Pain pumps are used following surgical procedures in order to reduce pain, particularly in shoulder and knee joints. Because the pumps can get medication so close to the injury, pain pumps are considered advantageous because they require smaller doses of pain drugs, compared to oral medications.
Unfortunately, the FDA warns pain pumps may actually cause Postarthroscopic Glenohumeral Chondrolysis (PAGCL), a form of permanent cartilage deterioration that may require additional surgery or complete joint replacement to correct.
UPDATE: Medtronic Pain Pump Lawsuit Filed by Paralyzed Man
June 23, 2014 — A paralyzed man’s pain pump lawsuit will continue against Medtronic after the Supreme Court refused to hear an appeal from the device-maker, according to MassDevice. Click here to read more.
Pain Pumps: An Overview
Anesthetic infusion devices or elastomeric infusion devices — more commonly known as pain pumps — consist of a pump and catheter, which is placed in the joint of the surgical site. The pump automatically releases medication into the catheter, which delivers it to the joint space. Because of the catheter’s close proximity to the injury site, pain pumps are considered advantageous because they require smaller doses of medicine than oral pain killers, especially following a surgical procedure.
The reality, however, is that pain pumps were never approved by the FDA for continuous infusion of local anesthetics into intra-articular (joint) spaces. Instead, the FDA warns pain pumps may be causing more harm than anything, especially when used during shoulder and knee surgeries. Something in the pumps — whether it’s the doses of the drugs, the device material itself, or another factor — have caused the painful condition called Postarthroscopic Glenohumeral Chondrolysis (PAGCL), which is characterized by permanent cartilage deterioration in the surgical location. It may require additional corrective surgery or even a complete joint replacement in otherwise healthy young adults.
Due to the severity of the side effects associated with pain pumps, you or someone you know may want to contact a pain pump lawyer or attorney with The Clark Firm to discuss the potential of a pain pumps lawsuit.
Side Effects of Pain Pumps and PAGCL
Patients who have recently had a shoulder or knee surgery and who received a pain pump as part of their procedure may experience symptoms similar to the following as a result of PAGCL:
- Pain (even while motionless or sleeping)
- Decreased range of motions
In a Drug Safety Information report updated by the FDA on February 16, 2010, the FDA said it had reviewed 35 reports of PAGCL between 2006 and 2008 in patients given continuous intra-articular (within the joint) infusions of local anesthetics from pain pumps.
As the FDA explains, the local anesthetics were infused for anywhere between 48 and 72 hours directly into the intra-articular space using a pain pump.
Patients began reporting joint pain, stiffness and loss of motion as early as two months after receiving the infusion, with PAGCL being diagnosed on average 8.5 months after surgery. In more than half of the 35 reports, the patients required additional surgery, including complete joint replacement.
Thirty-four of the 35 cases of PAGCL occurred in the shoulder joint; one report involved the knee joint. Since 2008, the FDA has received four more reports of PAGCL in patients administered pain medications in the shoulder.
While the median age of the patients was 25 years old, six of the reports involved pediatric patients between 16 and 18.
Said the FDA,
“The FDA is requiring manufacturers of local anesthetics and of pumps that may be used to infuse local anesthetics to update their product labels to warn healthcare professionals about this potential serious adverse effect. . . Because the reported cases involved significant injury to otherwise healthy young adults, FDA wants to advise healthcare professionals that elastomeric infusions 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.”
Postarthroscopic Glenohumeral Chondrolysis
Postarthroscopic Glenohumeral Chondrolysis is the complete loss of articular cartilage. This cartilage covers bones where they contact other bones and acts as a lubricant, allowing for smoother movement, reduced friction and protected bones.
Articular cartilage cannot repair itself easily because it grows very slowly and has no blood supply. When the cartilage deteriorates, it leaves nothing in the joint but bone. As a result, bone rubs against bone, which may be extremely painful.
While anti-inflammatories and other drugs may provide limited relief, PAGCL may ultimately require complete joint replacement surgery.
Medications Used in Pain Pumps
Of the 35 reports received by the FDA, 32 of them occurred after receiving infusions of:
Other dangerous pain pumps may contain the anesthetics:
Pain Pump Manufacturers
The FDA found pain pump injuries were not associated to a single manufacturer. Instead, the FDA has received pain pump injury reports related to the following pain pump manufacturers:
- Don Joy
Pain Pump Class Action Lawsuit
Hundreds of people who developed chondrolysis after using a pain pump have filed lawsuits, but these are not consolidated into a pain pump class action. Instead, they are individual lawsuits. Lawyers tried unsuccessfully in 2008 and 2010 to centralize the litigation in a Multi-District Litigation (MDL) in federal court. For now, the litigation is proceeding as individual lawsuits. Contact our law firm today for more information.