Brazil suspends and recalls Essure

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.

The decision was published in Brazil’s official gazette Feb. 17 and took effect the same day. Anvisa published its notice Monday.

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…

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