On September 8th and 9th, 2011, the U.S. Food & Drug Administration (FDA) will convene with a panel of experts to discuss the safety and efficacy of controversial transvaginal mesh products. The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will focus on evaluating the inherent risks vs. benefits of transvaginal mesh devices, which are widely used to treat women who suffer from pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Sadly, there have been concerns about the safety of these products for more than a decade.
Free Vaginal Mesh Lawsuit Case Evaluation: If you or a loved one has been injured by vaginal mesh, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
Surgical Mesh: A Brief History
Surgical mesh, which was originally designed to repair abdominal hernias, has been in use in the United States since the 1950’s. In the 1970’s, gynecologists saw the potential for benefit with mesh and began using it to treat pelvic organ prolapse. By the 1990’s, surgical mesh was beginning to be used in the treatment of stress urinary incontinence and transvaginal repair of pelvic organ prolapse.
As the years went by and the demand for surgical mesh in vaginal applications increased, manufacturers developed a number of products specifically designed for POP and SUI. In 1996, the FDA approved the first mesh product specifically designed for use in SUI. In 2002, the administration cleared the first mesh product to be used exclusively for POP. Over the next few years, surgical mesh continued to evolve into a number of modern FDA-approved vaginal mesh systems.
FDA-Approved Vaginal Mesh Systems
The following vaginal mesh systems have been granted FDA approval though the much-criticized 501(k) process:
- Perigee/Apogee Vault Suspension System: The Perigee system is designed to treat anterior vaginal wall defects through the use of four side-specific transobturator trocars. The Apogee system is designed to treat posterior and apical vaginal wall defects using two side-specific trocars passed to the level of the ischial spine via the ischiorectal fossa. Both products may be used either with a polypropylene mesh or a porcine dermal graft.
- Gynecare Prolift Pelvic Floor Repair System: Contains a metal trocar with a flexible mesh retrieval device designed to be passed through the obturator foramen to correct an anterior vaginal wall defect, or through the sacrospinous ligament via the ischiorectal fossa to correct concomitant posterior and apical vaginal wall defects.
- Avaulta Support System: Utilizes compartment-specific trocars with a flexible InSnare retrieval device to be passed anteriorly through the obturator foramen, or posteriorly though the ischiorectal fossa.
- Pinnacle Pelvic Floor Repair Kit/Uphold Vaginal Support System: Utilizes the Capio Suture Capturing Device to attach mesh placed in the anterior compartment to the sacrospinous ligament, therefore requiring no trocar passes.
- Elevate Prolapse Repair System: Designed to correct concomitant posterior and apical vaginal defects via a single posterior vaginal incision. The Elevate system utilizes a trocar with a self-fixating tip to attach either a double armed polypropylene mesh or porcine dermal graft to the sacrospinous ligament.
Landmark Transvaginal Mesh Study
In 1996, the first randomized trial involving transvaginal mesh to correct pelvic organ prolapse was conducted. Hoping to improve upon failure rates of up to 40 percent with traditional anterior colporrhaphy, the study divided 24 patients suffering from a recurrent cystocele to undergo either the traditional colporrhaphy or treatment with surgical mesh. Two years after the surgeries, the research found a recurrence rate of 0 percent for the group treated with vaginal mesh, compared to 33 percent from the colporrhaphy group. The trade-off was that 25 percent of the mesh group suffered complications consisting of erosion through the vaginal epithelium or persistent granulation tissue.
Do You Have a Transvaginal Mesh Lawsuit?
If you were the recipient of a transvaginal mesh product and suffered from any adverse health complications, you may be entitled to compensation. Contact the transvaginal mesh lawyers at Schmidt & Clark, LLP today for a free case evaluation. Act now – there is a limited amount of time in which to file your claim.
The Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in transvaginal mesh lawsuits. We are handling individual litigation nationwide and currently accepting new transvaginal mesh injury cases in all 50 states.