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Thousands of lawsuits have been filed against the makers of transvaginal mesh devices alleging the medical devices were defectively designed and caused serious health problems. The meshes are implanted to treat pelvic organ prolapse or stress urinary incontinence, but have been linked to mesh erosion, organ damage, chronic pain, bowel and bladder perforation, vaginal scarring, urinary problems and infections.
Transvaginal Mesh Lawsuits
Some women have undergone surgery to remove the vaginal mesh, but in some cases the damage has allegedly been permanent. In addition to surgery, treatment of complications associated with the mesh can include IV therapy, blood transfusions and drainage of hematomas or abscesses.
As of November 2014, more than 65,000 transvaginal mesh lawsuits had been filed against a number of manufacturers, including C.R. Bard, Ethicon (a Johnson & Johnson subsidiary), American Medical Systems and Boston Scientific and consolidated for pretrial proceedings. Some lawsuits have been settled or resulted in awards to the plaintiffs, but many lawsuits are still pending.
According to the U.S. Judicial Panel on Multidistrict Litigation in a report from November 17, 2014, US District Judge Joseph Goodwin is currently overseeing approximately 10,000 lawsuits against C.R. Bard; 18,000 lawsuits against American Medical Systems; 14,000 lawsuits against Boston Scientific; 22,000 lawsuits against Ethicon; 1,700 lawsuits against Coloplast; 250 lawsuits against Cook Medical; and 70 lawsuits against Neomedic.
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:
- mesh erosion into the vagina, bladder, intestines and uterus
- 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
Transvaginal Mesh Lawsuits by Manufacturer
C.R. BardC.R. Bard currently faces around 10,000 lawsuits consolidated for pretrial proceedings in US district court before Judge Goodwin. Lawsuits filed against Bard involve the Avaulta transvaginal mesh.
Ethicon/Johnson & JohnsonJohnson & Johnson subsidiary, Ethicon faces approximately 22,000 lawsuits consolidated for pretrial proceedings. Ethicon makes the Gyncare mesh products. In early 2014, Ethicon came under fire for negligently destroying thousands of documents related to the development of some of its vaginal mesh products.
American Medical SystemsAmerican Medical Systems faces approximately 18,000 lawsuits consolidated for pretrial proceedings in US district court before Judge Goodwin.
Boston ScientificBoston Scientific currently faces approximately 14,000 lawsuits consolidated for pretrial proceedings in US District Court before Judge Goodwin.
Some Boston Scientific lawsuits have gone to trial. The first federal bellwether trial to go to court resulted in an $18.5 million award to four women who filed lawsuits against the company. The award was announced in November 2014. The previous month saw an award of $26.7 million against Boston Scientific regarding its Pinnacle mesh device. In September 2014, a $73.4 million award was given to plaintiffs who filed a lawsuit concerning Boston Scientific's Obtryx device.
Tissue Fixation System (TFS)Lawsuits have been filed against Tissue Fixation System (TFS), a pelvic mesh tape that is used to treat Pelvic Organ Prolapse (POP). The lawsuits allege that TFS Manufacturing Pty and TFS Surgical (US) aggressively marketed their Tensioned Mini-Sling with Anchors while exaggerating the product's safety.
Other Transvaginal Mesh CompaniesOther companies reportedly involved in transvaginal mesh lawsuits include Coloplast (approximately 1,700 lawsuits pending in district court) Cook Medical (approximately 250 lawsuits pending in district court) and Neomedic (approximately 70 lawsuits pending in district court).
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