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.

FDA warning

The FDA's 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.

Here's a quick summary of what the FDA reported:

• Reports of chondrolysis associated with shoulder pain pumps (sometimes called shoulder pain balls) and anesthesia were received between 2006 – 2008
• The most common pumps were manufactured by Stryker, I-Flow, Donjoy and Breg
• The most common anesthetics used were marketed under the names bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine
• Ninety-one (91) % of patients received a bupivacaine intra-articular infusion
• The average infusion time was between 48 and 72 hours
• The most common infusion site was the glenohumeral space (shoulder joint)
• More than half of the patients required additional surgery, arthroscopy or arthroplasty (join replacement)
• The average patient age was 25, although the range was from 16 to 58 years of age
• Joint pain, stiffness and loss of motion reported as early as the 2nd month after receiving the infusion

Intra-articular postoperative infusions never approved

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.

Manufacturers Ignored FDA Denial

According to shoulder chondrolysis lawyers, the FDA specifically told manufacturers not to use pain pumps intra-articularly years ago, but they ignored that denial – causing hundreds of shoulder surgery patients to develop chondrolysis. As a result, pain pump manufacturers and anesthetic manufacturers are defending hundreds of product liability lawsuits.

Numerous articles about the dangers of shoulder pain pumps have been published and PAGCL attorneys say that more and more lawsuits are expected to be filed by injured pain pump victims – all over something that could have been avoided had manufacturers put consumer safety over profits and market share.