FDA Says 'No More Mesh' for Hernia Repairs -- What Are the Consequences?

I think these are not the important lessons. I think the FDA's approval process has little to do with it and I think the real losers are going to be (again) women with prolapse.
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The FDA just announced that mesh, used during surgery to treat pelvic organ prolapse, has an extremely high rate of erosion (up to 10 percent) and probably shouldn't be used.

Now for the finger pointing: Either cowboy gynecologic surgeons were too quick to adopt mesh in the O.R. or the FDA's 510(k) approval process was too quick to allow mesh in gynecologic surgery.

I think these are not the important lessons. I think the FDA's approval process has little to do with it and I think the real losers are going to be (again) women with prolapse.

But first some background: pelvic organ prolapse occurs when the support structures for women's pelvic organs -- their bladder, urethra, vagina, uterus, even rectum -- weaken or stretch, allowing those organs to shift in a way that causes discomfort or affects function. If the supporting tissue between the bladder and the vagina weakens, for example, the bladder can push into the vagina, causing an inability to urinate, incontinence and discomfort. Intercourse can become problematic. In general, pelvic organ prolapse is no fun.

The surgeries to repair prolapse -- which all involve strengthening supporting structures and sometimes involve suspending organs that have "fallen" -- has a long and troubled past. The history of gynecology is littered with surgical procedures for prolapse that didn't work. In the past 15 years, however, a lot of old surgeries have been abandoned when well-designed clinical trials demonstrated that they didn't work, and a series of new procedures have come into vogue -- many incorporating mesh.

The problem now is that the mesh in some procedures (but not all) has a tendency to erode -- wearing through the vaginal mucosa and exposing its rough and uncomfortable surface to the patient and her sexual partner -- or constrict and scar, causing tightening and discomfort.

Some of these procedures have been stunning successes. Procedures that place mesh under the urethra (the tube that carries urine from the bladder to the outside) are generally quick, require minimal recovery, are safe and are proven to cure a particular type of incontinence. (This use of mesh is not part of the FDA warning, although this distinction may be lost on patients.)

But other mesh procedures, in which mesh is used to support one or more of the vaginal walls, have led to complications. The mesh used for these surgeries is essentially the same mesh used (successfully) by general surgeons to repair hernias and other abdominal wall defects. Here is why FDA reform, for the most part, isn't going to help.

Medicine cross pollinates from one field to another -- we call it innovation. There is a long tradition of taking drugs and devices approved for one purpose and using them for another purpose. Once a device is FDA approved, physicians can (at their peril) use them for pretty much whatever they like. So it is with mesh. I believe that making it harder to get mesh approved for hernia repairs isn't going to make it less likely to erode into women's vaginas -- it's just going to slow down the process of getting discoveries into the clinics and into the O.R.

And the cowboy gynecologic surgeons? These are the innovators who brought about the successful mesh sling procedures that now cure 95 percent of women of incontinence in 30 minutes (when surgeries with 50 percent success rates used to take 5 hours in the O.R. and require weeks of recovery). Millions of women have benefited from the extraordinary era of innovation in gynecologic surgery over the past 15 years. Do we really want these surgeons to stop innovating?

The irony is that as gynecologic surgeons became aware of the mesh problem, they turned back to surgeries that don't use mesh -- but also aren't as effective. Vaginal wall repairs without mesh fail 35-40 percent of the time (and the repeat procedures are even less successful), so surgeons are now stuck using a technique with a high failure rate to avoid a 10 percent risk of erosion. "It ruins my ability to take care of patients," says Dr. Neeraj Kohli, a urogynecologist in private practice near Boston. "I've reduced my use of mesh by 80 percent in the past five years, but when I find the patient where I feel that there is more benefit than risk to use graft or mesh, she's going to look at me as if I've got three heads." Kohli also notes that there are alternatives to mesh or the "old way," including special suture or non-mesh implants, although each has its own downsides.

What would have prevented the mesh complications? For starters, I believe that we need better collaborative surveillance networks so that complications like mesh erosion can be recognized earlier. Also, I believe that larger data collection efforts are a necessity -- so that instead of throwing out all mesh for vaginal repairs, the particular types of mesh that are the worst offenders in particular surgeries could be targeted, and the rest could be tested in carefully monitored trials. As it is so often in medicine: communication and collaboration are our best tools.

I can only imagine that the spirit of innovation that led to such great surgical successes in recent years has been diminished by all of this. I sincerely hope I'm wrong.

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