Though the number of women who may develop the disease is small, there is apparently no way to identify those who are likely to develop it — making it a source of potential concern to all women with the implants.
Among women who do not have implants, the cancer — anaplastic large cell lymphoma, or ALCL — develops in the breast tissue of about 3 out of 100 million women nationwide.
But among women who do have implants, FDA investigators say they have identified as many as 60 women who have developed ALCL worldwide, out of an estimated global population of 5 million to 10 million women with implants.
The FDA did not provide an incidence number for women with implants who developed the disease in the United States alone.
The agency said the number of known cases was too few to draw a conclusion that implants were linked to the disease.
FDA officials emphasized the small risk and said that women with implants don’t need to do anything more than be vigilant.
The FDA advised women not to change their routine medical care, but it said they should consult a physician if they notice swelling, pain or lumps around implants after postsurgical healing. […]
“It raises a red flag about what other immune disease could be occurring that are not obvious,” said Diana Zuckerman, president of the National Research Center for Women & Families.
Zuckerman noted that there have been reports that Allergan and Mentor have lagged in meeting benchmarks for 10-year safety studies of implant recipients required by the FDA.[…]
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