Patients who undergo shoulder, knee and ankle surgery often experience significant pain; particularly immediately post surgery. To try and manage that pain, physicians have often employed the use of pain pumps. These pumps inject pain killer into the body in a regulated fashion to minimize pain, while controlling the tendency toward addiction.
The pain pump is attached to a catheter, which was routinely inserted into the soft tissue near the affected joint. This use of the pump worked fine until the manufacturers of these devices started recommending that physicians could insert the catheter directly into the affected joint space and provide a much higher degree of pain relief. This was, of course, welcome news for physicians who always want to attempt to relieve or minimize the suffering of their patients. So all was good, then?
What pain pump manufacturers failed to tell physicians is that the Food & Drug Administration had never reviewed, let alone approved, the use of the pumps directly into the joint space. What the manufacturers should have known is that at least one of the manufacturer’s, McKinley Medical, asked the FDA to permit insertion of the devices into the joint space and the FDA asked for proof of efficacy. As far as we know, no data or evidence was presented to the FDA. Soon after this, Stryker Corporation purchased the exclusive rights to the pain pump from McKinley.
With full knowldge, the pain pump manufacturers failed to tell doctors that:
- The FDA never cleared or approved the use of pain pumps to administer medications in a joint space
- The safety of pain pumps for use in the joint space is unknown and has not been tested or otherwise established through proper studies; and
- Medications commonly used in these pumps are reported to be harmful to cartilage
- The FDA rejected proposed requests for a new marketing indication for use of pain pumps in the synovial cavity;
Studies seem to be reasonably clear that the use of the pain pump within the joint space causes potentially significant damage to cartilage . The damage caused by use of the pumps in the joint space often result in requiring full joint replacements and more.