The Cochran Firm Legal Blog

The FDA has stated that between 2006 and 2008 it received 35 reports of cartilage damage caused by pain pumps. A pain pump is a small device surgically implanted beneath the skin. It has a plastic tube that slowly and continuously delivers pain medication, usually for several days after surgery.

Pain pumps are an excellent idea in that they eliminate the need for any systemic narcotic. They deliver the anesthetic locally and thus avoid the usual side effects of ingested narcotics – nausea, constipation, headaches, etc.

However, in the cases reported to the FDA, the patients, who had mostly had shoulder surgery, lost cartilage tissue from the shoulder joint and had to have additional surgery, even a joint replacement in some cases. These particular pain pumps were not FDA-approved for shoulder surgeries, just for abdominal surgery such as a hysterectomy.

New Labeling Required

The pain pump companies are I-Flow Corp., Moog, Inc. and Stryker Corp. and the manufacturers of the anesthetics used are APP Pharmaceuticals, Inc. Hospira, Inc., and perhaps others. They are all being asked to update their labels to include a warning about potential cartilage damage.

In a November 13, 2009 notice to doctors and others involved, the FDA states:

• “The significance of this injury to otherwise healthy young adults warrants notification to health-care professionals.”

The reports of cartilage problems have been trickling in for several years and the Canadian government warned surgeons about the potential problem in January 2009.

Dr. Constance Chu is the director of a cartilage restoration center at the University of Pittsburgh and has written several medical articles on this topic. She describes the problem as “continuous use over two or more days”. The tissue is being saturated with so much anesthetic that its integrity is threatened. Her words were:

• “If you don't give these tissues a break the toxicity is so high you can lose the tissue."

Hundreds of Pending Lawsuits

Because of the FDA’s statement that it never approved these pain pumps for joint surgery, the door is open to plaintiffs who were given a pump after their shoulder surgery and subsequently lost cartilage tissue. The defendants will not be able to say that they are covered by the FDA’s approval of the pumps for other kinds of surgery.

If you have been injured by any sort of defective product, you may have a valid legal case. To learn more about your rights and options, please contact our personal injury lawyers today. Our offices are nationwide for your convenience.

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