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FDA Focuses on Silicone Breast Implant Safety Studies
Date:8/30/2011

By Steven Reinberg
HealthDay Reporter

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 and older.

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 approval.

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 slim.

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 United States.

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 surgery.

"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
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