Manufacturers of surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) have been ordered by the Food and Drug Administration (FDA) to stop selling and distributing these devices.
Since 2011, the FDA has seen an increase in the number of reported adverse events association with the use of surgical mesh for transvaginal POP repair. In response to these safety concerns, in 2016, the agency reclassified these mesh devices as class III (high risk) which required manufacturers to submit and obtain approval of premarket approval (PMA) applications.
The remaining manufacturers, Boston Scientific and Coloplast, submitted PMAs that, according to the FDA, “have not demonstrated a reasonable assurance of safety and effectiveness for these devices.” Boston Scientific filed PMAs for the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System; Coloplast filed a PMA for the Restorelle DirectFix Anterior.
To support a favorable benefit-risk profile, the agency decided that the “effectiveness of surgical mesh for transvaginal repair of POP should be superior to native tissue repair at 36 months and the safety outcomes for surgical mesh for transvaginal repair of POP should be comparable to native tissue repair;” the PMAs, however, did not provide this information and were therefore not approved. While the products will no longer be available for use, the companies are still expected to follow-up with patients that were enrolled in their clinical studies.
For patients who are satisfied with their surgery, the FDA notes that no additional action apart from routine follow-up care is necessary; alternative treatment options should be discussed with patients who were planning to have mesh placed transvaginally for the repair of POP.
For more information visit FDA.gov.