Headline from over one year ago - FDA hearings - Still no approval!

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FDA Reconsidering Silicone Breast Implants

Three days of hearings on rupture rates begin

By Janice Billingsley

HealthDay Reporter

MONDAY, April 11 (HealthDay News) -- The U.S. Food and

Drug Administration opened a three-day hearing Monday

on whether to allow silicone breast implants back on

the market for women who want aesthetic

breast-enhancement surgery.

The first day was devoted to public comment, with some

women who had received the implants detailing what

they called devastating health problems caused by the

devices.

Other women, however, called silicone implants a

superior product to saline implants for breast

enhancement. They also said consumers should be

allowed to chose freely between the two.

" They poisoned my mother, " testified Brenna Dowd of

Boise, Idaho, according to the Associated Press. " I

have never known a healthy mother. "

" I don't want anybody else to suffer this way, " said

Helman of Florida, who blamed her autoimmune

diseases on platinum that leaked into her body when

her implants broke, the AP said.

But Virginia Silverman, of Orange County, Calif.,

said, " We have a right to decide what is right for our

own bodies. " She said she initially opted for salt

water-filled implants for reconstruction after breast

cancer surgery. But she found them too hard, so she

replaced them in 2001 with silicone gel implants that

she finds more comfortable, the news service said.

The hearing is the latest in the long and contentious

history of the medical devices.

In October 2003, the FDA's General and Plastic Surgery

Devices Panel, by a nine-to-six vote, approved the

sale of the silicone implants for aesthetic purposes.

But the panel chairman, Dr. Whalen, disagreed

with the vote and recommended that the FDA not follow

the panel's decision.

The following January, the FDA disregarded the panel's

recommendation and refused to approve the devices,

pending more data on long-term safety issues,

particularly the devices' rate of rupture.

Now the FDA has decided to once again review the

applications from two companies that manufacture the

products, Inamed Corp. and Mentor Corp., both in Santa

Barbara, Calif.

These companies are again presenting data on the

safety of the products among women who have had the

devices implanted. Inamed will offer results of new

research on why silicone implants have ruptured and

where silicone ends up when an implant does rupture,

said Dan Cohen, the company's vice president of

corporate and government affairs.

" The FDA, in its non-approval letter in January of

2004, focused on two questions: Why do the implants

rupture and where does the gel go to? And we have

studied those questions, " he said.

Another big concern for opponents of the implants is

their long-term safety. The FDA, in research presented

on its Web site, estimates that up to three-quarters

of the devices might rupture within 10 years of

implantation.

Cohen questioned that FDA research.

" Their findings are based on statistical models rather

than actual data because the number of ruptures is too

low to predict future trends, " he said.

He added that more than 200,000 women have received

silicone implants in the United States and in Europe,

either through clinical trials or through exceptions

allowed by the FDA, like breast cancer reconstruction

or severe asymmetry.

" That's a substantial number of women, and that

rupture rate would be manifested in the world today,

and it's just not there, " he said.

But opponents of silicone implants say there is still

not enough data on long-term safety to justify lifting

the ban.

" There is no real new information. What approval of

the implants will do is to expose lots of women to

what we don't know is safe, " said Barbara Brenner,

executive director of Breast Cancer Action, a San

Francisco advocacy group for women with breast cancer.

A representative from the organization will be

testifying at the hearing, she said.

There has been a big increase in the number of women

choosing to have breast augmentation, up from 32,000

in 1992 to 237,000 in 2002, an increase of nearly 600

percent, according to the American Society of Plastic

Surgeons. The large majority of these women had saline

implants, which are FDA-approved.

However, many women prefer the silicone gel implants,

saying they look more natural.

The controversy about silicone breast implants traces

back 13 years, when the devices were thought by some

to cause a variety of serious ailments. In 1992, the

FDA banned the sale of the silicone implants for

cosmetic surgery.

By 1998, more than 170,000 lawsuits had been filed

against implant manufacturers by women claiming their

silicone gel implants had made them sick with problems

such as immune system disorders and chronic diseases

such as rheumatoid arthritis and systemic lupus. Four

companies paid out millions of dollars in settlements

to the women, and one of them, Dow Corning, filed for

bankruptcy to pay $3.2 billion to settle its claims.

However, studies by the Mayo Clinic, Harvard Medical

School and the Institute of Medicine (IOM) panel from

the National Academy of Sciences subsequently found no

evidence that leaked silicone from gel implants caused

systemic disease.

More recent research has focused on the problems of

scar tissue developing at the site of the implant and

on the rate of rupture of the devices.

The U.S. Food and Drug Administration (www.fda.gov )

offers more information about breast implants.

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