FDA says Breast Implants could lead to a Rare Cancer

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Questions about the safety of breast implants, whose sale was restricted for more than a decade until 2006, resurfaced Wednesday with an announcement by federal health officials that the implants may be linked to a rare cancer.

The Food and Drug Administration said it believed the risk is small but statistically significant. It acted after reviewing studies and doctors’ reports in recent years about a small number of women with implants developing a cancer called anaplastic large cell lymphoma.

Health officials cautioned patients and doctors not to panic or have the implants removed if they don’t have symptoms. They said the disease, which has been found in scar tissue near the implant, isn’t the same as breast cancer and can be treated.

The FDA said it had identified as many as 60 cases of ALCL and verified 34 since 1997 among the five million to 10 million women who have received the implants after breast-cancer surgery or for cosmetic enhancement. The cancer was diagnosed after women began experiencing problems with the implants, such as pain, swelling and lumps— in some cases years after their surgery.

“One of our most important messages today is that women with breast implants who are not showing any symptoms or problems” require only routine checks with their doctors, said William Maisel, the FDA’s chief scientist in the device division.


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