The U.S. Food and Drug Administration (FDA) on Wednesday issued safety notifications on two Boston Scientific heart devices, after recent reviews connected them to injuries and multiple deaths.
Officials with the FDA publicly alerted physicians and patients in two separate advisories, warning of serious risks tied to specific Boston Scientific defibrillator systems and to the company’s Watchman heart implant. These advisories come following hundreds of reports of serious harm and more than 30 deaths in total.
As of late July, Boston Scientific had reported 386 serious injuries and 16 deaths connected to this problem. The company said 10 of those deaths resulted from the device not working as intended, while another four were linked to surgical attempts to remove the malfunctioning wires. Two other fatalities were deemed unrelated to the implants.
Air Embolism Fears
The FDA’s second alert targeted Boston Scientific’s Watchman device, a widely used implant intended to prevent blood clots in the heart from causing strokes. The advisory cited updated implant instructions following concerns over an increased risk of potentially deadly air embolism during procedures.
The heightened risk is during implantation, especially in patients with low left atrial pressure or airway complications. The alert instructed doctors to ensure patients are not hypovolemic and to use specific insertion techniques to mitigate air entry.
Company data reported to the FDA showed that, as of July 30, there were 120 serious injuries and 17 deaths attributed to the issue. The FDA noted that the design and manufacture of the Watchman system were not a factor in such incidents.
Cardiac devices, including the defibrillator in question and the Watchman implant, account for two-thirds of Boston Scientific’s $5 billion quarterly revenue. After the news broke about the safety notifications, Boston Scientific shares fell 1.8 percent to $102.95 at close on Wednesday.
The FDA has urged clinicians to review updated instructions, inform all relevant medical staff and complete acknowledgement documentation. Patients with a previously implanted Watchman were not instructed to take additional action, but should maintain standard follow-up care as directed by their physicians.
The Associated Press contributed to this report.
