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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
          Recommendations for Health Care Providers Treating Stress Urinary IncontinenceUrogynecologic Surgical Mesh Implants Recommendations for Health Care Providers Treating Stress Urinary Incontinence
  
  	
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Obtain specialized training for each SUI mesh placement technique.Patient Selection

Be vigilant for potential adverse events from the mesh sling, such as erosion.
	Watch for complications associated with the use of the tools used in transvaginal placement of the mesh sling during the surgical procedure, such as bladder perforations.Informing your Patient

Inform the patient about her choice to have incontinence repair with or without a mesh sling. The patient should understand:
	the likely success of transvaginal SUI surgery with mesh compared to non-surgical treatment options and non-mesh surgery based on the individual patient factors.
		the potential postoperative complications of a mesh sling surgery compared to non-mesh surgery and their effect on quality of life.
		that there is limited information about outcomes after one year.
		whether or not mesh will be used in the repair, and if so, which specific product will be used.
		that a mesh sling is a permanent implant.
		that, as with any SUI surgery, the use of surgical mesh for SUI can make any future surgical repairs more challenging and can put the patient at risk for additional complications and surgeries.
	Ensure that the patient understands the postoperative risks and potential complications of mesh sling surgery.
	Provide patients with a copy of the patient labeling or brochure, if available from the manufacturerFollow-up with your patient

Be vigilant for potential adverse events from the mesh, especially erosion and infection.
	Watch for complications associated with the tools used in placement, especially bowel, bladder and blood vessel perforations.
	Submit a voluntary report about any problems experienced with surgical mesh slings through Medwatch, the FDA Safety Information and Adverse Event Reporting program

                                                                                  Content current as of:
      04/16/2019
              
              
Regulated Product(s)
		 Medical DevicesUrogynecologic 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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