For more than a decade, there has been serious concerns about the safety of transvaginal mesh devices and whether they should be used in treating women who suffer from pelvic organ prolapse (POP). The U.S. Food & Drug Administration (FDA) first sounded the alarm about vaginal mesh products in 2008 with a safety alert stating that it had received over 1,000 reports of serious mesh complications. Since then, the administration has received nearly 3,000 additional adverse event reports involving transvaginal mesh, prompting a massive public outcry to ban the controversial products.
Transvaginal Mesh Lawsuit Update 8/1/12: According to a plaintiff’s attorney in what appears to be the latest in a string of transvaginal mesh (TVM) lawsuits filed around the country over the past several months, Boston Scientific Corporation knew – or should have known – about the health risks associated with its products. The plaintiff, from Tennessee, was reportedly implanted with a Boston Scientific Obtryx Tansobturator Mid-Urethral Sling System, and subsequently suffered debilitating personal injuries. Click here to learn more.
Vaginal Mesh Lawsuit Update 7/26/12: Last Friday, a jury ruled that medical technology giant C.R. Bard and a doctor must pay a total of $5.5 million in damages over a vaginal mesh implant that left a woman with persistent pain and potentially irreversible injuries.The landmark case is the first to go to trial among hundreds of lawsuits alleging that vaginal mesh implants made by Bard, Johnson & Johnson, and Boston Scientific caused severe organ damage and other serious injuries. Click here to learn more.
Transvaginal Mesh Update 6/26/12: Healthcare behemoth Johnson & Johnson (J&J) continued to sell its controversial Gynecare Prolift transvaginal mesh patch for nine months after the FDA ordered it to stop, according to court records. In a letter sent Aug. 24, 2007, the administration asked the company to halt sales of the Prolift until it could determine whether the device was ‘substantially equivalent’ to other products on the market. Click here to learn more.
Transvaginal Mesh Lawsuit Update 6/21/12: A judge has lifted the discovery stay in the federal transvaginal mesh (TVM) litigation, as scores of new cases continue to be filed on behalf of women in courthouses around the country. All discovery was stayed earlier this year in federal lawsuits involving transvaginal mesh products used for surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Click here to learn more.
Vaginal Mesh Lawsuit Update 5/16/12: The first trial date in the federal litigation involving women allegedly injured by vaginal mesh products manufactured by C.R. Bard has been set for early next year. Although the specific lawsuit has yet to be selected, the trial will involve a claim filed on behalf of a woman who allegedly suffered injuries after being implanted with a Bard vaginal mesh product. Click here to learn more.
Free Transvaginal Mesh Lawsuit Case Evaluation: If you or a loved one has been injured by a vaginal mesh product, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
Vaginal Mesh: An Overview
First introduced in the mid-1990’s, transvaginal mesh was originally hailed as a breakthrough treatment for pelvic organ prolapse (POP) occurring in women after childbirth, menopause, or hysterectomy. POP occurs when ligaments inside the pelvis become stretched, making the uterus press on the bladder. It was hoped that transvaginal mesh would resolved these incontinence issues, but a large number of patients who were treated with surgical mesh are facing devastating injuries as a result of erosion and decay of the mesh into their vaginal wall. As a result, women are facing not only multiple revision surgeries to correct the problem, but chronic pain and recurring infection.
In 1996, the first randomized trial involving vaginal mesh to correct POP 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. Unfortunately, the trade-off was that 25 percent of the mesh group suffered from complications consisting of erosion through the vaginal epithelium or persistent granulation tissue.
FDA Warning on Transvaginal Mesh Products
On July 13, 2011, the FDA issued a press release stating that transvaginal placement of surgical mesh to treat POP may carry more risk than other surgical options. The administration warned that vaginal mesh had been conclusively linked to a number of adverse events including:
- erosion through the vaginal tissue
- pain during sexual intercourse
- urinary problems
- organ perforation from surgical tools used in the placement procedure.
Unfortunately, many of these side effects require additional surgeries or hospitalization to treat complications and/or remove the mesh.
According to the FDA, the number of adverse events linked to transvaginal mesh has been increasing dramatically in recent years. More than 2,900 reports were filed with the administration between 2008 and 2010 – five times as many as were reported from 2005 to 2007.
In its review of the medical literature from 1996 to 2010, the FDA found that patients treated with transvaginal mesh are exposed to unnecessary additional risks compared to those who have repair with stitches alone. The administration found that while vaginal mesh often corrected the anatomy, there was no evidence of greater clinical benefit over non-mesh surgery.
In 2010 alone, there were more than 100,000 POP repairs conducted involving surgical mesh products, 75,000 of which were transvaginal procedures. The FDA stated that in the vast majority of cases, POP can and should be treated without vaginal mesh. The administration also warned that mesh implants are permanent, and revision procedures may be complicated, putting patients at risk for additional complications and surgeries in the future.
“The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh,” William Maisel, MD, MPH, deputy director of FDA’s center for devices and radiological health, said in a statement. “Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”
Click here to learn more about transvaginal mesh from Schmidt & Clark, LLP.
Do You Have a Transvaginal Mesh Lawsuit?
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 vaginal mesh injury cases in all 50 states.