Vaginal Mesh Sling

On July 13th, the FDA issued an Alert stating that serious complications associated with vaginal mesh/bladder slings for transvaginal POP repair are not rare. In fact, the FDA noted that they have received thousands of voluntary reports from patients, friends or doctors indicating complications occurring as a result of the vaginal mesh/bladder sling, with at least 10 of the reports resulting in death.  Recent studies estimate that the actual rate of injury is likely to increase significantly, which should not be surprising considering that more than 100,000 of these types of procedures are performed annually.  There could be tens of thousands of injuries and hundreds of deaths according to reports made to the FDA.

Contacting Attorney and Your Legal Rights

If you have been injured as a result of an ob tape, vaginal sing or vaginal mesh product, you may be eligble for compensation and should contact an attorney who specializes in product liability litigation. Mentor Corporation is facing mounting lawsuits for it’s vaginal mesh sling and many sever pain and several types of injuries. Lawsuits are being consolidated and look to get started early 2010.

If you feel you may be affected by it, find personal injury law firms to discuss your legal options regarding a potential injury lawsuit and all surrounding circumstances to be sure your rights have been protected. A injury lawyer who specializes in your type of injury lawsuit will be the best legal option.

What Is Vaginal Mesh Sling?

Surgical mesh, which is used for transvaginal mesh surgery and bladder slings, is a medical device that is generally used to repair weakened or damaged tissue (specifically in pelvic organ prolapse (POP) or stress urinary incontinence (SUI)). It is made from either porous synthetic material or biologic material.

Complications

On October 20th, 2008, the FDA put out a public health notification regarding Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence. That notice stated that over the past three years, the FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.

The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.

Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.

Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.

An excerpt below from the New York Times piece brings the story to reality for those of who haven’t experienced the pain and suffering or can’t imagine:

“It was supposed to be a simple ‘in one day and out the next’ kind of thing,” said Ms. Suriani, now 43, who lives in a suburb of Syracuse.

And so it seemed, at least at first. The surgery went smoothly, and the leakage stopped. But several months later, Ms. Suriani developed a persistent, painful and often bloody vaginal discharge.

She was convinced that she had cancer. It did not occur to her that the sling was the source of the problem until a piece of the meshlike tape started working its way through her vaginal wall.

Since then, she has had five operations, each one removing bits of the sling but not the entire thing; another operation is scheduled. She still has chronic discharge and says her sex life with her husband has been affected. She relies on Motrin to get through the day and a sleeping pad to get through the night.

“I feel like I’m never going to be the same again,” Ms. Suriani said, adding: “I’m beginning to feel like this has ruined my life. Not just ruining my life, as in ‘It will get better,’ but ruined, as in ‘I’m stuck with this for the rest of my life.’ I try to stay positive, but it’s getting harder and harder.”

Ms. Suriani’s lawyer, Matthew Metz of Seattle, said she was one of dozens of women suing the maker of the vaginal sling, called ObTape.

Vaginal Mesh Lawyers

Vaginal Mesh Attorneys – Robinson Calcagnie Robinson Shapiro Davis, Inc.