Post-Surgical Shoulder Pain Pumps Can Inflict Devastating Damage
Arthroscopic surgery to treat or repair a variety of conditions in injured joints has become routine. In our law practice, we frequently have clients who have undergone these procedures to joints such as the knee, shoulder, or hip. Arthroscopic surgery has several potential advantages over open surgical procedures. It is minimally invasive. It typically involves little or no hospital stay. It often allows a quicker recovery time. Although typically less painful than open surgery, some patients do suffer significant pain.
Along with the advances in surgical procedures, the medical community has created many options to treat pain. One of these modern options is the pain pump. What is a post-surgical pain pump? It is a device that can be implanted during surgery to deliver pain-relieving medication via a catheter to the surgical site. The pump is typically used for short-term pain relief in the days immediately following surgery. It is then removed and discarded.
How are the pumps implanted in a shoulder surgery? They can easily be placed by the anesthesiologist so that they deliver pain relieving medication at the site of the anesthetic block in the tissue around the shoulder. When used properly, pain pumps appear to be an effective and convenient alternative for temporary pain relief in the days immediately following the shoulder surgery. So, what is the problem? Apparently, the pump manufacturers sought approval from the FDA to implant the devices not just in the soft tissue of the shoulder, but instead, to allow implantation that would deliver medication via catheter directly into the shoulder joint itself. The FDA said no. According to information now being revealed, it appears the FDA said no on more than one occasion.
Instead of informing surgeons that the FDA had rejected intra-articular use of their pain pumps, the manufacturers acted in an opposite manner. According to a recent publication by the American Academy of Orthopedic Surgeons:
sales representatives either directly told surgeons to use the pump intra-articularly or simply left it up to the doctor to figure out what "intra-operative site," as listed in the general Instructions for Use for the pain pumps, meant.
As surgeons began placing the pumps intra-articularly, patients began developing a disabling condition called post-arthroscopic glenohumeral chondrolysis (PAGCL). Basically, this is a devastating condition where the cartilage in the shoulder joint is badly damaged or destroyed.
Recently, the FDA took the additional step of issuing a specific warning that these devices should not be used as previously marketed for placement intra-articularly. The FDA also required the device manufacturers to update their product labels to reflect this serious warning. According to an FDA study, almost all reported cases of chondrolysis (97%) occurred after these shoulder procedures. Thankfully, the FDA has begun to warn the physicians and public about this dangerous use of pain pumps. Unfortunately, it is too late for some patients. The damages caused by the previously defective warning and subsequent mis-use of this product have resulted in several claims against the manufacturers. This is a story of companies placing sales over safety. I suspect much more information about this practice will come to light in the near future.