C.R. Bard used plastic in their transvaginal mesh devices that was, according to the plastic’s manufacturer, unsuitable for human implantation.
Court records that have been unsealed in the multidistrict litigation against the transvaginal mesh manufacturer show that managers in the company’s Davol unit used a resin-based plastic that was made by a Chevron Phillips Chemical Company unit, which the supplier officially stated that the plastic should not be permanently implanted in people. Davol used the plastic to create transvaginal mesh and hernia repair products anyway.
In 2004 and 2007, emails filed in a federal court in West Virginia show that an executive from Davol warned colleagues not to tell the plastics manufacturer that the transvaginal mesh company was using the material, despite warnings, in medical devices to be implanted in humans.
“Do not use this Phillips Sumika Polypropylene Co. material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues,” according to the warning. It continued: “Do not use this Phillips Sumika Polypropylene Co. material in medical applications involving brief or temporary implantation in the human body or contact with internal body fluids or tissues unless the material has been provided directly from Phillips Sumika Polypropylene Co. under an agreement that expressly acknowledges the contemplated use.”
Suppliers such as Chevron Phillips “will likely not be interested in a medical application due to product-liability concerns,” Roger Darois, the Davol executive, now a Bard vice president, said in a March 2004 e-mail. “It is likely they do not know of our implant application. Please do not mention Davol’s name in any discussion with these manufacturers.”
In response, Scott Lowry, a Bard vice president, said in an email: “During the upcoming trial, Bard will provide all the relevant evidence for the jury to consider and render a decision, which will demonstrate that Bard acted appropriately in its acquisition of polypropylene resin. We believe that the Avaulta polypropylene mesh implant is a safe and effective treatment for pelvic organ prolapse when used in accordance with its instructions. To this day, after more than 50 years of use, polypropylene remains one of the most widely implanted and best materials for mesh products in medical applications in the human body.”
However, Lowry did not comment on the emails filed in federal court.
Transvaginal Mesh Injury Trial Against Bard to Begin July 8th
The latest in thousands of lawsuits against transvaginal mesh manufacturers will be the case of Donna Cisson, 54, in the US District Court of West Virginia.
Like many plaintiffs against transvaginal mesh manufacturers, Mrs. Cisson suffered pain, bleeding, and bladder spasms after the implantation of her transvaginal mesh, which required follow-up surgeries.
Cisson’s personal injury case is the first bellwether trial in the Bard transvaginal mesh MDL.
Last year, the FDA ordered Bard, Johnson & Johnson, and other transvaginal mesh manufacturers to make three-year studies of rates of organ damage, perforation, infection, and painful sex that have often been linked to transvaginal mesh. In just 2012, according to the FDA, 250,000 women had surgeries for incontinence problems, and 80% of those surgeries involved mesh products.
In response to the FDA’s order, Bard said they would pull their Avaulta mesh completely off the market.
The company “is simply making a business decision not to invest in clinical trials on this product,” Brenda Hammans, a vice president, said in the e-mail.
Further testimony in the base against Bard came from Jim Ross, a California-based gynecologist who worked for Bard as a consultant on their transvaginal mesh implants. He testified that he suggested clinical trials of the device, but to no avail.
“I felt at least a pilot study would have been good to do,” he said.
Three more bellwether trials against Bard have been scheduled to follow Cisson’s case.
The Strom Law Firm Fights for Women in Transvaginal Mesh Personal Injury Cases
Transvaginal mesh kits were initially produced to help with pelvic organ prolapse and stress urinary incontinence. Several varieties of mesh kits exist, but transvaginal mesh specifically was supposed to produce less scarring and pain, because the procedure was less invasive. However, vaginal mesh slings can cause a host of problems, including organ perforation, infection, internal scarring, continued organ prolapsed, and bleeding. If you or a loved one has pelvic organ prolapse or stress urinary incontinence, have had a transvaginal mesh device implanted, and have since experienced detrimental complications, you may be entitled to compensation. The experienced lawyers at Strom Law, LLC can help. We offer free consultations, so please contact us today, and we can help get you on the road to recovery. 803.252.4800