FDA: Number of U.S. Women With Breast Implant-Caused Cancer Has Increased
Textured implants linked to cases of anaplastic large cell lymphoma
THURSDAY, Feb. 7, 2019 (Pharmacist's Briefing) -- There has been an increase in the number of U.S. women diagnosed with a cancer caused by breast implants, the U.S. Food and Drug Administration said Wednesday.
The number of women with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) now stands at 457, compared with 414 in the last report. Worldwide, there have been more than 600 documented cases of BIA-ALCL. There have been 16 deaths, including nine in the United States. Most cases have been linked to the textured breast implants used in cosmetic and reconstructive surgery. In France, regulatory authorities are scheduled to meet Thursday to discuss the safety of textured implants, which account for 85 percent of the French market, NBC News reported. Late last year, French regulators told Allergan to recall its textured implants after the agency revoked its safety approval.
The FDA first alerted women about the risks from textured breast implants in 2011. The agency said Wednesday that for the first time, it is sending letters to primary care physicians, gynecologists, and other doctors encouraging them to learn more about ALCL to better diagnose and treat at-risk women. Next month, the FDA is meeting to review the safety of all breast implants.
"We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL," Binita Ashar, M.D., director of the Division of Surgical Devices in the FDA Center for Devices and Radiological Health, said in a statement.