On-Q and other shoulder pain pumps with 'intra-articular' use may lead to chondrolysis
Did an On-Q or other pain pump implant cause injury? Our lawyers can help.
A recent study about shoulder pain pumps such as the On-Q pain pump model highlighted the risk of chondrolysis with so-called "intra-articular infusions"--the surgical approach of inserting pain pumps directly in the shoulder joint. Pain pumps, which are used to manage post-operative shoulder surgery pain, should only be placed in the muscle or outside the shoulder joint. The article, by Joan Ferlo Todd, MS, BSN, RN, was published in the June 2010 issue of Nursing.
Read the complete article in Nursing (2010, June, Issue 6, Volume 60), available on the website of the FDA
The author detailed the experience of a patient who, after left shoulder arthroscopy, received a shoulder pain pump infusion device to deliver a continuous infusion (over about 48 hours) of the local anesthetic bupivacaine directly into the intra-articular space for pain control after surgery.
Approximately 5 months following the infusion, the patient developed pain, stiffness, and loss of motion in the left shoulder joint.
Unfortunately, the patient's surgeon subsequently diagnosed diapostarthroscopic glenohumeral chondrolysis (PAGCL), which is necrosis and destruction of articular cartilage.
Background on On Q and other shoulder pain pumps
The FDA has received over 35 reports of chondrolysis in patients who received continuous intra-articular infusions of local anesthetics with shoulder pain pumps such as the On Q model for postoperative pain management. Chondrolysis, a severe, life-altering complication, is usually irreversible.
Before 2000, the reported incidence of chondrolysis was low. Reports of PAGCL began to appear more frequently as surgeons began to use newer techniques such as intra-articular postoperative infusion of anesthetics into the glenohumeral joint.
The FDA has approved pain pumps such as On Q for the postoperative infusion of local anesthetics for pain management. However, these devices haven't been approved by the FDA for intra-articular administration.
Because chondrolysis can affect patients of any age and the effects aren't reversible, healthcare professionals must be informed of the risks associated with intra-articular infusion of local anesthetics with these devices. The FDA now requires pain pump manufacturers to warn healthcare providers and patients about the potential for severe joint damage when these devices are used for intraarticular anesthetic administration.
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