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

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

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

This sort of story is happening to more and more young athletes due to the pain pumps used after shoulder surgeries. Shoulder problems are occurring in young athletes, causing them to look to surgery to relieve the pain and get back into the game. Little did they know that after the surgery, the pain pump used to alleviate their pain would leave them with permanent damage and little hope of returning to sports.

Since nothing can be done about past cases, the only thing to do is try to prevent shoulder injuries for young athletes in the future. Some of the sports that put pressure on the shoulder include swimming, baseball, softball and motorcross. No matter which sport, the steps to shoulder injury prevention are all the same.

First, using the proper technique is very important when throwing or using shoulder motions. When fatigue sets in, more strain is put on the shoulder causing problems to increase. Know the correct technique!

Next, flexibility of the shoulder is crucial. The rotator cuff muscles are dependent on good positioning of the scapula, which create the ability for the muscles to produce power. However, flexibility does not automatically mean stretching. Recent studies have shown that static stretching for flexibility should not be done prior to training. Static stretching is used to stretch muscles when the body is at rest. It is recommended that instead of static stretching, dynamic stretching is best for the shoulder. Dynamic stretching uses speed of movement, momentum and active muscular effort to bring about a stretch, according to Sports Fitness Advisor.

The next step to preventing shoulder injuries is core strength and stability. The important areas for the shoulder include the lumbar spine (lower back), cervical spine (neck) and the scapulothoracic joint (shoulder). If these areas are strained, it is passed onto the shoulder joint. It is crucial to strengthen and stabilize these areas.

The last step is muscle strength. Once the core is stabilized, it is important for the shoulder and arms to be strengthened. This can be done through weights or Thera-Bands.

Practicing these steps can help prevent shoulder problems that would eventually lead to surgery. Practice them. It’s worth it.

SOURCE: Pain Pumps › Steps to prevent shoulder injuries

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