Race to the bottom': Investigation reveals toll of weak medical device laws

A new investigation highlights how weak medical device laws can leave patients exposed, including cases involving Medtronic’s SynchroMed™ system for spinal cord-related pain treatment. The article describes safety reports involving three patients who suffered bleeding on the spinal cord—two with nerve deficits or paralysis and one who died—prompting Medtronic’s 2008 recall of the pumps after catheters were discovered to be able to cause inflammatory masses to develop on the spinal cord. Medtronic said available data show paralysis associated with the system is extremely rare and that benefits outweigh risks, and it emphasized that patient safety is its top priority. In Australia, where about 1.4 million medical devices are registered with the TGA versus roughly 40,000 drugs, regulators may allow “substantially equivalent” devices to enter without full clinical trials. The article cites the pelvic mesh pathway and its $300 million class action outcome, underscoring concerns about ensuring both safety and efficacy.