C.R. Bard Implanted Mesh that its Supplier Deemed Unfit for HumansJun 26, 2013
Unsealed court records indicate that device maker C.R. Bard Inc. sold vaginal mesh devices constructed of a plastic that its manufacturer warned was unfit for humans.
The resin-based plastic is made by a unit of Chevron Phillips Chemical Co. and was used by C.R. Bard’s Davol unit managers to manufacture hernia repair mesh after Chevron Phillips registered a warning that it should not be used for permanent implantation in people, according to Bloomberg News. Plaintiffs say the same mesh was used in some vaginal mesh products made by Davol.
Emails from 2004 and 2007 filed in federal court indicate that a Davol executive warned his colleagues against advising Chevron Phillips and other resin makers that the firm was using the material in implantable medical devices. According to Bloomberg News, Roger Darois, the then-Devon executive who is now a vice president at Bard, wrote in a 2004 email that Chevron Phillips and other suppliers “will likely not be interested in a medical application due to product-liability concerns…. It is likely they do not know of our implant application. Please do not mention Davol’s name in any discussion with these manufacturers.”
Meanwhile, attorneys representing thousands of women who have brought lawsuits over Bard’s Avaulta implant line say that documents reveal officials at Davol were aware that the resin-based mesh was inappropriate for human implantation and also attempted to hide its use of the material, according to Bloomberg News.
On June 4, U.S. District Judge Joseph Goodwin ruled that the emails concerning the resin mesh raised “a genuine issue of material fact about whether Bard was aware its conduct was practically certain to cause injuries.” Judge Goodwin is overseeing 20,000 lawsuits against a number of vaginal mesh device makers, including C.R. Bard, Johnson & Johnson, Endo Health Solutions Inc.’s American Medical Systems, Boston Scientific Corp., Coloplast Corp., and Cook Medical Inc., wrote Bloomberg News. The lawsuits allege injuries from vaginal mesh implants; the firms all deny wrongdoing, according to court filings.
The first of these cases is scheduled for trial next month. The plaintiff alleges that the Avaulta design was defective; Bard failed to warn of the risks; and that the device caused pain, bleeding, and bladder spasms that necessitated other surgeries, Bloomberg News reported. Three other bellwether trials over Bard’s vaginal device’s are scheduled before Judge Goodwin.
Vaginal mesh devices received U.S. Food and Drug Administration (FDA) approval for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP), conditions typically caused by weakened pelvic muscles. Vaginal mesh devices are meant to help correct these problems by providing additional strength to the pelvic walls.
According to a July 13, 2011 FDA safety alert, complications linked to vaginal mesh implants are “not rare” and, in fact, using these devices may actually be more harmful when compared to alternative methods for treating these conditions. The FDA asked 33 manufacturers to conduct post-market safety studies to investigate health concerns associated with vaginal mesh, including organ damage. The agency reports that the most common complications associated with transvaginal mesh surgery may include mesh erosion through the vagina (exposure, extrusion, or protrusion); pain; infection; bleeding; dyspareunia (pain during sexual intercourse); and organ perforation.
FDA officials estimate that some 300,000 women underwent POP surgery in 2010; mesh was used in one-third of these procedures, according to Bloomberg News. FDA data also revealed that more than 250,000 incontinence surgeries in women took place that year and that about 80 percent involved vaginal mesh implants.