How has the FDA’s mesh guidance affected POP treatment?

May 26, 2020

"I prefer doing transvaginal prolapse surgery with native tissue and always have. So I was not affected when mesh was restricted," says one urologist.

Urology Times® reached to three urologists (selected randomly) and asked them each the following question: How has the FDA's mesh guidance affected POP treatment?

"It didn’t change my treatment. I never used transvaginal mesh for prolapse, maybe because I’m old. I trained in an era that didn’t really use it for prolapse. It became popular after I was already in practice.

I used mesh for recurrent prolapse through abdominal sacrocolpopexy. I adopted the new technology of robotics, but it was still placement of mesh from a transabdominal route. It was the same procedure I already did, just less invasive access.

I prefer doing transvaginal prolapse surgery with native tissue and always have. So I was not affected when mesh was restricted.

It wasn’t just that transvaginal mesh came along after I trained. We all adopt new technologies and advancements to some degree. I just wasn’t comfortable with transvaginal mesh because of the exposure to the outside environment required to place it. Data might have swayed me, but there was never a study that changed how I wanted to approach prolapse.

I have 2 smart partners who used transvaginal mesh. Of course, they’re a different generation, and their training experience was different. They’re doing mostly transvaginal native tissue repairs now, with occasional robotic abdominal sacrocolpopexies or biologic graft material. Neither did a fellowship, and my additional training probably influenced my thinking.

A lot of people did very good transvaginal prolapse surgeries using mesh, and some didn’t; then there are people who just didn’t adopt it, like me.”

Harriette Scarpero, MD / Nashville, Tennessee

 

“I do more robotic sacrocolpopexies than I used to. I did more vaginally with mesh kits, because I never really had a problem. They were great; my patients loved them, and they lasted longer.

Prior to mesh, I did native tissue repairs, which didn’t last long. Anecdotally, for the average woman, a native repair would last 3 to 5 years, while mesh could easily go 8 to 10. I trained with transvaginal mesh and used it for about 15 years. Now, I’m doing native tissue repairs, if the patient wants it done vaginally, over the past 6 to 8 months. We’ll see how long they last.

I don’t do as much vaginally as I used to. For severe prolapse, I do robotic sacrocolpopexies using the mesh that’s still available, and patients do well, but it’s more invasive.

It was a knee-jerk reaction by the FDA to pull those products off the market. There are issues with mesh, but a lot had to do with technique and experience. With mesh, I had some complications, but nothing major. The FDA should have considered how many cases surgeons were doing and what their complication rates were prior to taking the product off market. They could have told surgeons they needed more training or that patient selection needed to change, but that would’ve been a lot more work…for the government.

Kit manufacturers actually shot themselves in the foot. When kits were developed, they took them out to every surgeon and said, ‘This is great! Just do it this way.’ Some surgeons adapted, were able to do it efficiently, incorporated it into their practices, and had few complications. Other surgeons did it infrequently and therefore had more complications.”

Pankaj Jain, MD, MBA / Phoenix, Arizona

 

“I’m fortunate. I trained more recently and do a lot of robotic surgery. From that sense, it hasn’t changed things for me except reinforce my training in a better surgery. I wasn’t doing much transvaginal mesh anyway, because the writing was on the wall. Plus, results weren’t as good. I’m in a big group, and it seems to have affected older surgeons more than me.

It’s a more fellowship-driven field now. Instead of doing certain vaginal surgeries or one specific aspect of the surgery well, now you have to address it in a variety of ways.

From that standpoint, fewer urologists are willing to operate in that space. A number of my older partners trained at Mayo Clinic and used a lot of Xenform. Technically, it’s not “synthetic mesh” but was included in the FDA warning. A lot of my partners have completely stopped doing that surgery. That makes somebody like me busier.

When it initially happened, there were a lot of questions. People wanted things removed that were done 10 years earlier that weren’t hurting them. They wanted the mesh removed because of the warnings. But that’s kind of slacked off.

Transvaginal mesh came in kits; doctors trained in weekend courses. Mesh kits weren’t terrible if the patient was chosen correctly and doctors knew what they were doing. But there was a mixture of doctors who didn’t do many procedures and on people who shouldn’t have had that particular surgery. That’s probably where we got ourselves in trouble.”

Sam Kuykendall, MD / Kansas City, Missouri