Recommendations for Health Care Providers Treating Pelvic Organ Prolapse
The FDA recommends the following to health care providers using surgical mesh to treat pelvic organ prolapse (POP):
- Obtain specialized training for each mesh placement technique, and be aware of the risks of surgical mesh.
- Recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.
- Choose mesh surgery only after weighing the risks and benefits of surgery with mesh versus all surgical and non-surgical alternatives.
- Consider these factors before placing surgical mesh:
- Recognize that in most cases, POP can be treated successfully without mesh.
- Surgical mesh is a permanent implant that may make future surgical repair more challenging.
- Having a mesh surgery may put the patient at risk for requiring additional surgery or for the development of new complications.
- Removal of mesh due to mesh complications may involve multiple surgeries and significantly impair the patient’s quality of life. Complete removal of mesh may not be possible and may not result in complete resolution of complications, including pain.
- Mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
Informing your Patient
- Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
- Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall in POP repair.
- Inform the patient about the benefits and risks of non-surgical options, non-mesh surgery, surgical mesh placed abdominally and the likely success of these alternatives compared to transvaginal surgery with mesh.
- Notify the patient if mesh will be used in her POP surgery and provide the patient with information about the specific product used.
- Ensure that the patient understands the postoperative risks and complications of mesh surgery as well as limited long-term outcomes data.
- Provide patients with a copy of the patient labeling from the surgical mesh manufacturer if available.
Follow-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 transvaginal placement, especially bowel, bladder and blood vessel perforations.
- Federal Register: Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh
Federal Register: Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair Federal Register: Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair