Women who get silicone breast implants are likely to need additional surgery within 10 years to address complications such as rupturing of the device, U.S. health regulators said on Wednesday.
The Food and Drug Administration will work to revise safety labels for silicone breast implants after reviewing data from several long-term studies, which also showed that the products had a small link to a rare form of cancer.
“The key point is that breast implants are not lifetime devices,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “The longer you have the implant, the more likely you are to have complications.”
There were almost 400,000 breast enlargement or reconstruction procedures in the United States in 2010, according to the American Society of Plastic Surgeons. Up to 70 percent of all women who received surgery due to disease or trauma, and up to 40 percent of those getting an enlargement procedure using silicone, needed another operation within 10 years, post-approval studies showed.
Based on the data, the FDA said 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 local complications include implant wrinkling, asymmetry, scarring, pain, and infection at the incision site.
The report also found a small correlation between implants and anaplastic large-cell lymphoma, a form of cancer that affects about 3,000 Americans a year.
