Transvaginal Mesh Complication Increases with Procedures Performed in Tandem

New York, NYA recent study published in JAMA Surgery online (11/30/16) references an association with transvaginal mesh complication most plaintiffs having filed a transvaginal mesh lawsuit could identify and understand: a high risk for repeat surgery and mesh erosion requiring management.

The study looked at TVT side effects associated with procedures for Stress Urinary Incontinence alone, v. a correction for Pelvic Organ Prolapse performed at the same time.

“There is evidence for a dose-response relationship between the amount of vaginal mesh used and subsequent mesh erosions and other complications, leading to repeated surgery,” said Art Sedrakyan, MD, PhD, of Weill Cornell Medical College in New York, and colleagues in the study: Association Between the Amount of Vaginal Mesh Used With Mesh Erosions and Repeated Surgery After Repairing Pelvic Organ Prolapse and Stress Urinary Incontinence, published November 30 online in JAMA Surgery.

Transvaginal mesh has evolved to a modern-day treatment for stress urinary incontinence (SUI) and Pelvic Organ Prolapse (POP) by way of minimally invasive surgery. Previously, more invasive surgery for SUI and POP involved a longer healing window, but was associated with fewer complications long-term.

In contrast, minimally-invasive TVT sling and POP surgery requires less recovery time, but has been associated with more transvaginal mesh complication, especially when done together, according to the study.

To that end the study found that SUI correction alone, and not performed in concert with POP, was associated with the lowest risk for mesh complication.

There were four procedures examined for the study, with authors finding that the amounts of mesh used increased with each of the four procedures identified: transvaginal POP repair with mesh and concurrent sling (vaginal mesh plus sling group), transvaginal POP repair with mesh and no concurrent sling (vaginal mesh group), transvaginal POP repair without mesh but concurrent sling for SUI (POP sling group), and sling for SUI alone (SUI sling group).

A database headquartered in New York State comprised 41,604 women with an average age of 56.2 years having undergone one of the four procedures during a four-year window ending in 2012.

Across one year of follow up, clinically relevant mesh erosions occurred in 2.72 percent of the vaginal mesh plus sling group v. 1.57 percent of the SUI sling group. Repeated surgery with concomitant erosion followed the same pattern: vaginal mesh plus sling group 2.13 percent v. SUI sling group at 1.16 percent. The vaginal mesh group (1.95 percent) and POP sling group (1.90 percent) were found to have similar risks of mesh erosion. The SUI sling group had the shortest time to repeated surgery (median 123 days), despite their low rate of complications. Patient age did not appear to have any bearing on the results, and the severity of POP or SUI could not be assessed.

In an editorial accompanying the study, authors noted that clinical practice may not realistically change in response to study findings given the tendency for patients suffering from both SUI and POP to seek a correction to both issues with a single surgical procedure, rather than two.

“Does placing a sling at the same time as opposed to later increase the risk of mesh-related complications?” asked Dr. Bhumy Davé and Dr. Anne-Marie Boller, MA, MD. FACRS in the accompanying editorial entitled ‘Mesh – Is Less More?’

“A study answering this question would guide treatment decisions and reflect a scenario in which the dose response would be clinically important.”

Transvaginal mesh lawsuits number into the tens of thousands.