Inspire Sleep Apnea Implant Lawsuit Alleges Device Failed After Just 15 Months, Requiring Surgery

Lawsuit claims Inspire sleep apnea implant failure left woman without treatment for 78 consecutive days.

An Illinois woman claims Inspire Medical Systems failed to warn patients and doctors about potential manufacturing defects in its sleep apnea implants, despite an FDA Class I recall involving the same model.

The complaint (PDF) was brought by Carol Bish and Brent Bish in the Circuit Court of Cook County, Illinois on September 22, naming Inspire Medical Systems Inc. as the sole defendant. The case was later removed to the U.S. District Court for the Northern District of Illinois on November 2.

Bish claims she received the implant in June 2023, after struggling with CPAP therapy, but the device began delivering weaker stimulation in October of the following year before failing completely.

Inspire Sleep Apnea Implant Problems

The Inspire sleep apnea implant is a medical device designed to treat obstructive sleep apnea, a condition in which the airway repeatedly becomes blocked during sleep, disrupting normal breathing. The system uses a small pulse generator surgically implanted in the chest, which is connected to leads that monitor breathing patterns and deliver electrical stimulation to help keep the airway open.

The implant stimulates the hypoglossal nerve, which controls tongue movement, using mild electrical pulses to prevent the airway from becoming obstructed during sleep. Patients turn on the device using a handheld remote before bedtime, allowing it to coordinate stimulation with their natural breathing cycle.

However, concerns about the reliability of the technology emerged following a June 2024 Inspire sleep apnea device recall, which involved certain implants that could malfunction and potentially require additional surgery. Federal health officials recommended continued monitoring of affected patients to identify problems with device performance and determine whether further medical intervention was necessary.

Beyond the problems identified in the recall, reported Inspire implant complications include infections, nerve injuries, painful stimulation and movement of implanted components. Some individuals may also experience unexpected electrical impulses or excessive stimulation, potentially causing muscle spasms, prolonged shocks and significant discomfort.

In other cases, the implant may fail to adequately control sleep apnea symptoms, leaving patients facing additional medical procedures, device replacement or surgical removal. These concerns have prompted product liability lawyers to investigate potential claims involving Inspire implant malfunctions and injuries requiring further treatment.

Inspire Sleep Apnea Implant Failure Allegations

According to the complaint, Bish underwent implantation of an Inspire Upper Airway Stimulation System in June 2023. A March 2024 sleep study indicated the device was successfully controlling her sleep apnea.

However, the device began delivering weaker stimulation in early October 2024 before stopping altogether on October 3. Bish reported the malfunction to her doctors and Inspire, and subsequent evaluations revealed erratic operation. Inspire recommended surgery to replace the pulse generator.

On December 20, 2024, Bish underwent revision surgery, during which doctors replaced the Model 3028 pulse generator but found the original stimulation and respiratory sensing leads were functioning properly. She claims the failure left her without sleep apnea treatment for 78 consecutive days.

Inspire Sleep Apnea Implant Recall

The lawsuit also cites the June 2024 FDA Class I recall involving certain Inspire IV Model 3028 generators due to a potential manufacturing defect that could cause electrical leakage, inconsistent stimulation, premature battery depletion and loss of therapy.

Despite not being included in the recall, Bish alleges her implant experienced similar malfunctions, suggesting the defect may have affected devices beyond those identified by the manufacturer.

However, Bish claims her replacement generator has also failed to adequately control her sleep apnea. A June 2026 sleep study reportedly showed her condition remained nearly as severe as before implantation, despite repeated programming adjustments and evaluations.

Bish maintains Inspire knew about the manufacturing problems but failed to adequately warn patients and doctors. She claims the device failures caused persistent fatigue, headaches, anxiety and additional surgical scarring, resulting in at least $178,000 in medical charges.

“Mrs. Bish continues to carry in her body an implanted Class III medical device that does not perform as intended, comprising leads implanted in 2023 that have never been replaced and a second Model 3028 generator that has not restored her therapy, and faces likely further surgical intervention.”

— Carol Bish v. Inspire Medical Systems Inc.

The lawsuit raises allegations of manufacturing defect, negligence, failure to warn, strict product liability, breach of express and implied warranties, negligent voluntary undertaking, loss of consortium and violation of the Illinois Consumer Fraud and Deceptive Business Practices Act. It seeks damages for her injuries and financial losses, while her husband, Brent Bish, seeks compensation for the impact on their marriage.

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