The FDA has received many adverse reports regarding transvaginal mesh devices, including the Gynecare TVT sling. TVT systems typically involve mesh tape with vaginal sling surgery, also known as a TVT sling procedure, which results in a transvaginal sling to correct urinary incontinence.
FREE CASE EVALUATION
Send your Transvaginal Mesh claim to a Lawyer who will review your case at NO COST or obligation. 
Transvaginal Mesh Complication
Transvaginal Mesh and Transvaginal Sling are medical devices that are surgically implanted to treat Pelvic Organ Prolapse (POP) and/or Stress Urinary Incontinence(SUI).
SUI typically occurs in women after childbirth and/or pregnancy: Due to muscle weakness in the pelvic area, urine leaks from the body during activities such as coughing, laughing, exercising, etc. POP, known as Cystourethrocele, typically occurs in older women whose muscle and tissue groups in the uterus, bladder and pelvic region have become stretched and weakened. As well, women have an increased risk of developing POP with menopause and hysterectomy.
Vaginal sling surgery is supposed to strengthen the internal organs and prevent them from coming into contact with each other by implanting mesh tape.
Since 2005 more than 1,000 TVT sling complaints from nine different manufacturers have been reported to the FDA, which culminated in a FDA safety alert in 2008 about serious complications associated with the use of mesh products--also known as pelvic or vaginal mesh and bladder slings-- in treatment of SUI and POP. A number of women have undergone surgeries to have the mesh removed. In 2009 the FDA issued another FDA safety alert. According to the FDA, about 1,500 reports were filed between 2008 and 2010.
In January 2012, the FDA ordered the makers of transvaginal surgical mesh products to study the risks associated with the products. The order came following the recommendation of an FDA advisory panel in September 2011. According to the FDA, between 2008 and 2010 the number of adverse events reports to the FDA about transvaginal meshes increased five times. Not all surgical mesh products are affected by the FDA's order; those that are implanted through the abdomen are not included.
In July 2011, the FDA warned that transvaginal placement of surgical mesh to treat pelvic organ prolapse may carry more risks than other surgical options, without any evidence of greater benefit. The agency stressed that this warning “warning does not apply to mesh placed abdominally, or to treatment for stress urinary incontinence”. An advisory committee will be meeting in September 2011 to discuss the safety and efficacy of the mesh products in those indications.
Before TVT slings were approved, POP and SUI were treated without mesh in a procedure called an abdominal sacrocpopexy, which uses the patient's own ligaments to support weakened muscles. Now, polypropylene mesh is woven through pelvic tissue and placed underneath the urethra, creating a support sling. The tape is designed to support the urethra when pressure is exerted. However, TVT lawsuits claim that many of the transvaginal mesh products have not met reasonable safety standards and that the manufacturers failed to warn of significant risks. Some experts believe the mesh to be a defective design (the Mentor O.B Tape vaginal sling was removed from the market due to a design defect) and that complications develop because it prevents surrounding tissue to receive nutrients. As well, the mesh can erode into the vagina, migrate or shrink, which results in urinary problems, pelvic pain, and infections.
In The Journal Obstetrics & Gynecology (Oct 2005), safety reviewers found that more than 15 percent of the patients who received the mesh experienced erosion, which often results in pain and infections. The study concluded that “Surgeons should be aware of the potential complications of synthetic meshes. Until data on the safety and efficacy of the intravaginal slingplasties are available, these procedures cannot be recommended.”
Transvaginal sling complications include the following:
- mesh erosion into the vagina, bladder, intestines and uterus
- infection,
- pelvic pain,
- urinary problems, including recurrence of prolapse and/or incontinence,
- development of urinary retention
- bowel, bladder, and blood vessel perforation during insertion,
- vaginal scarring,
- dyspareunia (pain with sexual relations),
- fistulas and recurrence of prolapsed organs
- neuropathic pain
Some women have undergone additional surgical procedures, often to remove the mesh, along with IV therapy, blood transfusions, and drainage of hematomas or abscesses.
Transvaginal Mesh/Sling Lawsuits
Currently product liability lawsuits are being filed against a number of transvaginal mesh manufacturers, including Ethicon, a Johnson & Johnson subsidiary, Bard and Boston Scientific. The vaginal mesh lawsuits claim that the vaginal slings were negligently designed, causing pain and other complications.
Johnson & Johnson
Johnson & Johnson’s Ethicon Women’s Health & Urology division is responsible for manufacturing many transvaginal mesh devices. This division of Johnson & Johnson offers treatment solutions for a variety of female pelvic and reproductive organ health conditions. Brand names of Johnson & Johnson/Ethicon’s transvaginal mesh patches include:
- Ethicon TVT
- Gynecare TVT
- Gynemesh PS
- Prolene Polypropylene Mesh Patch
- Secur
Johnson & Johnson subsidiary Ethicon and C.R. Bard vaginal mesh lawsuits have been consolidated in New Jersey state court.
Bard
Bard, based in Georgia, manufactures, distributes, and markets numerous medical devices. Brand names of Bard’s transvaginal mesh patches include:
- Avaulta Plus™ BioSynthetic Support System
- Avaulta Solo™ Synthetic Support System
- Faslata® Allograft
- Pelvicol® Tissue
- PelviSoft® Biomesh
- Pelvitex™ Polypropylene Mesh
The Bard Avaulta litigation has been consolidated as part of an MDL in October 2010 in the US District Court for the Southern District of West Virginia.
American Medical Systems, based in Minnesota, produces SPARC, which is a type of transvaginal mesh patch designed to treat stress incontinence.
A woman in California has filed a defective medical device lawsuit, alleging AMS and other unnamed manufacturers caused her injuries and health complications from POP surgery in 2009.
Boston Scientific
Boston Scientific, based in Massachusetts, has been making medical devices for over 25 years. The company is also responsible for making potentially defective and dangerous transvaginal mesh systems effects, some of which are potentially fatal. Boston Scientific’s transvaginal mesh patch brands include:
- Advantage™ Sling System
- Obtryx® Curved Single
- Obtryx® Mesh Sling
- Prefyx Mid U™ Mesh Sling System
- Prefyx PPS™ System
To date, the above manufacturers continue to make these potentially harmful TVT slings, despite warnings by the FDA and medical experts, and more than 1,000 known cases of women who have been seriously harmed by these medical devices.
Transvaginal Mesh Legal Help
If you or a loved one has suffered damages in this case, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Last updated on May-24-12 |
TRANSVAGINAL MESH ARTICLES AND INTERVIEWS
Real Life Transvaginal Mesh Horror Stories
 Toronto, ON: With lawsuits over transvaginal mesh ricocheting across both the US and Canada, a noted health writer for a major Canadian newspaper says it's time to bring transvaginal mesh complication out of the shadows and into the spotlight [READ MORE]
Transvaginal Mesh: Hold the Sex
 Kingston, ON: Marion remembers well the first time she had sex with her husband after having a transvaginal mesh sling procedure to correct urinary incontinence. Like so many other women with transvaginal mesh problems, sex meant pain. "My husband said, 'I've never hurt anybody in my life unless I hit them over the head with a hockey stick,'" says Marion, laughing. "Now we hardly ever do it. [READ MORE]
Victim Overcomes Embarrassment to Share Transvaginal Mesh Story
 Vancouver, BC: Noreen had suffered from urinary stress incontinence for many years; she says it was a problem even when she laughed, coughed or sneezed. So when her doctor said that transvaginal mesh was a new, minimally invasive procedure and highly effective, with a very rare chance of pain during intercourse, Noreen had TVT implanted. "I figured that 'rare' meant about the same chance as winning the lottery," says Noreen [READ MORE]
YOUR TRANSVAGINAL MESH STORIES
Publish your Transvaginal Mesh experience here for our readers to learn from.
|
