Should Pain Pumps Be Used For Acute Pain Management?
When pain pumps were first used, consumers felt that with a constant supply of local anesthetic to an injury, there could be no downside to their acute pain management. Through repeated use of the pain pumps several problems have come to light. Some of these problems can lead to permanent and irreversible damage that can lead to a lifetime of excruciating pain. Other problems can lead to death.
The FDA felt compelled to advise the public on the safety of the pain pump devices as recently as Feb 16, 2010. A pain pump is a medical device that feeds a local anesthetic through a catheter implanted within the body and is used primarily for chronic pain management. This device automatically administers an uninterrupted dose of local anesthetic using the catheter.
FDA Issues Pain Pump Warning
The Food and Drug Administration has issued a warning to health care professionals and patients that using a pain pump for an extended period of time could lead to the development of chondrolysis (the destruction or necrosis of cartilage).
Before issuing the warning the FDA reviewed 35 cases involving chondrolysis that occurred in otherwise healthy patients following surgery that used a pain pump for acute pain management, after the surgery. The local anesthetics were infused for up to 3 days straight, directly into the joint using a pain pump. Chondrolysis was diagnosed in most cases within 8 months after the infusion.
Chondrolysis occurred in 97% of the reported cases following shoulder surgery. Joint pain, stiffness, and loss of motion were reported as soon as the second month following the infusion. In over half of the reports, the patients required additional surgery. Some patients required a complete joint replacement. It has not been determined what caused the development of chondrolysis in these cases.
FDA Suggests Single Injections Over Pain Pump
It’s important to point out that single injections of the same local anesthetics in orthopedic procedures have been used for many years without any reported occurrence of chondrolysis. Chondrolysis was reported with the following continuously infused local anesthetics: bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine.
The only difference is the pain pumps being used for the pain management, and the fact that the anesthetics were infused continuously. Neither local anesthetics nor pain pumps are approved by the FDA for “continuous infusion” directly into the joint. The FDA instructed health care professionals to follow the instructions for use of the pain pumps, and to not use the pain pumps directly in the joint after orthopedic surgery.
The most common pain pump manufacturer mentioned among the reported patients was Stryker. The other pain pump companies were I-Flow, Breg, and the distributor Don Joy. This suggests that there is not any single manufacturer of the pain pumps leading to these cases of chondrolysis.
The FDA is requiring the manufacturers of local anesthetics and of pain pumps to update their product labels to warn healthcare professionals about chondrolysis. If you or a loved one has been injured by using a pain pump please contact our personal injury attorneys at The Law Offices of Nadrich & Cohen, we can help you.