EAU, EUGA issue consensus statement on implant use in treating POP and SUI

The European Urology Association (EAU) and the European Urogynaecological Association (EUGA) have issued a consensus review statement on the use of implanted materials in managing Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) in which both organisations have stressed the importance of following existing evidence-based guidelines, role of surgical expertise and the need for long-term assessment in high-quality research trials.

“It is clear that the use of synthetic midurethral slings (MUSs) for surgical treatment of SUI in both male and female patients has good efficacy and acceptable morbidity. However, synthetic mesh for POP should be used only in complex cases with recurrent prolapse in the same compartment and restricted to those surgeons with appropriate training who are working in multidisciplinary referral centres,” the EAU and the EUGA said in the joint statement.

“Patients should be adequately informed regarding the potential success rates and should be engaged in the decision-making process.”

Both organisations also underscored that doctors should fully inform their patients of the various therapies and their potential consequences on quality of life.

“Patients should be adequately informed regarding the potential success rates and mesh-related adverse events compared with non-mesh alternatives, and should be engaged in the decision-making process,” they added.

In the consensus document, which was published in European Urology, the EAU and the EUGA examined current evidence on the use of polypropylene (PP) materials used in treating SUI and POP. In their review they referenced the 2016 EAU Guidelines, the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) report on the use of surgical meshes, and other high-quality evidence, guidelines and national recommendations.

Pelvic floor dysfunction is a major health problem for women and SUI affects an estimated one in three women. POP, a condition when a pelvic organ such as the bladder “drops” (or prolapses) from its normal place into the lower belly and pushes against the vaginal walls, affects around one in nine women. POP is less commonly seen in men, and SUI in men occurs mostly as a consequence of prostate surgery, usually after radical prostatectomy. Percentages of SUI in men are recorded around up to 31%.

Controversies

In recent years, controversies arose with regards the use of implanted materials for SUI and POP, and in the US, the Food and Drug Administration (FDA) issued a series of warnings on the safety of transvaginal mesh (TVM) used in pelvic floor repair procedures. The FDA eventually reclassified TVM in prolapse repair into high-risk devices.

To address these issues, the EAU and the EUGA convened the expert group to discuss current evidence. They noted that current data indicate that the “…use of nonautologous durable materials in surgery has well-established benefits but significant risks, which are specific to the condition and location they are used for.”

“When considering surgery for SUI, it is essential to evaluate the available options, which may include synthetic midurethral slings (MUSs) using PP tapes, bulking agents, colposuspension, and autologous sling surgery. The use of synthetic MUSs for surgical treatment of SUI in both male and female patients has good efficacy and acceptable morbidity,” according to the statement.

Recommendations

The joint consensus also listed 12 recommendations such as establishing accurate and complete databases, long-term assessment in high-quality RCTs, research on new materials, designing implants specifically for their application, closely following evidence-based EAU and EUGA guidelines, and supporting the specialist training of surgeons, among other proposals.

For details access the complete abstract of the EAU-EUGA consensus statement on the website of European Urology.