Once thought to be revolutionary devices designed for repairing pelvic organ prolapse (POP) and stress urinary incontinence (SUI), transvaginal mesh products have recently been linked to severe complications including total mesh failure. When vaginal mesh fails, it can lead to a host of adverse health complications including the need for revision surgery, IV therapy, blood transfusions, and the treatment of hematomas or abscesses. On July 13, 2011, the U.S. Food & Drug Administration (FDA) issued an urgent safety communication to patients and their healthcare providers to consider alternatives to transvaginal mesh.
Free Transvaginal Mesh Failure Lawsuit Case Evaluation: If you or a loved one has suffered from vaginal mesh failure after being treated for POP or SUI, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
What is Transvaginal Mesh Failure?
Many women who suffer from pelvic organ prolapse (POP) and stress urinary incontinence (SUI) have undergone a surgical procedure with transvaginal mesh (TVM). Rather than simply stitching the tissue of the vaginal wall back together, TVM is inserted to help hold the internal organs in place, and to keep them from falling and sagging (prolapsing) inside the body cavity. In 2010 alone, more than 75,000 women had transvaginal mesh surgery to repair POP and SUI.
Vaginal mesh failure occurs when the surgical mesh fails to bind properly to the tissue in the vagina. When this happens, the mesh tends to work its way through the wall of the vagina and protrude out of the vaginal tissue. This, in turn, causes transvaginal mesh failure symptoms such as infection and pain. Mesh failure side effects may also require additional revision surgeries as a result of the damage caused by the implant.
The most common area surgically placed mesh can fail is in the vagina. The incision line may not heal well and the mesh may be felt during sexual intercourse. It can give a sense of pulling or tightness, and may lead to infection, discharge, blood or pain. Mesh failure is not a new phenomenon and has been thoroughly described in the medical literature.
FDA Warning on Transvaginal Mesh
According to a 2008 FDA Public Health Notification regarding transvaginal mesh complications, the administration had received over 1000 reports of problems with pain, recurrence of prolapse, urinary problems and perforation of organs during insertion:
“The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.”
Then in July 2011, the FDA issued an update to the 2008 Public Health Notification about the growing number of injuries reportedly suffered by women treated with vaginal mesh and bladder slings. Specifically, the FDA stated:
“Complications related to transvaginal mesh surgery are NOT rare; (ii) There is no evidence that transvaginal mesh repair is more effective than traditional non mesh repair; and (iii) Transvaginal mesh surgery exposes patients to greater risk than traditional non mesh repair.”
Additionally, the FDA update stated that between 2008 and 2010, over 1,500 complications were reported to the administration regarding mesh placed transvaginally for POP. Many of these complications required painful revision surgeries to resolve the issues. The FDA concluded the press release by stating that most cases of prolapse may not need vaginal mesh to be treated successfully, therefore eliminating the risks associated with the products. If transvaginal mesh is to be used at all, the agency states that doctors and patients should weigh the risks vs. benefits extremely carefully.
Brands of Transvaginal Mesh
Schmidt & Clark, LLP is currently accepting new transvaginal mesh claims against the following manufacturers:
Johnson & Johnson:
- Ethicon TVT
- Gynecare TVT
- Gynemesh PS
- Prolene Polypropylene Mesh Patch
- Avaulta Plus™ BioSynthetic Support System
- Avaulta Solo™ Synthetic Support System
- Faslata® Allograft
- Pelvicol® Tissue
- PelviSoft® Biomesh
- Pelvitex™ Polypropylene Mesh
American Medical Systems (AMS):
- Advantage™ Sling System
- Obtryx® Curved Single
- Obtryx® Mesh Sling
- Prefyx Mid U™ Mesh Sling System
- Prefyx PPS™ System
Transvaginal Mesh Revision Surgery
Once a transvaginal mesh patch has failed, it is likely to require additional revision surgery to correct the issue. Unfortunately, repairing weakened tissue that has already been repaired is extremely difficult. The surgeon will not only have to work with weakened tissue the second time around, but will also have less good tissue because the TVM and damaged tissue must be removed as well. Taking all this into consideration, TVM seems to be far more trouble than it’s worth. At this point, you may want to consider filing a transvaginal mesh failure lawsuit.
If you or someone you love was treated with transvaginal mesh to correct pelvic organ prolapse or stress urinary incontinence and subsequently suffered from vaginal mesh failure, please contact Schmidt & Clark, LLP today for a free legal consultation. Call us at (866) 588-0600 or fill out the confidential contact form below to get started. Act now – there is a limited amount of time in which to file your claim.
Do You Have a Transvaginal Mesh Failure Lawsuit?
The Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in transvaginal mesh failure lawsuits. We are handling individual litigation nationwide and currently accepting new vaginal mesh injury cases in all 50 states.