The FDA says it is not known what factor or combination of factors contributed to chondrolysis, but it is believed that the infused local anesthetic or the device materials may have contributed to the condition. Prior to 2000, reports of chondrolysis were low, but reports of PAGCL began to appear more frequently in recent years as surgeons began using newer devices and newer techniques, such as continuous postoperative infusion of anesthetics into the glenohumeral joint in the shoulder.

The FDA informs health care professionals that elastomeric infusion devices are safe when used properly; however, use of pain pumps has not been approved for use in shoulder surgery. The agency now requires pain pump manufacturers to warn health care providers and their patients about the potential for severe joint damage when these devices are used for intra-articular anesthetic administration.

The FDA advises nurses and other health care professionals when treating patients who will or have used elastomeric infusion devices for shoulder surgery to make sure the patient has given informed consent and understands the potential risks and benefits; teach the patient to immediately report signs and symptoms of chondrolysis such as chronic severe joint pain, stiffness, loss of motion, weakness in the shoulder, or popping, grinding or clicking of the shoulder joint; and prepare patients who have signs and symptoms of chondrolysis for additional diagnostic studies, such as X-rays or magnetic resonance imaging, as ordered.

In conclusion, the FDA urges health care professionals to “be vigilant to help patients avoid complications or get further treatment when needed.”

SOURCE: Pain Pumps › FDA offers shoulder pain pump safety tips to nurses

But beginning in the 1990s, orthopedic surgeons began seeing more and more patients who were complaining of limited range of mobility, pain and stiffness in their shoulder. Tests showed the cartilage was beginning to or had completely worn away causing bone to rub against bone, also known as chondrolysis. Doctors were baffled.

What they soon discovered is that all the patients who were developing or had developed chondrolysis had had shoulder surgery during which a pain pump was used to deliver anesthetics for 48 to 72 hours following surgery. The pain pumps were a new offering for surgeons who previously prescribed IV or oral painkillers to patients to help deaden the pain of shoulder surgery.

Pain pumps are balloon-like devices filled with anesthetic that rests outside the body. The anesthetic is administered directly into the joint space through a catheter, which is removed after the medication has been used. Pain pump manufacturers were quick to promote this new use of pain pumps to doctors in the 1990s even though the use was never approved by the Food and Drug Administration (FDA).

What doctors didn’t realize at the time is that the pain pumps, which dripped medicine directly into the joint space, were causing the cartilage in the shoulder to wear away. Doctors soon made the connection between pain pumps and shoulder chondrolysis. Last year, after studies on shoulder chondrolysis had been published in several medical journals, the FDA issued a warning to doctors informing them that pain pumps should not be used during shoulder surgery and that this use has never been approved by the agency.

SOURCE: Pain Pumps › What is Chondrolysis of the shoulder?

While this use of pain pumps was a convenient way to relieve pain from surgery, it also resulted in a surprisingly high number of cases of a painful and debilitating deterioration of cartilage in the shoulder joint known as chondrolysis, specifically Postarthroscopic Glenhumeral Chondrolysis (PAGCL). The condition is permanent and many who suffer from it require shoulder replacement surgery.

Last year, the Food and Drug Administration (FDA) issued a notice to health care professionals informing them that use of pain pump devices and anesthetics in shoulder surgery were never approved by the agency. Yet, knowing this, pain pump manufacturers still instructed surgeons to use the pumps in this manner. As a result, a surprisingly high numbers of cases of chondrolysis were reported by patients who had used the pain pumps. As many as 63 percent of patients who used shoulder pain pumps are at risk of developing chondrolysis.

Several shoulder pain pump lawsuits have been filed by people who allege that they developed chondrolysis because the manufacturers of pain pumps failed to notify the medical community about the possible harm the devices could cause. More lawsuits are expected to be filed as more victims of these devices are diagnosed.

SOURCE: Pain Pumps › Studies link shoulder chondrolysis to pain pump devices

It is not known whether the drugs or the device is causing the chondrolysis, or if it is a combination of several factors. However, reports of the debilitating shoulder condition have skyrocketed in the past few years since pain pump devices were used in this fashion.

Chondrolysis is a serious condition that causes pain and loss of motion. Some patients may require joint replacement surgery. Many of the patients who have developed chondrolysis following shoulder repair surgery were adolescents or young adults.

In the patient safety announcement, the FDA is reminding health care professionals that use of local anesthetics in pain pump devices is not an approved use, and the FDA is requiring makers of local anesthetics to update the labeling of these drugs to include a warning of the risk of chondrolysis. Similar warnings will also be placed on pain pump devices.

Source: FDA Patient Safety Notice

SOURCE: Pain Pumps › FDA issues warning about local anesthetics, pain pumps

The notice to patients was part of a recent announcement by the FDA warning health care professionals of the a painful and debilitating condition known as chondrolysis reported in patients who have had surgery followed by continuously infused local anesthetics for 48 to 72 hours through a pain pump device. The anesthetics involved are marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine.

While the local anesthetics are approved by the FDA as injections for the production of local or regional anesthesia or analgesia, the approved drug labels for local anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as pain pump devices, or elastomeric pumps.

Chondrolysis was diagnosed within a median of 8.5 months after infusion. Almost all of the reported cases (97 percent) 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, also known as joint replacement.

The numerous reported cases of chondrolysis following use of intra-articular infusion with local anesthetics has prompted the FDA to require the drug manufacturers to update their product labels to warn healthcare professionals about the potential serious adverse effect.

SOURCE: Pain Pumps › Orthopedic surgery patients urged to monitor symptoms