Pain Pumps Cause Cartilage Destruction in 12 of 12 Patients Studied
by Sandra Cassidy
Recent scientific evidence suggests that the use of intra-articular pain pump catheters temporarily implanted in the shoulder during surgery may be linked to a serious injury known as Postarthroscopic Glenohumeral Chondrolysis (PAGCL). The damage from PAGCL is believed to be irreversible.
PAGCL is an extremely painful condition that occurs when the cartilage in the glenohumeral joint which connects your arm to your shoulder is broken down resulting in bone on bone contact, significant pain and reduced range of motion or complete loss of use.
The American Journal of Sports Medicine asserts a 63% risk of developing PAGCL from a pain pump. (Oct. 2007). Dr. Charles Beck, the doctor who co-authored the study has been asking fellow surgeons not to use the pain pumps in arthroscopic surgery. Dr. Beck claims that hundreds of patients are at risk from developing this condition. He states that his results were sent to the manufacturers of the pain pumps two years ago but they have not adequately responded. In response to the study, I-Flow issued a warning with its ON-Q DFU shoulder pain pump: “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.”
Pain pumps linked to PAGCL infuse pain relievers including bupivacaine, lidocaine and or epinephrine directly into the affected shoulder. Bupivacaine is a local anesthetic that blocks the conduction of nerve impulses. In exchange for a few days of pumped pain relief patients may end up suffering lifelong shoulder pain, including clicking, popping, grinding, stiffness and decreased range of motion that sometimes results in the complete loss of the use of the shoulder. The symptoms of PAGCL present within three to twelve months after surgery. Unfortunately, PAGCL is irreversible and pain medications seem to worsen the symptoms.
The pain pump is a container located outside the patient’s body that slowly and continuously pumps pain medication through a small catheter inserted at the surgical site. It remains inserted for several days following surgery then is removed by the patient.
In 2006, the American Academy of Orthopedic Surgeons reported that the use of these pain pumps may be associated with PAGCL. Medical charts of 152 patients that underwent arthroscopic shoulder surgery were studied. Twelve patients developed PAGCL, and all those twelve had received pain pumps during their surgeries. In fact the use of the intra-articular pain pump was the only factor that the twelve PAGCL patients had in common. In a study of patients referred to Duke University Medical Center with severe chondrolysis, all six of the patients were between the ages of 15 and 32.
The pain pumps of these patients contained a combination of bupivacaine with epinephrine. The pH of this combination is between 3.5 and 5.5, which may play a role in the development of PAGCL. Eighty-three percent of the patients who developed PAGCL in the study required subsequent procedures to treat the pain. In severe cases the patients required an entire shoulder replacement. Despite surgery, many patients never fully regain use of their shoulder and some patients report increased pain.
Several lawsuits have been filed against companies that make, market or distribute pain pumps including, Stryker, I-Flow Inc., BREG Inc., and others. The lawsuits claim, among other things, that the defendants did not properly warn the medical community that the safety of the pain pumps had not been fully established.
Sources
American Journal of Sports medicine August 8, 2007
American Academy of orthopedic Surgeons
Shoulder pain Pump manufacturers May have Ignored FDA Instructions
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Prior Results Do Not Guarantee Similar Outcome