The Facts About Shoulder Surgery Pain Pumps
Pain pumps are elastomeric infusion devices, small pumps that deliver a slow and constant amount of pain medication directly into the body. When used to inject pain medication directly into a joint they are called intra-articular pain pumps. Pain pumps are often used to manage post-operative pain. However, pain pumps used after shoulder surgery have been linked to postarthroscopic glenohumeral chondrolysis, also known as simply chondrolysis or PAGCL. This is a condition that dissolves the cartilage in the shoulder, leaving shoulder bones to painfully grind against one another. Pain pumps made by Stryker, I-Flow, BREG, Moog and DJO have all been linked to cases of chondrolysis.
How do Shoulder Surgery Pain Pumps Cause Chondrolysis?
Chondrolysis is caused by the by dissolving of the cartilage in the shoulder. Although surgeons have been injecting pain killers directly into the shoulders of surgery patients for years, it’s only relatively recently that they have begun to use pain pumps to manage post-operative pain.
Shoulder Surgery Pain Pumps in the News
Since the introduction of pain pumps to treat shoulder surgery pain, doctors have been discovering that the same pain medications that are harmless when injected quickly into the shoulder can have devastating consequences when delivered slowly through a pain pump.
Pain medication introduced through a pain pump slowly eats away at shoulder cartilage, the connective tissue that helps bones move. This is thought to happen because the pain medications used in shoulder surgery pain pumps have a low pH, meaning that pain medication can essentially eat away at cartilage like an acid.
The symptoms of chondrolysis typically develop two to twelve months following surgery and may include extreme shoulder pain, decreased range of motion, stiffness or weakness in the shoulder, loss of strength in the shoulder joint and clicking, popping, or grinding of the shoulder.
The use of pain pumps to deliver pain medication directly into joints after shoulder surgery was never approved by the FDA, and in November of 2009, the F.D.A. issued a warning about using pain pumps in joints and ordered manufacturers of pain pumps to place use warning labels on their products.
Are warnings about Chondrolysis and Shoulder Surgery Pain Pumps Enough?
The FDA has never approved the use of shoulder surgery pain pumps to infuse local anesthetics in joints. However, doctors have been using pain pumps after shoulder surgery in what is known as an "off label" use, where a drug or medical device is prescribed for a reason other than its FDA-approved use. It is legal in the United States for doctors to prescribe medication for off-label use. However, it is not legal for pharmaceutical companies or medical device manufacturers to advertise or promote off-label uses, Despite this, allegations have been made that shoulder surgery pain pump manufacturers have been promoting pain pumps for off-label use.
Even though the FDA issued a specific warning against using pain pumps in joints in November 2009, some doctors have stated that these required warnings about shoulder surgery pain pumps are insufficient.
What Shoulder Surgery Pain Pumps Have Been Linked to Chondrolysis?
Pain pumps made by the manufacturers Stryker, I-Flow, BREG, Moog, Orthofix, Linvatec, Sgarlato R.P and DJO have all been linked to cases of Chondrolysis.
Experienced Shoulder Surgery Pain Pump Attorneys
The law firm of Blizzard & Nabers are experienced at handling shoulder surgery pain pump litigation. Our attorneys are experienced in medical device litigation, and for more than 25 years we have successfully represented our clients and stood up for the rights of people harmed by defective medical devices. We are a nationwide law firm serving clients from all over the country. We handle all shoulder surgery pain pump injury cases on a contingency basis.
To learn more, or for a free consultation with an experienced shoulder pain pump attorney, please contact us by email or call us at 1-800-349-0127.