Bard Vaginal Mesh Plastic Unfit for Humans 2016 According to unsealed court records, CR Bard Inc. sold vaginal-mesh devices made of a plastic that its manufacturer warned was not suitable for human surgical use. Managers at Bard’s Davol unit used a resin-based plastic made by a Chevron Phillips Chemical Co. unit to produce hernia-repair mesh…
The DUDLEY LAW FIRM announces that Plaintiff’s attorneys have discovered Bard documents showing that Bard was using a prohibited, industrial use only resin to make its medical grade pelvic mesh products. This raw polypropylene resin is normally sold for use in making carpet backing and has NEVER, EVER been APPROVED FOR MEDICAL USE. Plaintiff’s requested…
The first transvaginal mesh [“TVM”] case involving J&J’s Gynecare Prolift mesh used for pelvic organ prolapse [“POP”] & associated incontinence was tried to a jury in New Jersey & resulted in a verdict of $3.35 million in compensatory damages for plaintiff, Linda Gross. The trial lasted almost 3 weeks. Ms Gross was a Registered Nurse…
The recent edition of the NEJM contains an excellent article summarizing the differences between device approval and postmarketing surveillance regulations in the European Union [EU] & the US. Both have their pros & cons as it relates to allowing device innovation versus protecting the public safety and the quality of post marketing surveillance efforts to…
The FDA has called for stricter regulations against unsafe products approved by the 510K, substantially equivalent process, in light of thousands of lawsuits filed by patients implanted with metal on metal hip, knee and vaginal mesh devices, as reported by Bloomberg Health News.