FDA Affirms Increased Risk with Pelvic Mesh Products
Patients with pelvic organ prolapse (POP) who underwent surgical mesh repair had a greater risk of mesh exposure and tissue erosion compared with patients whose condition was repaired with native tissue, according to the Food and Drug Administration (FDA). In an update with its review of final results from postmarket surveillance of transvaginal mesh devices, the agency noted: "Therefore, the FDA continues to believe that these devices do not have a favorable benefit-risk profile." FDA's regulatory scrutiny of urogynecologic surgical mesh products for POP and other pelvic floor conditions began a decade ago, when it announced serious complications related to transvaginal placement of the mesh products. In its latest update, FDA reviewed two final reports submitted by Boston Scientific with 36-month follow-up data from two required postmarket surveillance studies of patients who received the company's transvaginal mesh to repair POP. In 2016, FDA reclassified surgical mesh for transvaginal POP repair into class III, or high risk. Thousands of patients had reported adverse events such as pelvic pain and bleeding after undergoing mesh placement for POP repair. In 2019, the agency chose not to approve Boston Scientific's premarket applications for two POP devices, saying "the data submitted did not provide a reasonable assurance of safety and effectiveness." Coloplast, which also marketed a mesh device for transvaginal POP repair, must also submit a final report on its product to FDA..
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