Brazil: ANVISA recalls Bayer’s Essure due to safety reasons
Brazil’s National health surveillance agency, ANVISA has banned the sale of a birth control device, Essure by Bayer after reviewing technical-scientific reports.
According to the agency, the class III controversial contraceptive device can cause menstrual bleeding, chronic pain, and unwanted pregnancy. The device can also trigger allergies, perforation and migration of device.
ANVISA could not confirm the sales volume in Brazil however, Bayer estimates the approximately 900,000 devices have been sold across the globe, with at least 70% in the US.
The device was introduced as a quick half hour procedure with reduced discomfort and faster recovery then traditional tubal ligation. Essure coils are inserted and “screwed” into the fallopian tubes in an outpatient procedure. The coils triggers inflammation and scar-tissue growth to block fertilization.
Bayer protects its products and says “appropriate option for a majority of women seeking a permanent form of birth control.” However, the US FDA in 2016 had issued a black box warning as it received reports on side effects (9,900), including 26 deaths and many pregnancy losses, between November 2002 and December 2015. Essure System in Brazil was registered by the company Comercial Commed Produtos Hospitalares Ltda. The Brazilian agency has ordered the suspension of the import, distribution and marketing, use and disclosure of the product throughout the country.