The U.S. Food and Drug Administration is looking into new reports of Bayer AG's implanted birth control device Essure causing potential problems during removal.
FDA Commissioner Scott Gottlieb said the agency received nearly 12,000 reports in 2017 related to Essure, a majority of which were sent in the last quarter of the year.
Essure was approved in 2002 as a non-surgical and non-hormonal permanent birth control device for women.
"While the FDA continues to believe that Essure may be appropriate for some women based on our current information, the agency also recognizes that serious problems have been associated with its use," Gottlieb added.
In February 2016, the FDA added a boxed warning — the agency's most prominent warning to address serious safety issues — on the device after receiving complaints. The regulator also asked the company to conduct a post-marketing study of the device.
The German drugmaker said the new reports did not raise any new concerns and were associated with ongoing litigation, Reuters reported, citing an emailed statement.
