Woman with surgical mesh still suffering, years after surgery

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by JANET ST. JAMES

WFAA

Posted on April 24, 2014 at 10:37 PM

Updated Thursday, Apr 24 at 10:43 PM

DALLAS — It's not just walking that's painful for 64-year-old Linda Batiste. Life, in general, is a physical struggle.

"I have pelvic pain," she said through tears. "It actually does feel like a scouring pad in your body. You can feel in your women parts, what it is. It's there."

The condition that brought Batiste to tears is embarrassing for her discuss. That feeling comes from a product left inside her body to fix urinary incontinence.

More than 20-million women in the United States suffer from urinary incontinence and/or pelvic prolapse. In thousands of cases — including Batiste's — doctors use a pliable, gauze-like mesh sling to support the bladder and other organs.

But what Batiste got from her 2011 procedure was not relief.

"I have never been pain-free since then,” she said.

Surgical mesh is a synthetic material manufactured by several companies and routinely used for urinary incontinence, pelvic prolapse, and hernia operations.

Attorney Tim Goss, a parner at the Dallas law firm Freese & Goss, represented Batiste in a product liability case against the Johnson & Johnson subsidiary Ethicon. It was the first mesh cast to go before a Texas jury.

"The polypropylene mesh, it degrades, it disintegrates, it extrudes, it frays, it ropes, and it has particle loss,” he said. “And all of those problems cause other problems — like scarring, chronic pain, for example."

The American Urogynecologic Society says mesh is "safe, effective, and has improved the quality of life for millions..."

Three years ago, Hal Samples described the side-effects of his mesh hernia surgery as "torture."

"It can be a bend-over pain, where it will be a sharp stab," he said.

Samples was forced to travel out of state for surgery to remove the mesh. The procedure was not a complete success, and Samples continues to have some pain, even now.

The FDA first issued a "Public Health Notification" in 2008, saying it had received "over 1,000" reports of "adverse events" "for surgical mesh devices."

In 2011, The FDA sent out another warning, saying "serious complications associated with surgical mesh" "are not rare" and that mesh "may expose patients to greater risk" than traditional procedures.

Since then, women across the country have formed organizations and online support groups trying to get mesh removed from the market.

Linda Batiste won a $1.2 million judgment against the maker of her mesh, Ethicon.

"It's significant because there are almost 100,000 other cases pending around the country regarding this type of product,” said Goss, who represents 9,000 mesh cases.

Goss said the lawsuits have the potential to become the largest mass-tort in history — bigger than the Phen-Fen diet drug mess.

A statement from Ethicon spokesman Matthew Johnson called the Dallas verdict mixed:

"A jury in the 95th Judicial District Court of Dallas County, Texas, returned a mixed verdict today in a product liability trial concerning Ethicon’s TVT-O pelvic mesh, which is used as a minimally invasive treatment for women suffering from stress urinary incontinence (SUI).

"The jury found Ethicon properly informed of the known risks associated with TVT-O. The jury also found that the product was defectively designed. The jury awarded $1,200,000 in compensatory damages. The jury declined to award punitive damages.

“We believe the evidence showed Ethicon’s TVT-O pelvic mesh was properly designed and that Ethicon acted appropriately and responsibly in the research, development and marketing of the product. The jury’s verdict on design defect is disappointing, and we believe we have strong grounds for appeal.

“We empathize with all women suffering from SUI, which can be a serious and debilitating condition, and we are always concerned when a patient experiences adverse medical events,” Johnson continued. “TVT-O has been deemed safe and effective by regulators and practitioners alike, and it continues to be an important option for treating physicians to offer to women suffering from SUI.”

In the meantime, Linda Batiste has had several surgeries to try to remove the mesh, which is embedded in her tissue. Her original problem of incontinence is back.

"And it's compounded the pain that I normally would have had,” she said. “I never wish for any other woman to feel this way or to have it happen to them."

E-mail jstjames@wfaa.com

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