Transvaginal Mesh Manufacturer CR Bard to Buy New Company for Edge in Urinary Retention and Incontinence Market
Rochester Medical manufactures products and devices, such as disposable catheters, to help patients outside the hospital with urinary incontinence or retention while at home.
“We believe that strengthening our position in the home care market, and specifically the large and fast-growing intermittent self-catheter segment, is strategically important at this time,” Bard Chief Executive Timothy Ring said.
CR Bard currently has a market share of $9 billion making medical devices for vascular, urology, oncology, and specialty surgical fields – including the problematic transvaginal mesh implants. Bard estimates that by 2018, around 1.1 billion people worldwide will be affected by some kind of lower urinary tract or bladder obstruction.
“Our agreement with Bard represents an attractive valuation for Rochester Medical shareholders and as an all-cash offer provides liquidity for shareholders,” said Anthony Conway, chief executive officer at Rochester Medical, in a news release. “We believe the merger represents a great opportunity for the combined companies to create a broad product portfolio.”
During a bellwether transvaginal mesh personal injury trial recently, which CR Bard lost, the medical manufacturer was accused of using materials in the manufacturing of their transvaginal mesh devices that were not compatible with the human body. They were also accused of not testing their devices enough to prove safety.
CR Bard Loses First Bellwether Case Due to Improper Materials and Testing
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 CR Bard 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.”
On Thursday, August 8th, Laura Bigby, director of research and development for transvaginal mesh manufacturer CR Bard, was cross-examined by the plaintiff’s lead attorney. She spent three hours dodging questions about transvaginal mesh safety and the validity of the tests Bard conducted on their mesh products. The questions Bigby faced in Donna Cisson’s personal injury trial dealt with product tests she allegedly oversaw for the transvaginal mesh slings. While on the stand, she took exception with nearly every question asked.
Lead attorney Henry Garrard asked point-blank of Bigby thought the cadaver studies were enough to simulate the stress a living body would put on the transvaginal mesh devices, to which Bigby responded, “It simulates the conditions, yes.”
Garrard continued: “So you had no functional testing of the entire Avaulta Plus model as it would be used in humans?”
“We did not believe it was necessary to do that,” Bigby said.
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