Poll Indicates F.D.A. Panel Would Recommend Reclassifying Transvaginal Surgical Mesh to Class III Device
On Thursday an informal poll of an F.D.A. advisory panel revealed that the majority of members would favor reclassifying transvaginal surgical mesh products from class II medical devices to class III devices. Though the panel did not formally vote at the Thursday meeting, the poll may be a harbinger of the things to come.
Reclassification to class III is significant because class II devices can take advantage of the 510k approval process, which only requires that the device be substantially equivalent to previously approved devices; read our previous post on 510k approval process. A change from class II to class III could not only force manufacturers to perform trials to prove the safety and efficacy of their products, but could also force manufacturers to obtain approval on manufacturing procedures, suffer plant inspections, and deal with longer review times. This would be a significant step in ensuring the future safety of these devices before they are released on the public. Unfortunately reclassification would come too late for the estimated 75,000 women who had transvaginal surgical mesh implanted last year alone. Though the majority of women implanted with transvaginal surgical mesh do not suffer adverse effects, a significant portion of them suffer debilitating complications; read our August 9th blog for more information.
The panel continued to meet on Friday, but it is not clear when a formal vote will take place. Though a recommendation from the panel to change the classification of transvaginal surgical mesh does not guarantee the change, the F.D.A. frequently follows the advice of its advisory panels.