Shoulder Pain Pumps Result in LawsuitsPosted on Apr 22, 2010
According to complaints, the manufacturers instructed physicians to insert the catheter directly into the shoulder joint. However, according to the U.S. Food and Drug Administration (FDA), the procedure was never approved by the governmental organization.
Apparently, manufacturers quickly rushed the devices to market without the necessary review and approval of the FDA. As a result, many victims have filed lawsuits against the pain pump manufacturers.
The FDA issued a warning on November 13, 2009 about the possible link between the use of the pain pumps and chondrolysis. The warning went out to physicians who currently use the pain pumps as a way to treat pain.
According to the FDA warning, “Neither local anesthetics nor infusion devices are approved for an indication of continuous intra-articular infusion.”
The FDA is also researching options to address the safety issues concerning the pain pumps. Some of these options include changes to package labeling that would highlight the risks.