NEJM Study: Transvaginal Mesh Complication Risk High

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A new study has confirmed prior research indicating that the use of vaginal mesh to treat pelvic organ prolapse carries the risk of serious complications including bladder perforation and pelvic hemorrhaging. These latest findings come just months after a number of doctors publicly expressed concerns about the risks associated with vaginal mesh surgery.

Free Transvaginal Mesh Complications Evaluation: If you or a loved one has suffered from complications associated with a transvaginal mesh device, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

What’s the problem?

May 16, 2011 – According to a recent study published in the New England Journal of Medicine (NEJM), transvaginal mesh devices are more effective at treating pelvic organ prolapse (POP) than conventional surgical procedures, but carry the risk of developing a number of extremely serious complications after surgery.

The study involved 389 women being treated for POP. 200 were implanted with transvaginal mesh devices and 189 were treated with colporrhaphy, a more traditional form of vaginal wall repair that involves surgical intervention of a defect in the wall of the vagina. Of these, approximately 3.5% of women implanted with surgical mesh suffered from a bladder perforation during the surgery, compared to only about 0.5% of the women who received colporrhaphy. The rate of urinary incontinence was more than 12% for women who received a mesh device compared with only 6.3% for a colporrhaphy. The study also found that 3.2% of the women who received the mesh required revision surgery to correct problems with the device. According to the study’s authors, “As compared with anterior colporrhaphy, use of a standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events.”

These new findings confirm what many in the medical community have suspected for some time. In November 2010, a letter from Dr. Anne M. Weber of Pennsylvania published in the American Journal of Obstetrics & Gynecology suggested that there is a lack of specific scientific information on vaginal mesh health risks. Weber told the journal that the lack of information made it impossible for patients to give informed consent and suggested all vaginal mesh surgery be considered experimental.

Transvaginal Mesh Complications

In the last five years alone, over 1,000 patients have suffered from serious complications following the use of a transvaginal mesh device. Complications include reports of:

• erosion of vaginal tissue
• infection
• mesh erosion
• pain
• perforations of the bowel, bladder or blood vessels
• recurrence of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI)
• urinary problems
• vaginal scarring

Transvaginal Mesh Products

Manufacturers of transvaginal mesh products include:

Johnson & Johnson:

• Ethicon TVT
• Gynecare TVT
• Gynemesh PS
• Prolene Polypropylene Mesh Patch
• Secur

Bard:

• Avaulta Plus™ BioSynthetic Support System
• Avaulta Solo™ Synthetic Support System
• Faslata® Allograft
• Pelvicol® Tissue
• PelviSoft® Biomesh
• Pelvitex™ Polypropylene Mesh

American Medical Systems (AMS):

• SPARC®

Boston Scientific:

• Advantage™ Sling System
• Obtryx® Curved Single
• Obtryx® Mesh Sling
• Prefyx Mid U™ Mesh Sling System
• Prefyx PPS™ System

 

Do I have a Transvaginal Mesh Lawsuit?

The Product Liability and Defective Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in transvaginal mesh lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.