Pharmaceutical

C.R. Bard knew its transvaginal mesh plastic was unfit for human use, surgeon alleges

vaginal mesh sling C.R. Bard knew its transvaginal mesh plastic was unfit for human use, surgeon allegesThe first of thousands of personal-injury lawsuits filed in federal courts against six makers of transvaginal mesh devices is underway in Charleston, W.V.

A lawsuit filed by plaintiff Donna Cisson, 55, against C.R. Bard was selected as the first of more than 27,000 cases consolidated for multidistrict litigation (MDL) in a West Virginia federal court to be heard. Ms. Cisson’s lawsuit is one of more than 4,000 that manufacturer C.R. Bard faces. Other manufacturers of transvaginal mesh in the MDL include Boston Scientific, Cook Medical Inc., Coloplast Corp, and Ethicon (a unit of Johnson & Johnson).

Ms. Cisson was implanted with a Bard Avaulta Plus Posterior BioSynthetic Support System mesh device on May 8, 2009, to correct a rectocele, a form of pelvic organ prolapse (POP). She underwent the procedure at Stephens County Hospital in Toccoa, Ga.

The implanting physician, Dr. Brian Raybon, testified in court that C.R. Bard should have warned him and others about the risks of implanting polypropylene mesh in humans, but never did. According to Mesh Medical Device News Desk, Dr. Raybon “was particularly adamant because he was a consultant for the company and a ‘preceptor,’ a doctor trained to teach other doctors on the use of [the] device.”

Dr. Raybon was also the first surgeon to implant C.R. Bard’s Avaulta mesh device in the U.S., Mesh Medical Device News Desk reported. He continued to use the device for years because he “felt like it was a good system at the time.” However, after patients implanted with the device started complaining of pain and injury, he discovered that the mesh was made of a petroleum-based plastic that should never have been used in the human body. Dr. Raybon was visibly angry about C.R. Bard’s failure to warn about the device, Mesh Medical Device News Desk said.

“As someone who spent four or five years at Bard teaching other physicians (about Bard products), and there’s this MSDS sheet around, I’m really concerned I’ve put something in these patients that shouldn’t have been put in,” Dr. Raybon told the court. “I’m sorry … it was a little irritating to work with someone four or five years, and they didn’t tell me.”

According to Mesh Medical Device News Desk, an “MSDS is a Material Safety Data Sheet that was uncovered in the discovery process pre-trial.  Executives for Bard knew the resin they were using was not intended for medical implants and discuss not revealing that to the source of the raw material, Chevron Phillips.”

Dr. Lennox Hoyte, professor of urogynecology and pelvic reconstructive surgery at the University of South Florida, testified that he is having to correct more and more mesh implantations gone wrong, about a quarter of which involve C.R. Bard mesh devices.

Dr. Hoyte used 3-D models to show how parts of the mesh devices are exceedingly difficult to remove because they become “anchored deep within a woman’s pelvis in muscle, tissues, and frequently in or near nerves,” Mesh Medical Device News Desk reported.

C.R. Bard recalled the Bard Avaulta last year.

Ms. Cisson’s case was originally heard on July 8 but ended in a mistrial two days later.

Source: Medical Mesh Device News Desk