The FDA warns pain pumps may be associated with the risk of a rare, but painful condition called Postarthroscopic Glenohumeral Chondrolysis (PAGCL), which leads to the permanent deterioration of cartilage, often requiring additional surgeries and even complete replacement of the joint.
Anesthetic infusion devices, more widely known as pain pumps, are commonly used following surgical procedures in order to reduce pain. They can be used from anywhere between a few hours to a few days after surgery.
Pain pumps consist of a pump and a catheter, which is placed in the joint of the surgical site. The pump automatically releases medication, which is delivered to the joint space by the catheter. Due to their close proximity to the actual injury, pain pumps are considered advantageous because they require smaller doses of pain medications, compared to oral drugs.
What is the problem?
However, the pain pumps were never approved by the FDA. Instead, the FDA warn pain pumps may actually cause permanent injury to patients, especially following shoulder or knee surgeries.
While the exact cause is not known, the anesthetic drugs, device material or another factor used in the pain pumps may have all caused the painful condition called Postarthroscopic Glenohumeral Chondrolysis (PAGCL), which is characterized by permanent cartilage deterioration, which may require additional surgeries or even a complete joint replacement.
Pain Pump Class Action Lawsuit
Hundreds of people who were injured by pain pumps have filed lawsuits, but they are not part of a pain pump class action. Instead, they are individual lawsuits that are proceeding separately in courtrooms around the United States.
In January 2010, a jury in Oregon awarded $4.75 million to Matthew Beale, a man who developed chondrolysis after he used the I-Flow On-Q Painbuster pain pump after bicep surgery in 2004. Lawyers have attempted to centralize the sprawling litigation in federal court, but judges denied motions in 2008 and 2010.
Symptoms of Shoulder Condrolysis
- Pain (even while sleeping or motionless)
- Decreased Range of Motion
In early 2010, the FDA released a safety alert to doctors and patients warning of the correlation between pain pumps and Postarthroscopic Glenohumeral Chondrolysis.
In the report, the FDA cited a review of 35 cases of Postarthroscopic Glenohumeral Chondrolysis between 2006 and 2008. Of the 35 cases, 34 of them occurred in the shoulder after a previous shoulder surgery. The other case occurred in the knee joint, following a knee surgery. Pain, stiffness and loss of motion were reported by patients within 2 months of their surgery and PAGCL was diagnosed an average of 8.5 months after surgery. Of the patients who developed chondrolysis after surgery, half of them required follow up surgery. Additionally, six of the cases involved pediatric patients between the ages of 16-18.
In their findings, the FDA noted that pain pumps are usually filled with anesthetics (numbing medications). The FDA explained anesthetics are only FDA approved for local or regional anesthesia or analgesia (pain killing), given at a superficial injection level. They are not FDA approved for continuous intra-articular infusions (to be used in pain pumps that go directly to the joint).
As the FDA stated, “Neither local anesthetics nor infusion devices (pain pumps) are FDA approved to be used for continuous intra-articular infusion (inside the joint). . . Health care professionals are encouraged to follow the instructions for use of elastomeric infusion devices (pain pumps), and to not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery.”
Postarthoroscopic Glenohumeral Chondrolysis, also referred to as PAGCL or chondrolysis, is the deterioration of cartilage material. The word “chrondrolysis” describes cells in cartilage that once dead, cannot regenerate. As the cartilage wears away, it leaves nothing behind in the joint besides bone. As a result, it causes bone to rub against bone, which is extremely painful.
What Causes Chondrolysis?
The exact cause of PAGCL is unknown. It cannot be traced back to one specific aspect of pain pumps, although there is a correlation between the two.
The FDA advised that it may be caused by the anesthetic drugs, device material or other factors in the pain pump. One possible explanation is that the amounts of medication released were too high, often at lethal levels, which killed the cartilage material.
The following medications have been included in pain pumps: