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 In this section:

                Urogynecologic Surgical Mesh Implants

Urogynecologic Surgical Mesh Implants

                        Pelvic Organ Prolapse (POP)
          Stress Urinary Incontinence (SUI)
          Considerations about Surgical Mesh for SUI
          Recommendations for Health Care Providers Treating Stress Urinary Incontinence
          FDA's Activities: Urogynecologic Surgical Mesh
          Pelvic Organ Prolapse (POP): Surgical Mesh Considerations and Recommendations
          Urogynecologic Surgical Mesh Implants: Reporting Problems to the FDA Home
          Medical Devices
          Products and Medical Procedures
          Implants and Prosthetics
          Urogynecologic Surgical Mesh Implants
          Urogynecologic Surgical Mesh Implants: Reporting Problems to the FDAUrogynecologic Surgical Mesh Implants Urogynecologic Surgical Mesh Implants: Reporting Problems to the FDA
  
  	
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    PrintPrompt 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
	Size
	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 treatmentIf you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 800-638-2041 or 301-796-7100.

                                                                                  Content current as of:
      04/16/2019Urogynecologic Surgical Mesh Implants

          
                        Pelvic Organ Prolapse (POP)
          Stress Urinary Incontinence (SUI)
          Considerations about Surgical Mesh for SUI
          Recommendations for Health Care Providers Treating Stress Urinary Incontinence
          FDA's Activities: Urogynecologic Surgical Mesh
          Pelvic Organ Prolapse (POP): Surgical Mesh Considerations and Recommendations
          Urogynecologic Surgical Mesh Implants: Reporting Problems to the FDA
 
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