On October 20, 2008, the Food and Drug Administration (FDA) issued a Public Health Notification warning consumers and health care practitioners about serious complications associated with trans-vaginal placement of surgical mesh products. These trans-vaginal mesh are used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence.

In July 2011, the FDA issued a Safety Communications titled "UPDATE on Serious Complications Associated with Trans-Vaginal Placement of Surgical Mesh for POP" to inform the medical community and patients that:


Serious complications associated with surgical mesh for vaginal repair of POP are NOT RARE, contrary to what was stated in 2008.

2. It is not clear that trans-vaginal POP repair with mesh is more effective than traditional non-mesh repair.

The SAFETY COMMUNICATION also provided a list of recommendations for health care providers and patients to consider before and after trans-vaginal POP repair with mesh.

What is Trans-Vaginal Mesh (TVM)?
Trans-vaginal mesh is a type of surgical mesh which is generally made from polypropylene or polyester. It is implanted in the vagina and is used to create what is sometimes called a pelvic sling or bladder sling. As mentioned above, it is used to treat POP and Stress Urinary Incontinence. These conditions sometimes appear after childbirth or other surgical intervention of the female organs such as a hysterectomy.

Complications from Use of Trans-Vaginal Mesh

  • Mesh Erosion
  • Pain
  • Infection
  • Urinary Problems
  • Vaginal Scarring
  • Vaginal Shrinkage
  • Bleeding
  • Recurrence of Prolapse or Incontinence
  • Painful Sexual Intercourse
  • Organ Perforation
  • Emotional Problems

Trans-Vaginal Mesh Erosion
The FDA finds that trans-vaginal mesh erosion is the most common side effect of use of a TVM or bladder sling. As the mesh erodes, it can require multiple surgeries to repair and can be debilitating for many women. In some cases, even multiple surgeries will not resolve this complication and will significantly impair the patient’s quality of life. The complete removal of the mesh often may not be possible and may not result in complete resolution of complications including severe pain. In some cases, when pieces of the mesh erode, they break off and enter the blood stream. This may cause such major complications as lung infections and kidney problems, as well as injuries to the bowel and bladder.

Women dealing with complications from TVM implantation may also suffer from mesh contraction or shrinkage. This side effect has been reported to cause significant vaginal shortening. This will often cause severe pelvic pain and painful sexual intercourse or a complete inability to engage in sexual intercourse.

Please contact our office for a free confidential consultation with one of our trans-vaginal mesh lawyers today.

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