The mess with the mesh
“For the first time, we are establishing some firm rules for mesh use, which can only be a good thing for the safety of patients.” This was one of the hopeful conclusions of Prof. Stefano Salvatore (IT), gynaecologist and President of the European Association of Urogynaecology.
On Sunday morning, Prof. Salvatore gave a well-received state-of-the-art lecture as part of Thematic Session 7: challenges in incontinence treatment.
Prof. Salvatore briefly summarised the problem with meshes: “Despite improving the anatomical outcome, particularly when we use them to repair what is commonly called cystocele, prolapse of the anterior vaginal wall. It brings a high rate of complications including pain: not just during sexual intercourse but also spontaneously. Also there is the case of infections, erosion, and exposure in the vaginal canal. Pain during sex can occur not just for women but for their partners as well. This has given rise to a new term: dyspareunia.”
“Taken all together, this brought a huge reaction against meshes from the patients themselves. There is also media pressure. Meshes can be helpful, but we don’t yet have the ideal material, and we currently have no certification for the surgeons who perform the procedure. We should identify the patient but also units where this procedure should be performed, with a high workload and high number of cases in order to minimize complications.”
Recent attention to the dangers of mesh use (including reclassifications from the FDA from Class II to Class III, or high-risk) has reached a peak because complications aren’t immediately clear. “Patients can experience shrinkage of mesh, worsening of the condition of women. The increasing number of cases means more awareness of these problems, including two class-action lawsuits. This caused a revolution in the market: devices were withdrawn, whole industries shut down.”
Careful optimism and the future
The backlash to meshes is also driving reassessment and improvement in legislation, safety and technology. Salvatore: “The FDA is encouraging not just post-marketing surveillance but, even better, pre-market approval and appraisal. This means drawing up a safety and efficacy profile of any new device or any new markets before being implanted in a human being.”
“There are also many new developments with great potential in the treatment of pelvic organ prolapse, which may replace mesh use altogether. Regenerative medicine has great potential: stimulating the growth of vaginal tissue, remodelling with the improvement of collagen, neovascularization. Stem cells may also be part of that future, along with absorbable scaffolds.”
As President of the European Assocation of Urogynaecology, Prof. Salvatore visits the Annual EAU Congress as much as he can. “We are now trying to work together with EAU offices and sections to try to create a common training programme or initiative with the European Commission, improving treatment on a European level.”