Throughout the country, thousands of women who have suffered serious complications due to vaginal mesh erosion have sought redress in the courts for their pain and suffering. Tranvaginal mesh devices were originally marketed to urologists and gynecologists as a method that would effectively resolve pelvic organ prolapse and stress urinary incontinence. However, no clinical trial data concerning transvaginal mesh safety or efficacy was available at that time. As more and more surgeries were performed utilizing transvaginal mesh, surgeons were faced with increasing reports of adverse reactions, including vaginal mesh erosion.
Vaginal mesh erosion is likely the most challenging, painful, and life-altering injury associated with transvaginal mesh. As the mesh travels through the wall of the vagina or area organs, erosion can lead to an array of serious complications, including:
- Bladder damage
- Bowl damage
- Recto-vaginal fistula
- Serious, sometimes debilitating, pain.
These mesh erosion injuries all require surgery to remove the device. However, complete removal of the mesh typically requires many procedures. Even then, doctors may find that the mesh cannot ever be fully removed, nor the damage fully repaired.
Transvaginal Mesh Devices May Lead to Vaginal Mesh Erosion
Over the last eight years there has been a marked increase in the use of synthetic mesh to treat pelvic organ prolapse and stress urinary incontinence. When the supporting muscles on the pelvis floor weaken—following childbirth and due to age—either condition can occur. When a woman is diagnosed with pelvic prolapse, at least one pelvic organ—the vagina, cervix, uterus, bladder, urethra, rectum—has dropped into her vagina. An incontinence diagnosis means that the bladder muscles have weakened and urine is leaking. These conditions cause similar symptoms, including:
- Pelvic pain, pressure
- Bulging tissue in the pelvic area
- Protruding organs that reach or go beyond the vaginal opening
- Discomfort during intercourse
Prolapse surgery with transvaginal mesh involves permanent mesh implantation that is meant to strengthen the pelvic floor, maintain an appropriate pelvis position, and eliminate symptoms. During incontinence surgery with transvaginal mesh, a so-called “bladder sling,” a small piece of mesh, creates a surgical hammock that supports the bladder.
Following more than 1,000 reports of adverse reactions associated with transvaginal mesh surgeries received during 2005-2007, the U.S. Food and Drug Administration (FDA) issued a warning in October 2008 to surgeons concerning the devices. The agency noted that no determination had been made that explains why patients were at increased complication risks; however, factors may include patient health; the mesh used; accompany procedures, such as hysterectomy; and the patient’s estrogen level. The FDA also provided surgeon recommendations that include:
- Inform each patient that transvaginal mesh implantation is permanent and that some reactions might call for revision surgery, which may not correct the complication.
- Undergo specific training for each type of vaginal mesh implantation procedure, including understanding the risks associated with each procedure.
- Be aware of, and watch for erosion, infection, and other adverse reactions and check for implantation-related complications, especially blood vessel perforations and injuries to the bowel and bladder.
Three years after its first warning, the FDA issued another warning in July 2011 after having received 2,874 additional complication reports associated with transvaginal mesh devices used in POP and SUI procedures from 2008 to 2010. Reports typically involved the following, many of which required medical or surgical treatment, sometimes with hospitalization:
- Vaginal mesh erosion
- Painful intercourse
- Organ perforation
- Urinary problems
Lawsuits Associated with Transvaginal Mesh Devices and Vaginal Mesh Erosion
Some lawsuits involving transvaginal mesh devices and vaginal mesh erosion have been combined in a number of different litigations:
- Six multidistrict litigations (MDL) have been filed in the United States against several makers of transvaginal mesh implant device makers including C.R. Bard Inc., Johnson &Johnson’s Ethicon Inc. unit, Boston Scientific Corp. American Medical Systems, Coloplast and Cook. The lawsuits have been consolidated and transferred to the U.S. District Court for the Southern District of West Virginia.
- An MDL involving lawsuits brought over the bladder sling, Mentor ObTape, is pending in the U.S. District Court for the Middle District of Georgia.
- A class-action lawsuit has been filed against Johnson & Johnson in Canada.
- Two consolidated litigations are underway in New Jersey’s Atlantic County Superior Court for lawsuits involving C.R. Bard and Ethicon mesh products.
Contact a Vaginal Mesh Erosion Attorney Today
Victims of vaginal mesh erosion or other complications associated with pelvic mesh may be entitled to compensation for damages related to their injuries, including:
- Medical expenses, including the costs associated with additional surgeries
- Pain and suffering
- Loss of spousal consortium
- Loss of quality of life
- Lost wages
Bernstein Liebhard LLP offers free legal reviews to women who have suffered transvaginal mesh injuries, including mesh erosion. Contact the firm to start the process of filing a claim against the manufacturer at 1-(888)-217-3033.