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

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

“When you lose someone like that,” Hillman said to The Kansas City Star, “it’s tough to replace. We tried to protect it, and we rested him a couple of times, but it’s just one of those things that needs to be repaired.”

The surgery will end the season prematurely for Crisp, but it shouldn’t hamper his chances for a full recovery. But for hundreds of individuals who had surgery for repairs like a torn labrum in the shoulder, the pain treatment turned out to be more painful and debilitating than the torn labrum itself.

The problem traced back to a pain pump device that is designed to deliver pain medication directly into the shoulder tissue for up to 72 hours following surgery. With the catheter placed in the shoulder tissue, the pumps were effective.

However, in the early 2000s, pain pump manufacturers advised surgeons to place the catheter in the shoulder joint. As the pain medication dripped into the joint rather than the tissue, it began eating away at the shoulder cartilage. The result was a painful condition known as chondrolysis, or specifically Postarthroscopic Glenohumeral Chondrolysis. The condition has caused greater disability and in some cases, shoulder replacement surgery was required.

Hundreds of lawsuits have since been filed against manufacturers of the pain pumps. Patients who have used a pain pump to regulate pain following shoulder, knee, hip, ankle or back surgery, should consult their doctor if they experience continued pain; weakness in the shoulder; clicking, popping or grinding in the shoulder; or a decreased range of motion. Individuals who have been injured by an intra-articular pain pump may have a claim against the manufacturers.

SOURCE: Pain Pumps › Coco Crisp to undergo season-ending shoulder surgery

Crisp, who has not played since June 12, was put on the disabled list and restricted from all swinging and throwing activities. “Obviously, that’s not a good sign,” says general manager Dayton Moore.

Once thought of as a career-ending injury, torn labrums can be repaired and one’s throwing ability restored. Recovery usually takes several weeks. It also can be considered a safer procedure than in years past, when the device used to alleviate pain following surgery ended up causing more damage and, in many cases, rendering the shoulder useless.

Intra-articular pain pumps are devices that are approved by the Food and Drug Administration (FDA) to deliver medication through a catheter placed directly into the tissue near the wound site. In the early 2000s, pain pump manufacturers asked the FDA if the catheters could be placed directly into the shoulder joint rather than the tissue. The FDA said no; more testing would be required.

Instead of working the proper channels to get the alternative use approved, pain pump manufacturers began advising surgeons to place the catheters into the shoulder joint. As a result, patients began suffering from a condition known as chondrolysis. Chondrolysis is the disappearance of cartilage in the shoulder resulting in joint narrowing and stiffness. In some cases, shoulder replacement may be necessary.

The improper use of pain pumps has ceased, but those injured by the devices are just beginning to experience problems and as a result numerous lawsuits have been filed against the manufacturers of pain pumps.

SOURCE: Pain Pumps › Royals’ Crisp may need shoulder surgery

Labrum repair surgery requires months to heal because the fibrocartilage has a poor blood supply. During surgery, the labrum is stitched together and anchored to the bone. It generally takes about six months for the tissue to heal. Typically, surgeons perform authroscopic surgery to repair shoulder injuries in patients and often use pain pumps to help alleviate pain for up to 72 hours following surgery. Pain pumps offer an alternative to narcotics and pain killers; however, misinformation about how the pain pumps should be used provided by pain pump manufacturers years ago have resulted in debilitating – and for some athletes, career-ending – injury to the shoulder joint.

The injuries stem from a change in the way pain pump manufacturers began to market the devices to surgeons, according to Frank Woodson, shareholder for Beasley Allen Law Firm. When the pain pumps were originally approved by the Food and Drug Administration (FDA), the pump’s catheter was to be placed in the shoulder tissue. However, in the 1990s and early 2000s, pain pump manufacturers began advising surgeons to place the pain pump catheters in the joint space, or intra-articular area, allowing pain medication to go directly into the joint space. This use had not been approved by the FDA. Shortly after the pumps were used in the inappropriate manner, per the advice of the pain pump manufacturers, “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.”

Source: Google: AFP

SOURCE: Pain Pumps › Magic’s Nelson plays just months after shoulder surgery

Pain pumps are devices that hold pain medication that is gradually released into the shoulder tissue through a catheter implanted in the surgical site. Once the pain medication has been released into the joint, the catheter is removed by the patient. When used properly, pain pumps offer a convenient alternative to oral or intravenous painkillers for those undergoing shoulder surgery. And most patients can expect a good recovery following physical therapy.

However, in the late 1990s manufacturers of pain pumps sought FDA approval to have the catheters placed directly in the joint area, rather than the shoulder tissue. “To the FDA’s credit, they said no,” says Frank Woodson, shareholder with Beasley Allen Law Firm. “The FDA said, ‘If you want permission to do that, you’re going to have to do safety studies to determine whether or not that is a safe practice or a safe method to use your product.’ The companies did not do that and just went ahead and started advising physicians to place the pain pump catheter in the joint space.

“They never studied it and they never obtained FDA approval,” he says. As a result, physicians began seeing their patients with a debilitating condition called chondrolysis, or a narrowing of the cartilage. As the cartilage begins to wear away, bone rubs against bone causing pain and disability. In many cases, shoulder replacement is required.

Approximately 140 lawsuits have been filed in state and federal courts against manufacturers of pain pump devices and several cases are set for trial in 2009. “I hope this litigation will continue to educate the medical community to use pain pumps in a proper manner because if it is done in that way, then we should stop seeing these injuries occur,” Woodson said.

SOURCE: Pain Pumps › FDA told pain pump manufacturers ‘no,’ but they refused to listen

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.”

SOURCE: Pain Pumps › Pain pump manufacturer’s bad advice leads to ‘tragedy’

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. 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 stop these devices from ruining any more lives.
Dr. Beck’s warning comes at an appropriate time now that football season is in full swing. Manufacturers report that the number of orthopedic surgeries rise sin the fourth quarter of each year tied to increased sports activity, particularly football and skiing. It appears that patients may 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, 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. Dr. Brent Hansen, an orthopedic surgeon, was the senior author of the study. The complication discussed in the article, known as Postarthroscopic Glenohumeral Chondrolysis (PAGCL), is permanent and can lead to extreme pain and lifelong suffering in 63% of the patients that use the pain pumps. It is suggested that the complications may occur following open surgery as well.

Numerous lawsuits are pending against the companies that manufacture, market, or distribute the pain pumps, including Stryker, DJO Inc., I-Flow Inc., BREG Inc. and others. Included among the many claims in the lawsuits are the allegations 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 space had not been established or that the continuous injections of commonly used anesthetics may cause permanent injury.

Our firm is looking into a number of claims from people across the country whose lives have been devastated by these pain pumps. These are supposed to be routine outpatient procedures, but the patients often endure several more surgeries, and most will eventually need complete shoulder replacement. We expect hundreds of individuals across the country to come forward with their own stories of ongoing pain and suffering they have experienced after using one of these devices. Frank Woodson, who is in our Mass Torts Section, is heading up a team that is investigating cases that include the use of pain pumps, not only in the shoulder, but in the knee, ankle and hip. If you need additional information relating to this matter, you can contact Frank at (334) 269-2343.

Source: Associated Press

November 15th, 2007

SOURCE: Pain Pumps › Pain pumps can cause cartilage damage