Shoulder pain pumps deliver painkilling medications directly to a shoulder joint after surgery. Unfortunately, they have been associated with a rare condition called chondrolysis or PAGCL, which causes the progressive destruction of cartilage in the shoulder joint. There is no cure for this debilitating and painful condition, and hundreds of victims are now filing shoulder pain pump lawsuits against manufacturers for failing to warn about the risk.
$5.5 Million Awarded in Shoulder Pain Pump Lawsuit
In January 2010, the first shoulder pain pump lawsuit to go to trial ended in a huge victory for the plaintiff. A jury in Oregon awarded $5.5 million to a 38 year-old father of four who has chronic shoulder pain after an I-Flow pump destroyed cartilage in his right shoulder.
More than 300 additional shoulder pain pump lawsuits have been filed by people who developed chondrolysis (shoulder cartilage damage). Lawyers allege that manufacturers knew or should have known about the risk, but failed to warn doctors and patients.
What is a Shoulder Pain Pump?
Intra-Articular Shoulder Pain Pumps are used to manage pain following shoulder surgery. The self-contained devices deliver a local anesthetic, such as bupivacaine or epinephrine, directly to the shoulder joint through a plastic tube. Pain pumps became popular in the 1990s as alternatives to long hospital stays and prescription narcotic painkillers. Manufacturers have also marketed them as a way to speed up recovery time.
Types of Shoulder Pain Pumps
- Accufuser Plus Shoulder Pain Pump
- Donjoy Pain Control Device
- I-Flow Shoulder Pain Pump
- Intra-Articular Shoulder Pain Pump
- On-Q Painbuster Shoulder Pump System
- Stryker Pain Pump
- Stryker Pain Pump 1
- Stryker Pain Pump 2
FDA Denies Approval of Shoulder Pain Pumps in Joints
The U.S. Food and Drug Administration (FDA) never approved shoulder pain pumps for use in joints — they are only approved for soft tissue surrounding the shoulder. In 1998, manufacturer McKinley Medical requested permission to approve the uses for intra-articular treatment in the synovial cavity (joint space between the humerus and scapula in the shoulder). The FDA refused, saying that there was no evidence that this use was safe.
Lawsuits allege that manufacturers ignored the FDA and instructed sales representatives to market the pumps “off-label” for use in the joints. They left the instructions for use intentionally vague, without warnings against using it in the joints.
Shoulder Pain Pumps and Chondrolysis
Many studies indicate that exposing cartilage to local anesthetics from a shoulder pain pump can be toxic. This devastating medical condition is called Post-Arthroscopic Glenohumeral Chondrolysis (PAGCL), or simply “chondrolysis.” It typically manifests 2-12 months after surgery (median of 8.5 months). Orthopedic surgeons noticed an increase in chondrolysis as early as 2004. Over the next decade, more than 400 people were diagnosed with chondrolysis after using a a shoulder pain pump.
Symptoms of Shoulder Cartilage Damage (Chondrolysis)
- Shoulder pain (while in motion or at rest)
- Clicking, popping, or grinding noise in the shoulder
- Stiffness, lack of flexibility or range of motion
- Chronic inflammation
- Shoulder weakness
- Narrowing of joint spaces
- Necrosis and destruction of cartilage in the shoulder
FDA Safety Warning for Shoulder Pain Pumps
In 2009 and 2010, the FDA published Safety Warnings after receiving 35 reports of chondrolysis associated with shoulder pain pumps between 2006-2008. According to the FDA:
“Because the reported cases involved significant injury to otherwise healthy young adults, FDA wants to advise healthcare professionals that elastomeric infusion devices or any other infusion pump are not cleared by FDA to deliver intra-articular infusions of local anesthetics and should not be used for this purpose.”
Treatment Options for Chondrolysis and PAGCL
- Arthroscopic debridement
- Humeral head replacement
- Resurfacing of the shoulder joint
- Total shoulder replacement surgery
- Cartilage transplant (mosaicplasty)
- Microfracture surgery