http://www.comcast.net/news/index.jsp?cat=GENERAL&fn=/2006/11/17/523404.htmlBan on Silicone Breast Implants Lifted
By ANDREW BRIDGES, Associated Press Writer
1 hour ago
WASHINGTON - The government ended a 14-year virtual ban on silicone-gel
breast implants Friday despite lingering safety questions, making the
devices available to tens of thousands of women who have clamored for them.
The Food and Drug Administration approved the implants for women 22 and
older, or those undergoing breast reconstruction surgery, but warned that
patients probably would need at least one additional operation because the
implants don't last a lifetime.
The decision clears implants made by two California manufacturers, Inamed
Corp. _ now part of Allergan Inc. _ and Mentor Corp.
"There is reasonable assurance that Allergan and Mentor silicone-gel breast
implants are safe and effective, and there is adequate information to enable
women to make informed decisions," said Dr. Daniel Schultz, the FDA's
medical device chief.
Mentor called the decision a "historic moment." Allergan said it created new
options for women.
However, Dr. Sidney Wolfe, a longtime opponent, called the implants "the
most defective medical device FDA has ever approved." And a lawmaker called
on Congress to investigate the FDA's approval process.
The twin approvals came with conditions, including a requirement that the
companies complete 10-year studies on women who have already received the
implants to study leaks, as well as begin new decade-long studies of the
safety of the devices in 40,000 women. The FDA set the age minimum because
women's breasts aren't fully developed before then.
Schultz called the implants "one of the most extensively studied medical
devices."
FDA warned that the implants are not without risk and that women may not
immediately know if their implants break. That means women with the implants
will need to undergo regular MRIs to catch those so-called "silent
ruptures." Such MRIs typically cost several hundred dollars _ a cost not
always covered by insurance.
Patients will have to be given special brochures that explain these risks.
The FDA decision opens the implants to much wider use by women seeking to
reconstruct or augment their breasts. Since 1992, the silicone implants had
been available only as part of research studies.
Silicone-gel breast implants first went on the market in 1962, before the
FDA required proof that all medical devices be safe and effective. Thirty
years later, they were banned amid concerns about their safety.
At the time, there were worries about a possible connection to a variety of
diseases, including cancer and lupus. Alarming cases of ruptures added to
the concern.
Since then, most studies have failed to find a link between silicone breast
implants and disease.
The rupture issue persists. An Institute of Medicine report in 2000 found
rupture rates as high as 77 percent. The FDA's Dr. Donna-Bea Tillman said
women should expect them to last for the "reasonably foreseeable future,"
without elaborating.
Rep. Rosa DeLauro, D-Conn., called on Congress to investigate the FDA's
decision-making process to make sure it is "based on science and not on
corporate and political considerations."
"From a scientific standpoint, the decision we are making tonight is in the
best interests of American women," Schultz responded.
Women whose silicone implants ruptured have reported years of pain,
swelling, numbness and other symptoms that they blame on the devices. Leaked
silicone gel can migrate throughout the body, forming lumps. Implants also
can cause infection and form hard, painful scar tissue that can distort the
shape of a breast.
Some researchers also worry that the platinum used to manufacture the
implants can seep into the body and cause harm. The FDA says there is no
evidence of that.
Proponents say silicone-gel implants look and feel more natural than do
those filled with saline, or salt water. Those implants are sold without
restrictions.
"It's a hugely positive piece of news for plastic surgeons and for patients
and for the company _ all three _ because it really allows us to turn a page
and to work with what we have believed for a long time is a better
technology and better device," said Dr. Scott Spear, head of plastic surgery
at Georgetown University Hospital and an Allergan consultant.
Last year, the FDA told both companies their implants could be approved once
they met additional, undisclosed conditions. Federal advisers had narrowly
recommended that Inamed's implants not receive FDA approval, citing concerns
about the long-term durability. The same advisers endorsed Mentor's
implants.
In October 2003, FDA advisers had recommended allowing the implants to be
sold again. The agency overruled that recommendation.
Breast implants have become more popular, despite a history of lawsuits.
Last year, 291,000 women had their breasts surgically enlarged in the United
States, a 37 percent increase since 2000, according to the American Society
of Plastic Surgeons.
The popularity of implants for reconstructive surgery shrank over the same
five-year period by 29 percent, to 58,000 procedures, according to Society
statistics. Last year, 39,000 women had their implants removed.
Overall, the use of breast implants has grown since 1992 despite the FDA's
de facto ban on silicone-gel implants.
Just three years later, Dow Corning Corp., once the major manufacturer of
silicone breast and other implants, faced 19,000 lawsuits, pushing it into
Chapter 11 in 1995. The company emerged from Chapter 11 in 2004, after
setting aside $2.35 billion to settle claims.
Allergan Inc. shares rose $1.76, or 1.6 percent, in trading that was almost
double its average volume to close at $112.50 on the New York Stock
Exchange. Mentor Corp. shares increased $1.47, or 3.19 percent, also in
heavy trading, closing at $47.58.
___
On the Net:
Food and Drug Administration breast implant information:
http://www.fda.gov/cdrh/breastimplants/index.htmlInamed Corp.:
http://www.inamed.com/Mentor Corp.:
http://www.mentorcorp.com/Copyright 2006 The Associated Press.
