title: Orthopedic medical devices: ethical questions, implant recalls and responsibility.
abstract: The hip replacement is a surgical procedure to replace the femoral head and acetabulum with prosthetic implants to improve function, increase mobility, and relieve pain caused by damage from disorders such as osteoarthritis and fractures. In recent years, we have seen several recalls of poorly functioning implant systems, most recently, the Johnson and Johnson (J&J) Articular Surface Replacement device. Product recalls are often the results of premature failure of implants requiring additional surgery to exchange the failed device. This raises many questions - technical, medical, regulatory, ethical, and legal - that ultimately put patients at risk, compromise confidence in medicine and regulatory agencies, and important relationships including those between the physician-patient and physician-industry. Where do the responsibilities lie for the patients' suffering, morbidity, and costs of removing the failed device? This article discusses the current recall of the J&J implant, the responsibilities of the manufacturer, surgeons, and the regulatory agency.
authors.affiliation: MBA candidate at the University of Rhode Island, Academic Coordinator and Research Associate, Department of Orthopaedics, The Warren Alpert Medical School of Brown University.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Racine
mesh_terms: D001675:Bioethics; D006801:Humans; D007221:Industry; D009984:Orthopedic Fixation Devices; D057051:Product Recalls and Withdrawals; D011475:Prosthesis Failure; D014481:United States
keywords: Orthopedic; federal regulations; implant failures,; medical industry responsibilities; physician-industry relationships; product recalls