Changes ahead for medical device regulation? Regulation, recalls and class actions

Thanks to the well publicised issues with the De Puy Orthopaedics hip replacement and the breast implants manufactured by Poly Implant Prosthese (PIP), prosthetic medical devices have had a much higher profile in recent months than their manufacturers would prefer.

The problems with both devices are well known. As of 9 March 2012, the Australian Therapeutic Goods Administration (TGA) had received 171 confirmed reports regarding ruptures of PIP implants which may have been manufactured with industrial rather than medical grade silicone. Medicare rebates for MRI scans have now been offered to women with the implants in place. The De Puy hip replacements have been subject to a recall, and are the subject of at least two Australian class actions.