Events

Safety Alert for Name of the product: SISTEMA ESSURE /// Registration number: 80274190001 /// model: ESS305 /// Lots: ALL LOTS /// Product risk 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
    1869
  • Date
    2016-04-12
  • 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 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.
  • Reason
    Commercial commed warns that the "thermablate eas procedure and the essure micro implant can not be performed on the same day due to potential damage to non-target tissue. the procedure should be performed only after the tubal occlusion confirmation test of 3 months ".
  • Action
    Action code: 001/2016 /// The field action consists of issuing Field Alert regarding endometrial ablation and the Essure procedure. Any intrauterine procedure, including endometrial ablation, may result in stretching or removal of the micro implant Essure. This could affect the patient's ability to rely on Essure for contraception. /// LETTER TO THE CUSTOMER IN ANNEX.

Device

Name of the product: SISTEMA ESSURE /// Registration number: 80274190001 /// model: ESS305 /// Lo...

Manufacturer

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