Brazil Bans Essure
Feb. 21, 2017
Yesterday, the Brazilian government agency, Anvisa banned the sale of the Essure Sterilization Device from the market in Brazil. The National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian regulatory agency that is responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services and, among others, medical devices. After reviewing various technical and medical reports and studies regarding Essure, ANVISA took Essure out of circulation. The Essure system was registered and sold in Brazil by the company Comercial Commed Produtos Hospitalares Ltda.
ANVISA determined that the contraceptive device was rated at maximum risk due to the injuries suffered by the users of the device. Essure can cause changes in menstrual bleeding, allergy and sensitivity, chronic pain, perforation and migration of the device, unwanted pregnancy and/or immune-type reactions. Due to the frequency and serious nature of the injuries, Essure is classified as a maximum risk device.
The suspension of the importation, distribution and commercialization, use and dissemination of the Essure product throughout Brazil was codified by Resolution RE 457 which was enacted on February 17, 2017. Essure victims worldwide were excited by the news that steps are being taken to remove Essure from the marketplace in the hopes that not one more woman is implanted with the dangerous device. It is hoped that the FDA and other global health authorities will soon follow suit and pull the device from their respective marketplaces. For more information, contact Holly Ennis at Ennis & Ennis, P.A. at 800-856-6405 or visit us online at www.EnnisLaw.com