CR Bard Inc. sold vaginal mesh devices that were constructed of a plastic that its manufacturer warned was not fit for humans, according to unsealed court records.
The plastic, a resin-based compound, is manufactured by a unit of Chevron Phillips Chemical Co. and was used by Davol, a unit of CR Bard, in the making of hernia repair mesh. This, after Chevron Phillips registered a warning that the material should not be used for permanent implantation in humans, Bloomberg News reported, according to emails and documents in a lawsuit involving CR Bard implants. Plaintiffs say this mesh was used in some vaginal mesh devices Davol manufactured.
Emails from 2004 and 2007 that were filed in federal court reveal that a Davol executive warned his colleagues not to advise Chevron Phillips and other resin makers that the firm was using the material in its implantable medical devices. Bloomberg News reports that Roger Darois, a 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.”
Lawyers representing thousands of women who have brought lawsuits over Bard’s Avaulta implant line report that documents indicated that Davol officials knew the resin-based mesh was not appropriate for implantation in humans and attempted to cover up its use of the material, according to Bloomberg News.
U.S. District Judge Joseph Goodwin ruled on June 4th 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.” Goodwin is the judge overseeing 20,000 lawsuits brought against some vaginal mesh device makers including CR Bard, Johnson & Johnson, Endo Health Solutions Inc.’s American Medical Systems, Boston Scientific Corp., Coloplast Corp., and Cook Medical Inc. wrote Bloomberg News. Lawsuits allege injuries from vaginal mesh implants; according to court filings, the firms all deny any wrongdoing.
The first of these lawsuits is scheduled for trial next month. In that case, the plaintiff alleges that the Avaulta design is defective; that Bard failed to warn of the device’s risks; and that the mesh device caused her pain, bleeding, and bladder spasms that resulted in her having to undergo additional surgeries, according to Bloomberg News. Three other bellwether trials over Bard’s vaginal device’s are scheduled to be heard before Judge Goodwin.
Transvaginal mesh devices were approved to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP), conditions most commonly caused by weakened pelvic muscles. Vaginal mesh devices are supposed to help correct these conditions by providing additional strength to the pelvic walls.
The U.S. Food and Drug Administration (FDA) reports that the most common complications associated with transvaginal mesh surgery may include:
- Mesh erosion through the vagina (exposure, extrusion, or protrusion)
- Dyspareunia (pain during sexual intercourse)
- Organ perforation
A July 13, 2011 FDA safety alert indicated that complications associated with vaginal mesh implants are “not rare” and that use of these devices may be more harmful when compared to alternative methods for treating POP. The FDA also asked 33 manufacturers to conduct post-market safety studies to investigate the health effects of vaginal mesh, including on organ damages, according to Bloomberg News.