FDA Focuses on Silicone Breast Implant Safety
TUESDAY, Aug. 30 (HealthDay News) -- A U.S. Food and Drug
Administration advisory panel began a two-day meeting Tuesday on
silicone breast implants to consider ways to improve the
effectiveness of post-approval safety studies.
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, the
only two companies that make silicone implants available in the
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.
But Allergan and Mentor acknowledged problems with poor patient
follow-up, to monitor their health. The situation is "improving,"
Shuren said in June, but wouldn't say what the rate of follow-up
was at that point.
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.
The goal the FDA has set for the next two days for its General
and Plastic Surgery Devices Panel is to find ways to better assess
the overall performance of silicone implants in "real-world"
The FDA plans to update the panel on what is happening with the
current studies and to ask for recommendations about how to make
these studies more effective. The panel will also be asked for its
recommendations on ways to track and study future breast implants
after they are approved.
The FDA said it wants to find ways to improve post-approval
safety studies and to identify new approaches to mandated studies
and surveillance of silicone implants that are likely to yield
valuable information on their safety and performance.
This week's review does not include saline implants.
The U.S. Food and Drug Administration has more about
silicone breast implants.
Copyright © 2011
. All rights reserved.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.