Alerte De Sécurité sur Name of the product: SISTEMA ESSURE /// Registration number: 80274190001 /// model: ESS305 /// Lots: ALL LOTS /// Product risk 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 company states that "endometrial ablation and the Essure procedure should not be performed during the same surgical session. Reviewing medical information on women who underwent both an Essure procedure and an endometrial ablation revealed that they may be at increased risk for certain events known to be associated with each procedure. " ### 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.