http://www.detnews.com/2005/health/0504/21/healt-148871.htm

[Guest guest]

Wednesday, April 13, 2005

FDA advisers oppose lifting silicone breast implant

ban

By n Neergaard / AP Medical Writer

WASHINGTON -- Thirteen years after most silicone-gel

breast implants 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. 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 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. , a plastic surgeon

at Houston's M.D. 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, " 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. 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 Li,

a Florida medical device testing expert, saying

research-destined implants are supposed to be closely

tracked. He ultimately opposed approval.