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

It is not known whether the drugs or the device is causing the chondrolysis, or if it is a combination of several factors. However, reports of the debilitating shoulder condition have skyrocketed in the past few years since pain pump devices were used in this fashion.

Chondrolysis is a serious condition that causes pain and loss of motion. Some patients may require joint replacement surgery. Many of the patients who have developed chondrolysis following shoulder repair surgery were adolescents or young adults.

In the patient safety announcement, the FDA is reminding health care professionals that use of local anesthetics in pain pump devices is not an approved use, and the FDA is requiring makers of local anesthetics to update the labeling of these drugs to include a warning of the risk of chondrolysis. Similar warnings will also be placed on pain pump devices.

Source: FDA Patient Safety Notice

SOURCE: Pain Pumps › FDA issues warning about local anesthetics, pain pumps

UCLA

Shoulder injuries among athletes is not uncommon and can bench a player for weeks or months. There was a time when such injuries that required surgery brought about career-ending fears, but technology over the years has made full recovery a more likely possibility. However, just a few years ago, surgery to repair the shoulder often was the cause of more serious injury.

A recent study published in The American Journal of Sports Medicine first brought to light the connection between chondrolysis, a condition in which the cartilage in the shoulder has been eroded away, and the use of pain pump devices during and following arthroscopic shoulder surgery. Pain pumps are balloon-like devices that hold local anesthetics. During surgery catheters that lead from the balloon area of the device are inserted into the surgical site. Pain medication is then administered for up to 72 hours following surgery. Once the medication has been used up, the patient simply pulls out the catheter.

Pain pumps are approved by the FDA with the catheter placed in the shoulder tissue. However, in the late 1990s, pain pump manufacturers began instructing surgeons to insert the catheter directly into the shoulder joint, allowing the medication to drip directly onto the cartilage, a use that was not FDA approved.

In the early 2000s, doctors became puzzled when more and more patients who had surgery to repair shoulder injuries – and who showed no signs of cartilage wear at the time of surgery – were suffering from pain and loss of motion, and were ultimately diagnosed with chondrolysis. It didn’t take long for doctors to make the connection between the debilitating chondrolysis and the use of pain pump devices.

Since the connection was made, the FDA and professional groups have instructed surgeons of the correct, FDA-approved use of shoulder pain pumps, making the surgery safer for patients. Meanwhile, the lawsuits against pain pump manufacturers are mounting.

SOURCE: Pain Pumps › UCLA’s Keefe benched due to shoulder injury, but recovery likely

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

On Friday, the FDA notified health care professionals of 35 reports of chondrolysis in patients who received regular infusions of the anesthetics for up to 72 hours following surgery. In the reported cases, the anesthetics were used with pain pump devices in which the medication was fed through a catheter that was placed directly into the joint space. The catheter was attached to a balloon that rested outside the body and was filled with the anesthetics.

These pain pump devices, often used with shoulder surgery, were approved by the FDA with the catheter placed in the shoulder tissue, not the joint space. But in the early 2000s, pain pump manufacturers began advising doctors to place the catheters directly into the joint space even though that use was not approved by the FDA. The constant drip of medication into the joint caused the serious breakdown of cartilage known as chondrolysis. Currently, patients who have been injured by the pain pump devices have filed suit against the manufacturers of pain pumps.

The anesthetics listed in the FDA notice include bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine. These anesthetics are approved as injections for the production of local or regional anesthesia or analgesia. The approved drug labels for local anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as elastomeric pumps. The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics.

The FDA is encouraging healthcare professionals to follow the instructions for use of elastomeric infusion devices, and to not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery.

SOURCE: Pain Pumps › FDA warns of chondrolysis risk with unapproved use of local anesthetics

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

Oklahoma Sooner

Bradford wowed Sooners fans with his talent and his humility. Following last season’s successes, Bradford turned down what many expected would be millions of dollars from the NFL and opted instead to stick with his college team for another year. However, during the first game of the season against Brigham Young University, Bradford suffered a shoulder sprain. He missed three more games before aggravating the shoulder injury more in a loss to Texas. His decision to have the season-ending shoulder surgery prompted questions from media about whether he regretted his decision not to go pro last year.

“No. Absolutely 100 percent no regrets,” he said at a press conference announcing his decision. He later elaborated about his decision to stay: “Considering this is where I grew up and this is where I dreamed about playing, to put this in the past is extremely tough. I’ve been blessed to be here. The past 3 1/2 years have been 3 1/2 of the best years of my life. I wouldn’t trade a day of it.”

Shoulder surgery will put Bradford in a difficult situation with the NFL, as he will have to convince recruiters that he can make a full recovery. As of now, Bradford has until mid-January to declare for the draft.

Source: Tulsa World

SOURCE: Pain Pumps › Bradford to undergo season-ending shoulder surgery

But Smith’s doctor, Bryan Wall, an orthopedic surgeon at the Core Institute of Phoenix, Ariz., wasn’t giving up. He suggested Smith have a new procedure, a reverse shoulder replacement. Approved by the Food and Drug Administration (FDA) in 2004, the procedure offers relief to some patients who suffer long-term rotator cuff tears with arthritis. During the procedure, surgeons place an implant in the shoulder that is designed so that the ball portion of the shoulder is attached directly to the shoulder blade. The socket is then placed at the upper end of the arm bone. The procedure essentially reverses the anatomy of the shoulder.

“What it does is it allows us to not only replace the joint that has become arthritic, but it puts the shoulder in a better mechanical position and changes the mechanics of the shoulder to allow people to elevate their arm,” Dr. Wall explained.

The result was life-changing for Smith, who said he no longer has pain in his right arm and is able to get on with an active retirement. However, Dr. Wall warns, the procedure is not recommended for all patients. The best recipients are older patients who are less likely to put extreme stress on the shoulder joint.

SOURCE: Pain Pumps › New procedure may prove effective for some shoulder injuries

Lawsuits

Pain pump manufacturers, such as I-Flow, Don Joy, Stryker, Moog, and Breg, to name a few, dismiss the claims that their products have caused numerous people harm. But by 2006, physicians and scientists clearly began to see the connection between the shoulder pain pumps and chondrolysis.

At issue was the placement of the pain pump’s catheter directly into the joint space, a use that was promoted by the devices’ manufacturers but not approved by the Food and Drug Administration (FDA). The constant and steady dripping of anesthetic drugs such as Marcaine, bupivacaine and ropivacaine into the shoulder joint for up to 72 hours after surgery gradually ate away at the cartilage. In most cases, it was months or years before patients began experiencing the serious symptoms of chondrolysis.

There is no cure for chondrolysis, and in some cases shoulder replacement surgery is required. Yet pain pump manufacturers say they are not liable despite aggressively promoting the devices for joint surgeries of the shoulder as well as the knee, ankle and foot.

No lawsuits have yet gone to verdict. Some have reached confidential settlements. But plaintiff victims are focused on 2010 as the year when justice is served.

SOURCE: Pain Pumps › Pain pump victims seek justice against manufacturers

The pain pumps eliminate the need for narcotics and costly hospital stays, and revolutionized pain management for procedures such as shoulder surgery. However, pain pumps didn’t always prove to be the best solution.

The pain pumps were first approved by the Food and Drug Administration (FDA) with the catheters feeding into the shoulder tissue. However, in the 1990s, the manufacturers of pain pumps asked the FDA to approve an alternative use – placing the catheters directly into the shoulder joint. The FDA required more testing before it would approve such a use. Rather than following proper protocol and running tests on the alternative use, the device manufacturers began advising surgeons to place the catheters in the shoulder joint.

Months and years later, doctors began noticing patients who had had shoulder surgery were beginning to suffer from a serious and debilitating condition known as chondrolysis in which the cartilage in the joint is worn away. Those doctors began to make the connection between patients with chondrolysis and the alternative use of the pain pumps.

Today, manufacturers of pain pumps are facing hundreds of lawsuits from people who have been injured by the devices. If you or a loved one has had shoulder surgery and now suffer from pain, weakness in the shoulder, decreased range of motion in the shoulder, or weakness in the shoulder, you may have a claim against the manufacturer.

Source: WCTV-TV

SOURCE: Pain Pumps › Shoulder pain pump makers face numerous lawsuits

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?

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 culprit was not the surgery itself but the device used to deliver pain medication to the wound site. Used properly, as approved by the Food and Drug Administration (FDA), the pain pumps were hardly dangerous. But pain pump manufacturers began advising surgeons to use the pain pumps differently, by inserting the catheter directly into the shoulder joint space. Over time, the pain medication was toxic to the cartilage, resulting in chondrolysis.

In 2008, a petition was filed for a multidistrict litigation (MDL) to consolidated the lawsuits pending against the manufacturers of pain pumps. MDLs help coordinate the litigation that is pending in federal courts across the country involving the same allegations or same parties. The Judicial Panel on Multidistrict Litigation decides whether cases should be consolidated under MDL and where to transfer the cases. The judicial panel denied the initial petition requesting an MDL. Many more lawsuits have been filed in federal courts across the country and the panel may revisit its initial decision.

“Denial of the MDL  may be a good thing for patients and consumers because there are already cases that are going to trial,” Woodson says. Several of those cases were settled right before or after the opening statement and others were resolved on a confidential basis in early 2009.

“These are substantial injury cases. This is a very severe injury that should not have occurred,” Woodson says. “Most of these people did not know what occurred to them until they started seeing advertisements from lawyers for these cases. So, that’s the first time that they had any inkling in their mind that there could have been a connection between the use of a pain pump and what’s ultimately happened to their shoulder.

“I’d advise (individuals who believe they may have been injured by the pain pump) that people  see an attorney as soon as possible. ”

SOURCE: Pain Pumps › Pain pump makers may be liable for injury after shoulder surgery

“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

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

Labrum repair surgery requires months to heal because the fibrocartilage has a poor blood supply. During surgery, the labrum is stitched together and anchored to the bone. It generally takes about six months for the tissue to heal. Typically, surgeons perform authroscopic surgery to repair shoulder injuries in patients and often use pain pumps to help alleviate pain for up to 72 hours following surgery. Pain pumps offer an alternative to narcotics and pain killers; however, misinformation about how the pain pumps should be used provided by pain pump manufacturers years ago have resulted in debilitating – and for some athletes, career-ending – injury to the shoulder joint.

The injuries stem from a change in the way pain pump manufacturers began to market the devices to surgeons, according to Frank Woodson, shareholder for Beasley Allen Law Firm. When the pain pumps were originally approved by the Food and Drug Administration (FDA), the pump’s catheter was to be placed in the shoulder tissue. However, in the 1990s and early 2000s, pain pump manufacturers began advising surgeons to place the pain pump catheters in the joint space, or intra-articular area, allowing pain medication to go directly into the joint space. This use had not been approved by the FDA. Shortly after the pumps were used in the inappropriate manner, per the advice of the pain pump manufacturers, “doctors began to see patients suffer severe damage to their shoulder cartilage that we’ve rarely seen before,” Woodson said.

What resulted was the loss of cartilage, or joint space, commonly called chondrolysis. It leads to severe pain because the cartilage in the shoulder space is gone, causing bones to rub together. As the condition progresses, patients may require shoulder replacement and it makes normal daily activities painful and difficult.

There are approximately 140 lawsuits filed by people who have been injured by misuse of these pain pumps. All are pending in state and federal courts throughout the country. “There are many more cases under review across the country and there will likely be many more filed,” Woodson said. “As patients and physicians learn more about the link between pain pumps and chrondrolysis, I think you’ll see many more people come forward.”

Source: Google: AFP

SOURCE: Pain Pumps › Magic’s Nelson plays just months after shoulder surgery

The nine are among a growing number of lawsuits filed against the makers of shoulder pain pumps that were used in patients following shoulder surgery. The devices have a catheter that is implanted into the surgical site and delivers regular does of anesthetics to the wound for up to 72 hours. Doctors soon began to see a connection between the use of the devices and a painful and debilitating condition known as chondrolysis.

The pain pumps were approved by the Food and Drug Administration (FDA) with the catheters placed in the shoulder tissue, but in the 1990s pain pump manufacturers sought approval from the FDA to have the catheters placed directly in the shoulder joint.

“To the FDA’s credit, they said no,” says Frank Woodson, shareholder with Beasley Allen Law Firm. “The FDA said, ‘If you want permission to do that, you’re going to have to do safety studies to determine whether or not that is a safe practice or a safe method to use your product.’ The companies did not do that and just went ahead and started advising physicians to place the pain pump catheter in the joint space.”

When the catheters were placed in the shoulder joint instead of the tissue, the medication began to eat away at the cartilage in the joint, causing the painful condition known as chondrolysis.

As a result, more than 140 lawsuits have been filed in state and federal courts against manufacturers of pain pump devices. “I hope this litigation will continue to educate the medical community to use pain pumps in a proper manner because if it is done in that way, then we should stop seeing these injuries occur,” Woodson said.

SOURCE: Pain Pumps › Lawsuits seek more than $68 million from pain pump manufacturers

Zone maintains that the cover of I-Flow’s On-Q pain pump contains holes that allow latex to come in contact with patients and health care professionals. The company contends that individuals who come in contact with the pump and suffer a latex reaction may not be properly treated based on the assumption that the I-Flow product does not pose a latex risk. Zone is the worldwide distributor for the Solace pain pump, which has a latex-free design.

I-Flow may want to take a closer look at patient safety. The company is one of several pain pump manufacturers – a list that also includes Stryker Corporation, DJ Orthopedics Inc., and Breg Inc. – facing lawsuits from plaintiffs that allege the pumps have caused lifelong and painfully debilitating shoulder injury. Lawsuits contend that manufacturers of pain pumps instructed physicians to use the pumps in a manner that was not approved by the FDA for shoulder surgery.

Instead of implanting the catheter of the pain pumps into the shoulder tissue as was FDA approved, surgeons were instructed to place the catheters into the shoulder joint area. Doing so allowed medication to drip into the shoulder joint and essentially eat away the cartilage, causing bone to rub against bone and resulting in a serious, irreversible condition known as chondrolysis.

Source: PR Web

SOURCE: Pain Pumps › I-Flow pain pump manufacturers face more lawsuits

Pain pumps are devices that hold pain medication that is gradually released into the shoulder tissue through a catheter implanted in the surgical site. Once the pain medication has been released into the joint, the catheter is removed by the patient. When used properly, pain pumps offer a convenient alternative to oral or intravenous painkillers for those undergoing shoulder surgery. And most patients can expect a good recovery following physical therapy.

However, in the late 1990s manufacturers of pain pumps sought FDA approval to have the catheters placed directly in the joint area, rather than the shoulder tissue. “To the FDA’s credit, they said no,” says Frank Woodson, shareholder with Beasley Allen Law Firm. “The FDA said, ‘If you want permission to do that, you’re going to have to do safety studies to determine whether or not that is a safe practice or a safe method to use your product.’ The companies did not do that and just went ahead and started advising physicians to place the pain pump catheter in the joint space.

“They never studied it and they never obtained FDA approval,” he says. As a result, physicians began seeing their patients with a debilitating condition called chondrolysis, or a narrowing of the cartilage. As the cartilage begins to wear away, bone rubs against bone causing pain and disability. In many cases, shoulder replacement is required.

Approximately 140 lawsuits have been filed in state and federal courts against manufacturers of pain pump devices and several cases are set for trial in 2009. “I hope this litigation will continue to educate the medical community to use pain pumps in a proper manner because if it is done in that way, then we should stop seeing these injuries occur,” Woodson said.

SOURCE: Pain Pumps › FDA told pain pump manufacturers ‘no,’ but they refused to listen

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

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

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

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

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