(Adds Bayer comment)
March 7 (Reuters) - The U.S. Food and Drug Administration is investigating new reports of Bayer’s implanted birth control device Essure causing problems during removal, the agency said on Wednesday, two years after it slapped a warning label on the product.
The FDA received nearly 12,000 reports in 2017 related to Essure, a majority of which were in the final three months of the year, FDA Commissioner Scott Gottlieb said in a statement. (bit.ly/2G188uF)
Essure, approved by U.S. regulators in 2002, is a non-surgical and non-hormonal permanent birth control device for women.
In early 2016, the FDA slapped the strongest safety warning label onto the device following thousands of complaints, and asked the German drugmaker to conduct a post-market study. Concerns around the device included abdominal pain, abnormal uterine bleeding and device migration.
Bayer said the new reports did not raise any new concerns and that they were related to ongoing litigation.
“In fact, the number of Essure medical device reports that are not related to the litigation is declining, while litigation-related medical device reports are dramatically increasing,” Bayer spokeswoman Courtney Mallon said via email.
The FDA said almost 90 percent of the new reports mentioned issues involving potential removal of Essure.
“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 said.
Bayer estimates that more than 750,000 women worldwide have received the device implant since it was first approved by global regulators. (Reporting by Anuron Kumar Mitra and Tamara Mathias; Editing by Sai Sachin Ravikumar)