Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
- If you suspect a problem with surgical mesh, we encourage you to file a voluntary report 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.
To help us learn as much as possible about the adverse events associated with surgical mesh to repair SUI and POP please include the following information in your reports, if available:
- Manufacturer's name
- Product name (brand name)
- Catalog number
- Lot number
- Date of implant
- Date of explant (if mesh was removed)
- Details of the adverse event and medical and/or surgical interventions (if required)
- Reason for mesh implantation: (e.g., SUI; POP)
- Type of procedure (e.g., Sling procedure: retropubic, transobturator, or mini-sling procedure for SUI; anterior repair, vaginal vault suspension, or posterior repair, for POP repair)
- Surgical approach: (e.g., vaginal, abdominal, laparoscopic)
- Specific postoperative symptoms experienced by the patient with time of onset and follow-up treatment
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at email@example.com, 800-638-2041 or 301-796-7100.