Media reports suggest that between 2005 and 2014 an estimated 8,500 patients were injured (including 170 deaths) in Australia by defective medical devices. An Australian representative action against two manufacturers and a supplier of certain medical devices used for the treatment of stress urinary incontinence and pelvic organ prolapse by three women representing over 700 registered class members alleging serious complications of vaginal mesh repair gave rise to a judgment in favour of the plaintiffs in late 2019. The judgment suggests that replacing a set of suspensory components of the levator ani muscle with a rigid matrix of mesh which provided strong support at the expense of flexibility may have been a misguided choice.
Journal of law and medicine. 2020 Apr [Epub]
Mike O'Connor, Bill Madden
Professor of Obstetrics & Gynaecology, School of Medicine, University of Western Sydney., Adjunct Fellow, School of Law and School of Medicine, University of Western Sydney.