One of the complainants, Glen Gore, says a Stryker pain pump was implanted in his shoulder after repair surgery in December 2002. After using the pain pump, he was had lost almost all of the cartilage in his shoulder joint, is unable to raise his arm above shoulder level, and now needs replacement surgery.

Gore is among hundreds of patients who are suing the manufacturer of the pain pumps used in shoulder surgery after the pain pumps caused serious and likely permanent injury to their shoulders. The problem dates back to the early 2000s, when pain pump manufacturers began instructing doctors to place the catheter of the pain pump directly into the shoulder joint. The Food and Drug Administration (FDA) had previously approved its use with the catheter placed in the shoulder tissue but had rejected the manufacturers’ request to have the alternative catheter placement approved, citing the need for studies to ensure the safety.

Placed in the shoulder joint, the catheter dripped medicine that began eating away at the cartilage. Doctors soon began to make the connection between the pain pumps and a condition known as chondrolysis, or specifically Postarthroscopic Glenohumeral Chondrolysis. As a result, pain pump manufacturers like Stryker are facing numerous lawsuits from individuals who have been irreversibly harmed by their product.

Source: Boston.com

SOURCE: Pain Pumps › More lawsuits filed against maker of shoulder pain pumps

The labrum is a cartilage found in the shoulder’s ball-and-socket joint where the arm meets the body. It serves to deepen the socket so that the ball stays in place and helps stabilize the arm. When the labrum is torn due to injury, the ball may slide part or all of the way out of the socket. Symptoms of a labral tear depend on where the tear is located, and may include an aching sensation in the shoulder joint, catching of the shoulder when moved, and pain during physical activity.

Treatment for a torn labrum depends on the type of tear. They often do not require surgery; however, patients with persistent symptoms that do not respond to other therapies may need surgery. Recovery from surgery usually depends on where the tear occurred and how severe the tear was. Typically, it takes four to six weeks for the labrum to re-attach itself to the rim of the bone and another four to six weeks to strengthen and fully heal.

A majority of patients regain full functioning of their shoulder after labrum repair, but that was not always the case. Just a few years ago orthopedic surgeons began seeing more and more patients suffering from a painful and debilitating condition known as chondrolysis in patients who had had shoulder surgery. The condition was traced back to pain pumps used to deliver medication to the shoulder joint for up to 72 hours after surgery.

An investigation found that pain pump manufacturers were advising doctors to insert the pump catheters directly into the shoulder joint rather than the tissue, as was approved by the Food and Drug Administration (FDA). As a result, more than 140 lawsuits have been filed in state and federal court against manufacturers of pain pump devices.

Source: Johns Hopkins Medicine

SOURCE: Pain Pumps › Recovery more likely after shoulder surgery than in years past

The company’s Regional Anesthesia sales, which includes the company’s flagship On-Q product lines, also increased 9 percent during the same quarter, according to the report.

There are approximately 140 lawsuits against manufacturers of pain pumps, including I-Flow Corporation, currently pending in state and federal courts throughout the country, says Frank Woodson, shareholder with Beasley Allen Law Firm. That number has jumped considerably since the summer of 2008, as more and more evidence began to link pain pumps to a serious and debilitating shoulder injury known as chondrolysis.

Pain pumps are commonly used by surgeons when performing shoulder surgeries. The pump, which sits outside the body but is attached to a catheter that is implanted into the surgical site, delivers medication for up to 72 hours. Once all the medication has been injected, the catheter is gently pulled out by the patient.

Pain pump manufacturers were given Food and Drug Administration (FDA) approval to market the devices with the catheter in the shoulder tissue. In early 2000, manufacturers sought to have FDA approval to put the catheters directly into the shoulder joint but the FDA rejected the request. However, pain pump manufacturers went ahead and instructed physicians to implant the catheter in the shoulder joint. The medicine that dripped into the shoulder joint area ate away the cartilage in the shoulder joint causing the painful and debilitating condition known as chondrolysis. There is no cure for the condition and in some cases, more surgery may be required.

SOURCE: Pain Pumps › Pain pump manufacturer enjoys gains despite mounting lawsuits

Mathew McKeown

But during a game in October 2006, McKeown’s left shoulder was injured while trying to recover a fumble. Doctors implanted the catheter of a On-Q PainBuster pain pump manufactured by I-Flow into his shoulder joint. For up to 72 hours, medication gradually dripped into his shoulder and slowly began eating away at the cartilage.

But McKeown was tough. He rehabbed quickly and bulked up to 300 pounds. He lead the team in weightlifting statistics, bench pressing a maximum of 460 pounds. His chances at making to the NFL one day seemed promising.

Even as he worked out, he ignored the burning pain in his shoulder, refusing to admit to anyone how badly it hurt. And then he injured his shoulder again. Once again, he was put on an I-Flow pain pump that dripped medication into his shoulder joint. A follow up MRI revealed a horrible mess. The promising athlete’s shoulder cartilage had been worn down so badly that repairing it was impossible. McKeown’s hopes for a professional football career were ruined.

McKeown is now suing I-Flow, the manufacturer of the pain pump, after he and his doctor learned that a 2006 study had revealed that by inserting the pain pump’s catheter in McKeown’s shoulder joint instead of the muscle tissue, the medicine essentially destroyed his shoulder. The Food and Drug Administration (FDA) had granted approval to have the pain pump’s catheters inserted into the muscle tissue, but denied manufacturers’ request to instruct surgeons to place the catheters in the shoulder joint. As a result, countless patients have suffered similar fates as McKeown.

Source:
Cincinnati.com

SOURCE: Pain Pumps › Athlete’s hopes of playing pro ball dashed by shoulder pain pump

“I think what we’re seeing is that physicians are finally seeing the relationship between pain pumps and chondrolysis – especially since the first lawsuits were filed a couple years ago,” he says. “In addition, literature is now being published about the connection between the pumps and chondrolysis. So, the more information that becomes available, the more people are learning what may be causing their shoulder problems.”

The problem traces back to about the year 2000, when pain pump manufacturers began advising physicians to place the device’s catheter into the joint space, or intra-articular area. The catheters were intended and approved by the Food and Drug Administration (FDA) to be placed into the shoulder tissue, and not the joint space. As a result, medicine was feeding directly into the joint space causing the cartilage to gradually wear away. This narrowing of the cartilage, called chondrolysis, causes severe pain and disability. There is no cure for the condition and many individuals are faced with lifelong disability as a result.

Recently, a study published by The American Journal of Sports Medicine identified intra-articular pain pumps as the likely cause of chondrolysis.

“People who had surgery seven or eight years ago who thought they had recovered are now seeing that they’re losing their cartilage and they don’t know why,” Woodson says, adding that several cases are set for trial in 2009. “I think that you’re going to see juries return verdicts against these defendants and then others will start to file lawsuits as well.”

SOURCE: Pain Pumps › More lawsuits filed as link made between pain pumps, chondrolysis

The On-Q PainBuster pain pump offers an alternative to traditional intravenous and oral painkillers, which can leave patients feeling groggy. The pain pump uses a small balloon that holds a local anesthetic that is fed through a thin antimicrobial catheter that is inserted into the surgical site. The device injects the pain relief medication directly to the surgical site on a continuous basis for up to 72 hours following surgery. Following surgery, the patient goes home with the implanted device and after two or three days, the patient gently pushes out the catheter and discards the device.

Doctors who have used the pain pumps for hysterectomies and C-sections say the device helps women get up and about faster than using more traditional pain meds.

The I-Flow On Q PainBuster pain pumps have been a popular choice for orthopedic surgeons performing knee and shoulder surgeries. The pain pumps are designed and intended to be used with anesthetics that are administered continuously over time.

However, in shoulder surgeries in particular, the medication delivered directly to the surgery site has caused serious and permanent damage to the cartilage of the shoulder joint. This narrowing of the joint space is known as chondrolysis, a condition in which the complete or nearly complete loss of cartilage in the shoulder joint. Chondrolysis is an irreversible disabling and extremely painful condition.

A recent study published by The American Journal of Sports Medicine identified these intra-articular pain pumps as the likely cause of chondrolysis in shoulders.

There do not appear to be any reported problems with pain pump use following C-sections and hysterectomies at this time.

SOURCE: Pain Pumps › Pain pumps used following C-sections, hysterectomies

Astros

“It gives me a little peace of mind to go get (the surgery),” Hall told the Chronicle. “Seeing the MRI and seeing what I’ve been dealing with the last couple of years, it kind of puts me at ease to go get it fixed. That way I can get back out there (as) the player that I used to be and be healthy (and) go out there with two labrums.”

The labrum is located in the ball-and-socket joint of the shoulder. Since the shoulder socket is very shallow, a cuff of cartilage called the labrum allows the arm bone to move within the shoulder socket, giving it more stability and range of motion. The labrum, however, is susceptible to injury. Most labrum tears do not require surgery, but patients with persistent symptoms after trying other treatments unsuccessfully may need surgery to correct the problem.

Shoulder surgery often requires the use of pain pumps for post-operative pain management. The pain pump is implanted into the shoulder joint during surgery and delivers a steady amount of medication to the wound site.

A recent study published in The American Journal of Sports Medicine identified post operative pain pumps, or intra-articular pain pumps, as a likely cause of Postarthroscopic Glenohumeral Chondrolysis, a debilitating condition in which the cartilage in the shoulder joint breaks down, causing the bones in the shoulder to rub together. The condition can cause chronic pain and can limit mobility. Additional surgeries may be required.

The Astros will void Hall’s minor-league contract, as he will be out at least four months for surgery as opposed to just one month if he had tried rehab without surgery.

SOURCE: Pain Pumps › Astros Toby Hall opts for shoulder surgery to correct torn labrum

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

Post-operative pain pumps are a pain-management system that deliver medication directly to the surgical wound. The pumps came under fire recently after The American Journal of Sports Medicine linked intra-articular (or post-operative) pain pumps to cases of Postarthroscopic Glenohumeral Chondrolysis, a progressive degeneration of the cartilage in the shoulder resulting in pain and loss of motion. Chondrolysis is a chronic condition that often requires surgery.

Until the 1990s, the pumps delivered medication at a limited flow rate. In the late 1990s, manufacturers increased the amount of anesthetic used in the pain pumps. The lawsuit contends that continuous injection of the high-volume anesthetics into the shoulder can cause serious and permanent damage to the joint cartilage in the shoulder. The lawsuit also claims the pumps were marketed without first doing studies to determine the safety of the high-volume pain pumps or what damage could have occurred, instead encouraging use of both the pain pumps with the high doses of anesthetics.

“The plaintiffs are demanding compensatory damages for fraudulent misrepresentation, negligent misrepresentation negligence, strict liability, and breach of warranty,” according to the report.

SOURCE: Pain Pumps › Pain pump manufacturers named in lawsuit

Postoperative pain pumps are a pain-management system designed to deliver medication directly to the surgical wound or in close proximity to the nerves associated with the surgical area. A recent study published by The American Journal of Sports Medicine identified the post-operative pain pumps as the likely cause of articular chondrolysis, a progressive degeneration of the cartilage. Chondrolysis of the shoulder results in the narrowing of the joint space, which can cause pain and loss of motion. Chondrolysis is a chronic condition that often requires surgery.

As of July 2008, Health Canada had received eight reports of articular chondrolysis one month to one year following shoulder surgery. In all cases, the chondrolysis was thought to have been related to pain pumps. All patients listed in the incidence reports received bupivacaine, a local anesthetic, with epinephrine, a hormone and neurotransmitter.

Instructions for use on the label of the postoperative pain pumps discourages continuous intra-articular infusion of anesthetics, particularly when epinephrine is used.

In its announcement, Canada Health also urged health care professionals to report any adverse incidents following the use of pain pumps or other medical devices to the Health Products and Food Branch Inspectorate through the Inspectorate Hotline at 800-267-9675.

SOURCE: Pain Pumps › Health Canada issues warning about postoperative pain pumps

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

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

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