Pharmaceutical

Transvaginal mesh complications leave some women facing lifetime of injury

vaginal mesh sling Transvaginal mesh complications leave some women facing lifetime of injuryOne in 10 women implanted with transvaginal mesh to correct pelvic organ prolapse (POP) or stress urinary incontinence (SUI) will develop complications, according to the U.S. Food and Drug Administration (FDA). For women who have had a successful implant, life is usually greatly improved. But for the 10 percent who experience problems with their vaginal mesh implant, life can become an excruciating nightmare.

One woman who was implanted with a transvaginal mesh bladder sling in 2010 told Oklahoma City’s KFOR News that she thought she was receiving the newest and best type of surgery to correct her incontinence problems, one that was minimally invasive yet more advanced than conventional forms of surgery.

But soon after the mesh surgery, the patient, Lori, began to experience pain so intense that  she says it felt like she was being ripped apart from the inside. For almost three years she has tried to have revision surgery to remove the mesh from her body before it does even more damage, but she has since lost her health insurance.  Making matters worse, she has been refused treatment by at least one local urologist “because of her involvement in ongoing litigation,” KFOR reported.

Lori is just one of hundreds of Oklahoma women and thousands nationally who are barely coping with the consequences of a transvaginal mesh surgery gone wrong.

Another Oklahoma City woman who asked KFOR not to be identified “because she is embarrassed about her failed surgery” told the news station she has nearly given up on trying to attain a normal, pain-free life after her mesh surgery.

“Mine turned out just incredibly wrong and no one knew how to fix it. I think that’s the problem is they put it in, and then when they see there’s a problem, they don’t have the slightest idea what to do to fix it.”

The woman still can’t empty her bladder after the surgery a year ago. She also told KFOR that she has undergone six revision surgeries to have pieces of the mesh removed.

“The thing is, I don’t even want to go to the doctor anymore,” she told KFOR. “I don’t want to go in there, hear them say, ‘Well, we can fix that.’ I don’t think I can stomach another surgery. Whatever is left, I want to be left with it. Knowing what I know now, if I could go back, I would not have the surgery at all.”

Several companies manufacture and market transvaginal mesh kits, and a half dozen of them face mounting lawsuits over the allegedly defective products. Complaints typically include tightening and erosion of the mesh through the vaginal walls, perforation injury to surrounding organs, infection, pain, incontinence, vaginal scarring, and inability to engage in sexual intercourse.

Any of those conditions might be manageable on a temporary basis, but for some vaginal mesh implantees, there is no way to remove the mesh. The thin, gauze-like products are designed to become incorporated with surrounding tissue, making their removal impossible in some patients.

Judge Joseph R. Goodwin, who is overseeing multidistrict litigation (MDL) against several manufacturers of transvaginal mesh in a West Virginia federal court, said he will begin hearing the first of these personal injury lawsuits on December 3, 2013. The news comes as a welcome sign of progress for thousands of women experiencing devastating complications from surgical mesh implantation. Most plaintiffs allege the makers failed to properly test their products before marketing them and failed to adequately warn doctors and patients about the potential risks.

The first lawsuit that will be tried has been brought by a plaintiff against American Medical Systems over injuries caused by the company’s female pelvic repair products. Judge Goodwin will then hear a case against Johnson & Johnson subsidiary Ethicon, whose Gynecare division manufactured a number of transvaginal mesh products, and Boston Scientific Corp.

Source:

KFOR Oklahoma City