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Study Identifies Risk Factors for Bladder Sling Injuries

female patient with doctorResearchers recently reported that 3% of all women who receive vaginal mesh implants will suffer from injuries so severe that the mesh will need to be removed or replaced within 10 years. The Canadian report appeared this month in the medical journal JAMA Surgery.

The purpose of the study was to examine the incidence of removal or revision after stress urinary incontinence (SUI) procedures in light of recent U.S. Food and Drug Administration (FDA) warnings regarding the safety of transvaginal mesh.

 Surgeon’s role in bladder sling injuries

The researchers, from Western University and the Institute for Clinical Evaluative Sciences, in London, Ontario, analyzed the records of nearly 60,000 women who received vaginal mesh implants for SUI over a 10-year period. They found that just over 2% of the women experienced complications related to either the mesh itself or the surgery to implant it and 3% faced a revision or removal surgery.

Both the FDA and Health Canada had previously warned that vaginal mesh should be inserted by specially-trained surgeons in order to avoid complications. Therefore the study examined how often vaginal mesh must be removed or revised after a SUI sling procedure, whether a surgeon’s number of mesh insertions per year and area of specialty (urology or gynecology) impacted the revision rate, and whether there were other specific risk factors for complications.

According to the findings, women who underwent mesh implantation at the hands of a low-volume surgeon were 37% more likely to experience complications. This supports the authorities’ warnings that vaginal mesh procedures should be performed by specialists. There was not, however, a difference in outcomes between urologists and gynecologists.

Lawsuits pending over transvaginal mesh complications

Urinary incontinence can be so disruptive that doctors and patients are both willing to go to great lengths for a solution. When more conservative treatment fails, a bladder sling is often considered. A sling procedure is a surgery in which a strip of tissue, often a synthetic surgical mesh, is inserted to create a support under where the bladder meets the urethra to help keep the urethra closed.

Polypropylene surgical mesh has been used successfully for some time to treat medical conditions such as hernias and perform organ repair. The use of surgical mesh for pelvic procedures is a more recent trend that gained popularity because it greatly simplified pelvic organ prolapse repair.

However, what was not immediately apparent is that over time, surgical mesh used in the pelvic region can begin to shrink and erode. The result tends to be painful and can cause serious injuries that are debilitating in nature.

Some of the associated complications include:

  • Infection
  • Incontinence
  • Bleeding
  • Organ perforation
  • Nerve damage
  • Vaginal pain during intercourse

Because there have been so many injuries from transvaginal mesh and bladder slings, tens of thousands of women have filed lawsuits. There are 8 multidistrict litigations currently ongoing. Plaintiffs have already won a dozen lawsuits, with each victory delivering a multi-million dollar reward.

Research like the recent Canadian study is promising because it may help identify the women most at risk for serious complications to that their conditions may be monitored. But in situations where that is too late, transvaginal mesh lawsuits can help victims hold manufacturers accountable if defective products are found to cause lasting harm.

  1. JAMA Surgery, Removal or Revision of Vaginal Mesh Used for the Treatment of Stress Urinary Incontinence,

  2. WebMD, FDA: Repairing Pelvic Organ Prolapse with Mesh Risky,

  3. FDA, FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse,