The agency issues two strict final orders related to mesh for transvaginal repair of pelvic organ prolapse.
Editor’s Note: A previous version of this article contained an inaccurate description of the type of mesh included in the FDA’s action. The article has been updated.
The FDA has issued two final orders to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally.
One leading expert predicted the orders would have significant future implications for the use of surgical mesh for transvaginal repair of POP.
The first order reclassifies these mesh medical devices from class II (which generally includes moderater-risk devices) to class III (which generally includes high-risk devices), and the other requires manufacturers to submit a premarket approval application to support a device’s safety and effectiveness for transvaginal POP repair.
The FDA said in a press release that the orders apply only to mesh devices marketed for the transvaginal repair of POP and do not affect the use of surgical mesh for other indications, including stress urinary incontinence and abdominal repair of POP.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, MD, MPH, of the FDA’s Center for Devices and Radiological Health, in the FDA release.
“We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures,” Dr. Maisel added.
Manufacturers of surgical mesh to treat POP transvaginally will have 30 months to submit a premarket approval for devices that are already on the market. Manufacturers of new devices must submit a premarket approval before those devices can be approved for marketing, according to the FDA.
Urologist J. Christian Winters, MD, of Louisiana State University Health Sciences Center, New Orleans, told Urology Times the FDA’s moves have profound future implications for the use of surgical mesh for transvaginal repair of POP, but the immediate impact on urologists and their patients might not generate swift change.
“In my mind, the impact has already largely happened. There has been a substantial decrease in the use of that treatment modality already, both patient-driven and to some degree physician-driven,” said Dr. Winters, immediate past president of the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction. “It’s my understanding that products that are in existence have to undergo post-market studies and those studies are underway and ongoing. The studies have to compare the [surgical mesh] procedure to the safety and efficacy of other procedures. The final results of those studies will determine a lot-as to, in the future, whether this is going to be a modality that is going to be readily available or not.”
Manufacturers attempting to bring new surgical mesh products to market for transvaginal repair of POP will be required to go through the more rigorous data demands of a class III device approval, “which is going to require a lot more data and a larger wealth of pre-launch experience. So, that’s the big factor in the future for the manufacturers. It’s going to be harder to get these things to market,” Dr. Winters said.
For now, at least, surgical mesh for repair of POP is still part of the conversation between urologists and some of their patients, according to Dr. Winters.
“In a woman who has had multiple abdominal surgeries, who is relatively young, and has failed a vaginal prolapse repair already, I think the option of surgical mesh is a part of the informed discussion regarding treatment options that has to be had with that patient,” he said. “I think doing [the surgical mesh procedure] in a routine prolapse case, a more straightforward case-or in the posterior compartment-that’s largely fallen out of favor.”
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