Washington — Food and Drug Administration officials said they would consider setting up a registry that tracks safety problems with breast implants, even though they state that silicone devices are safe and should remain available, Reuters reports.
Experts who participated in a two-day meeting to discuss post-approval safety studies for silicone implants urged the FDA to establish such a registry.
Reuters quotes William Maisel, M.D., deputy director of the FDA’s devices division, as saying, “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.”
In 2006 the FDA approved silicone gel-filled breast implants sold by Allergan and Johnson & Johnson’s Mentor unit on the condition that both companies track 40,000 women for 10 years to assess safety issues, as well as extend smaller pre-approval studies. But 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 FDA-required 65 percent, according to Reuters.
The companies and FDA advisers said patients and their doctors may not have the incentive to stay in the company-funded studies, especially if they have to complete voluminous amounts of paperwork or undergo costly procedures, such as MRIs to determine whether the implants have ruptured. Panelists said a registry that would track any implant patient would provide broader data, making it easier to identify complications.
Reuters quotes panelist and biostatistician Jason Connor as saying, “It’s very inefficient to enroll 40,000 patients, and only get data on 400 (of) them (for rare symptoms). So having registries is a much more high-value approach.”
According to American Society of Plastic Surgeons statistics, nearly 400,000 breast-enlargement or reconstruction procedures were performed in the United States in 2010, including silicone and saline implants.
The FDA had banned silicone implants for most U.S. women in 1992 after some recipients said the devices leaked and made them chronically ill.