April 9, 2018 / 4:30 PM / 11 days ago

U.S. FDA restricts sale of Bayer's Essure birth control device

April 9 (Reuters) - The U.S. Food and Drug Administration (FDA) has restricted the sale of Bayer AG's implanted birth control device Essure, the agency said here on Monday, arguing that some women were not properly informed about risks related to the device.

Separately, Germany-based Bayer said on Monday that the benefit or risk profile of Essure had not changed and remained positive.

In early 2016, the FDA slapped the strongest safety warning label on the device following thousands of complaints, and asked Bayer to conduct a post-market study.

Concerns around the device included abdominal pain, abnormal uterine bleeding and device migration.

Essure, approved by U.S. regulators in 2002, is a non-surgical and non-hormonal permanent birth control device. (Reporting by Akankshita Mukhopadhyay in Bengaluru; Editing by Sai Sachin Ravikumar)

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