The Pain Pump Shouldering the Blame for Debilitating PAGCL

Lake Forest, CAThe watchword these days is actually a series of three words: 'reduced recovery time.' Anything to get the patient out of the hospital and back on his feet sooner. However, with the shoulder pain pump, shoulder injury has resulted from just that—the striving to reduce recovery time following shoulder surgery. And for the debilitating condition known as Postarthroscopic Glenohumeral Chondrolysis (PAGCL), there are few treatment options and no cure.

The shoulder pain pump has emerged as the likely culprit, according to a study published in the American Journal of Sports Medicine last year. In fact, PAGCL has been shown to occur only in patients who were hooked up to a shoulder pain pump and treated with a mixture of bupivacaine and epinephrine during surgery.

What's more, it has been determined through the course of study that 63 percent of arthroscopic shoulder surgery patients who receive a post-operative pain pump have the potential to develop PAGCL.

It doesn't appear to happen in the absence of a pain pump. That is telling.

To be fair, the medical community viewed the advent of the shoulder pain pump as a welcome alternative to the use of narcotic drugs, and other painkillers pressed into service to alleviate pain after shoulder surgery. The subsequent relief afforded to the patient by delivering bupivacaine and epinephrine directly to the shoulder, and the related improvement in recovery time, prompted a widespread adoption of the should pain pump.

However, like too many medical procedures, medical devices and drugs theses days the shoulder pain pump appeared to have been pressed into service without a lot of pre-market testing. The pain pump itself wasn't a new idea, but the application of bupivacaine and epinephrine directly to the shoulder was.

Here's the problem: Cartilage in the shoulder appears to view the combination of bupivacaine and epinephrine as toxic, and it begins to break down as a result. Once the cartilage is gone, there's no turning back. It doesn't re-generate. And you can't operate your shoulder without it. The resulting pain has immobilized countless people.

The only long-term treatment is the replacement of the shoulder. Sadly, shoulder replacements don't last. Thus, a patient requiring shoulder replacement early in life might require several over his lifetime. Given the cost of healthcare, this may be a hardship, or even an impossibility for many people. Some have had little choice but to go through life with a fused, or otherwise immobilized shoulder. There have even been amputations.

The disposable pain pumps, which are implanted in the intra-articular (inside the joint) space during the procedure, are often used for two or three days to deliver high doses of pain medication. Flexible plastic catheters deliver the medication directly to the shoulder joint, and have been known to boost the effectiveness of oral painkillers for up to 48 hours.

However, research presented at a 2006 meeting of the American Academy of Orthopedic Surgeons showed evidence that use of pain pumps lead to a complication—usually diagnosed with an x-ray—showing the narrowing of the shoulder joint space. As the cushioning cartilage begins to deteriorate, the individual starts to experience the extreme pain associated with PAGCL.

It was shown that PAGCL affects individuals of all ages and affects men and women equally

One manufacturer, I-Flow, issued a warning about its ON-Q DFU shoulder pain pump once the concern over pain pumps was revealed. "Avoid placing the catheter in joint spaces. Although there is no definitive established causal relationship, some literature has shown a possible association between continuous intra-articular infusions (particularly with bupivacaine) and the subsequent development of chondrolysis."

I-Flow is one of several manufactures that have been targeted for should pain pump lawsuits inherent with shoulder surgery. They include Stryker, DJO Inc., I-Flow Inc. and BREG Inc. The lawsuits allege that the defendants did not warn the medical community that the safety of the pumps had not been fully established, resulting in shoulder injury.