The FDA decision, based on an increasing number of cases and deaths from the implant-associated cancer, lags far behind action in Europe, where the Allergan devices were effectively banned late last year.
Worldwide, 573 cases and 33 deaths from the cancer have been reported, with 481 of the cases clearly attributed to Allergan Biocell implants, the FDA said. Of the 33 deaths, the agency said its data showed that the type of implant was known in 13 cases, and in 12 of those cases the maker was Allergan.
“The data regarding deaths was particularly informative of our decisions,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.
The disease is anaplastic large-cell lymphoma, a rare cancer of the immune system. It is not breast cancer, but develops in tissue around the implant. In most cases, removing the implant and the scar tissue around it cures the cancer, but if it is not detected early it can spread and kill the patient. The condition has occurred with implants placed for cosmetic breast enlargement and with those used for reconstruction after mastectomy for breast cancer. The FDA first recognized the link to breast implants in 2011.
The lymphoma is rare, given that millions of women have breast implants. Breast enlargement is the most popular type of plastic surgery in the United States, with more than 300,000 operations performed in 2017, a 3% increase over 2016, according to the most recent data from the American Society of Plastic Surgeons. About 100,000 other women received implants in 2017 during reconstructive surgery after mastectomy for breast cancer in the United States.
This article originally appeared in The New York Times.