Transvaginal Mesh Complications Associated with “Unfit” Plastic Material

V-meshUnsealed court records involving a C.R. Bard vaginal mesh device indicate a plastic material used to create the implant was “unfit” for use in humans. Bloomberg News reports that the company that manufactured the plastic, Chevron Phillips Chemical Co., created a plastic material that the company warned was not for use in humans. Bard’s Davol unit disregarded those warnings and used the plastic to manufacture implant devices that have now been reported to cause a number of transvaginal mesh complications. Click here to read about transvaginal mesh implants and related complications.

Manufacturer registers warning about material safety

According to the report, Chevron Phillips officially registered a warning after manufacturing its polypropylene, stating the material was not safe for permanent implantation in people. The material was used in Davol vaginal mesh products after the warning was registered. In addition, emails from a Davol executive dating to 2004 and 2007 cautioned employees of Davol not to disclose use of the product in human implant devices to the manufacturer.

The Davol executive that issued those warnings, Roger Darois, is now a vice president at Bard. In his emails to staff, Darois stated that Chevron Phillips will “likely not be interested in a medical application due to product liability concerns.” The executive then went on to ask employees to refrain from mentioning Davol’s name when in discussions with Chevron Phillips or other manufactures that created a similar plastic material with similar warnings.

Transvaginal mesh devices have been used for a number of years to treat chronic conditions like stress urinary incontinence and pelvic organ prolapse. However, reports of complications with these devices have left some medical providers and agencies concerned about their safety. Women who have been implanted with these devices have reported serious side effects including vaginal mesh erosion and extrusion, persistent abdominal pain and bleeding, and recurrent infections.

New evidence could be used against Bard in court

According to lawyers who have filed transvaginal mesh lawsuits on behalf of clients across the country, this new information is evidence that C.R. Bard knew of the risks associated with transvaginal mesh complications, but failed to disclose that information to the medical community or consumers. Lawyers plan to present this new evidence at a trial scheduled for July 8, 2013, in U.S. District Court in the Southern District of West Virginia.

The trial in question is actually a part of transvaginal mesh multidistrict litigation involving lawsuits alleging complications associated with Bard devices. Currently, more than 3,800 cases have been coordinated into this federal MDL, which was established for the purpose of preventing duplicate discovery and conflicting rulings. The case scheduled for July 8 is one of four bellwether trials – early trials selected to provide insight into how juries might respond to evidence and testimony in similar lawsuits.

On June 4, U.S. District Judge Joseph Goodwin ruled that the emails sent from Bard involving the polypropylene presented a “genuine issue of material fact” as to whether the company was aware its conduct raised the risk of personal injury. Judge Goodwin is the federal judge assigned to oversee the MDL and will be presiding over the early bellwether trials. Lawyers for the plaintiff in the first bellwether trial, Donna Cisson, will use the evidence to show Bard failed to notify consumers of the risks associated with their product.

Cisson alleges she has suffered severe pain, bleeding, bladder spasms and the need for additional revision surgery after being implanted with her Bard vaginal mesh device.

Plaintiff may be able to seek additional damages

Cisson is seeking compensatory damages from Bard. However, if the jury finds the company’s conduct warrants additional reward, Cisson may be able to seek punitive damages from the defendant as well. Once Cisson’s case is decided, three more bellwether trials will be heard before the rest of the pending transvaginal mesh lawsuits in the federal MDL proceed. If these early cases rule in favor of the plaintiffs, it increases the possibility of vaginal mesh settlements from Bard for others who have filed lawsuits after experiencing serious transvaginal mesh complications.

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