FDA: Silicone breast implants ‘mostly safe’

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The U.S. Food and Drug Administration has issued a 63-page report concluding that silicone breast implants are mostly safe in spite of a higher incidence of complications than saline implants, including leakage, infections, and a slightly elevated risk of a specific type of lymphoma. The report tracks two long-term studies, both conducted by companies that manufacture silicone implants, Allergan and Johnson and Johnson.

Silicone implants were reintroduced to the U.S. market in 2006 after being unavailable for several years. The FDA says that there are risks to getting silicone breast implants, but that the potential problems are well enough understood that patients should able to make an informed decision.

It’s estimated that as many as one in five women who opt for silicone implants ends up having them removed within ten years of the initial procedure. Complications can include asymmetry, wrinkling, rupture, scarring, pain, and infection. No correlation was found between silicone implants and connective tissue disorder, breast cancer, or reproductive problems.

There was however a slightly elevated risk for anaplastic large-cell lymphoma.

“Breast implants,” the FDA warns women, “are not lifetime devices. The longer you have your implants, the more likely it will be that you will have them removed.” The majority of patients, the study noted, are happy with the change in their body image, and the “shape, feel, and size” of their implants.