Implanted and stretched across the vaginal wall, transvaginal mesh patches are designed to help support internal organs that have been damaged. Unfortunately, a number of serious injuries have been reported in connection with these devices including mesh erosion, serious infection and the return of pelvic organ prolapse (POP). To date, the U.S. Food & Drug Administration (FDA) has received nearly 4,000 reports of significant complications associated with transvaginal mesh patches.
Free Transvaginal Mesh Case Evaluation: If you or a loved one has been injured by a defective transvaginal mesh patch product, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
Transvaginal Mesh Overview
A transvaginal mesh patch is a surgically implanted device that stretches across the vaginal wall to add extra support to damaged tissues. By adding strength to damaged vaginal walls, transvaginal mesh patches can be effective treatments for a number of conditions that may occur after childbirth and pregnancy. The conditions they are normally designed to correct include pelvic organ prolapse (POP) – a condition in which organs of the lower abdominal region slip out of place – and stress urinary incontinence (SUI), which is characterized by the inability to control urination when increasing pressure within the abdominal region. Unfortunately, the failure of these products can lead to the need for multiple operations to remove the mesh and to repair extensive damage caused by the products.
Side Effects of Transvaginal Mesh
Unfortunately, patients implanted with transvaginal mesh products are at risk for serious complications. To date, the FDA has received nearly 4,000 reports of surgical mesh complications including:
- erosion of vaginal tissue
- mesh erosion
- perforations of the bowel, bladder or blood vessels
- recurrence of pelvic organ prolapse (POP) and stress urinary incontinence (SUI)
- urinary problems
- vaginal scarring
Pelvic Organ Prolapse (POP)
POP occurs when the internal structures that support the pelvic organs become so weak or stretched that they drop from their normal position and bulge into the vagina. Women suffering from POP often experience pelvic discomfort, disruption of sexual and urinary functions, and an overall reduction in their quality of life. Signs and symptoms of pelvic organ prolapse include:
- heaviness or pressure on the pelvis
- vaginal pain, pressure or bleeding
- a bulge protruding from the vagina
- pain during intercourse
- urinary or fecal incontinence
- slow urinary stream or urinary urgency
A recent study published in the New England Journal of Medicine (NEJM) found that transvaginal mesh surgery was better at treating POP than colporrhaphy, a process that involves stitching the connective tissue in the vaginal wall back together. However, the procedure is not without risks, as many women have experienced excessive pain during sex, new urinary incontinence, and the need for revision surgery. The NEJM study found that approximately 3.5% of women who received transvaginal mesh suffered a bladder perforation during surgery, and nearly 13% suffered from urinary incontinence. Researchers also found that more than three percent of the women who received the mesh required revision surgery to correct exposure problems.
Though the study’s conclusions lend weight to the long-suspected link between transvaginal mesh patches and serious complications, they come as no surprise to many in the medical community. Complications involving transvaginal mesh products manufactured by several different companies have triggered numerous product liability lawsuits filed by patients who have fallen victim to infections, erosion of the vaginal mesh and other painful complications. A number of plaintiffs have alleged that companies neglected to design a safe product or properly warn the public of the inherent risks involved with the devices.
Transvaginal Mesh Manufacturers
Our law firm 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
FDA Warning on Transvaginal Mesh
In July 2011, the FDA issued a press release warning the public of significant complications linked to transvaginal mesh patches, some of which require revision surgery or may persist for the remainder of the woman’s life.
”There are clear risks associated with the transvaginal placement of mesh to treat POP,” said William Maisel, M.D., M.P.H., deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”
At Schmidt & Clark, LLP, we have extensive experience in the area of defective medical devices and mesh-related injuries. In addition to our national representation of consumers injured by defective medical devices, our attorneys are actively investigating cases involving the use of transvaginal mesh products. We are able to draw on the pool of experience gained in other mesh and product liability litigations to accurately investigate, evaluate and pursue potential transvaginal mesh injury claims.
Do I have a Transvaginal Mesh 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 lawsuits. We are handling individual litigation nationwide and currently accepting new transvaginal mesh injury cases in all 50 states.