The FDA has advised against a transvaginal mesh by Coloplast, and the manufacturer is compelled to keep the product off the market for the time being. The decision is based on a surveillance study of about 36 months. The Coloplast transvaginal mesh was for use in Pelvic Organ Prolapse (POP)
The agency has also made the data from the surveillance study public. Although the mesh is equally effective and safe compared to nature tissue repair, it comes with risks, according to the FDA.
In 2019, the FDA convened an advisory committee that suggested transvaginal POP repair need to be more effective and safe compared to natural tissue repair at 36 months and requires a favorable risk-benefit profile. Unfortunately, months later, Coloplast failed to extend a reasonable guarantee of the effectiveness and safety of the transvaginal mesh.
“For these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term. Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions”, said the FDA way back in 2019 on the POP mesh.
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Surgical mesh has long been in use in the medical world. For example, surgeons have leveraged them since the 1950s in the treatment of abdominal hernias. Likewise, the transvaginal repair of POP began in the 1990s. However, in the last few years, FDA has tried to create awareness about the possible risks of using a transvaginal mesh for POP repair. As a result, there has been a significant decrease in women undergoing similar treatment.