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

I-Flow had tried to prevent evidence from being included in the trial that would have been used to form the basis of punitive damage claims. That evidence allegedly included information that I-Flow’s chief executive officer was advised, prior to the plaintiffs’ injuries, to issue a warning that the pumps should not be used for shoulder surgery. Instead, I-Flow continued to instruct surgeons to use the pain pumps with local anesthetics for shoulder surgery, a use that was never approved by the Food and Drug Administration (FDA).

In November 2009, the FDA required manufacturers of pain pumps as well as the makers of local anesthetics used in the devices to add new warnings about the risk of chondrolysis. The warnings also alerted health care professionals not to use the pumps with local anesthetics.

There are at least 150 shoulder pain pump lawsuits pending against I-Flow and other manufacturers of pain pump devices from plaintiffs who allege that the devices caused them to develop chondrolysis of the shoulder. All lawsuits claim the manufacturers failed to warn patients and their doctors of the risk of chondrolysis.

SOURCE: Pain Pumps › I-Flow settles lawsuits from plaintiffs injured by shoulder pain pumps

Johnson is suing Moog Inc., Stryker Corp. and Stryker Sales Corp., McKinley Medical, Curlin Medical and Linvatec Corp. for economic, non-economic and punitive damages resulting from use of his pain pump.

Pain pumps are balloon-like medical devices filled with medication that rest outside the body. The device has a catheter that is placed into the shoulder area and feeds medication to the surgery site for up to 72 hours. When all the medication has been used, patients simply pull the catheter out of the body. While the pain pumps have reduced hospital stays and provided relief immediately following shoulder repair surgeries, the long-term effects can be dangerous. The anesthetic used in the pain pumps eats away at the cartilage in the shoulder joint, leading to a debilitating condition known as chondrolysis.

Chondrolysis occurs when cartilage in the shoulder joint wears away causing bone to rub against bone. Those with chondrolysis have pain in the shoulder joint and limited mobility. Many require shoulder joint replacements.

Several people treated with pain pump devices following shoulder surgery have developed this once-rare condition, and many are joining Johnson in the fight against pain pump manufacturers for justice.

Source: The Southeast Texas Record

SOURCE: Pain Pumps › Another lawsuit filed against pain pump manufacturers

Arthritis in the shoulder is somewhat uncommon, with about 40,000 shoulder replacements being performed each year in the United States. By comparison, 450,000 knee and 230,000 hip replacements are performed annually. But the increasing reports of shoulder arthritis in young patients is alarming on many levels.

For starters, current shoulder replacement techniques do not adequately address the high function demands of young active patients. And while shoulder replacement may help relieve pain, many of these young patients who have shoulder replacement surgery will require further shoulder reconstructive surgery in the future.

The arthritic condition many of these young people suffer with is known as chondrolysis, a condition in which the cartilage in the shoulder joint wears away causing bone to rub against bone. There is no cure, and those who have chondrolysis often suffer from pain, limited mobility and debilitation. In many cases patients require shoulder replacement surgery.

As more and more reports of chondrolysis were being reported in patients following shoulder surgery, surgeons and researchers began to ask why. Laboratory data and clinical reports began pointing to the same likely culprit – the prolonged use of intra-articular local anesthetics administered directly into the shoulder joint by a pain pump device. Investigations found that this was not an FDA-approved use for the pain pump or the anesthetic; however, that didn’t stop pain pump manufacturers from instructing surgeons to use the device in such a way.

Surgeons are now understanding how they have been misled by the makers of pain pumps and with luck, the number of new chondrolysis reports will decrease in time. Until then, the only recourse victims have is to go after the pain pump manufacturers in court.

Source: Gerson Lehrman Group

SOURCE: Pain Pumps › Reports of young patients with arthritis in shoulder increasing

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

UCLA

Shoulder injuries among athletes is not uncommon and can bench a player for weeks or months. There was a time when such injuries that required surgery brought about career-ending fears, but technology over the years has made full recovery a more likely possibility. However, just a few years ago, surgery to repair the shoulder often was the cause of more serious injury.

A recent study published in The American Journal of Sports Medicine first brought to light the connection between chondrolysis, a condition in which the cartilage in the shoulder has been eroded away, and the use of pain pump devices during and following arthroscopic shoulder surgery. Pain pumps are balloon-like devices that hold local anesthetics. During surgery catheters that lead from the balloon area of the device are inserted into the surgical site. Pain medication is then administered for up to 72 hours following surgery. Once the medication has been used up, the patient simply pulls out the catheter.

Pain pumps are approved by the FDA with the catheter placed in the shoulder tissue. However, in the late 1990s, pain pump manufacturers began instructing surgeons to insert the catheter directly into the shoulder joint, allowing the medication to drip directly onto the cartilage, a use that was not FDA approved.

In the early 2000s, doctors became puzzled when more and more patients who had surgery to repair shoulder injuries – and who showed no signs of cartilage wear at the time of surgery – were suffering from pain and loss of motion, and were ultimately diagnosed with chondrolysis. It didn’t take long for doctors to make the connection between the debilitating chondrolysis and the use of pain pump devices.

Since the connection was made, the FDA and professional groups have instructed surgeons of the correct, FDA-approved use of shoulder pain pumps, making the surgery safer for patients. Meanwhile, the lawsuits against pain pump manufacturers are mounting.

SOURCE: Pain Pumps › UCLA’s Keefe benched due to shoulder injury, but recovery likely

On Friday, the FDA notified health care professionals of 35 reports of chondrolysis in patients who received regular infusions of the anesthetics for up to 72 hours following surgery. In the reported cases, the anesthetics were used with pain pump devices in which the medication was fed through a catheter that was placed directly into the joint space. The catheter was attached to a balloon that rested outside the body and was filled with the anesthetics.

These pain pump devices, often used with shoulder surgery, were approved by the FDA with the catheter placed in the shoulder tissue, not the joint space. But in the early 2000s, pain pump manufacturers began advising doctors to place the catheters directly into the joint space even though that use was not approved by the FDA. The constant drip of medication into the joint caused the serious breakdown of cartilage known as chondrolysis. Currently, patients who have been injured by the pain pump devices have filed suit against the manufacturers of pain pumps.

The anesthetics listed in the FDA notice include bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine. These anesthetics are approved 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 elastomeric pumps. The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics.

The FDA is encouraging healthcare professionals to follow the instructions for use of elastomeric infusion devices, and to not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery.

SOURCE: Pain Pumps › FDA warns of chondrolysis risk with unapproved use of local anesthetics

The devices take the place of narcotics, which carry a laundry list of side effects from nausea to vomiting to constipation and decreased sleep. They also require more monitoring and may require the patient to have a longer stay in the hospital.

“It may be $2,000 a day to have a patient stay in the hospital, so in this era of trying to reduce health care costs, if we can reduce their hospitalization from three days to one – or even better, to discharge them on the day of the surgery as an outpatient – we’ve dramatically changed the cost of that shoulder replacement or other major surgery,” said Randall Malchow, director of the Regional Anesthesia and Acute Pain Fellowship at Vanderbilt University. Dr. Malchow discussed the benefits of pain pumps for ABC 7 News.

The biggest risk these days with shoulder pain pumps is that in some cases, the pump does not work. That requires the patient to be admitted to the hospital and have pain medications administered by doctors and nurses. There is also a slight risk – about 1 percent – of infection. Pain pumps can be used for shoulder, elbow, wrist, knee and hip replacements.

The risks have recently improved since doctors began to make a connection between an alternative use of pain pumps and a painful and debilitating condition known as chondrolysis. Chondrolysis is when the cartilage in the joint has worn away and bone begins to rub against bone.

For years in the late 1990s and early 2000s, manufacturers of pain pumps began telling doctors to implant the pumps’ catheters directly into the shoulder joint rather than into the shoulder tissue. Inserting the catheter into the shoulder joint was not an FDA-approved use, as was placing the catheter in the shoulder tissue. By placing the catheters into the joint space, the medication dripped directly onto the cartilage and began eating away at it. The result? Pain, loss of motion, and limited use of the shoulder.

Today, doctors are using pain pumps as the FDA had intended – with the catheters placed in the shoulder tissue, with few risks. However, many of those who suffered because the pain pump manufacturers gave the surgeons ill advice have slapped the manufacturers with hundreds of lawsuits seeking justice.

SOURCE: Pain Pumps › Pain pumps less risky these days