At least 457 breast implant recipients have been diagnosed with anaplastic large cell lymphoma (BIA-ALCL), up from 414 cases in the last report.
Worldwide, there have been more than 600 cases of BIA-ALCL, a rare type of non-Hodgkin lymphoma (NHL) that develops when white blood cells called T-cells become abnormal. At least 16 women have died from the disease, including 9 in the U.S., FDA said.
“We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL,” said Dr. Ashar, director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health.
FDA’s warning comes 1 day before French health authorities are scheduled to discuss the safety of textured implants, which are used in cosmetic and reconstructive surgeries, and account for about 85% of breast implants on the French market. Most cases of ALCL have been linked to the textured implants, FDA said.
In December, France’s National Agency for the Safety of Medicines and Health Products (ANSM) asked Allergan to recall its textured implants after the agency pulled its safety approval.
That recall came on the heels of an NBC News investigation which found that ALCL could be more common than previously thought.
The FDA, which first warned women about the cancer risk associated with textured breast implants in 2011, also announced Wednesday that for the first time that it is sending letters to primary care physicians and gynecologists urging them to learn about ALCL so they can better diagnose and treat women who may be at risk for the disease.
FDA is meeting next month to review the safety of all breast implants.
Source: NBC News