Bladder Sling Complications & Lawsuits

Thousands of women claim to have experienced serious complications after bladder sling or surgical mesh implantation. Many of these women are making their concerns heard in a chorus of lawsuits around the country; and, surveys suggest that as many as 33% of women who have undergone this surgery will eventually seek removal of their bladder sling because of severe complications.

Bladder slings & transvaginal mesh devices

With pregnancy, time, age, and because of other factors such as obesity, many adult women will experience a weakening of vaginal tissues, which in turn causes the bladders and other surrounding pelvic organs to descend, creating a condition called “pelvic organ prolapse.”  Common accompanying symptoms are urinary leakage and incontinence, affecting some 39 million American women.  As many as one in five of these women, for whom the condition has become especially serious or debilitating, will choose surgery to correct the problem.

Enter bladder slings and transvaginal mesh devices.  These surgical solutions hold out hope of greatly alleviating problems of urinary incontinence, as a recent study by the University of Michigan concludes.  The study, published in The New England Journal of Medicine, found that patients who receive a mid-urethral sling, which is a permanent, mesh-made “hammock” inserted underneath the bladder to support the pelvic organs, enjoy the prospect of significantly reducing their risks of urinary incontinence (by more than half).

But if an improved quality of life proves tempting for prospective recipients of this surgery, the University of Michigan study delivers some warnings, too.  Women who undergo surgery to receive a bladder sling and/or transvaginal mesh reportedly encounter higher rates of complications such as difficulty emptying their bladders, urinary tract infections, bladder perforations and bleeding.

In short, bladder slings pose a serious trade-off that comes with potentially serious side effects and risks of further personal injury.

Bladder sling complications and failures spark lawsuits

Hundreds of women are now suing the makers of the transvaginal mesh devices that promised them an improvement in their symptoms of pelvic prolapse and other urological or gynecological problems.  The pliable, gauze-like material that forms the mesh used to support the bladder or uterus has caused an outcry from plaintiffs like Oklahoma woman Lori Eggenberg, who underwent a bladder sling surgery in 2010.  Eggenberg says she thought she was undergoing the most up-to-date, least invasive form of treatment for her problem.  She alleges she received a rude awakening afterwards, in the form of debilitating pain.

Eggenberg joins other plaintiffs around the country in alleging:

• That the bladder sling mesh is tearing into their vaginal wall, causing unbearable pain
• That urination is painful and that they are unable to have sexual intercourse as a result of their bladder swing
• That they have been forced to embark on more corrective surgeries in an attempt to remove the mesh, which in many cases has become grafted into their body tissue and is potentially impossible to remove
• That their losses, in addition to an influx of medical bills, have included loss of consortium (marital intimacy and/or divorce)

Other side effects alleged to be associated with bladder slings are:

• Abscess formation
• Bladder spasms
• Bleeding and blood clots
• Pelvic organ injuries, including infections
• Mesh fragmentation, erosion, migration and protrusion
• Overactive bladder
• Vaginal prolapse

In other words, the complications of transvaginal mesh can be catastrophic. One source describes the plight of these plaintiffs in graphic, gruesome terms:  “The problem with these meshes is they’re becoming very rigid and very sharp.  It’s almost like taking a soft piece of fiberglass material and running a blowtorch over it until it shrivels up, gets hard. It’s cutting through the vagina wall. It’s cutting into organs. It’s actually acting like a knife inside a woman’s body. The pain is just horrible.”

FDA warnings regarding bladder slings and surgical mesh

The Food and Drug Administration (FDA) anticipated there would be troubles related to surgical mesh products as early as 2008, when the regulatory agency cited “1,000 reports of complications associated with surgical mesh.”  Problems cited included erosion, infection, pain, incontinence and vaginal scarring, often with no recourse for undoing the harm done.  The FDA released a second report about the risks associated with transvaginal mesh in 2011.  That report stated that 1 in 10 mesh surgeries will fail.  During their lifetime, a number of bladder slings produced by different makers have also seen recalls.

Makers of mesh products negligent, claim plaintiffs—jury agrees

Plaintiffs in transvaginal mesh lawsuits claim the makers of bladder sling devices have been intentionally misleading from the very beginning, when manufacturers sought clearance from the FDA on the basis of allegedly fraudulent data.  Plaintiffs allege that the companies marketing these devices could have been more forthcoming both with doctors and patients about the dangers of bladder slings.

Apparently at least one jury agrees.  One of the first of these transvaginal mesh lawsuits went to trial last year, reaping a mind-blowing $11 million verdict in favor of the plaintiff (versus Johnson and Johnson and its subsidiary Ethicon).  In a public statement, Ethicon promised to appeal the verdict.

Meanwhile, patients like one Oklahoma woman who refused to be identified in a recent piece by a local T.V. station in that state, still cannot empty their bladders—one year following mesh surgery.  This woman has undergone at least six revision surgeries to remove the fragmented mesh and to no avail.

“I don’t think I can stomach another surgery,” she said.  “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.”

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