Pelvic Mesh

Pelvic Mesh

Over 60,000 women have reported serious injuries resulting from the implantation of a transvaginal mesh device, and hundreds of thousands of women currently have these dangerous devices implanted in their bodies. The FDA has issued warnings regarding the dangerous side effects and potential harm that can result from these devices and the manufacturers of these devices are now providing settlement funds to women injured by transvaginal mesh products.

If you or a loved one have suffered from serious complications that may be due to the implantation of a tranvaginal mesh device —ACT NOW — as you may qualify for the substantial compensation you deserve.

  • Background

    A mass tort is a civil action involving numerous plaintiffs against one or a few corporate defendants in state or federal court. There are three main categories of mass torts: disaster; toxic torts; and product liability.

    Torts differ from class actions in that in U. S. federal courts, mass tort claims are often consolidated as multidistrict litigation (MDL). MDL’s refers to a special federal legal procedure designed to speed the process of handling complex cases such as air disaster litigation, toxic tort or complex product liability suits. MDL cases occur when civil actions involving one or more common questions of fact are pending in different districts. MDL’s efficiently process cases that could involve hundreds or thousands of plaintiffs in dozens of different federal courts which all share common issues.

    Transvaginal Mesh (TVM) mass tort cases are growing steadily. There are similarities between TVM cases and asbestos related cases. Asbestos cases, starting in the 1970’s have become the largest mass tort in history. Mesothelioma, a rare form of cancer, is caused by exposure to asbestos fibers. The symptoms or signs of mesothelioma may not appear for 20 to 40 years after exposure to asbestos. However it is conclusive that mesothelioma is caused by asbestos and in most cases, it is fatal.

    Challenges exist for attorneys representing plaintiffs in all mass tort or toxic tort cases where product liability is the cause. Proof of medical causation is the critical element in a toxic tort case (pharmaceuticals). In order to prevail, the plaintiff must prove general causation – that the agent of issue, is capable of causing the plaintiff’s particular disease or malady, and specific causation – that the plaintiff’s exposure to the “agent”, at the dose received, actually caused the disease or malady.

    However, like mesothelioma, Transvaginal Mesh cases are generally cut and dry. Either the plaintiff had the devise inserted into her body or she did not. Also like mesothelioma, Transvaginal cases have horrific outcomes.

  • History

    Transvaginal mesh (TVM) is used primarily to treat pelvic organ prolapse (POP), which is generally treated with mesh kits or systems, and stress urinary incontinence (SUI), which is generally treated with a mesh sling or mesh tape. Transvaginal mesh was first introduced as a derivative of general surgical mesh, which has been used widely for decades.

    Since the 1950’s, surgical mesh has been used for all types of internal repairs, particularly hernia repairs to strengthen the abdominal wall. In the 1970’s, gynecologist and urogynecologists began to develop products which used surgical mesh to repair pelvic organ prolapse and to treat urinary incontinence. Gynecologists began to cut small pieces of surgical mesh into precise shapes and later make several abdominal incisions to provide support for muscles in the pelvis and prevent organs such as the bladder from sagging (stress urinary incontinence) or falling completely into the vagina (cystocele). Sensing the potential for a breakthrough, a company by the name of Versica Medical introduced a product called the “Vesica Bone Anchoring System”, which was to be used solely for the purposes of urinary incontinence. While Vesica’s system was not inserted transvaginally, it was one of the precursors to transvaginal mesh devices that followed.

    The First Transvaginal Mesh Device

    In 1996, a company by the name of Boston Scientific acquired Vesica Medicdal and used its Vesica Bone Anchoring System as the basis for their own system for stress urinary incontinence treatment (SUI). Boston Scientific released a product called the ProteGen Sling, which was initially heralded for its innovative approach to SUI treatment. Unlike its predecessor, the Vesica Bone Anchoring System, the ProteGen Sling was implanted transvaginally, which is an approach that is less sterile and more susceptible to outside bacteria and infection. Transvaginal mesh also leaves the physician with a tougher task for mesh insertion with regard to visibility since internal organs and the mesh itself are much harder to see. While the ProteGen Sling was officially approved by the FDA in 1996 on the basis that it was similar to the Vesica Bone Anchoring System, it was recalled three years later after several patients reported injuries such as vaginal bleeding, organ perforation, mesh erosion, and infections.

    Before the recall of Boston Scientific’s ProteGen Sling, another major manufacturer, Johnson & Johnson / Ethicon, released a competing product for the FDA approval: the Gynecare TVT Vaginal Sling. Since the FDA had already approved the ProteGen Sling, Johnson & Johnson / Ethicon was able to release the TVT system without performing necessary clinical trials or studies. Other major manufacturers such as American Medical Systems and Tyco released similar products shortly after with AMS Monarc Subfascial Hammock (released in November 2002) and Tyco IVS Tunneler (released in April 2001). Dozens of transvaginal mesh products have been manufactured and approved since the ProteGen Sling.

    It’s important to note that before 2002, TVM products were only approved for use when treating stress urinary incontinence (SUI). Sling systems and tapes, such as Ethicon’s, Gynecare TVT, are used for urinary incontinence and act as a hammock or strap for tensioning prolapse bladders, which are the cause for SUI. POP is related to SUI but applies to all pelvic organs including the bladder (cystocele), uterus (urethrocele)< vagina (vaginal vault prolapse), bowels (enterocele), rectum(rectocele).

    In 2002, the FDA approved surgical mesh for the purpose of pelvic organ prolapse (POP). POP kits such as the Apogee, Perigee and Elevate Systems (American Medical Systems, The Pinnacle and Uphold Systems (Boston Scientific), the Avaulta Mesh Systems (C.R. Bard), and the Prolift System (Johnson & Johnson / Ethicon) began to appear to treat women with POP.

  • Timeline

    TVM Timeline

    (1996) Device Approval: The Food and Drug Administration (FDA) approved the first transvaginal mesh product. The product was called ProteGen Vaginal Sling manufactured by Boston Scientific to treat stress urinary incontinence (SUI) only.

    (1998) Johnson & Johnson: J&J was able to win FDA approval for its Gynecare TVT Vaginal Mesh Sling without conducting rigorous tests or clinical studies. FDA approved because it closely resembled Boston Scientific’s mesh device. Other manufacturers were able to win FDA approval solely because of their products’ similarity to ProteGen.

    (2002) Prolapse Treatment: The FDA approved surgical mesh for the treatment of pelvic organ prolapse (POP). Although increasingly popular for the treatment of POP, stress urinary incontinence, and other similar disorders, complications linked to transvaginal mesh devices are also increasing.

    (2008) 1st FDA Warning: October 20, 2008 – Due to more than a thousand reports of complications linked to transvaginal mesh devices, the FDA issued the first of two warnings. According to the FDA, women were experiencing infections, pain, mesh erosion, vaginal scarring and pain during intercourse, and bowel and bladder perforation after undergoing a transvaginal mesh procedure.

    (2011) 2nd FDA Warning: FDA issued its second warning of the use of surgical mesh for the treatment of stress urinary incontinence and POP. In this warning, the FDA stressed that reports of complications were not rare and that the risk of injury outweighed the benefit of the mesh device.