In November 2009, the FDA changed requirements on the labeling of pain pumps to include a warning regarding the potential increased risk of cartilage destruction with these devices. This change in labeling was prompted by the FDA’s revision of 35 case reports of chondrolysis (loss of cartilage) in otherwise healthy young patients given continuous infusions of local anesthetics with these infusion devices directly into the joint to control post-surgical pain after joint surgery. Chondrolysis was diagnosed approximately 8 months after the infusion, and reports of joint pain, stiffness, and loss of motion began as early as 2 months after surgery. Nearly all the cases involved patients who had undergone shoulder surgery; more than half of those cases resulted in additional surgeries, including joint replacement. It is unclear whether a specific factor (i.e. the locally infused drugs, the device materials, and/or other sources) or combination of factors played a role in the development of chondrolysis in these cases. Single local injections of anesthetics have been used in orthopedic procedures for many years without consequence. The FDA notes that it did not clear pain pump infusion devices using the anesthetics for “intra-articular” or joint surgery; the pumps are approved only for use after abdominal surgeries and other similar procedures.

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