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

Pain pump manufacturers named in the lawsuit include Moog Inc., Stryker Corp., Orthofix Inc., Linvatee Corp, I-Flow Inc, Breg Inc., and DJO Inc.

A study published by The American Journal of Sports Medicine first brought to light the connection between PAGCL, a type of chondrolysis in the shoulder, and pain pumps used during shoulder repair surgery. As a result of that study, hundreds of lawsuits have been filed against manufacturers of pain pump devices and pharmaceutical companies as more and more victims begin to put the pieces together and realize they were unnecessarily harmed by the devices used to alleviate pain during shoulder surgery.

There is no cure for chrondrolysis. The condition causes continuous pain; weakness in the shoulder; clicking, popping or grinding in the shoulder; and/or decreased range of motion. Some who suffer from chondrolysis may require complete shoulder replacement.

Source: Buffalo Business Journal

SOURCE: Pain Pumps › More lawsuits filed against pain pump manufacturers

Shoulder injuries are not uncommon among athletes. Hard and repetitive throwing motions like those needed for football and baseball leave many players with shoulder problems, many of which require surgery. While a full recovery is usually possible, some patients’ injuries were worsened by shoulder surgery.

The phenomenon even confused doctors who performed the shoulder repair surgeries. They were finding a growing number of patients months or years after surgery were back in their offices complaining of pain, stiffness and loss of motion. Upon further inspection, doctors found those patients had developed a condition known as chondrolysis, caused by the breakdown of cartilage. As the cartilage wears away, bone begins to rub against bone causing even more pain and damage.

What doctors finally deduced was that it wasn’t the surgery that was causing this specific type of chondrolysis known as postarthroscopic glenohumeral chondrolysis (PAGCL), but the pain pump used during and after surgery. The pain pumps are devices that have a balloon filled with pain-deadening medication. That medication is fed directly into the wound site through a catheter for up to 72 hours.

The pumps were approved by the Food and Drug Administration (FDA) with the catheter placed in the shoulder tissue. But pain pump manufacturers began telling doctors to place the catheters in the shoulder joint, which allowed the joint space to be bathed in medication. What doctors didn’t realize is that constant drip of medication into the shoulder joint was slowly eating away at the cartilage, resulting in chondrolysis.

Since this discovery, published in a recent issue of The American Journal of Sports Medicine, patients who have suffered serious disability from the wrongful use of pain pumps have sued the manufacturers of pain pumps. If you are experiencing the symptoms associated with chondrolysis or PAGCL, you too may have a claim against the manufacturer.

Source: St. Petersburg Times

SOURCE: Pain Pumps › FSU quarterback faces shoulder repair surgery

I-Flow Corp

I-Flow currently faces 212 lawsuits from people who claimed they were harmed by the company’s ON-Q pain pumps used for shoulder surgery, yet the company says it is optimistic that it can skirt the claims made against it. The most damning evidence includes a recent study published by The American Journal of Sports Medicine that identified intra-articular pain pumps as the likely cause of a condition known as chondrolysis. Postarthroscopic Glenohumeral Chondrolysis (PAGCL) is a specific type of chondrolysis associated with shoulder pain pumps.

PAGCL is a painful and debilitating condition in which the cartilage in the shoulder wears away causing bone to rub against bone. It can greatly decrease range of motion and cause weakness in the shoulder. There is no cure for PAGCL, and in severe cases, shoulder replacement surgery is required.

I-Flow’s total revenue for the first six months of 2009 increased 7 percent to $68 million, up $4.3 million over the first six months of 2008. First six month sales of the company’s On-Q product lines increased 5 percent, or $2.2 million, compared to the first six months of 2008. I-Flow projects a yearly revenue of $139.7 million to $146 million, over analysts’ average expectation of $138 million.

Sources:
Fox Business
Orange County Business Journal

SOURCE: Pain Pumps › I-Flow enjoys profits amid spike in product liability lawsuits

Chondrolysis is a rare condition in which the cartilage in a joint wears away causing bones to rub against bones. It was often seen in the hip where conditions such as birth defects caused the bones to rub against each other. This grinding of bones causes inflammation and pain and, eventually, destruction of the bones. It is painful and debilitating to those who suffer from this permanent condition.

In the 1990s, doctors began seeing chondrolysis in the shoulder, a place where it was rarely, if ever, seen before. As doctors began diagnosing more and more shoulder chondrolysis, also known as postarthroscopic glenohumeral chondrolysis (PAGCL), in patients who had previously had shoulder surgery, they began to make a connection between PAGCL and a new surgical use of pain pump devices used to manage pain following surgery.

That new use was to place the catheter of the pain pump directly into the shoulder joint rather than into the shoulder tissue. The constant drip of medication into the shoulder joint ate away at the cartilage in the shoulder.

It was the pain pump manufacturers who advised doctors to place the catheters directly into the joint space – a use that was not approved by the Food and Drug Administration. As a result, those manufacturers are facing hundreds of lawsuits against people who are suffering with PAGCL, a condition that is permanent and often requires shoulder replacement surgery.

SOURCE: Pain Pumps › Pain pumps blamed for painful chondrolysis in shoulder joints

Pain pumps

PAGCL is a painful and debilitating condition that occurs when the cartilage in the shoulder joint wears away, causing the bones to rub together. There is no cure for PAGCL. Some patients my require shoulder replacement surgery.

There are three medical device manufacturers at the crux of the shoulder pain pump controversy – Stryker Corporation, I-Flow Corporation, and DJO Incorporated. Stryker is a multinational, publicly traded corporation that sells the McKinley Medical LLP pain pump products in the U.S., Canada and Mexico. In 2006, the company reported net sales of almost $5.5 billion.

I-Flow’s family of products focuses on Regional Anesthesia, Intravenous (IV) Infusion Therapy, and Oncology Infusion Services. It’s acute pain management product line includes the ON-Q PainBuster Post-Op Pain Relief Sustem, The Soaker Catheter, and the C-bloc Continuous Nerve Block System. I-Flow has exclusive rights in the U.S. to distribute the On-Q PainBuster. In 2007, company recorded assets exceeding $81 million.

DJO is a global provider of solutions for musculosketal and vascular health that specializes in rehabilitation and regeneration products for the non-operative orthopedic, spine and vascular markets. The company manufactures and/or distributes the DonJoy Pain Control Device. In 2007, the company reported net assets of more than $173 million.

Allegations against the manufacturers include negligence, strict liability, warranty, and failure to warn physicians and patients of the risk of chondrolysis with use of the shoulder pain pumps. Those who have been injured by shoulder pain pumps are advised to seek legal counsel, as they may have a case against the manufacturer.

SOURCE: Pain Pumps › Three pain pump manufacturers at crux of controversy

Almost all torn shoulder labrums require surgery. In the early 2000s, however, surgery often made the injury worse, causing a painful and debilitating condition known as chondrolysis in which the cartilage in the shoulder joint wears away. Chondrolysis causes a decreased range of motion, weakness in the shoulder, and extreme pain. Some patients require shoulder replacement surgery. The resulting condition baffled doctors until they began to make a connection between chondrolysis and the pain pumps used to deliver medication to the wound site following surgery.

The problem was traced to a change in the way the manufacturers of pain pumps advised surgeons to use them. The pumps were approved by the Food and Drug Administration (FDA) with the catheters implanted into the shoulder tissue. Those catheters delivered medication to the area for up to 72 hours. However, pain pump manufacturers began advising doctors to implant the catheters directly into the shoulder joint. As medication dripped into the joint space, it gradually began to eat away at the cartilage, causing a specific type of condition now known as Postarthroscopic Glenohumeral Chondrolysis, or PAGCL.

Once the connection was made, doctors began stopping the practice if implanting the pain pump catheters in shoulder joints and outcomes have improved. While a torn labrum can still end a career, the outcome is much brighter than just a few years ago.

Sources: AZ Snakepit

SOURCE: Pain Pumps › Torn labrum not necessarily career-ending injury

Osteoarthritis is a common aliment that has earned the condition a top ranking in disability of Americans. Symptoms of stiffness, pain and limited movement are caused when the cartilage at the end of the bone breaks down, causing the bones to rub together at the joints. The most common remedy has been arthroscopic surgery, during which surgeons insert a scope with a camera through small incisions, where they smooth damaged cartilage surfaces and flush out bone chips. This allows for faster healing time than traditional surgery.

To alleviate pain following knee surgery, doctors at times will insert a pain pump to deliver medication directly to the surgical wound site. These post-operative pain pumps can help alleviate the pain associated with surgery, but they may come at a greater risk. Post-operative pain pumps, or intra-articular pain pumps, are routinely used in similar arthroscopic surgeries for shoulder injuries.

A recent study by The American Journal of Sports Medicine identified a link between the post-operative pain pumps and a painful, cartilage deteriorating condition known as Postarthoscopic Glenohumeral Chondrolysis, or PAGCL. PAGCL can cause irreversible damage and may require additional surgeries.

Patients who are considering knee surgery are advised to discuss alternative options with their physicians.

SOURCE: Pain Pumps › Studies show medication, physical therapy as effective as knee surgery

A torn labrum flap is an injury to the part of shoulder joint. Having the surgery could likely end the season for Francis. Though he is a month behind on his throwing program, he says he will continue to pitch and hope that he can work past the shoulder discomfort.

Perhaps one reason Francis hopes to avoid surgery is that shoulder surgery often requires a pain pump for post-operative pain management. The pump is implanted into the shoulder joint during surgery and delivers a steady amount of medication to the surgery wound site. This is often a preferred alternative to narcotics and pain-killers, which can have negative side effects.

However, post-operative pain pumps recently have been associated with a painful condition known as Post-arthoscopic Glenohumeral Chondrolysis , or PAGCL, in which the cartilage in the shoulder joint break down, causing the bones to rub against each other. The damage can occur rapidly. PAGCL is believed to be irreversible and may require extensive surgeries.

The symptoms of PAGCL can begin to develop as early as two months after surgery up to a year following the procedure. Symptoms of PAGCL include decreased mobility and range of motion; constant pain both at rest and in motion; shoulder stiffness and/or weakness; and popping, clicking, grinding noise in the shoulder. Those who experience symptoms are encouraged to contact their physicans.

SOURCE: Pain Pumps › Shoulder surgery decision weighs on Rockies’ Jeff Francis

The study analyzed data from the 2005-2007 National High School Sports Injury Surveillance System and showed that shoulder injuries made up 18 percent of all injuries caused during both baseball and wrestling, and 12 percent of injuries caused during football. The report identified that shoulder injuries were three times more likely to occur during competition.

Overall, six percent of shoulder injuries required surgery. The sport that caused more surgeries to shoulders was wrestling. When shoulder surgeries are performed, they most often require the use of a pain pump to deliver medication directly to the surgical site for post operative pain management.

However, these post-operative pain pumps, also known as intra-articular pain pumps, can cause severe problems in some patients. Many patients who have used pain pumps have suffered from Postarthroscopic Glenohumeral Chondrolysis, (PAGCL) a painful condition that occurs in the shoulder when the cartilage between the ball and socket of the shoulder breaks down causing the bones to rub against each other.

Individuals who have used a pain pump to manage pain following shoulder surgery – or any other joint-related surgery – should consult their physician if they experience continued pain; weakness; clicking, popping or grinding; or decreased range of motion.

SOURCE: Pain Pumps › Study: Shoulder injuries happen more often to high school boys than girls

Once the pain pumps were removed, the officer continued to have stiffness, but only in her left shoulder. The continued stiffness and pain caused her to have two additional surgeries on her left shoulder, hoping these surgeries would be the end to her shoulder problems. But when the second surgery was performed, the doctors noticed that the articular cartilage in her shoulder was nearly gone. Even after the second surgery, her left shoulder was still stiff and still in pain.

A physical examination was given to the officer post surgeries to test the flexibility and rotation of her shoulders. The difference between the movement of the right and left shoulder was staggering. The right shoulder (the one in which the pain pump leaked) had 140 degrees of forward elevation, 60 degrees of external rotation and internal rotation of T12. The left shoulder was extremely stiff and only had a 30 degree arc of rotation and flexion/extension.  Even if you do not understand medical jargon, these numbers are quite different.

The officer was given multiple cortisone injections, five viscosupplementation injections, physical therapy and narcotics, all of which did nothing to alleviate her pain and stiffness.  With little hope of her left shoulder ever being the same, the officer is currently considering her options of what to do next.

The article from UW Medicine, a publication of the Univeristy of Washington School of Medicine, shows in this particular case how the right shoulder that did not receive the pain medication did not show any problems post surgery. However, the left shoulder that did receive the pain medication is left with little to no cartilage and stiffness that might not ever go away. With her symptoms, the officer may suffer from Postarthroscopic Glenohumeral Chondrolysis (PAGCL), an extremely painful condition involving the deterioration of cartilage in the shoulder joint.

PAGCL has been linked to numerous cases where pain pumps were inserted after shoulder surgeries and is the most common complication following should surgeries, according to The American Journal of Sports Medicine. Unfortunately, the only treatment for PAGCL is more surgeries, and they cannot be arthroscopic.

When and if you decide on shoulder surgery, know the risks and outcomes of using a pain pump. A small device used to alleviate pain post surgery may result in more surgeries and never-ending shoulder problems.

SOURCE: Pain Pumps › Pain pump malfunction saves officer’s right shoulder

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