Inspire Medical Systems faces growing scrutiny over complications from its implantable hypoglossal nerve stimulator, a surgically implanted device used to treat obstructive sleep apnea. In June 2024, the FDA issued a Class I recall, its most serious classification, for a specific lot of Inspire IV pulse generators due to a manufacturing defect that could cause electrical malfunctions.
Doyle APC attorneys are investigating injury claims involving sensing lead malfunctions requiring revision surgery, device migration and infection, electrical leakage causing painful shocks, pneumothorax and pleural effusion, and cases requiring complete device explantation.
What Is the Inspire Sleep Apnea Implant?
The Inspire Upper Airway Stimulation system is an implantable neurostimulator designed to treat moderate to severe obstructive sleep apnea in patients who cannot tolerate CPAP therapy. The system consists of three surgically implanted components: a small pulse generator placed near the collarbone, a stimulation lead attached to the hypoglossal nerve that controls tongue movement, and a sensing lead that monitors breathing patterns.
The device received FDA approval in 2014 and has been marketed as a “mask free” alternative to CPAP machines. When activated by the patient before sleep using a handheld remote, the system monitors breathing and delivers mild electrical stimulation to move the tongue forward, keeping the airway open.
Inspire Medical Systems, headquartered in Golden Valley, Minnesota, is the leading manufacturer of FDA-approved hypoglossal nerve stimulation therapy for sleep apnea and was the first to bring this technology to market. Tens of thousands of patients have received the device since its approval.
Sensing Lead Malfunctions
Analysis of the FDA’s MAUDE adverse event database reveals that sensing lead failures represent the most significant complication requiring surgical intervention. The sensing lead is critical to device function as it detects breathing patterns and signals the pulse generator when to deliver stimulation.
Published research reviewing MAUDE reports found over a hundred adverse events specifically associated with the sensing lead component. Of these cases, a significant percentage required revision surgery to address the malfunction. The most frequently reported problem was separation of the sensing lead tip from the lead body, documented in 46 percent of sensing lead adverse event reports.
When the sensing lead fails, the device cannot properly monitor breathing, rendering the therapy ineffective. Unlike software adjustments or external fixes, sensing lead malfunctions almost always require a second surgery to replace the defective component.
In one documented case, a sensing lead migrated from its original implant site to the costophrenic angle near the base of the lung, requiring video-assisted thoracoscopic surgery for retrieval. This case illustrates how lead components can travel far from the surgical site, potentially causing damage to surrounding structures.
June 2024 FDA Class I Recall
On June 17, 2024, Inspire Medical Systems issued an urgent medical device correction for 32 Inspire IV Implantable Pulse Generators (Model 3028) due to a manufacturing defect. The FDA classified this as a Class I recall, indicating the defect could cause serious injury or death.
The manufacturing defect can cause electrical leakage in the sensing circuit, potentially resulting in stimulation below therapeutic levels, early battery depletion and loss of therapy, inappropriate or inconsistent stimulation, painful stimulation or perceived shocking sensations, and in the most serious cases, death.
The affected devices were distributed between August 2022 and May 2023. While Inspire has reported no injuries or deaths connected to the recall, the FDA warns that continued use of an affected device poses a risk of serious harm. Patients with recalled devices require ongoing monitoring and diagnostic testing to detect electrical irregularities, and some may need revision surgery to replace the pulse generator.
Other Documented Complications
A five-year analysis of the MAUDE database from 2014 to 2019 identified 134 adverse events across 132 patient reports. These events resulted in 32 device revision procedures and 17 complete explantations. Beyond sensing lead issues, the most commonly reported complications include:
Device Migration and Infection. The pulse generator or leads can shift from their original surgical position, causing discomfort, reduced therapy effectiveness, or complete device failure. Chronic infections around the implant site may not respond to antibiotics and often require surgical removal of the entire system.
Pneumothorax and Pleural Effusion. These serious lung complications were documented in the MAUDE database but had not been observed in the manufacturer’s clinical trials. Pneumothorax occurs when air leaks into the space between the lung and chest wall, while pleural effusion involves fluid accumulation. Both conditions can require emergency intervention.
Lead Migration into the Pleural Space. In some cases, device leads have migrated into the chest cavity, requiring surgical retrieval. These complications extend well beyond routine device adjustments and often necessitate complex procedures to remove wayward components.
Stimulation Discomfort and Therapy Failure. Many patients report painful or ineffective stimulation that cannot be resolved through programming adjustments. When the device fails to control sleep apnea symptoms or causes intolerable side effects, surgical removal may be the only option.
Revision Surgery and Explantation
Patients experiencing device complications often face difficult choices. Unlike external devices that can simply be removed, the Inspire system requires surgery both for implantation and removal. Revision surgery to replace a malfunctioning component carries standard surgical risks including infection, bleeding, and anesthesia complications.
Complete explantation, or removing all implanted components, is more extensive. The stimulation lead is wrapped around the hypoglossal nerve, and the sensing lead is positioned along the chest wall. Removing these components requires careful dissection to avoid nerve damage or other injuries.
For patients who underwent implantation specifically to avoid CPAP therapy, device failure means returning to square one, often after enduring multiple surgeries and significant recovery periods.
Emerging Legal Investigation
Unlike some medical device litigations that have progressed to multidistrict litigation status, legal claims involving Inspire devices are in an early investigative stage. No MDL has been established, and no bellwether trials are scheduled. However, product liability attorneys are actively investigating claims from patients who have experienced device malfunctions requiring surgical intervention.
The primary legal theories under investigation include manufacturing defects related to the recalled pulse generators, design defects in the sensing lead system that contribute to high failure rates, and failure to adequately warn patients and physicians about the risks of device malfunction and the likelihood of requiring additional surgery.
The June 2024 Class I recall provides evidence that Inspire Medical Systems identified a manufacturing problem serious enough to warrant the FDA’s most urgent classification. For patients with affected devices, this recall may support claims that the company knew or should have known about defects that could cause harm.
Our Investigation
Our firm is investigating Inspire sleep apnea device cases where complications have required revision surgery or complete explantation. We are particularly interested in cases involving sensing lead malfunctions requiring surgical repair or replacement, pulse generator failures (including, but not limited to, those linked to the June 2024 recall), device migration requiring surgical repositioning or removal, and infections or other complications necessitating explantation.
If you received an Inspire implant and subsequently required additional surgery to address device complications, we encourage you to contact our office.
Free Case Evaluation
Have you or a loved one experienced complications with an Inspire sleep apnea implant that required revision surgery or device removal? Our attorneys are reviewing potential claims against Inspire Medical Systems for patients who have suffered serious harm from device malfunctions.
We will review your medical records at no cost to determine whether your Inspire device complications may support a legal claim. All consultations are confidential, and we handle cases on a contingency basis, meaning you pay nothing unless we recover compensation for you.
Statutes of limitations restrict the time available to pursue legal claims. If you believe your Inspire device has failed and required surgical intervention, prompt consultation is advisable.
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