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Lee expected the pelvic mesh device she had implanted six years ago to fix her leaky bladder, which could be set off by a sneeze, laugh, cough or strenuous exercise.
But after experiencing serious health problems related to the device and two additional surgeries, the 50-something Lee has found just how badly things can go awry.
"When they come out with a product and make it sound like a cure-all, I don't know about other women, but I jumped at the chance to get it fixed," said Lee, whom The Salt Lake Tribune agreed to not fully identify because of the personal nature of her story.
Lee is among 50 Utah women — joined in many instances by their husbands — who filed lawsuits last week alleging they suffered "severe and permanent bodily injuries" from a pelvic mesh device implanted in their bodies to treat pelvic organ prolapse or stress urinary incontinence. The Utah lawsuits, which seek unspecified damages, target devices made by three companies: Ethicon Inc., a division of Johnson & Johnson; Boston Scientific; and American Medical Systems, a subsidiary of Endo Pharmaceuticals.
Rhome Zabriskie, the Provo attorney handling most of the Utah cases, said he expects to file an additional 100 or so cases in coming weeks. He said that, so far, close to 10,000 lawsuits have been filed around the country over the mesh implants.
"We estimate there are over 1 million women in the U.S. who have these products," Zabriskie said.
It is likely the Utah cases will be transferred to federal court in the Southern District of West Virginia. In February, a United States Judicial Panel on Multi-district Litigation agreed that lawsuits then pending in 27 states and the District of Columbia against makers of the devices should be heard by that court to eliminate duplication of discovery, provide consistent pretrial rulings and conserve resources.
Pelvic mesh implants are used to treat pelvic organ prolapse, which occurs when tissue and muscles weaken and allow the bladder and other reproductive organs to slip into the vagina, as well as stress urinary incontinence problems.
The lifetime risk of pelvic organ prolapse is 30 percent to 50 percent, with 2 percent experiencing associated sexual or urinary problems. According to the U.S. Food and Drug Administration, 20 percent to 40 percent of women experience stress incontinence problems due to pressure on the bladder as a result of coughing, sneezing, heavy lifting or other physical activity.
In 2010, approximately 300,000 women in the U.S. had surgery for pelvic organ prolapse; one-third of those surgeries used metallic or polymeric mesh implants, and most were implanted during a transvaginal surgery, according to the FDA. An additional 260,000 women had surgery for stress urinary incontinence.
The FDA first issued an alert about adverse events involving pelvic mesh devices in October 2008. In a report released last July, the agency said it found 2,874 reports filed between 2008 and 2010 of malfunction, injury and even death related to the products, with reports increasing dramatically in recent years as use of the devices increased. The FDA concluded that serious adverse events are "not rare" and there is not conclusive evidence of better outcomes with mesh devices placed through a vaginal incision, which may "expose patients to greater risk."
"Many of them are much worse off than they were before the surgery," Zabriskie said.
The most frequent complications include device erosion; pain, including pain during sexual intercourse for both partners; infection; urinary and bowel problems; bleeding; and organ perforation. Between 2008 and 2010, seven deaths were associated with pelvic mesh implants during placement surgery or as a result of organ perforation or bleeding.
Lee began having problems within a year of getting her implant. Her gynecologist performed a second surgery and for another year or two, she had no trouble. But then Lee began experiencing frequent yeast and bladder infections, which interfered with her daily life. She began having the same leakage problems that made her seek help in the first place. And, the "sensitivity had never gone away for my husband," she said.
"It just plain didn't work," Lee said. "I didn't want to do anything because I was constantly in pain. It was very frustrating because when I had the first initial sling done, I was under the impression I would never have to have it done again."
After hearing reports about problems other women were experiencing, Lee contacted Zabriskie. He put Lee in contact with another physician, who performed a third surgery about a month ago to remove the mesh and create a new pelvic sling using her own skin in an abdominal surgery.
"If he hadn't told me about how to get it fixed, I wouldn't have known," she said. "I can already tell a difference. I sneeze and I cough and I don't leak."
The FDA said some adverse complications were "life-altering for some women," and in some instances problems continue even after the devices are surgically removed.
Zabriskie said several surgeons have described the removal procedure as much more difficult because tissue often has grown around and into the mesh; in some cases, surgeons have been able to remove only a portion of the mesh.
"One doctor who described it to me said it was like trying to remove chicken wire from concrete," Zabriskie said.
Zabriskie said one study found problems typically surfaced about four to five years after implantation, which may be too late to file a claim for damages.
"We're encouraging people who have the product to talk to an attorney immediately, even if they are not having a problem yet," he said.
In January, the FDA ordered six companies that make the mesh devices to set up studies to track complications related to the devices.
But Johnson & Johnson announced last month it would stop selling surgical mesh implants within 120 days in the U.S. and phase out sales globally over a three- to nine-month period, according to The Associated Press, but stopped short of recalling the devices.
Last fall, after a two-day meeting organized by the FDA on the products' safety and effectiveness, Boston Scientific issued a statement saying it believes "that mesh products are a valuable option for surgeons who treat women with pelvic floor disorders and stress urinary incontinence and that these products offer a safe and effective alternative to non-mesh treatment options." It said it would continue to work with the FDA to "reinforce the safety and effectiveness" of the devices.
The Tribune requested but did not receive comment from the three companies named in the Utah lawsuits.