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Product Liability Lawyers

If you or a loved one have suffered complications after transvaginal implantation of surgical mesh, contact us or call toll free 1-800-448-0883 for a free consultation and case evaluation by our product liability lawyers.

FDA Safety Alert – Transvaginal Surgical Mesh Not Effective

Surgical mesh is a medical device that is used to repair damaged tissue. Gynecologists and other health care providers have implanted surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). It was thought that the surgical mesh would strengthen the vaginal tissue. However, the FDA has found there is little evidence that surgical mesh implants improve pelvic organ prolapse (POP). In addition, the FDA has found that the use of surgical mesh implants for pelvic organ prolapse (POP) did not improve symptomatic results or quality of life over traditional non-mesh repair of pelvic organ prolapse (POP).

FDA Safety Alert – Severe Complications with Transvaginal Mesh

On July 13, 2011 the FDA released a safety alert regarding serious complications associated with transvaginal placement of surgical mesh. Specifically, the FDA warned that serious complications associated with vaginal and pelvic surgical mesh devices are NOT RARE. Many of the complications with transvaginal surgical mesh cause women to suffer devastating results.

Serious Complications with Transvaginal Surgical Mesh

  • Mesh Erosion
  • Exposure, Extrusion or Protrusion
  • Pain
  • Infection
  • Bleeding
  • Vaginal Scarring/Shrinkage
  • Dyspareunia (pain during sexual intercourse)
  • Organ Perforation
  • Urinary Problems
  • Recurrent Pelvic Organ Prolapse
  • Emotional Problems
  • Need for Additional Surgeries
Product Liability Lawyers

If you or a loved one have suffered complications after transvaginal implantation of surgical mesh, contact us or call toll free 1-800-448-0883 for a free consultation and case evaluation by our product liability lawyers.

FDA Safety Alert – Increased Adverse Events with Transvaginal Surgical Mesh

Since 2008, the number of adverse event reports to the FDA for transvaginal surgical mesh has increased. Approximately 2900 adverse events or serious complications associated with vaginal and pelvic surgical mesh devices have been reported. The most frequent serious complication reported to the FDA is mesh erosion, also called exposure, extrusion or protrusion. This serious complication can require multiple surgeries to repair the complication. In some cases, multiple surgeries will not resolve the surgical mesh erosion.

What is Surgical Mesh?

Surgical mesh is a synthetic material manufactured to be used to strengthen tissues and provide support for internal organs. Surgical mesh can be made from a variety of materials, including polypropylene, polymers, titanium, Gore-Tex®, and/or Teflon®. The most common type of surgical mesh products are stress incontinence slings and surgical mesh used for treating prolapse.

Typically, to treat POP or SUI, a small incision in the vaginal wall allows surgeons to implant surgical mesh into spaces in the pelvis. The surgical mesh is held in place by sutures or tissue fixation devices to a pre-determined point in the pelvic floor muscles and ligaments. Over time, cells grow into the pores (tiny holes) in the surgical mesh to create a sling or hammock support system. This cell growth was thought to provide a framework of support and strengthen the tissue. That is what the many manufacturers promoted; however, the FDA now says transvaginal placement of surgical mesh does little to improve POP or SUI.

Transvaginal Surgical Mesh Manufacturers

Johnson & Johnson®

  • Ethicon® TVT
  • Gynecare® TVT
  • Gynecare® Prosima
  • Gynecare® Prolift
  • Gynemesh® PS

Boston Scientific®

  • AdvantageTM Sling System
  • Obtryx® Curved Single
  • Obtryx® Mesh Sling
  • Prefyx Mid UTM Mesh Sling System
  • Prefyx PPSTM System
  • Arise®
  • Pinnacle®
  • Lynx®
  • Solyx®

C.R. Bard®

  • Avaulta PlusTM BioSynthetic Support
  • Avaulta SoloTM Synthetic Support
  • FasLata® Allograft
  • Pelvicol® Tissue
  • PelviSoft® BioMesh
  • PelvitexTM Polypropylene Mesh

American Medical Systems®

  • SPARC®
  • BioArc®
  • MiniArc®
  • Elevate®
  • Monarc®
  • Perigee®
  • In-Fast®
  • Apogee®

What is Pelvic Organ Prolapse (POP) & Stress Urinary Incontinence (SUI)?

Many women will suffer from either Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI). Both can be uncomfortable, embarrassing and painful. Pelvic Organ Prolapse (POP) occurs when a pelvic organ, such as the bladder, uterus, bowel, etc., drops from its normal position in a woman's abdomen and pushes against the walls of the vagina. Typically, this happens when the muscles that hold the pelvic organs in place weaken or stretch from childbirth or surgery, such as a hysterectomy.

Symptoms of Pelvic Organ Prolapse include:

  • Feeing pressure from pelvic organs pressing against the vaginal wall
  • Feeling full in your lower abdomen
  • Feeling as if something is falling out or protruding from your vagina
  • Feeling a pull or stretch in your groin area
  • Feeling the need to urinate often
  • Releasing urine without meaning to (incontinence)
  • Having vaginal pain during sexual intercourse
  • Constipation

Stress Urinary Incontinence (SUI) is the loss of urine when coughing, laughing, sneezing, exercising or other movements. This occurs because the pelvic floor muscles are not strong enough. The urethra is located in the fascia on the pelvic floor. If the pelvic floor muscles are not strong enough the urethra moves downward increasing the abdominal pressure causing urine to pass involuntarily.

Product Liability Lawyers

If you or a loved one have suffered complications after transvaginal implantation of surgical mesh, contact us or call toll free 1-800-448-0883 for a free consultation and case evaluation by our product liability lawyers.

Court Documents

Pelvic Repair Systems Product Liability Litigation in the United States District Court for the Southern District of West Virginia, Charleston Division

On the Web: More Transvaginal Surgical Mesh Information

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