Stress Urinary Incontinence: Surgical Mesh Considerations and Recommendations

Surgical mesh sling procedures are a common surgery performed to correct stress urinary incontinence (SUI). The FDA has taken several actions to better understand the safety and effectiveness of surgical mesh used to treat SUI and provide this information to patients and health care providers. As described below, the FDA required the manufacturers of a specific type of surgical mesh used to treat SUI (also called mini-slings) to conduct long term follow-up studies for patients treated with these devices. The FDA has evaluated the results of these studies and completed an in-depth, systematic, literature review to evaluate the clinical performance of these devices. In addition, the FDA continues to monitor medical device reports (MDRs) for these devices to detect potential device-related safety issues.

Update on Mandatory Postmarket Studies 

Postmarket surveillance is the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device. The data collected in a mandatory postmarket surveillance study (also called a “522 study”) helps address important public health questions on the safety and effectiveness of a medical device.

In 2023, the FDA completed its evaluation of the mandated 522 studies conducted by mini-sling manufacturers. The 522 studies compared the safety and effectiveness outcomes of mini-slings and traditional mid-urethral slings. Mini-slings and traditional mid-urethral slings both have similar mesh designs and material but differ in length. Mini-slings are a shorter version of traditional mid-urethral slings. Traditional mid-urethral slings were chosen as the comparator for the 522 studies because of their well-established safety and effectiveness profile in treating female SUI.

The 522 studies assessed both objective and subjective outcomes to determine if the effectiveness of the mini-slings was comparable to that of the traditional mid-urethral slings through 36 months follow up. Objective outcomes included the 24-hour pad weight test and cough stress test. Subjective outcomes assessed quality of life related questionnaires. Additionally, the rates of device and procedure related adverse events were compared between the mini-slings and the traditional mid-urethral slings through 36 months. Adverse events assessed included mesh erosion, organ perforation, mesh exposure, severe pain and re-surgery. 

The completed 522 studies demonstrate that mini-slings have comparable effectiveness to mid-urethral slings over a 36-month timeframe. The mini-slings also showed similar types and rates of adverse events and re-surgery compared to traditional mid-urethral slings through 36 months. 

Additional detail regarding these studies can be found in FDA’s Postmarket Surveillance Study (“522 study”) database: 

• Contasure Needleless sling
• Altis single incision sling system
• Solyx Single Incision Sling System

2023 Update on the FDA’s Literature Review

The FDA conducted a systematic literature review (SLR) that included 30 randomized controlled clinical trials published between 2013-2023 comparing the safety and effectiveness of mini-slings with traditional mid-urethral slings. The effectiveness outcome measures for the SLR were 24-hour pad weight or cough stress test results collected over 1-5 years of follow-up. The rates of overall and specific device and procedure related adverse events, such as mesh erosion, organ perforation, mesh exposure, urinary retention, and painful intercourse (dyspareunia) and the rate of re-surgeries or need for mesh removal (explantation), collected over 1-5 years of follow-up were also compared between the SUI mini-slings and the traditional mid-urethral slings as part of the SLR. The SLR demonstrated that the clinical performance of SUI mini-slings is comparable to the traditional mid-urethral slings through 5 years.

Conclusions 

These results continue to support the FDA’s conclusion that surgical mesh mini-slings for SUI repair have comparable clinical performance to traditional mid-urethral slings through at least 36 months.

The FDA will continue to consider postmarket surveillance studies (“522 studies”) for mini-slings with novel designs or technological characteristics as described in Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff.

How Does the Food and Drug Administration Assure Products Used to Treat Stress Urinary Incontinence (SUI) are Safe and Effective? 

The FDA assures the safety and effectiveness of SUI devices by evaluating the clinical performance of a device before it is marketed in the U.S. and by monitoring its clinical performance while it is on the market.

While all surgeries for SUI carry some risks, it is important to understand the benefits and risks.

Recommendations for Health Care Providers

If you are using surgical mesh sling procedures to correct stress urinary incontinence (“SUI repair”), the FDA recommends that you follow these recommendations for training, patient selection, information sharing with patients, and patient follow-up.

Training

• Obtain specialized training for each SUI mesh placement technique.

Informing your Patient

• Inform the patient about their 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.
  • the 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.
  • a mesh sling is a permanent implant.
  • 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 manufacturer.

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 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.