C.R. Bard & Coloplast Hit with Lawsuit Over Vaginal Mesh Implant Side Effects
By Andrea Gressman
On October 19, 2012, another plaintiff filed a vaginal mesh implant lawsuit. The vaginal mesh implant lawsuit was filed in U.S. District Court in the Northern District of California and named both C.R. Bard and Coloplast as the defendants.
It is the plaintiff’s claim that she initially received a C.R. Bard vaginal mesh implant device implanted in order to treat her pelvic organ prolapse. The plaintiff goes on to state that she later had another transvaginal mesh implant surgically implanted when her first vaginal mesh implant device failed to properly treat the condition, which resulted in a tremendous amount of pain and suffering. This second vaginal mesh implant was manufactured by Coloplast.
Number of Complication Cited in Vaginal Mesh Implant Lawsuit
According to the transvaginal mesh implant lawsuit, the plaintiff claims she first received the C.R. Bard vaginal mesh implant on June 3, 2003 in order to treat the pelvic organ prolapse she was struggling with. The transvaginal mesh implant had previously received its FDA approval under section 501(k). This is also referred to as a “fast track” approval. When this happens, the manufacturer of the product is allowed to bypass the clinical testing with products that would normally have to go through the clinical trials in order to receive its approval. A company is only allowed to do this if the manufacturer can demonstrate that their product is similar to another product that is already on the market.
C.R. Bard was able to satisfactorily demonstrate that the vaginal mesh product targeted in the lawsuit was similar to other vaginal mesh implant products on the market in order to meet the FDA’s standards. As a result, C.R. Bard did not have to provide its own clinical testing on the product in order to show that the vaginal mesh implant was safe.
The vaginal mesh implant lawsuit also claims that the C.R Bard vaginal mesh implant devices were marketed in an aggressive manner to the general public as well as the health care community. It is claimed that the marketing strategy provided “exaggerated and misleading expectations” regarding the vaginal mesh implant health benefits it could provide.
It was also pointed out that the C.R Bard vaginal mesh implant devices had a high failure rate from the very beginning. It was claimed by this plaintiff’s vaginal mesh implant lawyer that the vaginal mesh implant device had already been linked to severe and, in many cases, irreversible injuries. These side effect risks included vaginal mesh extrusion and erosion, recurrence of the condition the vaginal mesh implant was originally treating, and chronic infection.
Vaginal Mesh Lawsuit Alleges Manufacturers are Negligent Because Of Withholding Information
It is the claim in this vaginal mesh implant lawsuit that the manufacturers are negligent because they withheld important information regarding the vaginal mesh implant products. As a result of withholding information, the manufacturers put the women receiving the vaginal mesh implant devices at an unnecessary risk of developing one of the many negative side effects. The plaintiff is seeking compensation in excess of $75,000 for the pain, suffering, and ongoing medical treatment she has to endure.
Visit the Transvaginal Mesh, Vaginal Sling, Vaginal Mesh and Bladder Sling Class Action Lawsuit Investigation page if you have developed one or more of the following side effects: urinary problems, vaginal scarring, pain during sex, multiple occurrences of pelvic organ prolapse, mesh erosion into the vagina, organ injuries, perforations within the bladder, bowel and blood vessels, and vaginal or bladder infections. Provide your information and receive a free consultation from a vaginal mesh implant lawsuit attorney.
Updated November 19th, 2012
All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.
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