April 7, 2005
High Rate of Failure Estimated for Silicone Breast Implants
By GARDINER HARRIS
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WASHINGTON, April 6 - In documents made public on Wednesday, health
regulators estimated that up to 93 percent of silicone breast implants
ruptured within 10 years. The surprisingly high figure will further roil a
debate next week about whether to lift the 13-year-old ban on silicone
implants for breast enhancement.
A committee of plastic surgeons and other experts will convene on Monday to
sort through studies of the safety and resilience of silicone implants. The
panel is also widely expected to hear emotional testimony from scores of
women who have had the implants.
The experts are to decide by April 13, the last day of the hearings, whether
the implants are safe enough to be approved for wide use. The Food and Drug
Administration then decides whether to follow the recommendation.
The panel voted, 9 to 6, in October 2003 to approve silicone implants. In an
unusual move, its chairman later wrote a letter to the F.D.A. urging that it
reject the recommendation. The agency sided with the chairman and ruled that
more information was needed about long-term safety.
The crucial issues are how often the implants break, what happens to the
silicone when they rupture and what health effects result. In the late
1980's and early 90's, thousands of women said ruptured implants had caused
myriad connective-tissue and autoimmune diseases that included multiple
sclerosis. The assertions bankrupted Dow Corning, a large maker of implants.
An expert committee of scientists found in 1999 that there was little
evidence that silicone implants caused such diseases. Instead, the primary
safety concern, the panel found, was the tendency of silicone implants to
cause local complications like infections, pain and scarring.
Critics have continued to insist that silicone implants are dangerous.
Organizations of plastic surgeons and companies like Inamed and Mentor that
make implants contend just as vigorously that they are safe.
Underlying the scientific issues are deeply emotional questions about
self-image. Physicians are allowed to use silicone implants for women who
need reconstructive surgery after major illnesses like cancer. Broader
approval would most likely accelerate the growing popularity of
Some advocates believe such operations should be discouraged. Others say
larger breasts can provide women with important help for self-esteem.
The panel will not resolve this debate. Its task is to assess safety, and
that will be hard enough. The F.D.A. provided the panel with wildly varying
estimates of just how often implants rupture.
Inamed studied its implants for four years and found that 9 percent a year
rupture. Those numbers are fraught, however, because most patients have no
idea when their implants rupture, and imaging tests are accurate in
assessing failures only about two-thirds of the time.
Projecting the numbers over 10 years called for even more guesses. If one
assumes that implants are no more likely to fail in their 10th year as they
are in their first, just 21 percent of a cross-section of women will see
their implants fail in 10 years.
But in comments posted on Wednesday on the agency's Web site, reviewers
wrote that implants, like cars and hearts, are more likely to fail as they
age. Adjusting for the increasing risks that come with age, the agency
estimated that 74 percent of a cross-section of women would suffer implant
failures in 10 years. For women undergoing reconstructive surgery, mostly
breast cancer survivors , the failure rate is 93 percent.
Saline implants fail, too, but such failures are quickly recognized by women
as their breasts deflate. And there is little risk associated with saline
The risks of silicone seepage are not fully known, however. Scar tissue
generally forms around most implants, but silicone leaks out of the scar
pocket in about one-fourth of patients, the agency found. Because most
failures of silicone implants go unrecognized, the agency suggested that
women with them should undergo medical screening every year or two.
Dr. Mark Jewell, president elect of the American Society of Aesthetic
Plastic Surgery, said he was surprised that the agency had estimated that
silicone implants failed so often.
"That's certainly news and does need to be addressed," said Dr. Jewell, who
has consulted for Inamed and Mentor. "But I feel that the devices should be
The companies can track the safety of the devices after they are approved,
he said. Women often find that silicone implants feel more natural than
saline, Dr. Jewell said.