Mesh Implants Work for Bladder Leakage, Long-Term Safety Unclear

By Lisa Rapaport

June 17, 2019

(Reuters Health) - Several different types of mesh implant surgery may be effective for treating bladder leaks, but the long-term safety and effectiveness of the procedures isn't yet clear, a new analysis suggests.

Researchers examined data from 175 clinical trials that randomly assigned a total of 21,598 women with stress urinary incontinence to receive different types of surgical treatments.

Over the short-term, three types of surgeries appeared most effective at curing the incontinence. Two newer procedures using slings to support the bladder had cure rates of about 89% and an older abdominal surgery to suture the bladder had a cure rate of about 77%.

"With regard to surgical treatments, there is limited evidence to suggest that there is one 'best' option for the treatment of stress urinary incontinence. Rather there are several trade-offs and risks that women need to be aware of and consider alongside their clinician when making their treatment choice," said study co-author Dawn Craig of Newcastle University in the UK.

"Based on our findings, the jury is still out on the long-term risks of vaginal mesh for stress urinary incontinence," Craig said by email.

Up to half of adult women experience stress urinary incontinence, when the pelvic floor muscles are too weak to support the bladder. As a result, urine leaks during coughing, sneezing or exercise. Childbirth is a common reason for weak pelvic muscles, and obesity worsens the problem.

Surgical treatment for stress urinary incontinence has evolved over the past two decades from open abdominal operations to support the bladder with sutures to less invasive procedures that insert mesh slings instead. Recently, however, the safety of mesh implants for stress incontinence has come under scrutiny due to reports of severe complications, litigation and product withdrawals, researchers note in a paper in The BMJ, online June 5.

One of the more effective mesh sling options in the study was a traditional suburethral sling, which involves placing a sling under the urethra and using one of a variety of techniques to secure it in place.

The other mesh sling option with similar effectiveness was the midurethral sling, a newer minimally-invasive procedure that enables surgeons to insert a narrow strip of synthetic mesh without the need to secure it in place.

In contrast, the older type of surgery -- open coloposuspension -- requires cutting through the abdomen to reach the bladder and then using sutures to support the neck of the bladder, the group of muscles that connect the bladder to the urethra. These muscles tighten to hold urine in the bladder and relax to release urine.

Most of the available safety data was for the newer mesh sling procedures.

Mesh procedures done with one vaginal incision and two groin or thigh incisions - known as transobturator midurethral sling surgery - had more repeat surgeries and groin pain but fewer vascular complications, bladder or urethral perforations, or voiding difficulties than retropubic midurethral surgery done with one vaginal incision and two abdominal incisions.

"We do not have good long-term follow up data for any of these surgeries as the trials analyzed lasted up to five years at most and mesh can cause problems many years after insertion," said Rufus Cartwright of Oxford University Hospitals NHS Trust in the UK, who co-authored an accompanying editorial.

Some women might be able to address stress urinary incontinence without surgery, previous research has found. Lifestyle changes like avoiding caffeine, drinking small amounts of fluid, using the bathroom at scheduled times throughout the day and doing exercises that target the pelvic floor muscles can improve bladder control.

"Women should consider surgery for incontinence if their symptoms are severely affecting their quality of life, and they haven't responded to conservative treatment (pelvic floor exercises)," Cartwright said by email. "The choice between the different procedures should be based on a process of shared decision making with the surgeon."

SOURCE: https://bit.ly/31w78Jv and https://bit.ly/2KeSIIt BMJ 2019.

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