The Food and Drug Administration will consider the issue in a three-day meeting with its scientific advisers next week. The meeting is a key hurdle in determining whether the implants can re-enter the market. Since 1992, they have been available only to women enrolled in strictly controlled research studies because of fears they could cause major health problems.
The implants have been largely exonerated of causing such serious illnesses as cancer or lupus. But painful scar tissue that can form around the implants, breaks that require surgery to remove or replace implants, and other complications remain contentious. Just 15 months ago, the FDA told manufacturers that it wouldn't lift restrictions on the implants' sale until questions about breakage in particular are settled.
The FDA posted documents on the controversy on its Web site Wednesday.
Competitors Inamed Corp. and Mentor Corp. believe they've met that requirement, arguing that breast implants, just like pacemakers or metal hips, don't last forever but that newer generations are acceptably durable. They're better than salt water-filled implants that U.S. women can buy today, Inamed Vice President Dan Cohen said.
Broken implants don't always cause immediate symptoms, so the FDA asked manufacturers to use MRI scans to track durability. Mentor cited one study suggesting three-year breakage rates ranging from fewer than 1 percent to 5 percent of patients. Inamed data showed that over four years, implants ruptured in 3.4 percent of women who had received them for breast enlargement patients — and in 20.5 percent of breast cancer patients who received implants after a mastectomy. The company attributed that higher rate to a particular implant model that is being redesigned.
But those studies tracked small numbers of women for a short time, FDA scientists cautioned in preliminary analyses posted on the Web site.