By TopClassActions  |  August 27, 2013

Category: Medical Devices
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Nebraska Couple Takes on Bard in Vaginal Mesh Lawsuit

By Amanda Antell

 

transvaginal meshNebraska couple Kristi Hughes and Randy Hughes are suing vaginal mesh manufacturer C.R. Bard for the injuries the primary plaintiff, Kristi Hughes, sustained after receiving a Bard transvaginal mesh implant.

The vaginal mesh product in question is C.R. Bard’s Pelvisoft Acellular Biomesh. It was implanted into the primary plaintiff on September 17, 2010, due to unspecified injuries. As a direct consequence of the implanted mesh, the primary plaintiff suffered mesh erosion, pain, infection and other medical complications. This caused the plaintiff to undergo revision surgery to correct the damage caused by the mesh.

Hughes still suffers pain to this day from the vaginal mesh implant and, together with her husband, is suing C.R. Bard for negligence, false advertising, concealing information, and misrepresenting a product. The damages they are seeking include medical compensation, pain and suffering, and other punitive damages.

Overview of Vaginal Mesh Complications

On October 12, 2008, the FDA announced that vaginal mesh may cause serious and debilitating side effects for patients who choose to use it for pelvic organ prolapse (POP) or stress incontinence. From that announcement, it was revealed that the FDA had received over 1,000 injury reports from nine vaginal mesh manufacturers reporting complications their patients suffered from their mesh products.

By 2011, the FDA received approximately 4,000 vaginal mesh injury reports, stating that the mesh products had caused severe injury, and even death in some cases. Based on the injury reports and years of data from clinical studies, the FDA concluded that vaginal mesh was too risky for most patients and offered little reward, so the agency stated that they no longer encourage medical practitioners to use vaginal mesh for any reason.

Among the side effects these patients reported are: mesh erosion, infection, bladder perforation, and tissue tearing and scarring. 

Since transvaginal mesh is placed directly where the damaged muscle and tissue are, the idea behind the mesh was that the muscle and tissue could repair themselves by using the mesh as a support wall. The mesh was designed to be a solution for women with POP, stress incontinence and other complications, and was advertised to be biologically compatible with humans. 

This turned out to be inaccurate for many patients, and many women were forced to undergo revision surgery after the mesh implementation to repair damage caused by mesh erosion. The mesh was either trimmed or removed during these revision surgeries, which caused additional pain and medical expenses for the patients. As a result, a number of these women developed serious infections and other long-term side effects.

Bard Reaches Settlements in Bellwether Cases 

Hughes’s lawsuit against C.R. Bard is part of a multidistrict litigation (MDL) against the vaginal mesh manufacturer. Recently, the first two bellwether cases in the Bard MDL reached a verdict, with the jury awarding the plaintiffs millions of dollars in damages for the injuries they suffered. 

The first Bard mesh settlement was awarded to Donna Cisson, who received $2 million for the injuries she sustained from Bard’s Avaulta Plus Posterior BioSynthetic Support System. Cisson alleged that the implant caused her pain, bleeding and bladder spasms, forcing her to undergo surgery to repair the damage.

The second Bard mesh settlement remains confidential, but was also awarded to a woman who had to undergo revision surgery to remove loose pieces of transvaginal mesh that had damaged her pelvic organs. 

The settlements may be an indicator that Bard is willing to settle cases to avoid the expenses of trial.

The Bard vaginal mesh MDL is In re: C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, MDL No. 2187, U.S. District Court for the Southern District of West Virginia.

File a Vaginal Mesh Lawsuit 

If you believe that you or a loved one has been the victim of a vaginal mesh injury, you have legal options. Please visit the Vaginal Mesh Sling Class Action Lawsuit Investigation. There, you can submit your claim for a free legal review and if it qualifies for legal action, a seasoned vaginal mesh lawyer will contact you for a free, no-obligation consultation. You will be guided through the litigation process at no out-of-pocket expenses or hidden fees. The vaginal mesh lawyers working this investigation do not get paid until you do.

 

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