June 23, 2011

Women With Implants Likely To Need Additional Surgery

U.S. health regulators said Wednesday that women who get silicone breast implants are likely to need additional surgery within 10 years to address complications like rupturing of the device.

The Food and Drug Administration said it will work to revise safety labels for silicone breast implants after reviewing data from long-term studies.

The agency said the studies confirmed its decision that implants can be used safely, but said the conclusions could be limited because some women dropped out.

"The key point is that breast implants are not lifetime devices," Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. "The longer you have the implant, the more likely you are to have complications."

According to the American Society of Plastic Surgeons, there were about 400,000 breast enlargements or reconstruction procedures in the U.S. in 2010.

Studies showed that about 70 percent of all women who received surgery due to disease or trauma needed another operation within 10 years.

The FDA approved silicone gel-filled breast implants sold by Allergan and Johnson & Johnson's Mentor unit in 2006.  The agency banned silicone implants for most U.S. women in 1992 after some complained the devices leaked and make them ill.

Both companies were required to conduct post-approval studies of 40,000 women for 10 years as a condition of taking the device to market. 

The FDA said that based on the data, the most common complications were localized, such as the hardening of the breast area around the implant, rupture or deflation of it, and the need for additional surgeries.

Other complications include implant wrinkling, asymmetry, scarring, pain, and infection at the incision site.

They reported a small correlation between implants and anapestic large-cell lymphoma (ALCL), which is a form of cancer that affects about 3,000 Americans each year.

Shuren said from 1997 to 2010 there were about 60 cases of ALCL reported for women worldwide out of about 5 million to 10 million women who had breast implants.

"If there's a true association between that cancer and implants, it's very, very rare," he said in a statement.

The FDA said most long-term studies confirmed initial results.

"Most women reported high levels of satisfaction with their body image and the shape, feel and size of their implants," the FDA report said.

The agency cautioned that post-approval study data could be limited due to the low response rates.

Allergan has collected preliminary two-year data for 60 percent of participants in the large 10-year studies of 80,000 women.

Diane Zuckerman, president of the advocacy group National Research Center for Women & Families, said most medical journals would not publish the studied cited by FDA because of the missing data.

"So many of the women dropped out before the research was completed that it is impossible to say what percentage of women need additional surgery or have health problems five or 10 years after getting breast implants," she said in a statement.

"This raises questions about FDA's reliance on studies required after a product is approved," she added.

The FDA said "both manufacturers have communicated to the FDA the difficulties in following women who have received silicone gel-filled breast implants."

The FDA said it is working with Allergan and Mentor to increase participation and follow-up.


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