The Legal and Medical Implications of FDA’s Recall of Abbott Neurostimulators Due to Technical Issues
In an unprecedented move that underscores the increasing concern over medical device safety, the Food and Drug Administration (FDA) recently announced a Class I recall for two models of implantable neurostimulators—Abbott’s Proclaim and Infinity devices. While Class I recalls signify the highest level of risk and potential severity, the FDA is not presently advising patients to have the devices surgically removed. This major regulatory action has significant implications for the healthcare industry, patient safety, and the broader conversation surrounding medical device accountability.
Implantable neurostimulators are devices that are surgically implanted near the spine or the brain. They emit low-level electrical impulses with the intention of blocking pain signals, serving as a last-resort treatment for individuals suffering from chronic pain in the back, leg, or head. Approximately 50,000 spinal cord stimulators are implanted in the United States each year. Their growing popularity can be partially attributed to the perception that they reduce the need for opioid medications and other forms of pain management. However, recent studies suggest that these devices do not necessarily decrease opioid use and are prone to severe complications requiring device removal or modification in one in five cases.
The FDA took this drastic measure after receiving 186 complaints that indicated a technical malfunction when patients underwent magnetic resonance imaging (MRI). Specifically, the devices failed to turn back on post-MRI, leading to a loss of therapeutic benefit and causing 73 reported injuries. No fatalities have been reported at this time. The malfunctioning essentially happens when these neurostimulators are switched off during an MRI scan and fail to reactivate, subsequently depriving patients of their pain therapy.
In response to these issues, Abbott had earlier sent an “urgent medical device correction” letter to healthcare providers who install these neurostimulators. The letter aimed to clarify guidelines on safely exiting MRI mode. It also advised medical professionals to instruct patients not to sever their device controller’s Bluetooth connection if they experience a malfunction and to consult a physician before undergoing an MRI scan.
The enormity of this recall cannot be overstated, affecting over 155,000 units of Abbott’s neurostimulators. Yet Abbott estimates that only a minuscule 0.06% of these devices have actually malfunctioned, resulting in a loss of therapy and additional surgeries in an even smaller 0.03% of cases. The specific models impacted by the recall range from various versions of the Proclaim and Infinity lines, extending as far back as devices implanted in patients in 2015.
The recall has broader ramifications for medical device safety and regulation. A 2018 research study revealed that spinal cord stimulators have some of the worst safety records among FDA-tracked medical devices, with nearly a third of adverse events reports citing poor pain relief as an issue. That same review identified nearly 500 deaths, almost 78,000 injuries, and around 30,000 malfunctions linked to these stimulators. The Abbott recall shines a spotlight on the urgent need for tighter controls, more rigorous pre-market testing, and enhanced post-market surveillance to ensure the safety and efficacy of implantable neurostimulators and other high-risk medical devices.
While Abbott’s technical malfunction appears relatively rare, the consequences for affected patients are severe and the FDA’s Class I recall has ignited serious questions about medical device safety. Medical professionals, regulatory authorities, and device manufacturers must come together to address these issues and improve patient safety and treatment outcomes. With lives potentially at risk, the urgency to resolve these problems cannot be underestimated.
If you or a loved one has been affected by the recent FDA recall of Abbott’s Proclaim and Infinity neurostimulators, don’t wait to take action. Your health and legal rights are at stake. The time to file your claim is limited by state law. Call Parker Waichman LLP today at 1-800-YOUR-LAWYER (1-800-968-7529) for a free consultation. We’re here to help you navigate the complex legal landscape, advocate for your rights, and help you receive the compensation your case deserves.
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