Reporting Problems to the FDA
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 hernia repair involving surgical mesh, please include the following information in your reports, if available:
Hernia mesh specifics:
- Manufacturer's name
- Product name (brand name)
- Catalog number
- Lot number
- Date of implant
- Date of explant (if mesh was removed)
Hernia repair involving surgical mesh operation specifics:
- Preoperative diagnosis, postoperative diagnosis and operative procedure
- Hernia description including size, location, and status (e.g. reducible, sliding, nonreducible, strangulated)
- Mesh placement (e.g. onlay, underlay, bridging, extent of fascial overlap, fixation method)
Adverse event specifics:
- Description of the problem including time of onset, inciting factors and severity,
- Time to resolution
- Detailed description of the medical and/or surgical interventions (if required) undertaken in response to the adverse event
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.
This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.