Vaginal Mesh Implants

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

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

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.

On the Web: More Transvaginal Surgical Mesh Information

• FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, July 13, 2011
• FDA Reevaluating Vaginal Mesh Implants, L.A. Times, August 1, 2011
• FDA Recommendation: Surgical Mesh Should Be Reclassified As "High Risk", Bloomberg News, September 1, 2011
• Transvaginal Mesh is High Risk - FDA Provides Recommendations, September 2, 2011
• FDA Executive Summary, 83 pages, Sugust 2011
• FDA Panel Takes Second Look: Expedited Approval of a Less Invasive Prolapse Treatment May Be Rescinded Following Injury Reports, Wall Street Journal, September 8, 2011
• J&J Vaginal Surgical Mesh Faces FDA Panel as Number of Lawsuits Increase, Bloomberg News, September 8, 2011
• FDA advisers urge closer scrutiny of pelvic mesh, AP/MSNBC, September 9, 2011
• FDA Panel Calls for Surgical Mesh Studies, Wall Street Journal, September 9, 2011
• Transvaginal Mesh Manufacturers Tell Advisory Committee They Agree to the Need for More Studies, September 9, 2011
  
• Obstetrics & Gynecology Medical Devices Panel, Discussion and Recommendations Regarding the Safety and Effectiveness of Surgical Mesh Used for Repair of Pelvic Organ Prolapse, Agenda, September 8, 2011 and September 9, 2011
  
• The Safety and Effectiveness of Pelvic Organ Prolapse Repair Depends on the Type of Biomaterial Used, Cook Medical, August 30, 2011
• Safety and Effectiveness of Transvaginal Surgical Mesh Used for Repair of Pelvic Organ Prolapse, Transvaginal Mesh Industry Working Group, Obstetrics & Gynecology Devices Advisory Committee Meeting, September 8, 2011
• Safety and Effectiveness of Surgical Mesh for the Treatment of Stress Urinary Incontinence,  Transvaginal Mesh Industry Working Group, Obstetrics & Gynecology Devices Advisory Committee Meeting, September 9, 2011
• Surgical Mesh for Repair of Pelvic Organ Prolapse (POP), Panel Discussion Questions, Obstetrics & Gynecology Devices Advisory Committee Meeting, September 8, 2011
• Suburethral Mesh Slings for Surgical Repair of Female Stress Urinary Incontinence (SUI), Panel Discussion Questions, Obstetrics & Gynecology Devices Advisory Committee Meeting, September 9, 2011
• Panel Roster, OB/GYN Devices Panel of the Medical Devices Panel Meeting, Obstetrics & Gynecology Devices Advisory Committee Meeting, September 8-9, 2011
• Surgical Mesh for Treatment of Women with Pelvic Organ Prolapse and Stress Urinary Incontinence, FDA Executive Summary, Obstetrics & Gynecology Devices Advisory Committee Meeting, September 8 and 9, 2011
• Meshing FDA and Manufacturers Together at Transvaginal Mesh Advisory Committee Hearings, September 14, 2011
• 510(K) Changes May Not Change the Problems with Surgical Transvaginal Mesh, October 21, 2011
• The Makers of Mesh Implants Face More Lawsuits, November 1, 2011
• What about the Transvaginal Surgical Mesh?, November 23, 2011
• F.D.A. Orders Surgical Mesh Makers to Study Risks, New York Times, January 4, 2012