THURSDAY, Sept. 1 (HealthDay News) -- After two days of hearings
into the potential health risks of silicone breast implants, U.S.
Food and Drug Administration officials said Wednesday that the
devices are safe and will remain on the market.
However, the agency said it would work with the two
manufacturers of the devices approved for use in the United States
to improve studies gauging the health of women who have received
Dr. William Maisel, deputy director of the FDA's Center for
Devices and Radiological Health, told
The New York Times that silicone breast implants are
"We felt that way before the meeting, and we continue to feel that way after the presentations and discussions over the past two days," he said.
Agency officials added that they would work with the two
manufacturers -- Allergan and Mentor -- to get more women to take
part in mandated post-approval studies. The numbers of women
involved with the studies so far have been limited, with Allergan
monitoring about 61 percent of patients, and Mentor monitoring
about 21 percent, the
Wall Street Journal reported.
Those numbers may be too small to reveal possible long-term
health problems, critics of the implants contend.
Those critics include Diana Zuckerman, president of the National
Research Center for Women and Families, an advocacy group for
improved health care. At this week's hearing, she said, "Without
proper data, we still don't know how safe or effective they
[implants] are and whether there are certain patients at risk for
extremely negative outcomes," the
After being banned for 14 years, the FDA in 2006 approved
Allergan and Mentor silicone gel-filled breast implants for breast
reconstructive surgery and for breast enlargement in women aged 22
Such implants had been banned because of concerns about possible
links to several diseases, including cancer and lupus.
However, when the FDA lifted its ban on silicone implants, it
noted that there was not a lot of data on adverse effects,
including what the agency calls "rare events" and "long-term
performance." In light of this, the agency required manufacturers
to do studies on the implants' safety and performance after their
Study findings announced earlier this year did not show an
increased risk of breast cancer or connective tissue disease,
although FDA officials noted that longer studies were needed.
Although the FDA has also recently cautioned that breast implants
might be linked to a higher risk of a rare form of lymphoma called
anaplastic large cell lymphoma, officials called those chances
The safety findings were based on preliminary data from six
ongoing post-approval studies conducted by Allergan and Mentor, a
unit of Johnson & Johnson.
FDA officials said in a June report that silicone breast
implants don't last forever, with as many as half of women with
such implants requiring removal within 10 years of the initial
"The longer a woman has the implants, the more likely she is to experience complications," Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration, said in June.
According to the agency's report, one in five women who receives
silicone implants to increase the size of their breasts will need
to have these devices removed within 10 years due to complications.
And as many as half of women who receive implants for
reconstruction after breast surgery will need them removed within
the same time frame.
Common complications include: hardening of the area around the
implant; the need for additional surgeries; and implant removal.
Other frequent problems include implant rupture, wrinkling, breast
asymmetry, scarring, pain and infection, the FDA said.
These are basically the same complications noted when the two
silicone implants available in the United States were allowed back
on the market in 2006, the FDA said.
Presently, the FDA recommends that women: follow-up regularly
with their doctor, which includes occasional MRIs to detect
potential ruptures; pay attention to any changes and notify their
health-care provider if they notice any unusual symptoms such as
pain, asymmetry or swelling; and educate themselves on the signs
and symptoms of complications.
According to FDA estimates, 5 million to 10 million women
worldwide have breast implants.
This week's review did not include saline implants.
The U.S. Food and Drug Administration has more about
silicone breast implants.
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