Transvaginal mesh or bladder slings are mesh inserts manufactured by medical device companies to aid in the repair of female reproductive issues including Pelvic Organ Prolapse and Stress Urinary Incontinence. It is estimated that thousands of woman suffer from some type Transvaginal Mesh injury
each year. One of the most commonly asked questions is, What is Transvaginal Mesh
? Below is a simple explanation of the procedure and some common complications resulting from the use of Transvaginal Mesh Implants.
What is Transvaginal Mesh?
Vaginal mesh is made up of a synthetic material implanted to buttress the vaginal wall of woman who have suffered Pelvic Organ Prolapse or Stress Urinary Incontinence. These synthetic mesh products are inserted through either the abdomen or vaginal canal and latched on to the vaginal wall to act as a secondary support structure. However, over the years a number of different recipients of the surgery have complained of serious pain resulting from the surgery. The FDA first approved transvaginal mesh products manufactures by Boston Scientific for the treatment of stress urinary incontinence in 1996. In 2002 the FDA approved the use of TVM products for the treatment of Pelvic Organ Prolapse. Since then tens of thousands of woman have undergone surgical procedures using mesh products for such ailments.
Vaginal mesh is made up of a synthetic material and is inserted through the vaginal wall. The mesh is used for pelvic organ prolapse
or POP or stress urinary incontinence
(SUI). Surgical mesh is implanted in order to hold up the vaginal wall. However, in many patients the mesh was not able to properly bind to the connective tissue and the body began rejecting it. As a result many woman are faced with consistent pain and other complications. In a nutshell surgical mesh was a re-branded and used in woman to help with hernias and vaginal wall collapse after pregnancy. This procedure was performed and continues to be performed today, even though it is known to be dangerous.
Failure to Communicated Known Risks
: Many of these women had been under the false impression that the insertion of a pelvic surgical mesh implants would result in a drastic improvement in their quality of life. Manufacturers of Vaginal Mesh implants and numerous medical doctors around the county failed to inform patients of the risks associated with the transvaginal mesh implantation procedure. Unfortunately, some of those women have suffered significant medical side effects resulting in a need for multiple trans-vaginal mesh revision surgeries.
Common Complications form Transvaginal Mesh Implant Procedures
Perhaps the most common complication is considered “mesh erosion”. Mesh erosion occurs when the surgical mesh begins to erode inside of the vaginal wall. This issue is attributed to the natural flora and bacteria present inside of the vaginal canal. As a result of the natural bacterial build up the mesh begins to erode causing serious infections and wounds. These wounds continue to cause pain, bleeding and may not heal. As a result wounds chronically breakdown adding to the injuries.
Common complications include the following:
- Pain during sexual intercourse;
- Internal Bleeding;
- Unable to engage in sexual intercourse;
- Pelvic pain;
- Organ perforation including bladder punctures or ruptures
- Urinary incontinence issues
- Erosion of the vaginal wall
In some cases the pain can become unbearable. It is advisable to seek immediate medical attention if this is the case. If you have any other questions feel free to contact our helpful transvaginal mesh injury helpline.
Over the past few years dozens of product liability claims against manufacturers of transvaginal mesh implants have been filed in jurisdictions nationwide. While most cases are still pending a few product liability cases against medical device manufacturers have received final verdicts.
Notable Cases against Manufacturers
In July a Bakersfield California Jury
found C.R. bard, manufacturers of a range of pelvic mesh implants, at fault for 60% of the injuries suffered to the woman and her husband. The medical doctor who performed the mesh implant was found 40% for negligent malpractice. The jury awarded the California couple $5.5 million, of which $3.6 billion will have to be paid by C.R. Bard, for her injuries including medical expenses, pain and suffering and loss of consortium for the couple.
In February of this year a New Jersey jury
handed down an $11.1 million verdict against Johnson and Johnson, making it largest transvaginal mesh verdict to date. The verdict included $3.35 million dollars for damages arising out of the defective medical device and a further $7.76 million in punitive damages against J&J. According to trial testimony Linda Gross the 47 year old plaintiff has had to undergo 18 revision surgeries resulting from the gynecare medical system produced by the defendant.
In response to such staggeringly high settlements pelvic mesh manufactures greatly reduced or end the production of mesh implants
Class Action Lawsuits
: The increasing incidence of severe complications resulting from the implementation of transvginal mesh implants procedures has prompted Law Firms to call for nationwide class actions lawsuits against manufacturers of Vaginal mesh implants. In response the Judicial Panel on Multistate Litigation made the decision to consolidate federal transvaginal mesh lawsuits in West Virginia under the guidance of United States District Court Judge Joseph R. Goodwin. Class action lawsuits are designed to streamline the litigation process in cases involving a large number of plaintiffs against one of just a few defendants. The goal of class action lawsuits is to ultimately reduce court cost not to increase the compensation a plaintiff will receive.
FDA Public Health Safety Communication on Transvaginal Mesh
List of Tranvaginal Mesh Producers and Manufactures:
American Medical Systems:
- Monere subfascial hammock
- Intepro Y Sling
- Elevate with Intepro
Johnson & Johnson also called Ethicon:
- Advantage Fit
- Advantage Sling System
- Lynx Suprapubic Mid-Urethral Sling System
- Obtryx Curved Single
- Obtryx Mesh Sling
- Pinnacle Pelvic Floor Repair Kit
- Pinnacle Pelvic Floor Repair Kit II
- Polyform Synthetic Mesh
- Prefyx Mid U Mesh Sling System
- Prefyx PPS System
- Gynecare Prolift Kit
- Gynecare Prolift + M Kit
- Gynecare TVT Secure
- Gynecare Prosima Pelvic Floor Repair
Other Vaginal Mesh Producers
- Avaulta Plus BioSynthetic Support System
- Avaulta Solo Synthetic Support System
- Faslata Allograft
- Pelvicol Tissue
- PelviSoft Biomesh
- Pelvitex Polypropylene Mes
- Ugytex and Ugytex Dual Knot Mesh