Pain pumps are balloon-like devices that are filled with anesthetic and rest outside the body. During surgery, a catheter from the pain pump is placed inside the surgical site and delivers pain medication directly to the joint space. This use of pain pumps in shoulder surgery became popular in the 1990s after manufacturers instructed surgeons to use the pumps in this manner. However, this use was never approved by the Food and Drug Administration (FDA), and soon complications began to arise.

Doctors were baffled at first to see so many former shoulder surgery patients coming back with even more pain than before. It didn’t take long for doctors to make a connection between pain pumps, anesthetics and debilitating shoulder chondrolysis. One likely theory is that the anesthetic delivered directly to the shoulder joint caused the cartilage to wear away in many people.

Treatment for chondrolysis is challenging, says Ortho Super Site. Nonsteroidal anti-inflammatory drugs, intra-articular corticosteroids, and hyaluronic acid may provide some relief but ultimately, most sufferers may need total shoulder replacement surgery.

SOURCE: Pain Pumps › Pain pumps likely cause of shoulder chondrolysis

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

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

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

Some rotator cuff disorders – especially the early stages of rotator cuff damage –  may be treated without surgery through rest and rehabilitation, ice and heat applications, anti-inflammatory medications, and physical therapy. Situations that may require surgery include symptoms that persist for more than 6 months, injuries that occurred suddenly, or if the tear is causing weakness.

Such injuries that may require surgery are those from a major sports injury or auto accident. Very large rotator cuff tears – larger than 2 inches – and tears that affect more than one of the four rotator cuff tendons sometimes cannot be repaired. But surgery may be able to relieve pain by removing damaged tissue from the joint.

Surgery, however, cannot always completely resolve problems with regular wear-and-tear over the years. And whether you choose to have surgery or not, rehabilitation and physical therapy will be required to get your shoulder back to near-par.

Surgery risks include infection, persistent pain, slow healing followed by stiffness, and the potential need for more surgery. In some cases, surgery may cause irregular heat rhythms, changes in blood pressure and heart attack.

Patients who have had shoulder surgery in the past have also suffered from a condition in which the cartilage has worn away, called chondrolysis. This condition was found to have been caused by a pain pump device that was implanted in patients following surgery to help relieve pain for up to 72 hours following surgery. If you have had shoulder surgery and are still experiencing pain and limited mobility, or have been diagnosed with chondrolysis, you may have a claim against the manufacturer.

SOURCE: Pain Pumps › Weigh pros, cons of shoulder surgery

KFx Medical Corporation was awarded a patent this week by the U.S. Patent and Trademark office for knotless surgery tissue fixation. The key patent covers a broad range of methods used to perform surgical knotless tissue fixation, including the double row tissue repair technique used to restore the rotator cuff to its correct anatomic position.

The new knotless surgery tissue fixation is designed to eliminate knot tying and thus reduce the overall surgical time, which may aid in the healing process. Recovery from rotator cuff surgery is slow and can be painful. To help manage pain, surgeons often implant a pain pump into the shoulder tissue that delivers a steady amount of medication to the surgical site for up to 72 hours following surgery.

Pain pumps offer an alternative to narcotics and speed healing time, though they are not without fault. Shoulder pain pumps have been linked to a painful and debilitating shoulder condition known as chondrolysis in which the cartilage wears away leaving bone to rub against bone. As a result, manufacturers of shoulder pain pumps are facing hundreds of lawsuits filed by individuals injured by the pain pumps.

Sources: eHealthMD, Reuters

SOURCE: Pain Pumps › New rotator cuff surgery method can help reduce surgical time, effort

Chondrolysis is a rare condition in which the cartilage in a joint wears away causing bones to rub against bones. It was often seen in the hip where conditions such as birth defects caused the bones to rub against each other. This grinding of bones causes inflammation and pain and, eventually, destruction of the bones. It is painful and debilitating to those who suffer from this permanent condition.

In the 1990s, doctors began seeing chondrolysis in the shoulder, a place where it was rarely, if ever, seen before. As doctors began diagnosing more and more shoulder chondrolysis, also known as postarthroscopic glenohumeral chondrolysis (PAGCL), in patients who had previously had shoulder surgery, they began to make a connection between PAGCL and a new surgical use of pain pump devices used to manage pain following surgery.

That new use was to place the catheter of the pain pump directly into the shoulder joint rather than into the shoulder tissue. The constant drip of medication into the shoulder joint ate away at the cartilage in the shoulder.

It was the pain pump manufacturers who advised doctors to place the catheters directly into the joint space – a use that was not approved by the Food and Drug Administration. As a result, those manufacturers are facing hundreds of lawsuits against people who are suffering with PAGCL, a condition that is permanent and often requires shoulder replacement surgery.

SOURCE: Pain Pumps › Pain pumps blamed for painful chondrolysis in shoulder joints

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

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 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

But during a game in October 2006, McKeown’s left shoulder was injured while trying to recover a fumble. Doctors implanted the catheter of a On-Q PainBuster pain pump manufactured by I-Flow into his shoulder joint. For up to 72 hours, medication gradually dripped into his shoulder and slowly began eating away at the cartilage.

But McKeown was tough. He rehabbed quickly and bulked up to 300 pounds. He lead the team in weightlifting statistics, bench pressing a maximum of 460 pounds. His chances at making to the NFL one day seemed promising.

Even as he worked out, he ignored the burning pain in his shoulder, refusing to admit to anyone how badly it hurt. And then he injured his shoulder again. Once again, he was put on an I-Flow pain pump that dripped medication into his shoulder joint. A follow up MRI revealed a horrible mess. The promising athlete’s shoulder cartilage had been worn down so badly that repairing it was impossible. McKeown’s hopes for a professional football career were ruined.

McKeown is now suing I-Flow, the manufacturer of the pain pump, after he and his doctor learned that a 2006 study had revealed that by inserting the pain pump’s catheter in McKeown’s shoulder joint instead of the muscle tissue, the medicine essentially destroyed his shoulder. The Food and Drug Administration (FDA) had granted approval to have the pain pump’s catheters inserted into the muscle tissue, but denied manufacturers’ request to instruct surgeons to place the catheters in the shoulder joint. As a result, countless patients have suffered similar fates as McKeown.

Source:
Cincinnati.com

SOURCE: Pain Pumps › Athlete’s hopes of playing pro ball dashed by shoulder pain pump

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