Joint Chondrolysis — Complete Cartilage Destruction Caused by Pain Pumps
Patients undergoing what should be routine shoulder and knee surgeries are being debilitated for life. In most cases it is occurring to relatively young, active people. The genesis of these severe injuries lies in surgeons’ use of intra-articular pain pumps. The real cause, though, lies in manufacturers’ practice of putting profits before safety in their marketing practices.
Patients undergoing arthroscopy typically experience 3 to 5 days of post operative pain. Staring in the year 2000, a number of manufacturers of medical devices began marketing infusion devices designed to introduce pain medication directly into the joints of patients; permitting significant pain relief during the post operative period of most severe pain.
Most manufacturers did not seek FDA approval for this new use of infusion pumps; those who did circumvented the FDA through their marketing programs. These manufacturers told doctors that placing a catheter inside the joint space and delivering pain medication directly to the surgical field would provide patients with optimal pain relief. Manufacturers also told physicians the application was safe for patients.
- Pain pump manufacturers did not tell physicians that no clinical trials had been conducted of the effects of infusion directly to the joint space.
- Pain pump manufacturers did not tell physicians that no laboratory evaluation of the effects of the pain medication on human cartilage had been conducted.
- Pain pump manufacturers did not tell physicians their medical devices had not been approved by the FDA.
- Pain pump manufacturers did not tell physicians that little or no literature concerning the effects of intra-articular infusion of pain medication existed and the literature that did exist was not favorable for the very application being sold by the manufacturers.
In an effort to maximize profits, pain pump manufacturers sold their devices to unsuspecting physicians who in turn used them on their unknowing patients. Young patients have suffered a condition called chondrolysis in which the joint cartilage is completely destroyed. This requires joint replacement and, in most cases, these young patients may have to go through additional joint replacements in the future.
The manufacturers now defend lawsuits filed against them by claiming that chondrolysis is being caused by other factors and not their pain pumps. They claim that no good science exists to prove their devices are the root cause of chondrolysis. The fact is a lack of science is due largely to these manufacturers conducting no investigation or evaluation that would have been required by the FDA.
The existence of joint chondrolysis before the year 2000 and the incidence increased rapidly after the use of intra-articular pain pumps began to be promoted. In addition, many of the effected patients presented with very good cartilage condition, until pain medication was injected into the patient’s joint space. Pain pump manufacturers were required to submit their device for FDA approval of the use they ultimately marketed – they never obtained approval.