Product Warning: Transvaginal Surgical Mesh

transvaginal mesh

A recent federal court judgment in West Virginia is holding medical manufacturer C.R. Bard Inc., responsible for $250,000.00 in compensatory damages and $1.75 million in punitive damages for manufacturing and promoting a transvaginal surgical mesh which it knew or should have known would cause injury when implanted.

Manufacturer ignored known dangers

Bard manufacturers the Avaulta Plus transvaginal surgical mesh used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). A polypropylene resin was used to make the Avaulta Plus vaginal mesh. According to court documents, Bard was aware of the dangers of the resin after the Phillips Company, makers of the polypropylene resin, warned against using it in permanent implantation devices. Phillips warned that any contact with the human body or internal body fluids or tissues would increase risk of erosion, infection, scar tissue formation, and a “tendency to unravel, creating sharp ‘fishing line’ effect……arms” that could slice through tissue. Even though Phillips declined to sell the resin to Bard for use in its devices, Bard surreptitiously purchased the harmful resin from third parties to conceal its use because it did not “want Phillips to know that [they] are using [the resin] for a medical device,” as stated in Bard company emails.

The email further stated that Bard avoided contacting the resin supplier directly, because the supplier refused to supply it to Bard after the supplier received the same usage warnings that Bard received.

  • Bard continued to ignore recommendations by physicians and researchers to conduct pre-market human trials and further declined to perform new tests on its product.
  • Bard also disregarded adverse results of the tests it did perform including not informing physicians about the results, according to the court opinion.

First case of 70,000 injured plaintiffs

The West Virginia case was the bellwether case tried to a jury out of seven multi-district litigations in which there are more than 70,000 cases pending, 10,000 of which are against Bard, according to the court opinion. The plaintiff in the West Virginia case was implanted with the Avaulta Plus mesh to treat her POP in May 2009. Afterwards, she experienced significant pain and “extrusion, erosion, excessive scarring, and inflammation as a result of the implant.” She had the Avaulta Plus removed in 2011, however the “arms” were unable to be removed and remain inside causing continued pelvic pain. The jury awarded her $250,000 in compensatory damages and $1.75 million in punitive damages.

Reckless disregard by Bard

The Federal Judge denied Bard’s motion to dismiss the punitive damages claim assessing the reprehensibility of their conduct as critical to the amount of punitive damages awarded. Bard attempted to minimize the plaintiff’s physical injuries, calling them “non-life threatening,” but the court cited trial facts of the plaintiff’s “life-altering” pain that is “permanent in nature” as evidence of Bard’s reprehensible conduct. The judge also pointed to Bard’s continuous indifference and reckless disregard of the harms caused to the plaintiff — by the use of the polypropylene resin in its device even after they were warned to avoid use in human bodies — as conduct that warranted the $1.75 million punitive damage award against it.

The Takeaway

In the appropriate cases, juries still serve the important function of protecting the community by awarding compensatory, and in some cases punitive, damages. The threat of punitive damages is still an effective tool in keeping defective products off the market and steering manufacturers to properly testing products prior to bringing products to market. If you have any questions on this product, the current litigation, or other defective products, please contact us.

Thank you.

Michael K. Gillis, Esq.


1150 Walnut Street

Newton, MA 02461

Phone: 617-244-4300

Fax: 617-964-0862


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