urogynecology

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What Went Wrong With Vaginal Mesh: The Podcast

Radio Boston ran a short piece on the problems with vaginal mesh earlier this week, but a key voice didn’t make the final cut: Dr. Anne Weber, a urogynecologist, formerly with the NIH, was the lead author of a clinical practice bulletin on pelvic organ prolapse published by the influential professional group, the American College of Obstetricians and Gynecologists.

In the bulletin, published back in 2007 Dr. Weber used the word “experimental” to describe a type of surgery in which synthetic mesh is implanted vaginally to repair prolapse, a condition many women face after childbirth and as they age in which tissues become stretched and weakened and pelvic organs, such as the bladder, can sag or bulge into the vagina. Seven months after the original bulletin was published, it was pulled, and replaced with another bulletin on prolapse, this one with the word “experimental” gone.

Dr. Weber says the revision, which she opposed, was based on some doctors’ fear that insurers would not cover a procedure deemed experimental. “I think ACOG was choosing to protect its clinicians’ insurance incomes over patients’ well being,” she told me in an interview.

You can read more about the controversy, and about why vaginal mesh surgery is now under scrutiny, here.

So, for the record, here’s the full Radio Boston segment, with Dr. Weber’s comments included.

Surgery Under Scrutiny: What Went Wrong With Vaginal Mesh

On a rainy night in early September, six women gathered for dinner at a Macaroni Grill restaurant in Gaithersburg, Maryland. They had come from around the country: Utah, Georgia, Florida, New York, Texas. But their mood wasn’t festive. All six were in town to speak publicly about their personal medical traumas in front of an advisory panel for the U.S. Food and Drug Administration.

Between them, the women figured they had undergone 45 surgical procedures to try to undo the damage resulting from vaginal surgery using synthetic mesh devices. The mesh implants were supposed to free them from the intimate discomforts that millions of women face after childbirth and as they age: pelvic organ prolapse, in which stretched, weakened tissues can allow the bladder or other organs to sag or bulge into the vagina, and stress urinary incontinence, which can lead to involuntary leakage with every laugh or cough. Once implanted, the hammock-like mesh was meant to shore up the supportive pelvic tissues and help keep sagging organs in place.

But rather than fix their problems, the mesh led to a range of far more awful complications. For some, the material eroded through the vaginal lining, causing infections and nerve damage, as well as excruciating pain, the inability to sit down or urinate without a catheter, multiple hospitalizations and a halt to their sex lives.

“I was in the most horrendous pain I’ve ever experienced,” said Amy Gezon, a 43-year-old mother of three and one of the women who testified before the FDA advisory panel. “I finally ended up in the ER after expressing a desire to end my life just to escape the pain. If I knew one-tenth of the information out there in the literature…I would have never consented to this surgery.”

A Higher-Risk Device

The FDA, which has already detailed the serious complications linked to vaginal mesh surgery in a series of public health alerts – one in 2008 and an update this summer – is now considering reclassifying some of the devices into a higher-risk category that would require more evidence of safety and effectiveness, including clinical studies. Continue reading