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.
Transvaginal Mesh Lawsuit Update 8/1/12: According to a plaintiff’s attorney in what appears to be the latest in a string of transvaginal mesh (TVM) lawsuits filed around the country over the past several months, Boston Scientific Corporation knew – or should have known – about the health risks associated with its products. The plaintiff, from Tennessee, was reportedly implanted with a Boston Scientific Obtryx Tansobturator Mid-Urethral Sling System, and subsequently suffered debilitating personal injuries. Click here to learn more.
Vaginal Mesh Lawsuit Update 7/26/12: Last Friday, a jury ruled that medical technology giant C.R. Bard and a doctor must pay a total of $5.5 million in damages over a vaginal mesh implant that left a woman with persistent pain and potentially irreversible injuries.The landmark case is the first to go to trial among hundreds of lawsuits alleging that vaginal mesh implants made by Bard, Johnson & Johnson, and Boston Scientific caused severe organ damage and other serious injuries. Click here to learn more.
Transvaginal Mesh Update 6/26/12: Healthcare behemoth Johnson & Johnson (J&J) continued to sell its controversial Gynecare Prolift transvaginal mesh patch for nine months after the FDA ordered it to stop, according to court records. In a letter sent Aug. 24, 2007, the administration asked the company to halt sales of the Prolift until it could determine whether the device was ‘substantially equivalent’ to other products on the market. Click here to learn more.
Transvaginal Mesh Lawsuit Update 6/21/12: A judge has lifted the discovery stay in the federal transvaginal mesh (TVM) litigation, as scores of new cases continue to be filed on behalf of women in courthouses around the country. All discovery was stayed earlier this year in federal lawsuits involving transvaginal mesh products used for surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Click here to learn more.
Transvaginal Mesh Update 6/6/12: Ethicon, a subsidiary of Johnson & Johnson, has announced plans to recall its Gynecare line of transvaginal mesh devices nationwide in response to a high number of injuries that have been linked to the products. To date, hundreds of Ethicon Gynecare Transvaginal Mesh lawsuits have been filed in courthouses around the country on behalf of women who allegedly suffered mesh erosion, infections, and severe pelvic pain after having the devices surgically implanted. Click here to learn more.
Vaginal Mesh Lawsuit Update 5/16/12: The first trial date in the federal litigation involving women allegedly injured by vaginal mesh products manufactured by C.R. Bard has been set for early next year. Although the specific lawsuit has yet to be selected, the trial will involve a claim filed on behalf of a woman who allegedly suffered injuries after being implanted with a Bard vaginal mesh product. Click here to learn more.
Transvaginal Mesh Update 3/22/12: Multi-national pharmaceutical and biotech giant Johnson & Johnson sold a transvaginal mesh implant for three years before the device was officially approved by the U.S. Food & Drug Administration (FDA). The product, known as the Gynecare Prolift, is currently the subject of more than 550 lawsuits filed on behalf of women who claim it injured them. Click here to learn more.
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.