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Transvaginal Mesh TVT Sling Procedure
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, to correct urinary incontinence.
Transvaginal mesh implant complications include the following:
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Plaintiffs who have filed transvaginal mesh lawsuits claim that the mesh and/or slings used to treat their pelvic organ prolapse or stress urinary incontinence were negligently designed, thereby causing serious side effects such as mesh erosion, organ damage, chronic pain and other vaginal mesh complications.
Transvaginal Mesh Lawsuits
As of January, 2014 more than 40,000 transvaginal mesh lawsuits have been filed against a number of TVM manufacturers, including C.R. Bard, Ethicon (a Johnson & Johnson subsidiary), American Medical Systems (AMS), and Boston Scientific. While some claims have been settled, approximately 3,000 TVM lawsuits a month are currently being filed, mainly against the aforementioned manufacturers.
Many of these lawsuits have been filed in multi-district litigation in federal court in Charleston, West Virginia. A number of bellwether trials have begun proceedings or are scheduled for trial.
(Bellwether trials take place to help both plaintiffs and defendants by determining how juries are likely to respond to evidence and testimony presented. These trials are the norm in complex medical device litigation, particularly in the case of transvaginal mesh products involving multiple medical device companies. Representative cases for bellwether selection include women aged 40 and 60 years old at the time when they had the pelvic mesh surgeries, with three or less revision surgeries. A successful outcome typically indicates a global settlement)
Transvaginal Mesh and Transvaginal Sling are medical devices that are surgically implanted to treat Pelvic Organ Prolapse (POP) and/or Stress Urinary Incontinence(SUI).
Transvaginal Mesh Complication
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:
Transvaginal Mesh Lawsuits by Manufacturer
Currently product liability lawsuits are being filed against a number of transvaginal mesh manufacturers, including Ethicon, a Johnson & Johnson subsidiary, American Medical Systems(AMS), Bard and Boston Scientific. The vaginal mesh lawsuits claim that the vaginal slings were negligently designed, causing pain and other complications.
Ethicon Gynecare transvaginal mesh lawsuits are set to go to trial in August 2014. Ethicon’s Prolift mesh went to trial in New Jersey and ended with the jury awarding the plaintiff $11 million in damages (In re: Pelvic Mesh/Gynecare Litigation, No. 6341-10; In re: Pelvic Mesh Litigation/Bard, No. L-6339-10).
The Ethicon MDL in West Virginia federal court is due for its first bellwether trial in February 2014, which would involve about 13,000 cases. The selected case for the trial is Lewis, et al. v. Johnson & Johnson, et al., 2:12-cv-04301. The Ethicon MDL is In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation MDL no. 2327 in the U.S. District Court for the Southern District of West Virginia.
More than 6,500 claims have been filed against Bard on behalf of women who suffered severe side effects allegedly due to its Avaulta mesh. Court documents indicate that an additional 940 Avaulta transvaginal mesh lawsuits pending in a multicounty litigation are underway in New Jersey (In re: Pelvic Mesh Litigation/Bard, No. L-6339-10).
AMS mesh cases were scheduled to begin last December. AMS settled a number of cases for $54.5 million, and the company is expected to attempt a global settlement in many more of the 6,000 cases pending in federal court in West Virginia before Judge Joseph R. Goodwin (In re: C.R. Bard, Inc., Pelvic Repair System Products Liability Litigation; MDL-2187, U.S. District Court for the Southern District of West Virginia).
Court documents also show that more than 14,000 vaginal mesh lawsuits pending in the Southern District of West Virginia involve AMS. The first AMS bellwether trial is scheduled to begin on April 7, 2014. The second trial is set for May 5, 2014.
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:
The first Boston Scientific bellwether trial is slated for March 10, 2014. The second is set for trial on July 14, 2014.
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Last updated on Oct-28-14
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