Dr. Charles Beck, a well-respected orthopedic surgeon this week issued a warning that a commonly used device designed to reduce pain after surgery is potentially dangerous when used in the shoulder joint space. The devices, manufactured by Stryker Corporation (NYSE: SYK), I-Flow Inc. (Nasdaq: IFLO) and others deliver high concentrations of pain medication directly to a surgical site, but according to a recently published article co-authored by Dr. Beck, they can cause permanent and debilitating damage to the shoulder.
"These devices have been used on thousands of patients nationwide, and based on our findings, hundreds appear to be at risk for this complication which results in severe pain, debilitating stiffness and eventual joint replacement surgery for many of those affected," says Dr. Charles Beck, an orthopedic surgeon and senior author of the study. "We sent the results of our study to the manufacturers more than two years ago, but their response has so far been minimal to non-existent. It is time to get the word out and I stop these devices from ruining any more lives."
Manufacturers report that the number of orthopedic surgeries rise in the fourth quarter of each year tied to increased sports activity, particularly football and skiing. Patients also tend to defer elective surgeries until the fourth quarter after annual insurance deductibles are satisfied.
The article, published in the October 2007 issue of The American Journal of Sports Medicine (AJSM), demonstrates a strong association between the intra-articular (inside the joint space) use of high volume pain pumps following arthroscopic shoulder surgery and an otherwise unexplainable loss of hyaline cartilage in the shoulder joint. The complication, known as Postarthroscopic Glenohumeral Chondrolysis (PAGCL), is permanent and can lead to extreme pain and lifelong suffering in 63 percent of the patients that use them. The medical records of numerous other patients suggest the complications may occur following open surgery as well.
"We estimate that this could affect hundreds, if not thousands, of people all across the country," says attorney Ted Meadows of the Montgomery, Alabama.-based law firm Beasley, Allen, Crow, Methvin, Portis & Miles. Meadows is spokesperson tor a group of firms that have already filed lawsuits against the companies that manufacture, market or distribute the pain pumps. The cases include U.S. District Court (Ore.) cases CV07-1318-HU, CV07-1309-AS and CV 07-1310 AA as well as Multnomah County Circuit Court (Portland, Ore.) case number 0703-02834. Their claims allege that the manufacturers failed to instruct or warn the U.S. medical community that the safety of using the pain pumps in the shoulder joint has I not been established, and that the continuous injection of commonly used anesthetics by these devices may cause permanent injury.