Shoulder Chondrolysis Problems with Surgery Pain Pumps Draws FDA Warning
The shoulder pain pump lawyers at Saiontz & Kirk, P.A. have represented individuals who are pursuing shoulder chondrolysis lawsuits for over two years. According to a statement released by the FDA on Friday, the agency is finally making the manufacturers of these pain pumps and the drugs used in them to add new warnings about the risk of the shoulder problems.
>>FDA SAFETY INFORMATION: Risk of Chondrolysis Problems
Following a mounting number of reports of chondrolysis following shoulder pain pump use, which involves a painful and irreversible destruction of cartilage, the FDA indicated that the “significance of this injury to otherwise healthy young adults warrants notification to health care professionals.”
Shoulder pain pumps, sometimes referred to as a shoulder pain ball, are small disposable infusion pumps that have been prescribed by many doctors following arthroscopic surgery as an alternative to oral pain medication. The pumps deliver medication through a catheter directly into the shoulder joint over a period of two or three days before they are removed by the patient.
In litigation pending throughout the United States, the pain pump manufacturers have denied that their products cause people to suffer shoulder chondrolysis problems or that there was anything wrong with their warnings. However, based on at least 35 reports involving chondrolysis following continuous intra-articular infusion with local anesthetics, the FDA is now requiring updated warnings about the potential side effect.
In a statement sent to healthcare providers describing the reports of necrosis and destruction of cartilage, known as chondrolysis, the FDA said:
The local anesthetics (with and without epinephrine) were infused for extended periods of time (48 to 72 hours) directly into the intra-articular space using an elastomeric pump.
Chondrolysis was diagnosed within a median of 8.5 months after the infusion. Almost all of the reported cases of chondrolysis (97%) occurred following shoulder surgeries. Joint pain, stiffness, and loss of motion were reported as early as the second month after receiving the infusion. In more than half of these reports, the patients required additional surgery, including arthroscopy or arthroplasty (joint replacement).
The FDA pointed out that none of the devices have been approved for intra-articular infusion of local anesthetics after orthopedic surgery, and urged doctors to follow the recommended uses.
SHOULDER CHONDROLYSIS LAWYERS
Following arthroscopic surgery where a pain pump is used, problems with shoulder chondrolysis typically begin to surface between three and 12 months after surgery. As the shoulder is used more, the loss of cartilage can result in shoulder problems like:
- Increased shoulder pain regardless of whether the shoulder is in portion or at rest.
- Clicking, popping or grinding of the shoulder joint.
- Shoulder stiffness or weakness.
- Decreased range of motion in the shoulder.
- Additional shoulder surgery, including the potential need for a total shoulder replacement.
The shoulder chondrolysis lawyers at Saiontz & Kirk, P.A. are continuing to review potential claims for individuals throughout the United States who have experienced shoulder pump problems. To review a potential case for yourself, a friend or family member, request a free consultation and claim evaluation.