Brazil's National Health Surveillance Agency, Anvisa (Agencia Nacional da Vigilancia Sanitaria), has suspended and recalled Essure from the Brazilian market.
The permanent sterilization device made by Bayer is facing hundreds of lawsuits in the U.S. that claim serious injury to patients.
As a measure of health, the official gazette said, Anvisa was suspending the importation, distribution, marketing use and dissemination of the Essure system. It was also recalling units that had already been distributed. It was not immediately clear whether the recall would extend to removing devices that have already been implanted in women.
The exact number that were implanted in Brazilian women is not known, but Bayer estimates the total number distributed worldwide is 750,000.
Essure is a device consisting of two coils implanted in a woman's fallopian tubes, inducing scarring to block the tube and prevent pregnancy. Women who have been implanted with the device in the U.S. have reported a wide range of problems to the Food and Drug Administration, including device migration, perforation of organs and autoimmune responses. Hundreds have filed lawsuits against Bayer alleging they were injured by the device
According to a translation of Anvisa regulations by Emergo Group, Anvisa can suspend the registration of a medical product in a few circumstances, including when the product is under investigation for irregularities or defects in the product or its manufacturing process that constitute a risk to patients and others. It was not immediately clear whether Essure was suspended for that reason.
Bayer pushed back against Brazil's decision.
"We disagree with the decision by health regulators in Brazil which was taken without the knowledge of Bayer," the company said in a statement, adding that it was working with local regulators to fully understand the decision. "Bayer stands behind the positive benefit-risk profile of Essure, the safety and efficacy of which is supported by clinical trials and more than a decade of science and real world clinical experience worldwide."
Bayer's statement also noted that the decision affected Essure only in the Brazilian market.
Bayer shares did not appear to be affected, having risen 1.59% from opening Tuesday to $114.98 a share by 2:30 p.m. ET.