Impact of Implanted Medical Deviceson Patient Quality of Life and Adverse Events: A Comprehensive Review

Abstract

Background: Implanted medical devices (IMDs) are increasingly used to restore, replace, or monitor vital body
functions in patients with chronic diseases, offering significant improvements in survival, functional independence,
and overall quality of life (QoL). Objectives: This review summarizes the major types of IMDs; evaluates
device-related, procedure-related, infection-related, immune-mediated, and tissue-interaction complications;
and examines their impact on patient-reported QoL outcomes. Results and Discussion: Evidence demonstrates
that cardiovascular, orthopedic, neurological, sensory, and metabolic implants contribute to improved physical
functioning, symptom reduction, and psychosocial well-being; however, challenges such as mechanical malfunction,
biofilm-associated infections, hypersensitivity reactions, and long-term device deterioration may compromise
safety and clinical success. Patient perspectives captured through QoL tools such as short-form health survey,
EuroQol 5-Dimensions, World Health Organization quality of life-brief version, and disease-specific instruments
are essential in evaluating real-world outcomes. In addition, materiovigilance systems such as the Food and Drug
Administration Manufacturer and User Facility Device Experience Database and the Materiovigilance Programme
of India play a crucial role in early detection of adverse events and strengthening post-market device surveillance.
Conclusion: Integrating clinical performance with patient-centered QoL assessment and robust safety monitoring
is vital to maximizing therapeutic benefits while minimizing risks associated with IMDs, and ongoing advances in
biomaterials and digital monitoring will further enhance device reliability and patient well-being.