Doctors: Pelvic mesh lawsuits are ill-advised

SEATTLE -- Doctors who specialize in female pelvic medicine say lawsuits by four states, including Washington and California, over products used to treat pelvic floor disorders and incontinence might scare patients away from the best treatment options -- or maybe even push the products off the market.

Sixty-three Washington surgeons signed a letter to state Attorney General Bob Ferguson, arguing his consumer-protection lawsuit against Johnson & Johnson and its Ethicon Inc. subsidiary is off-base. The lawsuit states the companies failed to disclose risks associated with the products, but in their letter the doctors said they were never deceived and the case is based on a misconception about how they assess dangers posed by medical procedures.

"We have served on national and regional medical societies in women's health," wrote Dr. Jeffrey Clemons, a pelvic reconstructive surgeon in Tacoma. "It is astonishing to us that the AG is proceeding with this lawsuit without first availing themselves of the significant experience and expertise of this group."

At issue is "transvaginal mesh" -- plastic mesh products implanted to correct a variety of pelvic floor disorders.

They came on the U.S. market in the late 1990s to treat stress urinary incontinence -- a condition triggered by physical activity such as coughing, sneezing or running common and sometimes debilitating in women after childbirth. The treatment involves using a thin mesh strip, called a "mid-urethral sling," to support the urethra, the tube carrying urine away from the bladder.

The products were so successful -- one of the most significant advances in women's health in recent decades, the physicians said -- companies began developing similar mesh products to treat another condition, called pelvic organ prolapse.

In such cases, pelvic organs such as the uterus and bladder drop from their normal position due to muscle weakening. A sheet of mesh can be used to support the pelvic floor.

However, treating pelvic organ prolapse with mesh proved problematic after those products were introduced in 2004. They were more likely to bring serious complications, including permanent incontinence, severe discomfort and an inability to have sex.

The U.S. Food and Drug Administration issued warnings in 2008 and 2011, and companies pulled most of the transvaginal mesh products for organ prolapse from the market.

Tens of thousands of women have filed liability claims against Johnson & Johnson and other companies, with some saying they knew nothing about the potential complications.