FDA warning on mesh held little surprise for urologists, Vaginal Mesh Helpline, Vaginal Mesh Lawsuits

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FDA warning on mesh held little surprise for urologists
Publish date: Jan 1, 2012
By:  Karen Nash
Karen Nash
Last summer, the FDA issued a strong warning about the dangers of complications from using mesh for the repair of pelvic organ prolapse and treatment of stress urinary incontinence. Between 2008 and 2010, the FDA said it received more a than 2,800 reports of complications associated with surgical mesh devices, generally placed transvaginally, when used for these indications.

The agency urged physicians to be thoroughly trained, to watch carefully for complications, and to make sure their patients are fully informed about procedures and their risks. In September, an FDA advisory panel concluded that the clinical benefits of using transvaginal mesh for prolapse repair have not been proven, but that available data support the safety and efficacy of first-generation suburethral slings for treating stress incontinence.

Urology Times wanted to know if urologists have changed their approach to prolapse and stress incontinence treatment as a result of the FDA's statement. Urologists say they aren't surprised at the warning, and it hasn't affected what they do, either because they weren't using mesh in the first place or because mesh can be used safely in the hands of the right surgeon.

Brian Cohen, MD, in Asheville, NC, has never used synthetic mesh for prolapse repairs.


Dr. Cohen
"I use all absorbable products, some Vicryl mesh, and Tutoplast by Coloplast, a product which is cadaveric fascia lata," Dr. Cohen said. "That's the way I learned in my residency and fellowship, and I've had good results. You don't have the worries you have with a synthetic mesh. I've seen plenty of patients with dyspareunia afterwards. There's no way to really deal with it."

In practice for 4 years, Dr. Cohen doesn't think the mesh should be banned, but he does think the risks outweigh the potential benefits.

"I just had an 85-year-old woman who had a prolapse repaired five years ago. I had to do a partial cystectomy in order to get the mesh out of her bladder," he said. "I take care of the problems; I'm not interested in causing them."

In Mammoth Lakes, CA, Tomi Bortolazzo, MD, agrees with that sentiment.


Dr. Aspera
"The FDA warnings haven't affected me," Dr. Bortolazzo said. "I work in a rural setting now, but when I worked downtown, I used to take care of all the complications from the gynecologists and other doctors doing all the TVTs with mesh. I even had a young, healthy patient spit mesh from her vagina. A lot of people just don't seem to react well to mesh, so now I use a Mylar sling that has pigskin."

Dr. Bortolazzo, a practitioner for 17 years, says she didn't like what she was seeing with the mesh long before the FDA came out with its statements, so she decided to avoid what she thought would be problems down the road.

"Now, I live in an area where everyone is an athlete and active. People don't like to put something foreign in their bodies," Dr. Bortolazzo said. "So I've been doing more and more autologous slings over the last 10 years."

Dr. Goldman
Although both Dr. Bortolazzo and Dr. Cohen are experienced with the complications, neither thinks the mesh should be banned.

"I'm sure there are places for it, perhaps in an older woman who is not sexually sexually active," Dr. Cohen said. "You'll get a longer-lasting repair."

"There are pros and cons," Dr. Bortolazzo added. "I occasionally use it, but I just don't think it's the best thing."

Other doctors question whether the problem is the mesh, as much as it might be surgical techniques or patient selection.