Medical Devices

Considerations about Surgical Mesh for SUI

Mesh sling procedures are currently the most common type of surgery performed to correct SUI. Based on industry estimates, there were approximately 250,000 of these procedures performed in 2010.

While all surgeries for SUI carry some risks, it is important for you to understand the unique risks and benefits for surgical mesh slings used in SUI repair.

In order to better understand the use of surgical mesh slings for SUI 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 surgical mesh slings used for SUI, both the panel and the FDA’s review found that:

  • The safety and effectiveness of multi-incision slings is well-established in clinical trials that followed patients for up to one-year. Longer follow-up data is available in the literature, but there are fewer of these long-term studies compared to studies with one-year follow-up.
  • The safety and effectiveness of mini-slings for female SUI have not been adequately demonstrated. Presently, it is unclear how mini-slings compare to multi-incision slings with respect to safety and effectiveness for treating SUI. Additional studies may help the agency to better understand the safety and effectiveness of these devices.
  • Mesh sling surgeries for SUI have been reported to be successful in approximately 70 to 80 percent of women at one year, based on women’s reports and physical exams. Similar effectiveness outcomes are reported following non-mesh SUI surgeries.
  • The use of mesh slings in transvaginal SUI repair introduces a risk not present in traditional non-mesh surgery for SUI repair, which is mesh erosion, also known as extrusion.
  • Erosion of mesh slings through the vagina is the most commonly reported mesh-specific complication from SUI surgeries with mesh. The average reported rate of mesh erosion at one year following SUI surgery with mesh is approximately 2 percent. 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 sling repair for SUI 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 slings currently on the market for SUI repair are not linked to a single brand of mesh.

The FDA conducted a review of Medical Device Reports (MDRs) received from Jan. 1, 2008 through Sept. 30, 2011. During this time frame the FDA received 1,876 reports of complications associated with surgical mesh devices used to repair SUI.

The most common complications reported through MDRs for surgical mesh slings for SUI repair, in descending order of frequency, include: pain, mesh erosion through the vagina (also called exposure, extrusion or protrusion), infection, urinary problems, recurrent incontinence, pain during sexual intercourse (dyspareunia), bleeding, organ perforation, neuro-muscular problems and vaginal scarring. Many of these complications require additional medical intervention, and sometimes require surgical treatment and/or hospitalization. With the exception of mesh erosion, the above complications can occur following a non-mesh surgical repair for SUI.

MDRs are submitted to the FDA by medical device manufacturers, importers, health care facilities, health care professionals and patients. MDR information is used to monitor marketed medical devices, and contribute to the detection of potential product-related safety issues as well as the 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, under-reporting of events, lack of denominator data (number of implants), and the lack of report timeliness.
 

Page Last Updated: 03/27/2013
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