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Transvaginal Mesh

Bladder Sling Risks, Complications and Side Effects

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A bladder sling is used to treat stress urinary incontinence (SUI) in women. A bladder sling is made of strips of surgical mesh and is usually inserted through one vaginal incision and two small abdominal incisions.

SUI, which primarily occurs in women, is the involuntary loss of urine caused by physical activities, such as laughing and sneezing. Experts say that’s because the urethra — the tube that carries urine out of the body — is much shorter in women (2 inches) than men (10 inches). In addition, the pressures of pregnancy and childbirth, and even aging, can contribute to SUI.

When successful, a bladder sling procedure can change a patient’s life. All too often, though, painful complications have made patients wish they had not chosen to correct SUI with this type of surgery.

To create a bladder sling, a surgeon uses strips of tissue or a synthetic material like mesh to create a pelvic hammock around the bladder neck and urethra to keep them closed during normal activities.

Bladder sling procedures are often confused with surgeries performed to correct pelvic organ prolapse (POP), a similar condition that can be treated by transvaginal mesh. The surgeries, although they involve many of the same organs, are different.

There are several types of bladder slings approved by the U.S. Food and Drug Administration (FDA). Some of the most common include:
Tension-free vaginal tape (TVT) sling: This outpatient procedure uses a polypropylene mesh tape, which acts as a sling under the urethra and is held in place by the patient’s own tissue rather than stitches. This debuted in 1996.
Transobturator tape (TOT or TVT-O) sling: This tension-free surgery has less risk of bladder and bowel injury in comparison with the TVT sling because there is no need to blindly pass a large needle through the retropubic space when inserting the mesh tape. It was invented in France and brought to the United States in 2002.
Mini-sling: This procedure has less risk of complications relative to the previous two because it eliminates the need for abdominal or groin incisions. In this procedure, a small single vaginal incision is made and a mesh tape is placed in a U-shaped configuration in the mid-urethra. It is the newest technology and was released in 2006.

One study of 75 women with a median age of 47 found an overall complication rate of 21.5 percent. Complications included one bladder injury, one patient with excessive bleeding and one vaginal extrusion. Overall, the study concluded that TVT “seems superior” to TOT in performance one year removed from surgery but that “TOT seems safer.”

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Bladder Sling Surgery Can Have Severe Complications

Complications from bladder slings made from surgical mesh are painful and cause both physical and emotional issues, and corrections usually require multiple treatments and revision surgeries.

Some serious problems after bladder-sling surgery have been reported. Patients who reported post-surgery issues said they have prolonged difficulty urinating or they incur new symptoms of incontinence, specifically urgency. The risks associated with the surgery also include infections at screw or staple points, internal bleeding or injury to an organ.

The most serious complications, however, have been reported with synthetic slings that have eroded into nearby organs in the pelvic cavity, such as the vagina, and rectum. Organ perforation has also been reported. This occurs when the sling punctures an organ. The patient may also experience inflammation, which means the body has rejected the sling.

Mesh contraction is another serious complication. It can lead to severe pelvic pain and painful sexual intercourse.

After each surgery, patients should be prepared to significantly alter their lives during the recovery period. They should expect that they will not be able to urinate on their own for several weeks and must be comfortable using a catheter, a small tube they can insert themselves. There also will be pain that can be controlled with prescription medication from their doctors, and over-the-counter fiber solutions are recommended for constipation.

Patients will not be allowed to perform any heavy lifting for at least one month and sometimes up to three months after the procedure. To minimize the risk of infection, patients must give up sexual intercourse or using the bathtub, swimming pools or hot tubs until the stitches dissolve, which can take up to two months.

According to one New England Journal of Medicine (NEJM) study that compared bladder slings to the older Burch technique, the most common side effect was urinary tract infections, which occurred in 63 percent of women undergoing a sling procedure.

Problems with ObTape

ObTape, a bladder sling manufactured by Mentor Corporation, had a multitude of issues. Mentor stopped manufacturing ObTape in 2006.

Problems with ObTape, which was implanted in women from 2003 to 2006, are twofold. First, its safety record was linked back to a product that the FDA had already recalled — Boston Scientific’s Protegen sling, which was taken off the market in 1999.

Second, ObTape was approved because it supposedly matched other tapes used in bladder slings, but, in fact, it was made of more dense materials that caused complications. The thicker weave did not allow the tissues around it to receive nutrients and the body could not easily accept the device.

ObTape was approved by the FDA under its 510(k) process, which means it did not have to undergo patient testing because the FDA agreed it was similar to other products on the market.

Meanwhile, Mentor sold its surgical urology business to Coloplast and then was acquired by Johnson & Johnson.

Hundreds File Bladder Sling Lawsuits

Hundreds of lawsuits that have been filed since 2008 over the defective Mentor ObTape have been funneled into a Multidistrict Litigation (MDL) in the U.S. District Court for the Middle District of Georgia. The MDL, presided over by Judge Clay D. Land, allows the pre-trial proceedings of similar cases to be consolidated. The MDL is slowly moving forward, and Johnson & Johnson has settled with plaintiffs after the first trial got under way.

About 35,000 women in the United States have had a sling implant that used ObTape, but only a fraction of patients have come forward so far to seek recourse.

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