Alerta De Seguridad para Trade Name: SISTEMA ESSURE Technical Name: Female Contraceptive Devices ANVISA Registration Number: 80274190001 Hazard Class: IV - Maximum Risk Affected Models: ESS305 Affected Lot Numbers: All lots

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Products in stock at distributors, hospitals or clinics should be segregated in order to prevent them from being inadvertently implanted. Contact the company to receive detailed guidance on picking up non-deployed units. ### UPDATED ON 07/18/2017, published in the Official Gazette of the Federal Government on July 10, 2017, RESOLUTION RE 1.846, OF JULY 7, 2017 - Repeal Resolution RE 457 of 17 / 02/2017, published in the DOU nº 36 of February 20, 2017, Section 01, fl.35, which had determined the collection, suspension of the importation, distribution and commercialization, use and dissemination of the product ESSURE, registration ANVISA nº 80274190001, registration process nº 25351.350321 / 2007-88, imported and registered in Brazil by the company COMERCIAL COMMED PRODUCTOS HOSPITALARES LTDA, CNPJ: 02.643.718 / 0001-21. ### Alert 1908 correlates with alert 2208.