Pain pump manufacturer's bad advice leads to 'tragedy'
April 27th, 2009 by Jennifer Walker-Journey
Surgeons who perform authroscopic surgery to repair shoulder injuries in patients often use pain pumps to help alleviate pain for up to 72 hours following surgery. The pain pumps are devices that hold pain medication that is gradually released into the shoulder area through a catheter implanted in the surgical site. Once all the pain medication has been released into the joint, the catheter is removed by the patient. When used properly, the process offers a beneficial alternative to oral or intravenous painkillers. And most patients can expect a good recovery after physical therapy.
However, in the 1990s and early 2000s, pain pump manufacturers began to market the product differently, according to Beasley Allen shareholder Frank Woodson. “The catheter was intended and approved by the FDA to be placed into the shoulder tissue. (But) with advice from manufacturers, the pain pump catheters were being placed in the joint space or intra-articular area, which allowed the pain medication into the joint space.”
By advising surgeons to use the pump in such a manner – one that had never been approved by the FDA – tragedy ensued. “Doctors began to see patients suffer severe damage to their shoulder cartilage that we’ve rarely seen before,” Woodson said.
What resulted was the loss of cartilage, or joint space, commonly called chondrolysis. It leads to severe pain because the cartilage in the shoulder space is gone, causing bones to rub together. As the condition progresses, patients may require shoulder replacement and it makes normal daily activities painful and difficult.
There are approximately 140 lawsuits filed by people who have been injured by misuse of these pain pumps. All are pending in state and federal courts throughout the country. “There are many more cases under review across the country and there will likely be many more filed,” Woodson said. “As patients and physicians learn more about the link between pain pumps and chrondrolysis, I think you’ll see many more people come forward.”
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