Pain pumps made by I-Flow, Stryker, and Sorenson are among the shoulder pain pumps, used after arthroscopic surgery, that have been linked to postarthroscopic glenohumeral chondrolysis (PAGCL). PAGCL is a condition in which the cartilage in the shoulder joint dies, causing pain and inhibiting motion in the shoulder. I-Flow, Stryker, and Sorenson are facing lawsuits, brought by injured patients, alleging that they promoted off-label use of the pumps while being aware of the harm the pumps could cause when used in shoulder surgery, and even lying about having approval from the Food and Drug Administration (FDA).
Shoulder Pain Pumps Used Off-Label
The FDA did not approve the pain pumps for use in shoulder joints, and, in fact, rejected requests for approval several times for at least one of the pumps, called the On-Q Painbuster and made by I-Flow.
When drugs and medical devices are used in ways for which they do not have FDA approval, it is called off-label usage or off-label prescribing. Doctors can legally use medical devices off-label, if they believe it will be helpful to their patients. The FDA does not regulate doctors make or how they practice medicine.
However, the FDA does regulate drug manufacturers and the makers of medical devices. Off-label marketing is not allowed. When drugs and medical devices are advertised for purposes for which they have not been approved it can mislead doctors into believing that these products are safe for their patients.
In November, 2009, the FDA issued a warning about the danger of using the pain pumps in shoulder surgery and required manufacturers to change their labels to include a warning about the risk of cartilage damage.
PAGCL is a life-altering injury. In some cases it requires joint replacement. It is characterized by pain, stiffness, and limited motion of the shoulder joint. It is believed that long-term exposure to local anesthesia is toxic to the cartilage in the joint and that this is how the pain pumps cause PAGCL.