Dive Brief:
- The Food and Drug Administration has published the final, 36-month data from a post-market surveillance study of Coloplast transvaginal mesh for pelvic organ prolapse (POP).
- The mesh provides similar effectiveness and safety outcomes to native tissue repair but also comes with additional risks, the FDA concluded after reviewing the data.
- The conclusion led the agency, which told Coloplast to stop selling POP mesh in 2019, to maintain its position that the devices do not have a favorable benefit-risk profile.
Dive Insight:
The FDA in 2019 convened an advisory panel that recommended that transvaginal repair of POP would need to deliver better effectiveness and comparable safety to native tissue repair at 36 months to have a favorable risk-benefit profile. Months later, the regulator found that Boston Scientific and Coloplast, the last two companies on the market, had failed to provide reasonable assurance of safety and effectiveness.
The conclusion led the FDA to tell the companies to pull their products from the market even as postmarket safety studies that predated the action continued. Coloplast now has completed its study, marking the end of all the trials the agency ordered for transvaginal mesh in POP.
The study split the 810 subjects into three groups, namely anterior-apical, posterior-apical and total repair. The rates of recurrent prolapse were numerically lower in anterior-apical and posterior-apical patients treated with the mesh than in their peers who underwent native tissue repair. The biggest difference, 18% in the mesh group versus 27% in the control arm, was seen in posterior-apical patients.
Similar trends in favor of mesh were seen in anterior-apical and posterior-apical groups when a different definition of recurrent prolapse was used. However, the results fell short of the bar needed to show that mesh is more effective than native tissue repair at 36 months. As such, the study failed to provide the data to meet the advisory committee’s definition of a favorable risk-benefit profile.
