~Salt Lake Tribune, July 8, 2012
“Lee” had a pelvic mesh sling implanted six years ago to treat incontinence, which was an inconvenience. But after two surgeries and continuing health complications, Lee and about 50 other Utah women have filed lawsuits alleging they are suffering “severe and permanent bodily injuries” from the pelvic mesh devices permanently implanted in their bodies to treat the condition of pelvic organ prolapse (POP) or stress urinary incontinence (SUI). The Provo lawyer handing most of the Utah cases is Rhome Zabriskie who expects to file another 100 or some cases in the coming weeks.
Named in the lawsuits are Ethicon Inc., a division of Johnson & Johnson; Boston Scientific; and American Medical Systems, a subsidiary of Endo Pharmaceuticals. Zabriskie tells the Salt Lake Tribune (here) he estimates there are more than 1 million women in the U.S. who have these polypropylene mesh products.
These cases likely will be transferred to the multidistrict litigation (MDL) which has consolidated thousands of cases in Charleston West Virginia. With one judge in charge, it’s estimated that the discovery process leading up to a resolution can be streamlined and pretrial court rulings will be consistent.
The paper reports that in 2010, an estimated 300,000 women had surgery to treat pelvic organ prolapse with about one-third of those using some type of metallic or polymeric mesh implant while an addition 260,000 women had stress urinary incontinence procedures.
Lee had problems within one year of receiving her implant. Others may go four or five years before they experience complications.
Her complications included bladder and yeast infections, pain, and a return of the urine leakage problems she sought help for in the first place. Other women experience bleeding, organ perforation, bowel problems, painful sex, device erosion, among other complications. Lee had a third surgery to remove the mesh. Her surgeon created a pelvic sling using her own skin in an abdominal surgery. She tells the paper “I can already tell a difference. I sneeze and I cough and I don’t leak.”
Unfortunately, for some women, a mesh removal surgery does not always end the complications. Mesh removal can be performed by few surgeons around the country and in some cases the life-altering complications may involve nerve damage and mesh erosion.
The article does not mention which type of implant Lee received, but Ethicon announced it was removing four different types of mesh from the market last month. The phase-out will occur over the next 9 months and Ethicon, a division of Johnson & Johnson requested the FDA suspend its requirement to have post-market surveillance conducted by the company to map the number and kinds of complications. The FDA has yet to issue a reprieve to the company but must get back to Ethicon in the first week of August. #