Since 2005, Dr. Bailie says he has seen dozens of patients come to him months after surgery with worsening pain and limited mobility. The diagnosis was chondrolysis, a condition in which the cartilage in the shoulder joint wears away leaving bone to rub against bone. There is no cure for chondrolysis and in some cases, total shoulder replacement is required.

But what could be causing his patients’ shoulders to worsen? Several studies began pointing to the same likely culprit – the pain pump device used during and after surgery to deliver medication into the joint space. As the anesthetic dripped onto the cartilage, the cartilage began wearing away over the course of weeks or months, sometimes longer.

Doctors soon realized that the way pain pump manufacturers were instructing them to use the devices was never approved by the Food and Drug Administration (FDA). In fact, the FDA had rejected the use on more than one occasion, saying more tests needed to be conducted to determine the safety of such use.

Now hundreds of patients injured by the pain pumps are suing manufacturers of the pain pumps, insisting the companies should have done more to warn surgeons of the potential risks. Lawyers say the manufacturers disregarded patient safety in an effort to bolster sales, but pain pump manufacturers argue more research is needed to determine if the cases of chondrolysis were actually caused by pain pump use.

SOURCE: Pain Pumps › Doctor ‘lost sleep’ over chondrolysis in patients

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

It is Dr. Carrese’s opinion that “to do otherwise would be a failure of expected ethical and professional conduct, and in turn a failure of good clinical practice.”

The opinion addresses the “ethical and professional obligations of orthopedic surgeons to patients who have had arthroscopic shoulder surgery in conjunction with postoperative use of a pain pump device that infuses medication continuously via a catheter directly into the shoulder joint and who are therefore at risk for developing severe pain and disability of the shoulder joint secondary to a condition known as chondrolysis.”

Dr. Carrese is an Associate Professor of Medicine and Director, Program on Ethics in Clinical Practice, at Johns Hopkins Berman Institute of Bioethics, Johns Hopkins University.

This recommendation follows a report from the FDA distributed today to health care professionals following a review of 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given “continuous intra-articular infusions of local anesthetics with elastomeric infusion devices to control post-surgical pain.” According to the study, 97 percent of the reported cases of chondrolysis followed shoulder surgeries.

The FDA report says early adverse affects following pain pump use after surgery included joint pain, stiffness, and loss of motion, occurring as soon as two months after surgery. In half the reported cases, the FDA report notes, patients required additional surgery, including arthroscopy or arthroplasty (joint replacement).

A number of lawsuits have been filed on behalf of patients suffering from chondrolysis as a result of pain pumps being inserted directly into the cartilage rather than into the muscle tissue following surgery. The FDA only approved pain pump use as inserted in the muscle tissue, but the lawsuits allege pain pump manufacturers marketed the devices to physicians with instructions to insert the catheter into the joint for faster and more efficient pain relief.

However, studies show that introducing the anesthetic medications directly into the joint in this manner destroys the cartilege and results in chondrolysis.

Read the Ethics Recommendation Letter.

Read the FDA Report.

SOURCE: Pain Pumps › Doctors have obligation to tell former patients about pain pump risks

According to the October 2007 issue of The American Journal of Sports Medicine, cases have been studied and it has been reported that a strong association between the intra-articular use of high volume pain pumps following arthroscopic shoulder surgery was linked to an unexplainable loss of cartilage in the shoulder joint.

To fully understand why these pumps can cause the loss of cartilage, the reader must understand how the pain pump works. The pain pump, inserted during the surgery, delivers high concentrations of pain medication to the surgical site.

Original product information instructs physicians to insert the pain pump into muscle tissue.  However, many physicians were instructed by representatives marketing the pain pump to insert the pain pump between the joints, into cartilage, to increase the effectiveness of the pump. This usage was never approved by the FDA.

When the pain medication is delivered into the cartilage, it actually kills the cartilage, resulting in severe pain, stiffness in the shoulder and, for most, joint replacement surgeries.

Dr. Charles Beck, an orthopedic surgeon and head of the study of pain pumps, believes that thousands of patients nationwide have been affected negatively by these devices.

SOURCE: Pain Pumps › The pump that doesn’t ease the pain

Shoulder arthroscopy is a rapidly expanding field because it offers a less invasive and less painful option for patients. In arthroscopy, two very small incisions are made, one for instruments and one for a miniature surgical camera to allow the surgeon’s viewing of the area without a large surgical site.

To manage post-surgical pain and extend the deployment of numbing agents, the use of temporary intra-articular shoulder pain pumps was introduced into these types of surgeries.

The procedure involves placing a flexible intra-articular shoulder pain pump catheter into the shoulder joint with the pump remaining in the joint for several days to deliver controlled doses of pain medication, often a combination of bupivacaine and epinephrine. This course of treatment became popular because it reduced recovery time without the need for narcotic pain relievers.

But a few days of relief can result in a debilitating and lifelong condition that causes severe-and often, permanent-pain and mobility loss and the need for constant medication. In some patients, complete loss of the use of the shoulder occurs.

PAGCL, one of the most common complications from shoulder surgeries is a condition where overwhelming damage to the shoulder occurs when cartilage deteriorates following these types of arthroscopic procedures. Without cartilage, there is no bone-to-bone cushion, causing bones to grind together and resulting in intense pain and, in some cases, chronic arthritis.

A study of 152 patients who underwent arthroscopic shoulder surgeries revealed that 12 of the patients developed PAGCL. All 12 PAGCL patients received pain pumps during their surgeries; the use of the pain pump was the only factor that the PAGCL patients had in common. In fact, studies suggest that up to 63% of arthroscopic shoulder surgery patients who received an intra-articular pain pump are at risk for developing PAGCL.

In addition to living with acute pain and daily medication, PAGCL may result in a need for follow-up surgery. Unfortunately, arthroscopic surgery is not an option. The damage that occurs with PAGCL requires the more painful and invasive shoulder joint replacement surgery (arthroplasty), a more intense surgery option over arthroscopy. Arthroplasty involves replacing the joint with plastic and metal components. Surgery lasts two and three hours and patients usually remain in the hospital for three nights. Physical therapy is almost always required following this type of procedure. Despite surgery, many patients never fully regain use of their joint and some patients report increased pain.

No consistently successful PAGCL treatment has emerged and the damage from PAGCL is believed to be irreversible. Unfortunately, pain medications seem to worsen the symptoms of PAGCL and offer no long-term value concerning treatment or cure.

PAGCL tends to develop two to twelve months following surgery. Symptoms include shoulder pain, whether in motion or at rest; increased shoulder stiffness; popping or grinding when the shoulder is in motion; decreased to full loss of range of motion; and loss of joint strength. Diagnosis of PAGCL is confirmed via an x-ray indicating narrowing of the shoulder joint space and indicating additional surgery is required to replace the destroyed joint.

November 15th, 2007

SOURCE: Pain Pumps › Shoulder pain pumps can result in lifetime disability

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