Transvaginal prolapse repair: Mesh is no longer an option
Dr. Gebhart: What led up to the US Food and Drug Administration’s (FDA) market removal of mesh for transvaginal repair of POP?
Dr. Ridgeway: To clarify, it was not a recall—a word that many people use—it was an order to stop producing and distributing surgical mesh intended for transvaginal repair of POP.1 There is a very long history. Transvaginal mesh was introduced with the goal of improving prolapse anatomic and subjective outcomes. Over the last 13 years or so, there were adverse events that led to FDA public health notifications. Consequently, these devices were reclassified, and now require additional testing prior to approval. The newest transvaginal mesh kits were studied.
These 522 studies were completed recently and needed to show superior outcomes because, historically, the risks associated with transvaginal mesh compared to those associated with native tissue repairs are higher: higher reoperation rates, higher rates of other complications, and very minimal improvements in subjective and objective outcomes. Data were presented to the FDA, and it was deemed that these mesh kits did not improve outcomes significantly compared with native tissue repairs.
Dr. Karram: Beri, you stated that very accurately. The pro-mesh advocates were taken back by the idea that the FDA made this recommendation without allowing the outcomes to be followed longer.
Dr. Gebhart: My understanding is that the FDA had a timeline where they had to do a report and the studies had not matured to that end point; thus, they had to go with the data they had even though the studies were not completed. I think they are requesting that they be completed.
Dr. Ridgeway: Additional data will be available, some through the 522 studies, others through randomized controlled trials in which patients were already enrolled and had surgery. As far as I know, I do not think that the decision will be reversed.
Continue to: Native tissue repair and failure risk...