follow 40,000 women for 10 years to look at safety issues, as well as extend smaller pre-approval studies.

So far, Allergan has collected preliminary two-year data for 60 percent of participants, while Mentor has collected three-year data for only 21 percent — well below the 65 percent the FDA said would be acceptable. […]

However, some groups said the agency was letting manufacturers, especially Mentor, off the hook.

“You can’t ignore the fact that Allergan has three times more patients participating than Mentor. You can’t not hold Mentor responsible for that,” said Diana Zuckerman, president of the National Research Center for Women & Families.

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