Alerta De Seguridad para Trade name: SISTEMA ESSURE - Model: ESS305 - Registration No.: 80274190001 - Hazard Class: IV

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.

The risk for these events is considered low based on the document prepared on 09/24/2015 regarding the review of the Essure Sterilization System (FDA Review Document). To ensure that healthcare professionals and patients have a clear understanding of the risks involved in using the Essure product, we include the risk warning that the Health Department of Canada and the FDA have identified in the form that is completed and signed by the physician and the patient before using the device. Bayer is reviewing the label and package leaflet for attention to safety information and making it clear to Essure users of possible complications that may occur with the use of the product. ### UPDATE ON 7/13/2017: (i). In compliance with the requirement, the company presented a clinical dossier for the registration area of ​​Anvisa, which was evaluated, being considered that the company fully complied with the request. (ii). According to the reports sent by the company, measures were implemented to strengthen post-market follow-up of the product, based on the awareness and training of physicians, as well as the availability of training modules that can be accessed by the Commercial Commed website. The aforementioned post-market awareness program is underway, with the completion of the actions planned for December / 2017.