The FDA says it is not known what factor or combination of factors contributed to chondrolysis, but it is believed that the infused local anesthetic or the device materials may have contributed to the condition. Prior to 2000, reports of chondrolysis were low, but reports of PAGCL began to appear more frequently in recent years as surgeons began using newer devices and newer techniques, such as continuous postoperative infusion of anesthetics into the glenohumeral joint in the shoulder.

The FDA informs health care professionals that elastomeric infusion devices are safe when used properly; however, use of pain pumps has not been approved for use in shoulder surgery. The agency now requires pain pump manufacturers to warn health care providers and their patients about the potential for severe joint damage when these devices are used for intra-articular anesthetic administration.

The FDA advises nurses and other health care professionals when treating patients who will or have used elastomeric infusion devices for shoulder surgery to make sure the patient has given informed consent and understands the potential risks and benefits; teach the patient to immediately report signs and symptoms of chondrolysis such as chronic severe joint pain, stiffness, loss of motion, weakness in the shoulder, or popping, grinding or clicking of the shoulder joint; and prepare patients who have signs and symptoms of chondrolysis for additional diagnostic studies, such as X-rays or magnetic resonance imaging, as ordered.

In conclusion, the FDA urges health care professionals to “be vigilant to help patients avoid complications or get further treatment when needed.”

SOURCE: Pain Pumps › FDA offers shoulder pain pump safety tips to nurses

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?

While this use of pain pumps was a convenient way to relieve pain from surgery, it also resulted in a surprisingly high number of cases of a painful and debilitating deterioration of cartilage in the shoulder joint known as chondrolysis, specifically Postarthroscopic Glenhumeral Chondrolysis (PAGCL). The condition is permanent and many who suffer from it require shoulder replacement surgery.

Last year, the Food and Drug Administration (FDA) issued a notice to health care professionals informing them that use of pain pump devices and anesthetics in shoulder surgery were never approved by the agency. Yet, knowing this, pain pump manufacturers still instructed surgeons to use the pumps in this manner. As a result, a surprisingly high numbers of cases of chondrolysis were reported by patients who had used the pain pumps. As many as 63 percent of patients who used shoulder pain pumps are at risk of developing chondrolysis.

Several shoulder pain pump lawsuits have been filed by people who allege that they developed chondrolysis because the manufacturers of pain pumps failed to notify the medical community about the possible harm the devices could cause. More lawsuits are expected to be filed as more victims of these devices are diagnosed.

SOURCE: Pain Pumps › Studies link shoulder chondrolysis to pain pump devices

“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

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

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

I-Flow Corp

I-Flow currently faces 212 lawsuits from people who claimed they were harmed by the company’s ON-Q pain pumps used for shoulder surgery, yet the company says it is optimistic that it can skirt the claims made against it. The most damning evidence includes a recent study published by The American Journal of Sports Medicine that identified intra-articular pain pumps as the likely cause of a condition known as chondrolysis. Postarthroscopic Glenohumeral Chondrolysis (PAGCL) is a specific type of chondrolysis associated with shoulder pain pumps.

PAGCL is a painful and debilitating condition in which the cartilage in the shoulder wears away causing bone to rub against bone. It can greatly decrease range of motion and cause weakness in the shoulder. There is no cure for PAGCL, and in severe cases, shoulder replacement surgery is required.

I-Flow’s total revenue for the first six months of 2009 increased 7 percent to $68 million, up $4.3 million over the first six months of 2008. First six month sales of the company’s On-Q product lines increased 5 percent, or $2.2 million, compared to the first six months of 2008. I-Flow projects a yearly revenue of $139.7 million to $146 million, over analysts’ average expectation of $138 million.

Sources:
Fox Business
Orange County Business Journal

SOURCE: Pain Pumps › I-Flow enjoys profits amid spike in product liability lawsuits

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

Pain pumps

Pain pumps are often used in shoulder surgery and work effectively when used as approved by the Food and Drug Administration (FDA), with the catheter implanted in the shoulder tissue. However, in the early 2000s, pain pump manufacturers began advising physicians to insert the catheter directly into the shoulder joint, a method not approved by the FDA. When pain pumps were used in this manner, medication dripped directly into the shoulder joint, slowly eating away at the cartilage. Patients began experiencing a painful and debilitating condition known as chondrolysis.

As a result, numerous lawsuits have been filed against the manufacturers of pain pumps by individuals injured by the devices. But aren’t the companies that supplied the drugs used in the pain pumps also liable?

“They are, when you can find them,” says Frank Woodson, shareholder with Beasley Allen Law Firm. “One of the issues that I think that the attorneys representing pain pump victims are seeing is that is that the hospitals and/or surgical centers, wherever you had the surgery performed, sometimes do not do the best jobs of tracking what medications they placed into the pumps. I can tell you for a fact from the medical and billing records that sometimes it is impossible to determine who manufactured the medicine.”

If the manufacturer can be determined, “It is likely they are going to be added as a defendant because they knew from the medical literature that their medicine was toxic to cartilage,” Woodson says. “If they knew that their medicine was going to be used in pain pumps that were being placed intra-articularly into that joint space, then they’re just as liable as the pain pump manufacturers.”

SOURCE: Pain Pumps › Are drug companies to blame for shoulder pain pump injuries?

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

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

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