Transvaginal Mesh Injuries
Surgical mesh can be used to repair or support weak tissues, treat stress urinary incontinence (SUI) and repair pelvic organ prolapses (POP). It is permanently implanted in the area that needs support. The use of this mesh is associated with many complications, including mesh erosion (breakdown), recurring POP, organ perforation or puncture, pain, bleeding, scarring and urinary leakage and incontinence. The FDA issued a warning in 2011 about a high incidence of mesh-related complications without much evidence of usefulness.
Surgical mesh is a woven fabric of fine wire used during surgical procedures to repair, reinforce, and strengthen weakened tissues. It is utilized in procedures to repair hernias, to perform chest wall reconstructions, and to create slings for stress urinary incontinence (SUI). There are a number of different types of mesh that are used depending on the size of the weakened tissue area.
To treat SUI, transvaginal mesh (also known as vaginal mesh) is used in the repair of a condition called pelvic organ prolapse (POP). POP is a condition that occurs when one of the pelvic organs such as the bladder, uterus, bowel or rectum, drops from the normal position and pushes against the wall of the vagina. This happens when the muscles and connective tissues holding the organs in place are stressed and weakened over time. When treating pelvic organ prolapse, physicians often permanently implant the mesh in order to hold the organs in place. When treating SUI, physicians often use the mesh to support the urethra or neck of the urinary bladder.
Complications and Injuries Associated with Transvaginal Mesh
Mesh can begin to erode into the vaginal walls or other organs within a year after surgery. It may tighten or shift, causing it to protrude into the vaginal canal.
The following complications and injuries have been reported as a result of the transvaginal pelvic organ prolapse (POP) procedure:
- Mesh erosion: This is the most commonly reported complication of transvaginal mesh. It occurs when the mesh erodes through the vaginal tissue. In this case, the mesh becomes exposed, or protrudes from the vagina. The woman may feel a lump in the vaginal opening. This complication may require multiple surgeries, and the surgery is not always successful.
- Painful sexual intercourse (dyspareunia)
- Recurrence of pelvic organ prolapse (POP)
- Perforation or puncture of the bladder, intestines and bowels, as well as blood vessels around the vaginal wall
- Mesh contraction (shrinkage): This can result in vaginal shortening, tightening and pain. Both mesh erosion and mesh contraction may cause severe pelvic pain and may interfere with the woman’s ability to engage in sexual intercourse.
- Chronic vaginal drainage, discharge and infections
- Pelvic and vaginal pain
- Abdominal pressure
- Vaginal bleeding
- Vaginal scarring
- Urinary leakage
- Urinary incontinence
FDA Issues Warning Regarding Transvaginal Mesh Use in POP Cases
The United States Food and Drug Administration (FDA) approved transvaginal mesh kits from manufacturers such as American Medical Systems, Ethicon, Inc. and C. R. Bard, Inc. The first surgical mesh kit for use in stress urinary incontinence (SUI) was approved by FDA in 1996, and the first surgical mesh kit for use in pelvic organ prolapse (POP) was approved by the FDA in 2002.
On July13, 2011, the FDA issued an updated safety communication to all U.S. medical providers and patients regarding a risk of serious complications resulting from the placement of transvaginal mesh to treat pelvic organ prolapse (POP). The communication noted that even though there was an increased risk of these serious complications, there was no corresponding clinical evidence of greater benefit, such as an improved quality of life. Furthermore, the FDA reported that these complications were not rare.
This represents a significant change from the FDA’s prior communications on this topic in 2008, and it signals growing alarm over the rate of side effects from the use of surgical mesh for this purpose. From 2008 to 2010 alone, the FDA received 2,874 adverse event reports documenting complications arising due to surgical mesh devices used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). There has not yet been any type of recall associated with the placement of transvaginal mesh to treat pelvic organ prolapse (POP).
Treatment for Transvaginal Mesh Complications
Vaginal mesh complications can make it painful for women to sit, walk and have sexual intercourse. In many cases, women require surgical excision to remove the mesh or sling and may even require multiple surgeries. Despite removal of the mesh, complications may not be reversed, and women continue to suffer with vaginal pain and impaired quality of life.
Treatment of the various types of complications include multiple surgical procedures (some are in addition to mesh removal surgery), IV therapy, blood transfusions, and drainage of hematomas (collection of blood within the tissues) or abscesses (pockets of infections, pus).
Potential Complications of Pelvic Organ Prolapse Surgery
Listed below are the issues many women face after surgical use of transvaginal mesh:
- Additional surgery and multiple surgical revisions
- Loss of ability to have sexual relations
- Emotional distress
- Loss of quality of life
- Pain and suffering
- Spousal loss of consortium
- Out of pocket medical, surgical and hospital expenses
- Lost wages
Options for Victims of Failed Pelvic Organ Prolapse Surgery
Complications and injuries resulting from a failed transvaginal mesh POP surgery can be devastating. In some cases, you may be able to recover damages for such things as medical expenses, pain, suffering, and future surgical expenses. Call the knowledgeable attorneys at Reiter & Walsh. We’ll review your case and confer with top-notch medical experts in the field to determine your legal options. Contact us via email or call us at 888-419-2229 for a free initial consultation.
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- Elmér C, Altman D, Engh ME, Axelsen S, Väyrynen T, Falconer C. “Trocar-guided transvaginal mesh repair of pelvic organ prolapse.” Obstetrics & Gynecology. 2009; 113(1):117-126.
- Maher C, Feiner B, Baessler K, Adams EJ, Hagen S, Glazener CM. “Surgical management of pelvic organ prolapse in women.” Cochrane Database Syst Rev. 2010; (4): CD004014. doi:10.1002/14651858.CD004014.pub4. PMID 20393938