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  4.  » Transvaginal Mesh Complications May Lead FDA to Classify Devices as High Risk

Transvaginal Mesh Complications May Lead FDA to Classify Devices as High Risk

The FDA is proposing stricter regulations for transvaginal mesh products used in the repair of pelvic organ prolapse (POP), according to the Wall Street Journal. A document on the agency’s website announced that the “rate and severity” of POP mesh complications in patients implanted transvaginally has called into question the safety of the products. Under the proposal, transvaginal meshes used in POP patients would be reclassified into Class III, the highest risk category available for medical devices. If the new mesh proposals are enacted, the devices would be subject to a premarket review process, which would mandate that manufacturers conduct research on the product’s safety and effectiveness before being approved. Currently, transvaginal meshes, which have been linked to serious complications including mesh erosion and vaginal scarring, are reviewed under a fast-tracked 510(k) process in which products are approved based on their similarity to those already on the market. 

The recommendations were announced just prior to a September 8th and 9th meeting of an OB/GYN panel of experts, which was convened by the FDA and looked to evaluate the safety and effectiveness of transvaginal mesh products. The panel met to discuss the risk of transvaginal mesh placement in POP patients, clinical trials which may be needed to assess the risks of benefits of mesh surgery, and the agency’s recommendations for patients and doctors. While the meeting reportedly focused on mesh treatment for POP, the panel was also asked to discuss the product’s use in stress urinary incontinence (SUI) patients. 

Transvaginal mesh products, which are manufactured by companies including Johnson & Johnson, C.R. Bard and Boston Scientific, aim to reinforce weakened vaginal walls or to support the urethra. Many women who have undergone transvaginal mesh surgery for POP or SUI, however, have found that these products can lead to a number of serious complications including mesh erosion, urinary problems, pain and discomfort, and vaginal scarring. The continued increase of vaginal mesh complications among patients led the FDA to update its initial announcement regarding the products to warn patients that the transvaginal placement of surgical mesh in POP repair can put patients at a greater risk for complications, without adding any greater clinical benefit. 

Due to the number of reported mesh complications, our attorneys are now available to review claims from women who suffered from vaginal mesh complications to determine if they have legal recourse. To have our New York vaginal mesh attorneys review your claim, at no cost to you, complete our free case review form today.