Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
- Patients and health care professionals are encouraged to submit a voluntary report about any problems experienced with Essure through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
- Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.
The FDA reviews the MedWatch reports and considers what actions are appropriate to address public health concerns. Each report is stored in a database monitored by FDA staff who evaluate the reports, consult with medical staff and the manufacturer, and determine if more study is needed.
To help us learn as much as possible about the adverse events associated with Essure, please include the following information in your reports, if available:
- Date of implant
- Patient age at time of implant
- Description of the problem including time of onset and follow up treatment Description of medical or surgical interventions taken, if any
- Pertinent medical history
- Operative reports
- Whether or not patients have had an Essure Confirmation Test