kathi

Silicone implants may return to market

WASHINGTON, Oct 10, 2003 (United Press International via COMTEX) -- The
Food and Drug Administration's plans to hold hearings next week to
determine whether to lift restrictions on the sale of silicone gel
breast implants for a California manufacturer has women's advocacy
groups up in arms, but the opposition is not likely to prevail, experts
say.

An FDA advisory panel will meet next Tuesday and Wednesday to discuss an
application from INAMED Corporation, a Santa Barbara company
specializing in products such as breast implants and facial aesthetics.
INAMED has asked the agency to remove its current ban on the commercial
sale of silicone gel breast implants for augmentation or cosmetic
purposes.

Silicone gel implants currently are available only through clinical
trials for augmentation or reconstructive surgery, such as for patients
who have undergone mastectomies for breast cancer.

Several companies stopped selling the devices and lawsuits sprang up
after numerous women claimed silicone gel breast implants had caused
them injury and illness. Some reports had linked silicone implants to an
increased risk of breast cancer and autism disorders, for example.
However, many experts now say current research has found no evidence to
support such claims.

Joann Kuhne, senior director for regulatory and clinical affairs for
INAMED, said the evidence supporting the long-term safety of silicone
gel breast implants already exists.

"Breast implants have been on the market for decades both in the United
States as well as outside the United States," Kuhne told United Press
International. "We've sold these breast implants to approximately 60
countries outside the United States and have been selling them for about
30 years."

Kuhne said the company has submitted its most recent clinical data on
silicone implants to the FDA. "The FDA sets very high standards for
devices and what companies have to comply with," she said. "The
two-to-three years of data is a standard amount of time period for any
product that goes through the FDA process."

INAMED stopped selling silicone implants for augmentation in 1997, but
the devices were available for reconstructive needs via clinical
research, Kuhne explained.

The company would not disclose its sales revenues from implants, nor
from any other specific medical device, but an INAMED spokesman told UPI
the company sells about $300 million a year in medical devices or
products worldwide.

Should the FDA approve lifting the ban, it could pave the way for other
health care companies waiting in the wings. For example, Mentor Corp.,
also of Santa Barbara, will be submitting its clinical data on silicone
gel breast implants to the agency in December.

"We believe after careful and thorough review, the FDA will eventually
approve the silicone gel implants, but we can't predict when that will
happen," a company spokeswoman told UPI.

If FDA removes the restriction, companies that resume selling silicone
gel breast implants could stand to make strong sales, explained David
Bernstein, a professor at George Mason University Law School in
Arlington, Va., who specializes in product liability and has published
papers on the breast implant issue.

"There is a money-making opportunity for a company that can get FDA
approval," Bernstein told UPI. The market will not be as flooded this
time because fewer companies will be selling the implants. Several
manufacturers bowed out after getting tangled in costly lawsuits, he
said. "Dow Corning had to pay out billions of dollars for a product that
all the evidence showed was ultimately safe. The safety concerns raised
about it were all false, so you can't really blame them for being really
leery about it."

Kevin Wiggins, spokesman and global manager of external relations for
Dow Corning in Midland, Mich., said the company would not resume selling
silicone gel breast implants even if other companies get the green light
from the federal government.

"Oh, definitely not," Wiggins told UPI. "It wasn't a core business for
Dow Corning. We've put this controversy behind us."

Despite the legal and financial imbroglio, Wiggins said, the company
stands behind a product he says has strong scientific support. "The
science is very definitive," he added.

The science remains the sticky issue for women's groups. Martha Burk,
chair of the National Council of Women's Organizations in Washington,
said the FDA will be examining clinical data that cover only
two-to-three years after a woman has undergone implants. Burk argues
that is not enough time to determine the long-term health consequences.

"The scientific evidence is clearly lacking," Burk told UPI. "The
anecdotal evidence is overwhelmingly on the side of not approving these
implants. Americans depend on the FDA to safeguard their health." An
approval, she said, "will give women a false sense of security."

Burk charged the FDA with caving in to corporate influences.

"This is just another example how another regulatory agency has been
captured by those it was chartered to regulate," she said. "It's a very
disturbing trend in government. I think it's something particularly
women voters will be paying attention to in next year's elections."

Burk was joined Wednesday by Kim Gandy, president of the National
Organization of Women, at a rally by women's groups against the FDA's
consideration.

"There's no question the FDA seems to be responding in an unprecedented
way to pressure from the implant industry and the plastic surgery
industry," Gandy told UPI. "It's like Halliburton started making
implants," she said, referring to the international corporation formerly
run by Vice President Richard Cheney. "Corporate interests are being
treated, if not more important, then equally important with health
interests," she commented. "The FDA is looking at far too little data."

Dr. Elizabeth Connell, professor emeritus of the department of
obstetrics and gynecology at Emory University in Atlanta, who chaired
the FDA advisory panel hearings on silicone gel breast implants in 1991
and 1992, said the latest scientific evidence supporting the safety of
these products is overwhelming.

The advisory panel will not just be looking solely at NAMED's data next
week, Connell explained, but also clinical data from scientists around
the world. "Twelve years have gone by and we have excellent researchers
addressing this," Connell told UPI. "The bottom line has been there's no
danger."

The demand for silicone gel breast implants is high, Connell explained,
because the alternative currently being used, saline implants, are not
as desirable among both physicians and patients. "The saline ones if
they rupture, the whole thing just disappears," she said. "They don't
feel like natural breast tissue and the silicone ones are preferred by
most people because they do feel like natural breast tissue. They don't
slosh around like a bag of water, which the other ones are."

Even lawyers are convinced science favors the use of silicone gel
implants, Bernstein said, so there is less fear from companies of
potential lawsuits should restrictions be abolished.

"Most lawyers wouldn't go anywhere near those cases now because the
evidence is just too strongly established on the other side," he said. A
decade ago, when women were suing over silicone implants, "the science
was immature." Now, he added, "the scientific evidence on implants is
sufficiently strong. Juries will be a lot more skeptical."

By KATRINA WOZNICKI, UPI Science News

Copyright 2003 by United Press International.

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kathi

Silicone implants may return to market
Posted on Monday, October 13 @ 14:21:02 CEST by Superuser


The Food and Drug Administration's plans to hold hearings next week to
determine whether to lift restrictions on the sale of silicone gel
breast implants for a California manufacturer has women's advocacy
groups up in arms, but the opposition is not likely to prevail, experts
say.

An FDA advisory panel will meet next Tuesday and Wednesday to discuss an
application from INAMED Corporation, a Santa Barbara company
specializing in products such as breast implants and facial aesthetics.
INAMED has asked the agency to remove its current ban on the commercial
sale of silicone gel breast implants for augmentation or cosmetic
purposes.

Silicone gel implants currently are available only through clinical
trials for augmentation or reconstructive surgery, such as for patients
who have undergone mastectomies for breast cancer.

Several companies stopped selling the devices and lawsuits sprang up
after numerous women claimed silicone gel breast implants had caused
them injury and illness. Some reports had linked silicone implants to an
increased risk of breast cancer and autism disorders, for example.
However, many experts now say current research has found no evidence to
support such claims.

Joann Kuhne, senior director for regulatory and clinical affairs for
INAMED, said the evidence supporting the long-term safety of silicone
gel breast implants already exists.

Breast implants have been on the market for decades both in the United
States as well as outside the United States, Kuhne told United Press
International. We've sold these breast implants to approximately 60
countries outside the United States and have been selling them for about
30 years.

Kuhne said the company has submitted its most recent clinical data on
silicone implants to the FDA. The FDA sets very high standards for
devices and what companies have to comply with, she said. The
two-to-three years of data is a standard amount of time period for any
product that goes through the FDA process.

INAMED stopped selling silicone implants for augmentation in 1997, but
the devices were available for reconstructive needs via clinical
research, Kuhne explained.

The company would not disclose its sales revenues from implants, nor
from any other specific medical device, but an INAMED spokesman told UPI
the company sells about $300 million a year in medical devices or
products worldwide.

Should the FDA approve lifting the ban, it could pave the way for other
health care companies waiting in the wings. For example, Mentor Corp.,
also of Santa Barbara, will be submitting its clinical data on silicone
gel breast implants to the agency in December.

We believe after careful and thorough review, the FDA will eventually
approve the silicone gel implants, but we can't predict when that will
happen, a company spokeswoman told UPI.

If FDA removes the restriction, companies that resume selling silicone
gel breast implants could stand to make strong sales, explained David
Bernstein, a professor at George Mason University Law School in
Arlington, Va., who specializes in product liability and has published
papers on the breast implant issue.

There is a money-making opportunity for a company that can get FDA
approval, Bernstein told UPI. The market will not be as flooded this
time because fewer companies will be selling the implants. Several
manufacturers bowed out after getting tangled in costly lawsuits, he
said. Dow Corning had to pay out billions of dollars for a product that
all the evidence showed was ultimately safe. The safety concerns raised
about it were all false, so you can't really blame them for being really
leery about it.

Kevin Wiggins, spokesman and global manager of external relations for
Dow Corning in Midland, Mich., said the company would not resume selling
silicone gel breast implants even if other companies get the green light
from the federal government.

Oh, definitely not, Wiggins told UPI. It wasn't a core business for Dow
Corning. We've put this controversy behind us.

Despite the legal and financial imbroglio, Wiggins said, the company
stands behind a product he says has strong scientific support. The
science is very definitive, he added.

The science remains the sticky issue for women's groups. Martha Burk,
chair of the National Council of Women's Organizations in Washington,
said the FDA will be examining clinical data that cover only
two-to-three years after a woman has undergone implants. Burk argues
that is not enough time to determine the long-term health consequences.

The scientific evidence is clearly lacking, Burk told UPI. The anecdotal
evidence is overwhelmingly on the side of not approving these implants.
Americans depend on the FDA to safeguard their health. An approval, she
said, will give women a false sense of security.

Burk charged the FDA with caving in to corporate influences.

This is just another example how another regulatory agency has been
captured by those it was chartered to regulate, she said. It's a very
disturbing trend in government. I think it's something particularly
women voters will be paying attention to in next year's elections.

Burk was joined Wednesday by Kim Gandy, president of the National
Organization of Women, at a rally by women's groups against the FDA's
consideration.

There's no question the FDA seems to be responding in an unprecedented
way to pressure from the implant industry and the plastic surgery
industry, Gandy told UPI. It's like Halliburton started making implants,
she said, referring to the international corporation formerly run by
Vice President Richard Cheney. Corporate interests are being treated, if
not more important, then equally important with health interests, she
commented. The FDA is looking at far too little data.

Dr. Elizabeth Connell, professor emeritus of the department of
obstetrics and gynecology at Emory University in Atlanta, who chaired
the FDA advisory panel hearings on silicone gel breast implants in 1991
and 1992, said the latest scientific evidence supporting the safety of
these products is overwhelming.

The advisory panel will not just be looking solely at NAMED's data next
week, Connell explained, but also clinical data from scientists around
the world. Twelve years have gone by and we have excellent researchers
addressing this, Connell told UPI. The bottom line has been there's no
danger.

The demand for silicone gel breast implants is high, Connell explained,
because the alternative currently being used, saline implants, are not
as desirable among both physicians and patients. The saline ones if they
rupture, the whole thing just disappears, she said. They don't feel like
natural breast tissue and the silicone ones are preferred by most people
because they do feel like natural breast tissue. They don't slosh around
like a bag of water, which the other ones are.

Even lawyers are convinced science favors the use of silicone gel
implants, Bernstein said, so there is less fear from companies of
potential lawsuits should restrictions be abolished.

Most lawyers wouldn't go anywhere near those cases now because the
evidence is just too strongly established on the other side, he said. A
decade ago, when women were suing over silicone implants, the science
was immature. Now, he added, the scientific evidence on implants is
sufficiently strong. Juries will be a lot more skeptical.

http://medserv.no/modules.php?name=mdnews&file=article&sid=2703&mode=thread&order=0&thold=0