FDA Panel Opposes Silicone Gel Implants - April 2005

[Guest guest]

I was soooooo excited when I saw this in 's news

alerts! . . . Unfortuately it's from last April.

Nevertheless, those new members may like to see what

was said then.

Since this time, this ruling was recinded and both

Inamed and Mentor are waiting for the FDA's approval

for the " new, improved " gel implant. . . the Gummy

bear implant has yet to be reviewed by the FDA.

Rogene

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http://www.washingtonpost.com/wp-dyn/articles/A48597-2005Apr13_2.html

FDA Panel Opposes Silicone Gel Implants

By Marc Kaufman

Washington Post Staff Writer

Wednesday, April 13, 2005; Page A07

A Food and Drug Administration expert panel voted

narrowly yesterday against allowing silicone gel

breast implants back on the market for general use,

saying the available scientific data are too scant to

provide assurance that newer versions would be safe.

After two days of emotional and technical testimony,

the panel decided 5 to 4 not to recommend that the

agency overturn its 1992 partial ban on the implants.

" This hearing was premature, " panel member Amy

Newburger, a suburban New York dermatologist, said

after the vote. " I don't feel secure about the safety

issue. I don't see how we can get or give adequate

informed consent for our patients based on the data

we've seen. "

Inamed Corp. sought the new advisory meeting a year

after the agency rejected its earlier application and

presented one additional year of safety data. While

panel members complimented the company on its

research, they concluded there was not enough new

information on key issues, including why some implants

leak, the effect of released silicone and the

long-term risks of intact implants.

Company officials appeared stunned by the decision.

" We believe in our data and think it was strong, " said

Dan Cohen, Inamed's vice president of global

government and corporate affairs. " I was surprised. .

.. . The panel's decision was disappointing. "

Cohen said the company will continue developing

silicone gel implants -- which are still available to

women after mastectomies and to some in clinical

trials -- and expects to be back before the agency in

the future.

The FDA usually follows the recommendations of its

advisory panels, but not always. An earlier panel

voted 9 to 6 for Inamed's silicone implants in October

2003, but the FDA turned down the application, saying

it left unanswered many of the same questions that

troubled the panel majority yesterday. After

yesterday's vote, Cohen held out the possibility that

the agency could again overrule the advisory panel,

this time to the company's benefit.

More than 320,000 U.S. women received implants last

year, about 260,000 for cosmetic reasons and 60,000

after a mastectomy, and the number has been growing by

more than 10 percent a year. Most are the less popular

saline-filled implants, which many women believe do

not look or feel as good as silicone gel models.

Many plastic surgeons and their patients were among

the more than 150 people who testified for and against

the silicone gel implants over two days of hearings.

They said the devices are safe and women deserve the

opportunity to make an informed choice about whether

to use them. Dozens of women testified about terrible

complications from their implants, often in graphic

detail.

Using another full year of data on rupture rates and

studies of why the failures occur -- as well as data

from abroad, where silicone gel implants are in wide

use -- Inamed argued that the number of failures was

low and that many were caused by errors by the

surgeons who implanted them.

Company officials also said there was no indication

that women with gel implants were more prone to

connective-tissue disease than other women, a fear

that contributed to the 1992 decision to take the

implants off the market. Many women have complained of

fatigue and sometimes severe joint and muscle problems

after getting implants.

Pearson, executive director of the National

Women's Health Network, cited the complaints in urging

the panel to reject the application. " What women want

to know is that if I'm healthy when this starts,

what's the chance the implant will cause me trouble

and how will I feel in the future? " she said.

, chief scientific officer of Inamed,

urged to the panel to focus on the company's data. " As

horrible and heartbreaking as the testimonials are, we

must rely on the science, " she said.

The panel, however, heard divergent views about the

science with Inamed and the FDA scientific staff at

odds about how many ruptures women can anticipate.

Using three years of its data and some longer

international studies, the company estimated that

about 14 percent of implants would fail within 10

years.

But FDA medical officers Sahar Dawisha and Pablo

Bonangelino said that judging from the best available

evidence, it is impossible to accurately project how

many ruptures would occur. Depending on which

assumptions are used, they said, the failure rate for

breast enlargements could be as low as 21 percent and

as high as 74 percent.

Complicating the issue is the growing understanding

that up to 85 percent of silicone gel implants that

fail do so " silently " -- leaving the women unaware,

sometimes for years, that the implants have ruptured.

Inamed officials said this was a positive thing and

showed that the gel held together so well that it did

not spill out. FDA officials and some panel members,

however, said the silent leaks could be worrisome

because small amounts of silicone could leak out over

years.

Panel member Li, president of Medical Device

Testing and Innovations LLC in Florida, who in 2003

voted in favor of the implants, yesterday voted

against the application. He said he wanted to see more

data on why implants rupture but was close to being

convinced.

" I think you'll be there soon, " he told Inamed

officials.

Continuing a controversy over who should sit on agency

advisory panels, the hearing began Monday with the

announcement that Olding, chief of the

division of plastic surgery at the Washington

University School of Medicine, had left the panel at

the last moment.

Olding told the FDA several weeks ago that he owned

stock in Medicis Pharmaceutical Corp., which recently

agreed to purchase Inamed.

Another implant maker, Mentor Corp., is scheduled to

present its data to the panel today.