FDA: Pain Pumps Associated with Adverse Events in Shoulder Surgery
BY LAUREN UZDIENSKI, NOVEMBER 18, 2009
The FDA is requiring manufacturers of pain pumps, including I-Flow and Stryker, to revise the labeling on their devices following reports of cartilage damage correlated with use of the pumps. Pain pumps are not indicated for intra-articular infusion after orthopedic surgery cases, so the updated labeling would warn healthcare providers of possible adverse effects associated with implanting the devices in these patients.
The FDA says that between 2006 and 2008, the agency received 35 reports of chondrolysis in patients who received pain pumps after surgery, with symptoms including joint pain, stiffness and loss of motion. Patients who underwent shoulder surgery comprised 97% of these cases, and over half these patients required additional surgery, including arthroscopy or arthroplasty.
Pain pumps offer continuous delivery of non-narcotic anesthetics (including bupivacaine and lidocaine) to a surgical site for two to three days following a procedure. While the FDA says no specific cause has been identified from the adverse event reports, the agency suggests that any combination of the drugs, materials and delivery protocol may be correlated with the adverse outcome. It should be noted that injections of the drugs alone have not been shown to cause similar cartilage deterioration.
