Events

Safety Alert for Trade name: SISTEMA ESSURE - Model: ESS305 - Registration No.: 80274190001 - Hazard Class: IV

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by COMERCIAL COMMED PRODUTOS HOSPITALARES LTDA; Bayer Health Care LLC.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1908
  • Date
    2016-06-07
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    Healthy canadians and the us food and drug administration have issued notices on the detection of risks of serious complications with the use of the essure product. these possibilities of occurrences have been reported by health professionals who use essure to perform a tubal obstruction procedure and consequent contraception. both the fda and the health department of canada have recommended that the likely risks with product deployment be disclosed.
  • Action
    Field action Code 003/2016 triggered by the company COMERCIAL COMMED PRODUCTOS HOSPITALARES LTDA.- CNPJ: 02.643.718 / 0001-21, holder of the registration of the product in Brazil: According to the company, health professionals and patients should be aware of the possible complications that have been reported that may occur with the deployment of the Essure device. Thus, COOMNED is sending a LETTER TO THE CLIENTS, published a note on its Internet Portal and changed the document TERM OF SCIENCE AND POST-INFORMED CONSENT TO CARRY OUT THE PROCEDURE OF THE MEDICAL PLACEMENT OF INTRA-TUBULAR DEVICE - ESSURE (ANNEXES).

Device

Trade name: SISTEMA ESSURE - Model: ESS305 - Registration No.: 80274190001 - Hazard Class: IV

Manufacturer

COMERCIAL COMMED PRODUTOS HOSPITALARES LTDA; Bayer Health Care LLC
  • Source
    ANVSANVISA