Musculoskeletal Care of the Mature Patient
A patient came in to my office this past week and asked me about a series of visco-supplementation injections for her hip. She had responded reasonably well last year to a series of such injections in her arthritic knee and wanted to enjoy relief of arthritic hip symptoms by a similar treatment protocol. I explained to the patient that visco-supplementation for the hip had not as yet been approved by the FDA, though it is a standard of care for the arthritic knee in many clinical settings. I have to make a decision between what is in the best interest of my patient and the regulatory medical device oversight dictates of the United States Food and Drug Administration. Is the standard of patient care out in front of regulatory device approval?
My conflict as to whether to cross the line between approved indications and patient needs is not new. If you have practiced as long as I have, there is little that I haven’t experienced as so much of what is marketed as new falls under the category“ been there, done that”. In 1979, I was involved in the first clinical study in the United States along with two other co-investigators of a new type of hip prosthesis, the cement-less hip. Now the standard of care in 95% of hip replacements done in the U.S., in 1979 we navigated uncharted waters as the 1976 Safe Medical Device Act did not regulate physician-directed off-label use that is in the best interest of the patient. The primary determinant I believe is ethical in that If I feel I can achieve a better result with the use of an off-label device or drug when contrasted to one that is FDA approved, with informed consent of the patient and a full scientific knowledge of the possible complications of the yet unproved treatment modality, I will make the decision with the patient.