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Archive August 2016 XVII, No. 8

The Trouble With Transvaginal Mesh

Why did the FDA ever approve a product that has injured thousands of women? There's plenty of blame to go around.

Jim Burger

Jim Burger, Senior Editor

BIO

transvaginal mesh

The controversy surrounding vaginal mesh is a tale of greed and incompetence. That's something people seem to agree on. The question of whose greed and whose incompetence is where they begin to vehemently disagree.

The truth may be somewhat elusive, obscured by accusations flying back and forth among plaintiffs' attorneys, medical device manufacturers, the federal government, physicians and patients. Caught in the crossfire are the women who've become collateral damage — those who had pelvic meshes and slings implanted to treat either stress urinary incontinence or pelvic organ prolapse (POP) and who suffered dire, sometimes irreversible, complications as a result, including urinary dysfunction, loss of sexual function, constipation and severe pain.

The saga, which began in the 1990s, continues in 2016, playing out in boardrooms and courtrooms across the country. Tens of thousands of product liability lawsuits against mesh manufacturers like Johnson & Johnson subsidiary Ethicon, Boston Scientific and Endo International are pushing forward and hundreds of millions, if not billions, of dollars have already changed hands as a result. In 2014, Endo said it would pay about $830 million to settle more than 20,000 personal injury lawsuits that alleged its vaginal mesh implants eroded in some women and left them incontinent and in pain.

What remains to be seen is whether surgeons will continue to implant vaginal mesh.

"What I'm afraid is going to happen is that 5 years from now we won't have any of these (mesh) products around," says urologist Brian A. Feagins, MD, medical director of the Texas Health Women's Specialty Surgery Center in Dallas.

That would be fine with L. Lewis Wall, MD, a professor of obstetrics and gynecology at Washington University School of Medicine in St. Louis, who has petitioned the U.S. Food and Drug Administration to recall all vaginal mesh products and ban further commercial sales. The wide disparity in the 2 physicians' attitudes reflects the different perceptions about what led to this epic problem, and about who's to blame for the mesh mess.

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