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

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

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’

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