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Surgeons fear pelvic mesh lawsuits will spook patients

Surgeons fear pelvic mesh lawsuits will spook patients

January 11th, 2019 in National News

In this Dec. 20, 2018, photo, Dr. Jeffrey Clemons, a pelvic reconstructive surgeon, poses for a photo in Tacoma, Wash., with a letter to state Attorney General Bob Ferguson that he helped draft and was signed by more than 60 Washington state surgeons. The letter argues that Ferguson's consumer-protection lawsuit against Johnson & Johnson and its Ethicon Inc. subsidiary over products used to treat pelvic floor disorders and incontinence in women might scare patients away from the best treatment options. (AP Photo/Ted S. Warren)

SEATTLE (AP) — Doctors who specialize in female pelvic medicine said 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 says 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.”

Doctors in California are drafting a similar letter to Attorney General Xavier Becerra, and the president of the American Urogynecologic Society, which represents 1,900 medical professionals, has issued a statement expressing some of the same concerns.

Clemons and two other doctors who signed the Washington letter have been retained by defense counsel as consultants in the case, but Clemons said he wrote it without payment or assistance from Johnson & Johnson.

At issue is “transvaginal mesh” — plastic mesh products that are 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 like coughing, sneezing or running that is 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 that carries 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 — that 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.

The doctors said Washington’s lawsuit conflates the acceptable risks of using pelvic mesh to treat incontinence with the less tolerable risks of using it for pelvic organ prolapse. They’re worried it could force mid-urethral slings off the market, though the attorney general’s office says that’s not the goal.

Washington, California, Kentucky and Mississippi are pursuing lawsuits that claim Johnson & Johnson deceived doctors and patients, and the surgeries ruined some women’s quality of life. They said product marketing brochures and instruction pamphlets should have contained much more detail about the risks.