In response to high-profile safety controversies involving its own Infuse Bone Growth product, as well as medical devices marketed by its rivals, Medtronic Inc. has announced that it will ramp up the way it monitors its products in the hopes of detecting serious safety problems early. According to a report from the Reuters, Medtronic’s CEO said the company will to invest “heavily” in tracking patients’ health after they get a new device, and in conducting regular data analysis to spot any patterns of concern.
Over the past year, Medtronic has taken heat over the safety of its Infuse Bone Graft, a bone growth protein used in certain spinal surgeries. Medtronic is currently embroiled in several regulatory investigations over the marketing of Infuse. Over the summer, questions were also raised about the way potential Infuse side effects, including cancer, were reported in clinical trials for the product.
The Infuse controversy has taken a toll on Medtronic’s bottom line. In its third quarter earnings report released in February, Medtronic said its spine business was down 9%, thanks in large part to slowing sales of Infuse.
Medtronic’s Infuse woes, along with safety debacles involving metal-on-metal hip implants, transvaginal mesh and implantable defibrillators made by other firms, have motivated consumer advocates to call on the U.S. Food & Drug Administration (FDA) to subject medical devices to more scrutiny before and after they come to market. But in an interview with Reuters, Medtronic CEO Omar Ishrak conceded that pre-market testing of medical devices is not adequate to spot safety problems. He also maintained that national registries that have been proposed by some groups would not be enough to catch issues early.
“We need improvements in device surveillance,” he told Reuters. “The FDA alone does not have the infrastructure… so companies have to play a leading role in this.”
Right now, medical device companies rely on what Reuters characterized as “irregular reports” from doctors and patients to spot safety issues. Ishrak, however, said it was the responsibility of companies to monitor devices for safety problems.