FDA affirms increased risk with pelvic mesh products

Regulatory NewsRegulatory News | 16 August 2021 |  By 

The US Food and Drug Administration (FDA) announced on Monday that its review of final results from postmarket surveillance of transvaginal mesh devices meant to treat pelvic organ prolapse (POP) found that patients who received mesh repair had increased risk of mesh exposure and tissue erosion compared to patients whose prolapse was repaired with native tissue.
“Therefore, the FDA continues to believe that these devices do not have a favorable benefit-risk profile,” wrote FDA in an update to its webpage detailing the agency’s regulatory oversight of urogynecologic surgical mesh products.
The announcement is the latest chapter in a decade-long history of regulatory scrutiny of surgical mesh products for POP and other pelvic floor conditions that began when the agency issued a July 2011 update detailing serious complications associated with transvaginal placement of the mesh products.
The two final reports submitted by Boston Scientific summarize 36-month follow-up data from the two required postmarket surveillance studies (522 studies) of patients who had received the firm’s transvaginal mesh for POP repair. FDA declined to approve Boston Scientific’s premarket approval applications for two POP devices, Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System, in April of 2019 “because the data submitted did not provide a reasonable assurance of safety and effectiveness.”
The 2019 actions followed a 2016 reclassification of surgical mesh for transvaginal POP repair into class III, the most stringent of its device review pathways and the route reserved for high-risk devices. Patients had reported thousands of adverse events, including pelvic pain and bleeding, that occurred after mesh placement for POP repair. (RELATED: FDA halts all US sales of surgical mesh, Regulatory Focus 16 April 2019)
Previously, FDA’s Obstetrics and Gynecology Devices advisory committee had recommended that surgical mesh should demonstrate superiority over native tissue transvaginal repair of POP at 36 months, with similar safety outcomes.
FDA is awaiting the final 522 report from Coloplast, who also marketed a mesh device for transvaginal POP repair.
The agency notes that it continues to track medical device reports and other postmarket information, and to conduct epidemiological research on the long-term performance of surgical mesh to treat POP and stress urinary incontinence.


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