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  6. Surgical Mesh Used for Hernia Repair: Reporting Problems to the FDA
  1. Surgical Mesh Used for Hernia Repair

Surgical Mesh Used for Hernia Repair: Reporting Problems to the FDA

The FDA encourages patients, caregivers and health care providers to report problems with medical devices to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting program. If you are unsure about the specific mesh manufacturer and brand used in your surgery and have questions about your hernia repair, contact your surgeon or the facility where your surgery was performed to obtain the information from your medical record. 

Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations. 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. 

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

To help us learn as much as possible about the adverse events associated with surgical mesh for hernia repair, please include the following information in your reports, if available:

Hernia mesh specifics:

  • Manufacturer's name
  • Product name (brand name)
  • Unique Device Identifier (UDI) 
  • Catalog number
  • Lot number
  • Size
  • Date of implant
  • Date of explant (if mesh was removed)

Hernia repair involving surgical mesh operation specifics:

  • Type of hernia (inguinal, femoral, incisional, ventral, umbilical, hiatal )
  • Preoperative diagnosis, postoperative diagnosis, and operative procedure
  • Hernia description including size, location, and status (for example, reducible, sliding, nonreducible, strangulated)
  • Mesh placement (for example, 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 surgical interventions (if required) undertaken in response to the adverse event
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