By Sarah Mirando  |  April 3, 2013

Category: Medical Devices
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Vaginal Mesh Research Finds Risk Indicators for Complications

By Courtney Coren

vaginal mesh implant studyNew research was recently released at the 28th Annual European Association of Urology Congress showing that there are risk indicators for vaginal mesh complications that include age, prior hysterectomies, and the severity of pelvic organ prolapse. The new study could help doctors and their patients in making an informed decision about whether or not a vaginal mesh sling implant is the right treatment for the patient’s pelvic organ prolapse.

The study was administered by a Russian medical team that looked at 677 patients from 2006 to 2010 who had received vaginal mesh implants to treat pelvic organ prolapse. Of the 677 patients, 152 patients had vaginal mesh complications during or following surgery.


Of the 152 women who suffered side effects from a vaginal mesh implant, 5 percent experienced vaginal and pelvic hematomas and 2.5 percent had perineal hematomas. A hematoma is a collection of blood outside of a blood vessel that has already clotted. This is different than a hemorrhage, where the bleeding is still active. In a hematoma, if enough blood has collected, it can cause severe pain and discomfort.

Rectal damage, bladder and urethra injuries, pelvic abscesses, fistulas, mesh contraction, and mesh erosion were also reported. Mesh erosion was the most significant, which was found in 32 patients; it occurs when the vaginal mesh itself erodes through the vaginal wall causing severe pain and discomfort.

The research also showed that the women who are most likely to experience major complications after a vaginal mesh sling was implanted were younger women, those with hysterectomies, and women whose pelvic organ prolapse was less severe.

Pelvic organ prolapse, which is the main reason for implanting a vaginal mesh sling, develops in woman usually due to child birth, a hysterectomy, or menopause. In a pelvic organ prolapse, the muscles that support the pelvic organs weaken and shift out of place. Vaginal mesh slings are implanted to hold the organs in place where the muscles have failed.

After receiving almost 3,000 complaints between 2008 and 2010, the U.S. Food & Drug Administration reported that complications with vaginal mesh implants were not rare as they had once reported.

According to the FDA, “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP.”

On February 25, 2013, a South Dakota woman was awarded over $11 million in compensatory and punitive damages in New Jersey Superior Court, Atlantic City due to complications caused by a pelvic mesh implant manufactured by Johnson & Johnson’s Ethicon unit. Four vaginal mesh bellwether trials are set to begin on June 11, 2013 in the U.S. District Court for the Southern District of West Virginia to help determine how to proceed in the multi-district litigation (MDL) proceedings that are currently underway in that court.

As vaginal mesh injury lawsuits continue to grow, this research could be used to assist doctors and their patients in making informed decisions about the risks involved with implanting a vaginal mesh sling to avoid further complications and lawsuits.

If you or someone you know has had similar side effects or symptoms caused by a transvaginal mesh, bladder sling or vagina sling implant, legal options are available to you. Learn more and get a free legal consultation regarding a claim’s eligibility at the Vaginal Mesh Sling Class Action Lawsuit Investigation. Experienced legal professionals have access to medical experts to assess whether or not a vaginal mesh implant may be playing a role in your current pain, discomfort or other serious side effects, so act now.

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Updated April 3rd, 2013

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