FDA Issues Pain Pump Warning

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The Food & Drug Administration has issued a warning about the improper use of pain pumps – and has received at least 35 reports of destroyed cartilage in at least 35 joint surgery patients.

FDA Warning on Pain Pumps

The U.S. Food & Drug Administration (FDA) has released a statement saying that it received 35 reports of chondrolysis – cartilage necrosis and destruction – in shoulder surgery patients who were given intra-articular infusions of local anesthetics. The FDA’s statement makes it very clear that it never approved this method and is now requiring pain pump and anesthesia manufacturers to warn healthcare professionals about the increased risk of developing chondrolysis.

The FDA Warning says that it has received 35 reports of chondrolysis, also known as Postarthroscopic glenohumeral chondrolysis, or PAGCL – a painful condition caused by the deterioration of cartilage around the shoulder area, after shoulder pain pumps (elastometric infusion devices) were inserted directly into the shoulder joint.

Additionally, The FDA stated that the approved drug labels for local anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as elastomeric pumps:

The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics. Health care professionals are encouraged to follow the instructions for use of elastomeric infusion devices, and to not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery.