Silicone-gel implants to remain off market

Inamed to try again
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.

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