Transvaginal Mesh Injury

FDA HEALTH NOTIFICATION

Serious Complications Associated with Transvaginal Placement of Surgical Mesh

FDA REPORT

It has been reported by the FDA that 300,000 women underwent vaginal placement of mesh for Pelvic Organ Prolapse and/or Stress Urinary Incontinence repair in 2010. The mesh placement was typically chosen due to the less invasive nature as compared to abdominal surgery. The downside is that the transvaginal placement of the device has been linked to several serious problems, which prompted the FDA’s letter to manufacturers. The FDA issued a notification letter to the manufacturers of the vaginal mesh implant devices and manufacturers have begun to recall their products as a result of serious problems which have resulted from the vaginal mesh products.

In addition to pelvic pain, vaginal bleeding and infection, women have reported experiencing pain during sexual intercourse, vaginal shrinkage, and urine leaks. More serious complications include recurrent prolapse, organ perforation during placement, and neuromuscular disorders, i.e., disruptions in the communication between the nerves and voluntary muscles.

One of the most common problems reported is mesh erosion. The device begins to migrate through the body’s tissue. Most cases of erosion (sometimes called extrusion) involve migration through the vaginal wall. The surgical mesh may even move into the vaginal canal, causing severe pain and making sexual intercourse uncomfortable, or even impossible. On rare occasions, the device may migrate through the tissue of the bladder or rectum. Both circumstances are serious and warrant immediate medical attention.