FDA eyes registry for breast implants problems

Anna Yukhananov

Reuters|August 31, 2011

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.

“It’s very inefficient to enroll 40,000 patients, and only get data on 400 on them (for rare symptoms). So having registries is a much more high-value approach,” said Jason Connor, a biostatistician on the advisory panel.

There were almost 400,000 breast enlargement or reconstruction procedures in the United States in 2010, according to the American Society of Plastic Surgeons. That includes silicone and saline implants.

In June, the FDA said the risks of breast implants are well understood, after looking at the companies’ results as well as reports of negative events and scientific literature. It said women who get silicone implants are likely to need additional surgery within 10 years.

The agency had banned silicone implants for most U.S. women in 1992 after some said the devices leaked and made them chronically ill.

The companies and FDA advisers said patients and their doctors may not have enough incentives to stay in the company-funded studies, especially if they have to fill out a 27-page questionnaire every year, or do expensive medical procedures such as MRIs that test if their implant has ruptured.

A registry, which would track any patient who has had a breast implant, can provide broader data, making it easier to identify any complications, such as rupturing of the device.

Panel members said women should be encouraged to enroll in the registry by linking participation to the warranty on their devices, or to their surgeons’ certification.

Maisel also said it was important to involve different groups, including advocacy groups and physicians, to make sure patients understand the benefits of sharing information about their implants.

“What we’ve heard over the last two days is that it takes a whole community,” Maisel said. “You can have the most well-meaning company, but if the patients don’t want to participate in the study, that’s out of their control.”

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.