The federal judge presiding over all transvaginal mesh litigation has upheld the jury verdict returned in the first federal C.R. Bard Avaulta trial, rejecting attempts by the manufacturer to overturn a $2 million award for the plaintiff.

U.S. District Judge Joseph Goodwin reaffirmed that the initial award was appropriate and that attorneys representing plaintiff Donna C. successfully proved that Bard’s Avaulta vaginal mesh was the cause of her injuries.

Donna brought filed her vaginal mesh lawsuit for severe injuries resulting from her use of Bard’s transvaginal mesh. Donna alleged that the Bard Avaulta Plus vaginal mesh implant gave her bladder spasms and caused bleeding as well as pelvic pain.

Her vaginal mesh lawsuit was the first out of tens of thousands transvaginal mesh lawsuits to reach a federal jury claiming the Avaulta line of transvaginal mesh implants, used in the treatment of pelvic organ prolapse, were prone to degrading and caused bleeding, painful sexual intercourse, bladder spasms, scarring and a host of other injuries.

Judge Goodwin has determined that the jury saw sufficient evidence during the trial that could have reasonably led to its verdict of both compensatory damages and punitive damages against Bard. The judge pointed to evidence that Bard knew some materials in the mesh were not for human use and went out of its way to try and obtain the materials “surreptitiously” so the makers wouldn’t know how the material was being used.

Bard allegedly knew that the composition of its product increased the risk of complications yet never apprised physicians of those facts, which created a legitimate question for the jury regarding the adequacy of the warnings, the federal judge said.

Judge Goodwin then found abundant evidence that physicians would not have implanted the pelvic mesh device had they known what Bard did, which established the required causal link between the alleged failure to warn and Donna’s injuries, the order said.

Vaginal Mesh Failure

In response to the growing concern over vaginal mesh problems, the U.S. Food and Drug Administration (FDA) mandated healthcare professionals to further study the rates of transvaginal mesh failure, suggesting that these devices should be subject to more rigorous regulation and oversight.

A significant number of the adverse events reported to the FDA regarding pelvic mesh implants are due to mesh erosion. Mesh erosion through the vaginal tissue can cause pain, bleeding and infection. In addition, most surgical mesh products are made of polypropylene, a material that can shrink after being implanted, causing serious side effects and the prolapsed organ condition to return.

Symptoms of vaginal mesh failure include:

• Urinary incontinence
• Abdominal pain
• Pelvic pain
• Pain during sexual intercourse
• Bleeding

Vaginal Mesh Lawsuits

Tens of thousands of ongoing transvaginal mesh lawsuits against C.R. Bard Inc. remain to be resolved, and are consolidated pursuant to In re: C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, MDL No. 10-md-02187, in the U.S. District Court for the Southern District of West Virginia.