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ANVISA issued Resolution RE 457, which suspends the importation, distribution, sale, and use of the product throughout the national territory of Brazil. This is a major victory for patient safety and women in Brazil.
However, despite a similar assessment of the device by the U.S. Food and Drug Administration (FDA), Bayer continues to market and sell Essure in the United States.
The device works by causing scar tissue to build up in the fallopian tubes to prevent fertilization of eggs. Bayer claims the device is over 99 percent effective at preventing pregnancy.
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