Transvaginal Surgical Mesh for Pelvic Organ Prolapse
In 2019, the FDA ordered mesh manufacturers to stop selling devices for transvaginal repair of pelvic organ prolapse in the United States. Based on the review of available evidence, the FDA continues to believe the benefits do not outweigh the risks of surgical mesh placed transvaginally to treat POP. The FDA will continue to monitor the safety of these devices in women who have already received transvaginal mesh for POP repair.
Transabdominal Surgical Mesh for Pelvic Organ Prolapse
Surgical mesh used for treating POP is currently only indicated for abdominal surgeries (open, conventional laparoscopic or robotic assisted laparoscopic sacrocolpopexy) to suspend the top of the vagina to a structure on the sacrum. While all surgeries for POP carry some risks, it is important for you to understand the unique risks and benefits for surgical mesh used in POP repair.
To better understand the use of surgical mesh for POP and evaluate their safety and effectiveness, the FDA held a panel meeting of scientific experts (Obstetrics and Gynecology Devices Panel of the Medical Device Advisory Committee) in September 2011 and conducted a systematic review of the published scientific literature from 1996 to 2011. For transabdominal surgical mesh used for POP, both the panel and the FDA’s review found that:
- The safety and effectiveness of abdominal placement of surgical mesh for apical POP repair are well established.
- Compared to traditional vaginal surgery without mesh, abdominal apical prolapse repair with mesh (sacral colpopexy) results in less recurrent prolapse, although it has not been shown to reduce the rate of repeat surgery for recurrent prolapse.
- Abdominal POP surgery using mesh (sacral colpopexy) appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh, with the median vaginal mesh erosion rate reported at 4% within 23 months of surgery.
- Erosion of mesh through the vagina is the most commonly reported mesh-specific complication from POP surgeries with mesh. Mesh erosion is sometimes treated successfully with vaginal cream or an office procedure where the exposed piece of mesh is cut. In some cases of mesh erosion, it may be necessary to return to the operating room to remove part or all of the mesh.
- The long-term complications of surgical mesh repair for POP that are reported in the literature are consistent with the adverse events reported to the FDA.
- The complications associated with the use of surgical mesh currently on the market for POP repair are not linked to a single brand of mesh.
The most common complications reported through medical device reports (MDRs) for surgical mesh for transabdominal apical prolapse repair, in descending order of frequency, include:
- Mesh erosion through the vagina (also called exposure, extrusion, or protrusion)
- Scar tissue
- Neuro-muscular problems
- Organ perforation
- Recurrent prolapse
- Abnormal vaginal discharge
- Bowel obstruction
- Pain during sexual intercourse (dyspareunia).
Many of these complications require additional medical intervention and sometimes require surgical treatment, hospitalization, or both. With the exception of mesh erosion, these complications can also occur following a non-mesh surgical repair for POP.
MDRs are submitted to the FDA by medical device manufacturers, importers, health care facilities, health care professionals, and patients. The FDA uses MDR information to monitor marketed medical devices and help detect potential product-related safety issues as well as to conduct benefit-risk assessments of these products. While MDRs are a valuable source of information, this passive surveillance system has notable limitations, including the potential submission of incomplete or inaccurate data, underreporting of events, lack of denominator data (number of implants), and the lack of report timeliness.
Recommendations for Health Care Providers
If you are using transabdominal urogynecologic surgical mesh to treat pelvic organ prolapse, the FDA recommends that you follow these recommendations for training, patient selection, information sharing with patients, and patient follow-up.
Obtain specialized training for each POP mesh placement technique.
- Be vigilant for potential adverse events from the mesh implant, such as erosion.
- Watch for complications associated with the use of the tools used in placement of mesh during the surgical procedure, such as bowel perforations.
Informing Your Patient
- Inform the patient about their choice to have prolapse repair with or without mesh. The patient should understand:
- The likely success of transabdominal POP 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 surgery compared to non-mesh surgery and their effect on quality of life.
- Whether or not mesh will be used in the repair and, if so, which specific product will be used.
- That, as with any POP surgery, the use of surgical mesh for POP 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 surgery.
- Provide patients with a copy of the patient labeling or brochure, if available from the manufacturer.
Following 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 through Medwatch, the FDA Safety Information and Adverse Event Reporting program.