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(Reuters) — The U.S. Food and Drug Administration on Monday slapped restrictions on the sale of Bayer A.G.’s implanted birth control device Essure, two years after the agency put a severe warning label on the product.
The FDA said 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 health care 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 nonsurgical, nonhormonal device have included hysterectomy, depression, unwanted pregnancies, abdominal pain, abnormal uterine bleeding and device migration.
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.
“Essure ... is a safe and effective medical device that benefits women by providing them with a valuable contraception option,” Bayer said.
Bayer is required to implement the FDA’s restrictions immediately.
U.S. sales of Essure have dropped approximately 70% since the agency ordered the company to conduct a post-market study, the FDA said in the statement. Bayer does not release sales figures for the device.
Bayer in September 2017 said it had decided to discontinue the sale of Essure in all countries except the United States. The company said the decision was made for commercial reasons and had no links to safety or product quality problems.
Bayer estimates about 750,000 women are using Essure worldwide, about 70% of them in the United States.
The FDA said last month it had received nearly 12,000 medical reports in 2017 related to Essure, with more than 90% mentioning issues around device removal.
The company is facing some 10,600 U.S. lawsuits, according to an October regulatory filing. Women allege Bayer knew of the risks associated with Essure but failed to warn sellers, doctors and regulators of the dangers.
A federal appeals court reinstated a state product liability claim against a medical device manufacturer that charges it falsely promised its spinal cord stimulator had a nine-year life.