(Reuters) - The U.S. Food and Drug Administration (FDA) on Monday slapped restrictions on the sale of Bayer AG’s (BAYGn.DE) implanted birth control device Essure two years after the agency put a severe warning label on the product.
The FDA said here some women were not being properly informed of the risks associated with Essure before getting implanted.
The FDA’s restrictions will limit the sale of Essure only to healthcare facilities that provide full information about the device’s risks and benefits, the agency added.
Essure, approved by U.S. regulators in 2002, was given the strongest safety warning label on the device in early 2016 following thousands of complaints.
Concerns around the non-surgical, non-hormonal device have included abdominal pain, abnormal uterine bleeding and problems during removal.
Separately on Monday, Germany-based Bayer said Essure’s benefit or risk profile had not changed and that the company remains positive about the product.
Bayer is required to implement the FDA’s restrictions immediately.
The agency said last month it had received nearly 12,000 medical reports in 2017 related to Essure, with more than 90 percent mentioning issues around device removal.
Reporting by Anuron Kumar Mitra and Akankshita Mukhopadhyay in Bengaluru; Editing by Sai Sachin Ravikumar