Abstract
Implants in urogynecology.
Highlights
There is a lack of appropriate preclinical tests and research on the risks of surgical meshes for use in female pelvic floor
What do we know ? Tension-free vaginal tape (TVT) developed as a gold standard for the treatment of female stress urinary incontinence (SUI) with good long-term functional results of 87% after 17 yrs of follow-up [3]; similar results were found for midterm follow-up of TOT
Proof of concept Procedure development Refinement, community learning and consensus, and learning curve evaluation Formal comparison of benefits and short-term safety Surveillance, quality assurance, and long-term safety data
Summary
Aggressive marketing helped to spread these products around the world, since there are millions of female patients in our aging society suffering from incontinence and pelvic floor prolapse. In a Public Health Notification (PHN), from 2008, the Food and Drug Administration (FDA) reported more than 1000 unexpected and severe adverse events, mostly associated with transvaginal placement of surgical mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). A minority of patients (less than 5% according to Manufacturer and User Facility Device Experience MAUDE database) suffered from the complications but due to partly severe course and rising public interest the trend for mesh application stopped. The plaintiffs claim that it is “the legal duty of the manufacturers to ensure the efficacy and safety of transvaginal meshes,” but instead they provide patients with “false and misleading information about the efficacy and safety of products.”. Various single incision slings for female SUI and male slings are used for over 10 years but there is still a lack of good scientific
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