Karen Nash is a medical reporter and media consultant based in Monroeville, PA.
Clinicians from the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction, AUA, and American Urogynecologic Society discuss the FDA ban on mesh for pelvic organ prolapse.
"Speaking on behalf of SUFU, we can’t discount the fact that some patients have had problems with mesh used for prolapse repair. That is an important issue. We await further data, but until then, the FDA has taken its position, and that’s where we are right now.
If you ask me what my biggest concern with the issue right now is, it would be the potential for slings to suffer the same fate as mesh for prolapse repair. Frankly, that would be a disservice to women given that the literature on slings supports slings as a safe and efficacious option for treatment of stress incontinence.
SUFU is focusing efforts on making sure that slings don’t get lumped together with the prolapse mesh and end up going down the same path.
Slings have been successful with very low risk. The midurethral mesh sling has been studied more than any other anti-incontinence procedure and the literature is very supportive of the sling as a safe and efficacious option.
If someone chooses not to have a sling, that’s fine. We just don’t want women to lose the option to choose something that the literature supports as very viable, with a very good risk-benefit ratio.
Prolapse mesh doesn’t have as much literature as the sling, so we would not want the ban on the use of mesh on prolapse to erroneously be translated to the slings.
I hope sling mesh is not affected, but the possibility is concerning given that it has been banned in other countries. This happened recently in the UK, although they’re calling it a ‘pause’ there, so hopefully it’s only temporary.”
Kathleen Kobashi, MD
Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
Next:"The AUA understands the rationale behind the FDA decision. It means we need to focus on using the patient’s own tissues when doing vaginal repairs.""The AUA understands the rationale behind the FDA decision. It means we need to focus on using the patient’s own tissues when doing vaginal repairs.
Also see - Mesh: Emotion vs. evidence
The other point is to distinguish that none of this ban has anything to do with abdominal mesh repairs, so that remains a viable, if not the most viable option for patients with advanced prolapse, particularly when vaginal repairs can’t be done.
It’s hard to know with the FDA if this is permanent. They certainly left open the possibility that vaginal mesh repairs would be permitted again. Some ongoing studies [in which] the FDA wants to assess safety and efficacy for vaginal repairs aren’t completed. It’s conceivable that if those come out and show an acceptable rate of adverse events and acceptable outcomes, the FDA will reevaluate.
A relatively select group of patients need mesh repair vaginally. In that group, it’s more of a challenge to offer vaginal repair that will be effective. For most patients with prolapse, the use of mesh isn’t necessary. Native tissue is perfectly reasonable and successful. It becomes a problem in advanced or recurrent prolapse where mesh may have been a good option but is no longer available.
The most important aspect is getting this procedure into the hands of surgeons who have adequate training and expertise, because if you’re not addressing all aspects of the prolapse, it’s very likely to recur. We understand there were unacceptable adverse effects with mesh, so we have to come up with better options moving forward.”
Gary Lemack, MD
American Urological Association
Next:"If companies want to show that mesh for prolapse is effective in the high-risk population, where most people actually use them, they can do that."“I spoke to the FDA OB/GYN device panel and asked the questions floating around social media, such as why they didn’t wait for the 3-year data and why they aren’t looking at the use of these devices in high-risk populations.
The FDA’s concern about these devices has been gradually escalating since 2008; then came 522 orders that are actually congressionally mandated processes with a specific timeline. The FDA released the recall on these devices because they ran out of time. The companies knew the deadline but didn’t turn the data in on time to support the proposals.
The companies had to show these devices have superior durability at the 3-year mark because that was the outcome recommended to offset the increased risk. But the companies didn’t have that data yet. So the FDA had to stop the sale. The FDA didn’t stop the studies; companies are actually compelled to complete the studies. If they show superiority, manufacturers can get the product back on the market.
My primary concern is that the studies are not completed and there’s a lot of angst that is probably unnecessary.
The companies are in the driver’s seat. If companies want to show that mesh for prolapse is effective in the high-risk population, where most people actually use them, they can do that. But companies haven’t submitted it that way. My hope is that the companies will submit research to support that.”
Geoffrey Cundiff, MD
American Urogynecologic Society