WASHINGTON – Thirteen years after most silicone-gel breast implants (search) were banned, federal health advisers on Tuesday narrowly rejected a manufacturer's request to bring them back to the U.S. market, citing lingering questions about safety and durability.
Inamed Corp. (search) had argued that today's silicone implants are less likely to break and leak than versions sold years ago. But the Food and Drug Administration was skeptical, and its advisers voted 5-4 that the company hasn't provided enough evidence about how long the implants will last — and what happens when they break and ooze silicone into the breast, or beyond.
Without that information, "How can we get an informed consent from our patients?" asked FDA adviser Dr. Amy Newburger, a New York dermatologist. "It makes me very uneasy. ... I don't feel secure about the safety."
The FDA (search) isn't bound by its advisers' recommendations — and the panel's vote was a surprise. This same panel, with a few different members, had narrowly recommended allowing Inamed's implants back on the market just 18 months ago, a decision the FDA rejected because of the durability concerns.
"Obviously we're disappointed," said Inamed Vice President Dan Cohen, who pledged to work with the FDA to get the necessary additional evidence as soon as possible.
That doesn't mean the implants can never be sold, the advisers stressed. No one expects them to last a lifetime, but women need evidence about how likely they are to last 10 years, several panelists stressed.
But FDA adviser Dr. Michael Miller, a plastic surgeon at Houston's M.D. Anderson Cancer Center who has used Inamed's implants, argued the devices are being held to too high a standard.
"There are women who would benefit from these implants that don't have access to them," Miller said, complaining that salt water-filled implants sold without restriction today have their own drawbacks.
"All of us feel very strongly that women have a choice," responded Dr. Barbara Manno of Louisiana State University. But she ultimately opposed lifting the ban because Inamed has tracked patients for only three or four years to check implant durability. She cited concerns that the older the implants get, the more likely they are to rupture.
The decision came after emotional testimony Monday pitting woman against woman: dozens who said implants broke inside their bodies to leave them permanently damaged, and others who want implants they say feel more natural to repair cancer-ravaged breasts or make their breasts bigger.
On Wednesday, Inamed competitor Mentor Corp. will try to change the FDA panel's mind. Mentor is seeking FDA approval of its own silicone implants, but hasn't tracked patients any longer than Inamed did.
Silicone-gel implants were widely sold in the 1970s and '80s until health concerns prompted the FDA in 1992 to limit their use to women in strict research studies.
The implants have largely been exonerated of causing such serious or chronic illnesses 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 the FDA and some panelists say questions remain about how often silicone then oozes into the body, and if it harms.
About 14 percent of the silicone implants will break within 10 years, Inamed officials told the FDA panel Tuesday, an estimate derived from a study of 940 patients tracked for three or four years.
In those who had breast enlargement, just 2 percent broke within three years. But 10.6 percent of implants given to breast cancer patients broke, a difference Inamed attributed to a particular implant model widely used in that population — a model it says it hopes to redesign.
But FDA scientists said as many as three-quarters of implants may break within a decade, because they'll likely become more fragile with age.
"In fact, we really don't know" their durability, said FDA statistician Pablo Bonangelino.
Also troubling, when gel implants break, they seldom cause immediate pain or other symptoms, so the woman doesn't know to seek medical care. Inamed is proposing that women undergo MRI scans every year or two. The scans cost several hundred dollars.
Even rare side effects become a concern with devices expected to be used by hundreds of thousands of women, Newburger warned. Last year, 264,000 breast augmentations and 63,000 breast reconstructions were performed in the United States, most with saline implants.
FDA's advisers wrestled with their decision, but in the end one patient's testimony seemed to have had the most effect. Vanessa Rose Presuto said plastic surgeons assured her silicone implants had been proven safe when she unknowingly entered a research study to receive them. She told the panel Tuesday that two years of illnesses ended when she had both her implants and silicone-riddled natural breast tissue removed — but that her side effects weren't properly recorded.
"How does this happen?" asked FDA adviser Stephen Li, a Florida medical device testing expert, saying research-destined implants are supposed to be closely tracked. He ultimately opposed approval.