Pain pumps

Pain pumps, also known as infusion pumps, are devices that feed a steady flow of anesthetic into the surgical space following surgery. The devices fell under strict review by the Food and Drug Administration (FDA) after numerous reports of chondrolysis were reported in patients who had used the pumps, leading the agency to launch the Infusion Pump Improvement Initiative to address infusion pump safety problems.

Chondrolysis is a condition in which the cartilage in the joint space wears away causing bone to rub against bone. It causes severe pain and loss of motion. There is no cure for chondrolysis other than total shoulder replacement.

While the pumps may be beneficial in surgeries such as “tummy tuck” procedures, they have been proven unsafe for shoulder surgeries and in fact were never even approved by the FDA to be used in that manner. But that didn’t stop pain pump manufacturers from instructing surgeons to use the pumps in shoulder surgeries. As a result, hundreds of chondrolysis sufferers have filed lawsuits against pain pump manufacturers claiming they were not adequately warned of the risk of developing chondrolysis.

SOURCE: Pain Pumps › Pain pumps cause problems for shoulder surgery patients

But beginning in the 1990s, orthopedic surgeons began seeing more and more patients who were complaining of limited range of mobility, pain and stiffness in their shoulder. Tests showed the cartilage was beginning to or had completely worn away causing bone to rub against bone, also known as chondrolysis. Doctors were baffled.

What they soon discovered is that all the patients who were developing or had developed chondrolysis had had shoulder surgery during which a pain pump was used to deliver anesthetics for 48 to 72 hours following surgery. The pain pumps were a new offering for surgeons who previously prescribed IV or oral painkillers to patients to help deaden the pain of shoulder surgery.

Pain pumps are balloon-like devices filled with anesthetic that rests outside the body. The anesthetic is administered directly into the joint space through a catheter, which is removed after the medication has been used. Pain pump manufacturers were quick to promote this new use of pain pumps to doctors in the 1990s even though the use was never approved by the Food and Drug Administration (FDA).

What doctors didn’t realize at the time is that the pain pumps, which dripped medicine directly into the joint space, were causing the cartilage in the shoulder to wear away. Doctors soon made the connection between pain pumps and shoulder chondrolysis. Last year, after studies on shoulder chondrolysis had been published in several medical journals, the FDA issued a warning to doctors informing them that pain pumps should not be used during shoulder surgery and that this use has never been approved by the agency.

SOURCE: Pain Pumps › What is Chondrolysis of the shoulder?

Shoulder surgeries among professional baseball players are about as common as foul balls but they don’t always end careers. Zaun injured his shoulder in April when he collided on a plate, but opted to play through the pain. Last month in Pittsburgh, Zaun aggravated the injury while batting. The surgery will repair a torn labrum.

Labrum repair surgeries are not uncommon and can often return players to the field after rehabilitation. But not all patients have been as lucky. Last Fall, the Food and Drug Administration (FDA) issued a warning to health care professionals that during such surgeries, pain pumps should not be used.

Pain pumps are balloon-like devices that are filled with anesthetics and rest outside the body. In many instances, a catheter is placed inside the cartilage at the surgical site, where it drips medication for up to 72 hours. This use has never been approved by the FDA, but pain pump manufacturers instructed surgeons to use them in this manner. As a result, numerous people who had shoulder repair surgeries began complaining of stiffness, a decreased range of motion, and pain. Doctors found that the cartilage in these patients’ shoulders had worn away, causing bone to rub against bone. This painful, debilitating and irreversible condition is known as chondrolysis.

Source: The Canadian Press

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

“We certainly knew that it was a possibility. We went through the rehab process in a very methodical way to give us the best chance to get him back on the mound, and it didn’t work,” executive vice president of baseball operations Andrew Friedman told USA Today. ”But in the meantime, we strengthened up the shoulder through the rehab process, which we feel like will aid in the recovery. And by all indications, (the surgery) went really well.” Howell is expected to recover in time to play during the 2011 season.

For some, however, shoulder surgery can exacerbate the injury. In the late 1990s, surgeons were told by the manufacturers of pain pumps that the devices could be used effectively in place of oral or IV painkillers. This reduced hospital stays and was to speed up the recovery process. However, doctors began seeing patients who underwent shoulder surgery but then developed a painful and debilitating condition known as chondrolysis in which the cartilage in the shoulder wears away causing bone to rub against bone.

It didn’t take long for doctors to realize that it was the pain pumps that were causing the chondrolysis. What was even more shocking is that the use of pain pumps in the manner in which pain pump manufacturers were telling doctors to do was never approved by the Food and Drug Administration (FDA). Last year, the FDA issued a notice to health care providers informing them that the pain pumps should not be used in shoulder surgery and that the use has never been approved.

SOURCE: Pain Pumps › Tampa Bay Rays’ Howell undergoes season-ending shoulder surgery

Shoulder chondrolysis is a condition that more and more people who have had previous shoulder repair surgery have been diagnosed with. It was the surgeons who first realized that what caused these patients to develop the serious shoulder ailment was the pain pump device used during and after surgery to deaden pain in the shoulder joint. Doctors later learned that pain pump manufacturers were instructing surgeons to use the devices in a manner that was not approved by the Food and Drug Administration (FDA). Unfortunately, there is no cure for chondrolysis and many patients who suffer from the condition must undergo shoulder replacement surgery.

For Justin, relief came in November 2008, when he had a humeral head transplant. The surgery was performed by Dr. Brian Cole with The Cartilage Restoration Center at Rush. Since then, Justin’s right arm mobility has been restored and he is back to living an active lifestyle.

Source: Life Active with Rush

SOURCE: Pain Pumps › Chondrolysis sufferer finds relief with humeral head transplant

Chondrolysis occurs when the cartilage in the shoulder joint wears away causing bone to rub against bone. The onset of symptoms, which includes joint pain, stiffness and loss of motion, can vary but may begin as early as the second month following surgery. There is no effective treatment for chondrolysis, and many patients who suffer from the condition require total shoulder replacement therapy.

The local anesthetics that now carry the warning include Carbocaine (Mepivacaine HCl), Marcaine (bupivacaine HCl), Naropin (ropivacaine HCl), Nesacaine (chloroprocaine HCl), Nesacaine-MPF (chloroprocaine HCl), and Xylocaine (lidocaine HCl).

The manufacturers of pain pump devices that hold the local anesthetics and infuse them into the joint space are also facing criticism for instructing surgeons to use the pain pumps to deaden pain following shoulder surgery, a use that was not approved by the FDA.

SOURCE: Pain Pumps › Local anesthetics add warning to label; risk of chondrolysis

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

Since 2005, Dr. Bailie says he has seen dozens of patients come to him months after surgery with worsening pain and limited mobility. The diagnosis was chondrolysis, a condition in which the cartilage in the shoulder joint wears away leaving bone to rub against bone. There is no cure for chondrolysis and in some cases, total shoulder replacement is required.

But what could be causing his patients’ shoulders to worsen? Several studies began pointing to the same likely culprit – the pain pump device used during and after surgery to deliver medication into the joint space. As the anesthetic dripped onto the cartilage, the cartilage began wearing away over the course of weeks or months, sometimes longer.

Doctors soon realized that the way pain pump manufacturers were instructing them to use the devices was never approved by the Food and Drug Administration (FDA). In fact, the FDA had rejected the use on more than one occasion, saying more tests needed to be conducted to determine the safety of such use.

Now hundreds of patients injured by the pain pumps are suing manufacturers of the pain pumps, insisting the companies should have done more to warn surgeons of the potential risks. Lawyers say the manufacturers disregarded patient safety in an effort to bolster sales, but pain pump manufacturers argue more research is needed to determine if the cases of chondrolysis were actually caused by pain pump use.

SOURCE: Pain Pumps › Doctor ‘lost sleep’ over chondrolysis in patients

The condition caused Moore pain and limited mobility in her shoulder, and left her little choice but to close her business. She even has to asks friends to do small chores for her, like cut the crust of a piece of pie. “Until this injury, I was in pretty prime physical condition,” Moore told the New York Times. “It’s a whole flip of my world.”

Moore is one of hundreds of victims of what a handful of studies say is a condition caused by the use of pain pumps. The devices look like balloons that are filled with anesthetic that sit outside the body. Attached to the pump are catheters that are placed in the wound site during surgery to drip painkillers in the shoulder during and after surgery. After 48-72 hours, the medication runs out and the patient simply pulls the catheter out.

Doctors were advised by pain pump manufacturers to place the catheters directly into the joint space, but what doctors later learned is that that use of pain pumps was not approved by the Food and Drug Administration (FDA), and was, in fact, turned down on more than one occasion for further safety studies.

Pain pump manufacturers now find themselves embroiled in a mass of lawsuits claiming they are responsible for the serious injuries, which in some cases requires total shoulder replacements and often a lifetime of pain.

SOURCE: Pain Pumps › Woman’s life turns topsy turvy after shoulder surgery

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

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

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

Source: Buffalo Business Journal

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

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

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 devices take the place of narcotics, which carry a laundry list of side effects from nausea to vomiting to constipation and decreased sleep. They also require more monitoring and may require the patient to have a longer stay in the hospital.

“It may be $2,000 a day to have a patient stay in the hospital, so in this era of trying to reduce health care costs, if we can reduce their hospitalization from three days to one – or even better, to discharge them on the day of the surgery as an outpatient – we’ve dramatically changed the cost of that shoulder replacement or other major surgery,” said Randall Malchow, director of the Regional Anesthesia and Acute Pain Fellowship at Vanderbilt University. Dr. Malchow discussed the benefits of pain pumps for ABC 7 News.

The biggest risk these days with shoulder pain pumps is that in some cases, the pump does not work. That requires the patient to be admitted to the hospital and have pain medications administered by doctors and nurses. There is also a slight risk – about 1 percent – of infection. Pain pumps can be used for shoulder, elbow, wrist, knee and hip replacements.

The risks have recently improved since doctors began to make a connection between an alternative use of pain pumps and a painful and debilitating condition known as chondrolysis. Chondrolysis is when the cartilage in the joint has worn away and bone begins to rub against bone.

For years in the late 1990s and early 2000s, manufacturers of pain pumps began telling doctors to implant the pumps’ catheters directly into the shoulder joint rather than into the shoulder tissue. Inserting the catheter into the shoulder joint was not an FDA-approved use, as was placing the catheter in the shoulder tissue. By placing the catheters into the joint space, the medication dripped directly onto the cartilage and began eating away at it. The result? Pain, loss of motion, and limited use of the shoulder.

Today, doctors are using pain pumps as the FDA had intended – with the catheters placed in the shoulder tissue, with few risks. However, many of those who suffered because the pain pump manufacturers gave the surgeons ill advice have slapped the manufacturers with hundreds of lawsuits seeking justice.

SOURCE: Pain Pumps › Pain pumps less risky these days

Stryker Corporation, a multinational, publicly traded corporation, sells McKinley Medical pain products in the U.S., Canada and Mexico. Pain pumps are devices that deliver pain medication directly into the surgery site for up to 72 hours. The pumps were approved by the Food and Drug Administration (FDA) for use with the catheters inserted into the shoulder tissue; however, pain pump manufacturers, like Stryker, began advising doctors to place the catheters directly into the shoulder joint, which was not approved by the FDA.

When the pain medication dripped directly into the shoulder joint – where it was not FDA-approved to do – the medication ate away at the shoulder cartilage, resulting in a painful and debilitating condition known as chondrolysis. Soon physicians began making the connection between this use of pain pumps and chondrolysis. As a result, Stryker and other pain pump manufacturers are now facing hundreds of lawsuits from individuals injured by the devices.

During the same time that pain pump manufacturers were telling doctors to place the catheters of the devices into the joint space, it also began paying orthopedic surgeons for using the Stryker hip and knee replacement products, which is illegal. Questions still remain about whether doctors were also paid by Stryker to encourage other doctors to use Stryker products.

SOURCE: Pain Pumps › Pain pump manufacturer no stranger to controversy

“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,” says Frank Woodson, shareholder with Beasley Allen Law Firm. “In addition, literature is now being published about the connection between pain pumps and chondrolysis. The more information that becomes available, the more people are learning what may be causing their shoulder problems.”
Chondrolysis is a condition in which the cartilage in the joint wears away, resulting in loss of mobility and pain. Over the past few years, surgeons began seeing several patients who have had shoulder repair surgery contract chondrolysis. It didn’t take long for doctors to discover what was causing the painful condition.

“This goes all the way back to about the year 2000. 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. “For a long period of time, physicians didn’t know why either. However, now that the literature is expanding and more and more doctors are finding out about this, they’re telling patients to contact attorneys to get advice on what recourse they may have.”

Several cases are set for trial this year. “I think you’re going to see juries return verdicts against these defendants and then others will start to file lawsuits as well,” Woodson says.

SOURCE: Pain Pumps › Why are there so many lawsuits against pain pump manufacturers?

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

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

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

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

“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

However, in the 1990s and early 2000s, pain pump manufacturers began to market the product differently, according to Beasley Allen shareholder Frank Woodson. “The catheter was intended and approved by the FDA to be placed into the shoulder tissue. (But) with advice from manufacturers, the pain pump catheters were being placed in the joint space or intra-articular area, which allowed the pain medication into the joint space.”

By advising surgeons to use the pump in such a manner – one that had never been approved by the FDA – tragedy ensued. “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: Pain Pumps › Pain pump manufacturer’s bad advice leads to ‘tragedy’

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

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

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

SOURCE: Pain Pumps › Pain pump manufacturers named in lawsuit