Women receiving silicone gel breast implants experience frequent complications including needing additional surgery to fix or replace them, the US Food and Drug Administration (FDA) said Wednesday, releasing preliminary data from post-approval studies.
Still, the agency said the studies did not show any unexpected or new safety concerns for silicone implants, two types of which were approved in 2006. The studies were funded by the implant manufacturers, Allergan Inc. and Mentor Worldwide LLC, a unit of Johnson & Johnson.
"Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make well informed decisions about their use," the FDA said in a safety update posted on its website Wednesday. The likelihood of complications increases the longer a woman has implants.
Jeffrey Shuren, the head of the FDA's device division, said it is important for women with implants to get routine MRI scans to look for problems such as implant ruptures and to talk to their doctors if they have any changes in their breasts such as pain or swelling.
One set of data involving a group of women who were part of the original studies used to gain approval of the implants in 2006, showed 20 percent to 40 percent of women receiving implants for augmentation, and 40 percent to 70 percent of women who received implants for reconstruction -- usually after breast cancer -- had to have a reoperation in the first eight to 10 years after they received their implants.
Overall, the FDA said the most common side effects are capsular contracture, or hardening of the breast around the implant, reoperation and implant removal. Other side effects include implant rupture, scarring, pain and infection.
Until 2006, sales of silicone implants had been restricted for more than a decade amid concerns that leaking silicone gel caused health problems like connective tissue disease.
FDA said there is no "apparent" association between silicone implants and connective tissue disease, breast cancer or reproductive problems.
However, in January the agency warned there may be a small but increased risk of women being diagnosed with a rare type of lymphoma called anaplastic large cell lymphoma (ALCL), which in about 60 cases has been found adjacent to the breast implant, including silicone and saline-filled implants. ALCL is a type of non-Hodgkin's lymphoma and is not breast cancer. There was no additional information released about ALCL Wednesday.
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