Advisers to the Food and Drug Administration cited lingering questions about how long the controversial implants really last before breaking and leaking inside women's bodies as they narrowly rejected Inamed Corp.'s bid Tuesday to bring the products back to the U.S. market.
On Wednesday, rival Mentor Corp. gets its chance to persuade the same advisory panel that today's silicone implants are better than versions sold years ago.
But FDA analyses say Mentor has studied the breakage question for an even shorter period than its competitor did, casting doubt on silicone implants' future.
The FDA isn't bound by its advisers' recommendations, but typically follows them.
Without long-term data on implants' safety and durability, "How we can get an informed consent from our patients?" said New York dermatologist Dr. Amy Newburger as she joined fellow FDA advisers in voting 5-4 that Inamed's implants aren't ready for widespread sale.
"It makes me very uneasy," she said. "I don't feel secure about the safety."
Silicone-gel breast implants began selling in 1962, before the FDA required proof that all medical devices are safe and effective. The implants were banned back in 1992, after thousands of women complained they ruptured and caused immune system diseases, joint problems and even suicides. But medical studies have never been able to prove the link, and now only women who have had breast cancer can opt for silicone, reports CBS News Correspondent Elizabeth Kaledin.
Thirteen years later, silicone implants largely have been exonerated of causing serious or chronic illnesses such as cancer or lupus. But they can cause side effects, including infection and painful, rocklike scar tissue. Also, they can break, requiring additional surgery to remove or replace them — and those ruptures can result in silicone oozing into the breast and, sometimes, farther into the body.
Just last year, the FDA rejected requests by Santa Barbara, Calif.-based Inamed and Mentor to lift the near-ban until those durability questions were better answered.