Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

In light of a recent report released by the U. S. Food and Drug Administration that confirms the link between chondrolysis and pain pump use, Joseph A. Carrese, MD, MPH, an expert in bioethics, has issued an opinion stating that physicians have a responsiblity to inform former patients on whom they used the device of the possible risk.

It is Dr. Carrese’s opinion that “to do otherwise would be a failure of expected ethical and professional conduct, and in turn a failure of good clinical practice.”

The opinion addresses the “ethical and professional obligations of orthopedic surgeons to patients who have had arthroscopic shoulder surgery in conjunction with postoperative use of a pain pump device that infuses medication continuously via a catheter directly into the shoulder joint and who are therefore at risk for developing severe pain and disability of the shoulder joint secondary to a condition known as chondrolysis.”

Dr. Carrese is an Associate Professor of Medicine and Director, Program on Ethics in Clinical Practice, at Johns Hopkins Berman Institute of Bioethics, Johns Hopkins University.

This recommendation follows a report from the FDA distributed today to health care professionals following a review of 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given “continuous intra-articular infusions of local anesthetics with elastomeric infusion devices to control post-surgical pain.” According to the study, 97 percent of the reported cases of chondrolysis followed shoulder surgeries.

The FDA report says early adverse affects following pain pump use after surgery included joint pain, stiffness, and loss of motion, occurring as soon as two months after surgery. In half the reported cases, the FDA report notes, patients required additional surgery, including arthroscopy or arthroplasty (joint replacement).

A number of lawsuits have been filed on behalf of patients suffering from chondrolysis as a result of pain pumps being inserted directly into the cartilage rather than into the muscle tissue following surgery. The FDA only approved pain pump use as inserted in the muscle tissue, but the lawsuits allege pain pump manufacturers marketed the devices to physicians with instructions to insert the catheter into the joint for faster and more efficient pain relief.

However, studies show that introducing the anesthetic medications directly into the joint in this manner destroys the cartilege and results in chondrolysis.

Read the Ethics Recommendation Letter.

Read the FDA Report.

This entry was posted on Friday, November 13th, 2009 at 3:37 pm and is filed under News. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.