Inspire Neurostimulator Therapy Injury or Death Lawsuit Lawyers

Inspire Recalls Key Component of Neurostimulator Therapy for OSA

Inspire Medical Systems has issued a recall for its Inspire IV implantable pulse generator, a critical component in the treatment of obstructive sleep apnea (OSA). This recall is due to a manufacturing defect that may cause the device to malfunction, potentially leading to serious health risks and necessitating revision surgery for patients. The U.S. Food and Drug Administration (FDA) has classified this as the most serious type of recall, indicating the potential for severe injury or death if the defect is not addressed.

Details of the Defect and Recall

The Inspire IV implantable pulse generator, model 3028, is an integral part of the Inspire upper airway stimulation system. This system is designed to treat OSA by delivering mild electrical stimulation to the hypoglossal nerve, which controls the muscles of the tongue, helping to maintain an open airway during sleep. However, a defect in the manufacturing process has led to instances of electrical leakage in the sensing circuit of the pulse generator. This defect can result in a range of malfunctions, including below-normal therapeutic stimulation, premature battery depletion, inconsistent stimulation effects, painful stimulation, or even a perceived shocking sensation.

Despite the seriousness of the defect, no injuries or deaths have been reported to date. Nonetheless, the potential health risks are significant enough that the FDA has identified this recall as the most severe category. Patients with the affected devices are advised to contact their healthcare providers for routine check-ups and to discuss the need for possible revision surgery to replace the defective pulse generator.

The Impact on Patients

Patients using the Inspire IV implantable pulse generator may experience various adverse effects due to the malfunctioning device. Symptoms can include a noticeable decrease in the effectiveness of their sleep apnea therapy, unexpected or painful stimulation, and other discomforts. These issues can severely impact a patient’s quality of life, causing increased fatigue, persistent sleepiness, and a return of other sleep apnea symptoms such as loud snoring and disrupted sleep.

For patients requiring revision surgery, the process involves replacing the defective implantable pulse generator. While this surgery can restore the proper function of the Inspire therapy, it also carries typical surgical risks and requires a recovery period. Regular follow-ups and diagnostic monitoring are crucial for identifying any device-related issues early on.

Legal Recourse for Affected Patients

Victims of defective medical devices like the Inspire IV implantable pulse generator have the right to seek compensation through a product liability lawsuit. Such legal action holds the manufacturer accountable for the defect and the resulting harm to patients. Compensation can cover medical expenses, lost wages, pain and suffering, and other related costs.

To file a lawsuit, patients need to establish that the defective product directly caused their injury. This process typically involves gathering evidence such as medical records, proof of device purchase, and documentation of the adverse effects experienced. An experienced attorney can assist in compiling this evidence and building a strong case.

The Legal Process and Importance of Representation

The process of pursuing a product liability lawsuit begins with a consultation with a personal injury attorney who specializes in medical device cases. The attorney will evaluate the case, provide legal advice, and file a complaint to initiate the lawsuit. The discovery phase follows, during which both parties exchange information and gather further evidence. Settlement negotiations may occur at any point, but if a fair settlement cannot be reached, the case may proceed to trial.

Having skilled legal representation is essential for navigating the complexities of a product liability lawsuit. An attorney will handle all aspects of the case, from negotiating with the manufacturer’s insurance company to representing the victim in court. This ensures that the patient’s rights are protected and that they receive fair compensation for their injuries.