While all major recalls inevitably tend to attract unwanted media attention, patient outrage, and admonishments from the medical community, the recall of the Riata and Riata ST pacing leads has served as a particular lightning rod for criticism of current postmarket surveillance systems. But will the controversy eventually die down or could the Riata recall be the catalyst for significant change?
Recalled by FDA in December, multiple models of the Riata and Riata ST implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) leads were at risk of experiencing externalized conductors. "The silicone insulation covering these defibrillation leads is at risk of premature abrasion. When abrasion occurs, the conductors inside the leads can come out (externalized) of the insulation," according to FDA. "Leads with externalized conductors may develop electrical dysfunction and not work as intended. In the event the device does not work as intended, should a life-threatening heart rhythm occur, pacing or defibrillation therapy may not be delivered as intended. This may result in serious adverse events, including death." News circulated this week that the company's QuickSite and QuickFlex wires were also prone to externalized conductors; St. Jude announced that it would stop selling the two wires.
In the wake of the recall, the Riata leads have been used as one of the go-to examples by critics arguing in favor of increased regulation and postmarket surveillance. Last month, for example, Robert Hauser of the Minneapolis Heart Institute wrote a scathing perspective in The New England Journal of Medicine titled "Here We Go Again--Another Failure of Postmarketing Device Surveillance." Calling out manufacturers and FDA, the piece condemns the lack of scientifically valid information available to physicians to guide them in dealing with the news of the recall. "The problem is that our current passive postmarketing surveillance system fails to detect significant device defects before large patient populations have been exposed. Consequently, we repeatedly find ourselves reacting ineffectively, even dangerously, to big problems with devices by subjecting patients to care strategies that are not supported by solid clinical evidence," Hauser writes.
Despite issuing a letter to physicians one year prior to the recall, neither St. Jude nor FDA launched clinical studies to investigate some of the natural questions that arose from initial reports that something could be awry with the leads, Hauser states. "Should the lead be replaced if the conductors are exposed but electrically intact? Is the ETFE coating on the externalized conductors sufficiently robust to perform reliably--that is, to deliver an effective high-energy shock when needed? Is monitoring with or without routine fluoroscopy a safe alternative to prophylactic replacement? What electrical parameters are important to adhere to?" he asks. "The answers to these questions are needed today, but only now has the manufacturer acknowledged that 'the clinical implications of leads with electrically intact externalized conductors are not fully known at this time. Consequently, more data are required in order to assess if specific patient subgroups with electrically intact externalized conductors are at greater risk or should be managed differently.'" Hauser concludes that St. Jude should launch a postmarket study on the Riata and similar Durata leads, adding that all manufacturers should be responsible for conducting postmarket studies for life-critical Class III medical devices.
While medical device manufacturers will likely disagree with Hauser's assessment, the groundwork for increased postmarket surveillance of Class II and III products has already been laid in such cases as metal-on-metal hip implants and surgical mesh to treat pelvic prolapse. On the heels of seemingly never-ending negative press and a steady stream of new and damning information, FDA issued 145 orders to 21 manufacturers of metal-on-metal hip implants for postmarket surveillance studies last May. Likewise, the agency issued an order in January to 33 manufacturers of surgical mesh, implanted to treat female urinary incontinence, for emergency postmarket studies on the devices that have been deemed by some as 'not worth the risk.'
So, could these events be signaling a trend in increasing postmarket surveillance demands? It's difficult to tell. But between patient safety concerns, the relentless negative press, and prominent criticism of such matters, discontent with current systems is certainly evident and becoming increasingly difficult to ignore. Pacing leads will likely avoid such a fate, but the tide does seem to turning. Do you think mounting criticism and the FDA's recent postmarket surveillance demands indicate impending change for the medical device industry? Or is it just the same-old reaction following a recall? And what do you think the future holds for pacing leads, and St. Jude's models in particular? Let us know in the comments section below and weigh in on our poll below. --Shana Leonard