FDA Focuses on Silicone Breast Implant Safety Studies

Agency asking advisers to devise ways to gather better data on 'real-world' safety and performance

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.

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" use.

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.

More information

The U.S. Food and Drug Administration has more about silicone breast implants.

SOURCE: U.S. Food and Drug Administration website

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