Pharmaceutical

European report shows adverse events with vaginal mesh greater than other procedures

vaginal mesh sling European report shows adverse events with vaginal mesh greater than other proceduresSurgical techniques using vaginal meshes to treat stress urinary incontinence and pelvic organ prolapse can cause serious adverse events, and doctors should inform their patients of the potential risks associated with the devices, according to a report complied by York Health Economics Consortium on behalf of the United Kingdom’s health authority.

The summaries included in the report were developed using data from systematic reviews of the effects and safety of vaginal slings and meshes, published in the past decade. The following outcomes were examined – pain persisting after six months, mesh exposure, sexual problems following the procedure, and procedures to remove the device or organ perforation. Researchers found that surgical techniques using vaginal meshes for the treatment of pelvic organ prolapse had as high as a 15 percent adverse event rate.

Vaginal mesh, also known as transvaginal mesh or bladder sling, is a surgical mesh device that has been used in some surgeries to treat pelvic floor disorders including stress urinary incontinence and pelvic organ prolapse. The conditions can cause pain, discomfort and incontinence.

During the procedure to repair these conditions, mesh is inserted vaginally to hold up organs that have dropped. In recent years, an alarming number of adverse event reports have resulted in an investigation by the U.S. Food and Drug Administration (FDA).

About 300,000 surgeries to repair stress urinary incontinence and pelvic organ prolapse are performed each year. In 2011, the FDA warned that complications with transvaginal mesh were increasing as much as fivefold since 2008. Nearly 3,000 complaints were filed and included injuries such as mesh erosion, pain, painful intercourse, infection, bleeding, urinary problems and organ perforation. Seven deaths were also associated to transvaginal mesh.

Source: Health Canal