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A trend starting in the late 1990s, the use of shoulder pain pumps after arthroscopic surgery grew, partially to cut down on narcotics’ side effects and further to speed up recovery time.
Yet, more recent data reveals pain pump usage is associated with postarthroscopic glenohumeral chondrolysis (PAGCL), a condition destroying the patient’s cartilage and leading to life-long impairment. As a result, patients questioning whether they should have been given one of these devices at all have started filing lawsuits against several manufacturers.
Usage and Background
After a patient goes through arthroscopic surgery, he or she is given a small, flexible plastic tube, also known as an intra-articular pain pump catheter. The device is implanted in the shoulder joint and left there for a few days to deliver pain medication directly to the area.
Yet, data from a 2006 study performed by the American Academy of Orthopedic Surgeons revealed that PAGCL is one of the most common complications after arthroscopic surgery. Researchers observed 152 patients who underwent the procedure; the 12 who developed PAGCL all had been given shoulder pain pumps and had no other factors in common.
When the pump is inserted directly into the joint, as opposed to the soft tissue, it results in a progressive loss of cartilage at the glenohumeral joint. With time, the patient finds he or she has reduced mobility of the joint and is often in significant pain. The following combination of symptoms often surfaces roughly three to 12 months after the initial surgery:
- Increased pain when the shoulder’s both resting and in motion
- Increased stiffness
- A clicking, popping, or grinding sound
- Less range of motion from the shoulder joint
- Loss of strength
- Joint narrowing
As a result, the patient often needs additional surgeries, and frequently doesn’t get full use of the joint. In extreme instances, the patient needs complete joint replacement.
The FDA issued a warning in 2010 concerning the association between PAGCL and pain pumps. The government agency had 35 reports from 2006 to 2008, half of which involved follow-up surgeries. Their document stated that the pumps weren’t approved for use directly into the joint – only into soft tissue – and warned that the anesthetics given were only approved for localized or regional use and should only be administered superficially. The document stated that how the drugs were being delivered makes them toxic to the patient.
More and more studies continue to show a correlation between shoulder pain pump usage and developing PAGCL. Data indicates as many as 63 percent of all patients given this medical device may develop PAGCL, while researchers have said pumps should be avoided after surgery, especially if they’re delivering bupivacaine with epinephrine.
Yet, because manufacturers pushed these devices for direct joint usage without the studies to back it up, patients who no longer have full use of their shoulder joint have started filing lawsuits. Although cases have not been consolidated, plaintiffs have targeted Stryker, I-Flow, Berg, Inc., and DJO, Inc.