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

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 has been eroded away, and the use of pain pumps during and following surgery. This type of chondrolysis, characterized by the complete loss of articular cartilage from the humeral head and glenoid, has been associated with intra-articular injection of dye, and with the post-arthroscopy infusion of local anesthetic into the joint.

Sixty-six cases of chondrolysis associated with shoulder arthroscopy followed by the intra-articular pain pumps with local anesthetic were identified among men and women between the ages of 15 and 57. Fifty-five of those patients had normal joint surfaces at the time of arthroscopy. All patients who suffered from chondrolysis suffered from pain and loss of motion that began between 91 to 1,650 days following surgery.

While pain pumps are approved by the Food and Drug Administration (FDA) to deliver pain medication into the shoulder tissue, they are not approved for use with the catheters placed directly in the joint space, as pain pump manufacturers had instructed surgeons. It is believed this non-approved practice led the anesthetic to erode the cartilage in the shoulder.

SOURCE: Pain Pumps › Surgeons discuss characteristics of chondrolysis caused by pain pumps

Jean-Thenistor Pascal

Pascal said he dislocated his right shoulder three times during the fight and had to have his shoulder popped back into place at least once by one of his cornermen. Despite having to box stretches almost entirely with his left hand, and looking hurt and worn down in the last few rounds, Pascal prevailed, earning a unanimous victory from the judges.

“I know I have a lot of guts,” Pascal said after the fight. “I knew it and now I really know it. When it happened the first time I told myself I was finished, but I couldn’t pull out in front of these fans. No way was I going to quit.”

Pascal’s surgery involved the removal of a bone chip and repair to the shoulder labrum, according to a statement released by promoter Groupe Yvon Michel. Pascal has been ordered to rest his shoulder for three weeks followed by five or six weeks of rehabilitation before he will be allowed to resume normal training. Pascal is scheduled to meet the WBC interim champion Chad Dawson in 120 days, but he may need to postpone that meeting until his shoulder recuperates.

Shoulder repair surgeries are about 85-95 percent successful. But some patients have had lingering problems, including the developing of a painful and debilitation condition known as chondrolysis. It wasn’t until after 2000 that doctors began to make a connection between a type of chondrolysis known as Postarthroscopic Glenohumeral Chondrolysis and the use of intra-articular pain pumps used in surgery. Details of that discovery were later published by The American Journal of Sports Medicine, and numerous lawsuits from those who suffer from chondrolysis have since filed suit against the makers of pain pumps.

Source: Montreal Gazette

SOURCE: Pain Pumps › WBC boxing champ undergoes 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

Intra-articular pain pumps

Intra-articular pain pumps are medical devices that hold pain medication. The devices have a tube with a catheter attached to them and that catheter is approved by the Food and Drug Administration (FDA) to be placed in the shoulder tissue for pain relief. The catheter is sort of like a garden hose with holes in it that you place in a flowerbed. Just as water would pass through the garden hose to water plants in the bed, medication is pumped through the catheter of the pain pumps into the shoulder tissue gradually over a 48- to 73-hour period. Once the pain medication has been completely used, the patient is instructed to simply pull the catheter out of his shoulder.

Before pain pumps became available for use, patients were given medication either orally or by injection and would have to be monitored by medical staff. The use of pain pumps allowed patients to go home earlier and require less medical attention post surgery. Used properly, risks associated with pain pumps are minimal and most patients have a relatively good recovery after physical therapy. But then tragedy struck.

“With advice from manufacturers, the pain pump catheters were being placed in the joint space or intra-articular area (as opposed to the joint tissue, as was approved by the FDA) which allowed the pain medication into the joint space,” says Frank Woodson, shareholder with Beasley Allen Law Firm. As a result, “doctors began to see patients suffer severe damage to their shoulder cartilage that we’ve rarely seen before.”

The condition, called chondrolysis, is the loss of cartilage in the joint space and causes extreme pain, loss of motion and in many cases, shoulder replacement. Those who relied on their shoulder strength, found themselves suffering from career-ending injuries.

Approximately 140 lawsuits against manufacturers of pain pumps are currently filed by individuals injured by those pumps. “As patients and physicians learn more about the link between pain pumps and chrondrolysis, I think you’ll see more people come forward,” Woodson says.

SOURCE: Pain Pumps › Pain pump manufacturers knowingly put patients at risk

The story focuses on the anesthetic and narcotics used in the devices, which rest outside the body with a catheter that feeds into the wound site. The pain pump allows medication to drip into the surgical area for up to 72 hours following surgery. While the pumps are effective for relieving pain, their use in shoulder surgery has recently come under fire after some patients reported suffering from a debilitating condition known as chondrolysis following use of the pain pumps.

The pain pumps were initially approved for use in shoulder surgery with the catheter implanted in the shoulder tissue, However, in the early 2000s, manufacturers of pain pumps began instructing surgeons to implant the catheters directly into the shoulder joint. The continuous dripping of medication slowly ate away at the cartilage in the shoulder joint, resulting in pain and limited mobility. In some cases, shoulder replacement surgery was required.

A study into the medications used in pain pumps showed that death rate of chondrocytes, or cells found only in the joints, increased with time. Some drug combinations offered worse results. The study’s authors advise caution when using the intra-articular pain pumps for more than 48 hours and to not use medications with epinephrine at all.

“There are still many things that remain unknown about this experiment,” the article says. “Do knee chondrocytes respond differently to these drugs than chondrocytes from the hip or shoulder?” The answers likely lie in more studies to determine the best use of intra-articular pain pumps.

SOURCE: Pain Pumps › Could pain pumps cause problems in knee surgery, too?

“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

Kansas City Royals

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

“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

Attorney Frank Woodson with Beasley Allen Law Firm along with attorneys with partnering firms filed two separate lawsuits on April 8, 2009, alleging that pain pump devices implanted in the shoulder during and after surgery to repair shoulder injuries were unreasonably and dangerously defective beyond the extent contemplated by ordinary patients.

Plaintiffs are Laura E. and Jeffrey K. Ashworth and Sheri L. and Wade S. Patrick, all residents of Maricopa County, Arizona.

According to the complaints, Ms. Ashworth underwent an initial arthroscopic surgery on her right shoulder on March 29, 2006 at the Arizona Orthopedic Surgical Hospital in Chandler, Arizona. At the end of the procedure, the surgeon inserted a pain pump in the subachromial space, or the space above the shoulder joint, and not directly into the intra-articular joint space. Less than three months later, on June 12, 2006, she re-injured her right shoulder and underwent a second arthroscopic surgery a the same facility. The orthopedic surgeon implanted the catheter of an “On-Q PainBuster” pain pump, manufactured and marketed by I-Flow Corporation, directly into the intra-articular space of her right shoulder. The device injected pain relief medication directly into the plaintiff’s shoulder joint on a continuous basis for up to 72 hours following surgery.

Ms. Patrick underwent arthroscopic shoulder surgery on September 2, 2004, at Scottsdale Healthcare Shea-Piper Surgery Center in Scottsdale, Arizona. At the end of surgery, an I-Flow “On-Q PainBuster” pain pump was implanted into her left shoulder by her orthopedic surgeon. As in Ms. Ashworth’s situation, Ms. Patrick received continuous pain relief medications injected into her pain pump for up to 72 hours or more following surgery. She underwent a second arthroscopic surgery on January 16, 2007 at the Metro Surgery Center in Phoenix, Arizona and received another “On-Q PainBuster” pain pump on her left shoulder and, once again, received the continuous injections of pain killers through the device.

While the pain pumps are designed and intended to be used with commonly used anesthetics, the continuous injection into the shoulder joint of those medications at the doses prescribed over time can cause serious and permanent damage to the cartilage of the shoulder joint.

As a result of both Ms. Ashworth’s and Ms. Patrick’s pain pumps, which delivered dangerous doses of continuously injected medication into their shoulders, both women suffered narrowing of the joint space and/or 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 intra-articular pain pumps as the likely cause of chondrolysis.

The lawsuits allege that defendant I-Flow did not warn the plaintiffs or their surgeons, who used the devices as instructed and directed by the defendant, about the unreasonable risks and dangers of using the pain pump and anesthetic medications in this manner.

Read the Ashworth complaint.

Read the Patrick complaint.

SOURCE: Pain Pumps › Women sue pain pump manufacturer for dangerously defective device

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

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

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