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Defective Pain Pump Shoulder Injury FAQWhat is a shoulder pain pump?
A shoulder pain pump is a small, portable medical device that is implanted during shoulder surgery to manage pain. Through a catheter, the pain pump delivers continuous doses of anesthetic drugs directly into the incision site. Typically they are used for two to five days post surgery and then removed and discarded.
The intra-articular pump was developed-- and anticipated-- to provide more effective pain control for shoulder injury patients who've undergone shoulder surgery without the use of narcotic pain medications which can cause side effects such as nausea, vomiting and altered levels of consciousness.
What kind of damage can a shoulder pain pump cause?
Pain pumps can cause shoulder surgery patients to develop Postarthroscopic glenohumeral chondrolysis or PAGCL, an extremely painful condition that can cause life-long disability. PAGCL is one of the most common complications following shoulder surgery.
How can a shoulder pain pump cause PAGCL?
Studies now indicate that continuous doses of these anesthetics directly into the shoulder can cause serious and permanent damage to the shoulder joint cartilage. The anesthetic destroys the shoulder cartilage cells (called chondrocytes), which progressively erodes the cartilage.
The destruction of articular cartilage is known as chondrolysis. When articular cartilage in the shoulder is destroyed, it leaves bone to rub against bone. At first this causes inflammation and pain in the bones. Later the surface of the bones are destroyed.
Prior to new surgical techniques and experiments such as pain pumps, chondrolysis typically occurred in the hip. For the past decade, however, reports of PAGCL have become more common with the increased use of shoulder pain pumps.
Is there a cure for PAGCL?
Unfortunately, the damage is irreversible: the articular cartilage does not repair itself. A shoulder transplant is the only treatment with a possibility of relieving the pain and allowing use of the shoulder. However, many patients never regain full use of their shoulder joint.
How do I know if my shoulder pain isÂ the result of a defective pain pump?
If you are experiencing pain two or more days after shoulder surgery with a catheter that delivered a powerful painkiller directly into your surgical site, it is likely that the pain you have is related to the pain pump. Medical experts say that pain and loss of range of motion that develop in the weeks after the pain pump is removed can be the result of cartilage loss. The following symptoms generally occur between three months to a year after someone has had shoulder surgery:
- Increased pain in the shoulder at rest and with motion
- Increased stiffness in the shoulder
- Clicking, popping or grinding (Crepitus) in the shoulder
- Decrease in range of motion in the shoulder
- Loss of strength
- Joint space narrowing as shown on an x-ray
I have a shoulder injury and I am scheduled to have shoulder surgery. Can I tell my doctor not to give me a shoulder pain pump?
You should definitely speak with your doctor before surgery; not all health professionals are aware of a shoulder pain pump link to PAGCL.
How did these shoulder pain pumps ever get FDA approval? Were they even tested for safety?
According to a number of attorneys, shoulder pump manufacturers did not perform any studies to determine whether the pumps were safe to use near cartilage, neither were any prior studies adequately researched that demonstrated the danger of anesthetic drugs to cartilage. Some critics say the shoulder pain pump manufacturers havenât conducted any studies of their own which have been made public.
Although a few pain pump manufacturers applied to the FDA several times for approval to place the pump's catheter in the intra-articular joint space-right next to the cartilage, the agency denied applications (on more than one occasion), citing safety issues. However, the manufacturers went ahead and promoted their products in this same manner, regardless of further patient injury.
The FDA has never approved shoulder pain pumps to deliver medication from a catheter directly into the synovial cavity.
Have any studies linked shoulder pain pumps to PAGCL?
Yes. According to a 2006 study by the American Academy of Orthopedic Surgeons, "the prognosis for these shoulders is grim" (Petty, D.H. et al., Glenohumeral Chondrolysis After Shoulder Arthroscopy, Am. J. Sports Med. 32:(2)509 (2004)). This study looked at 152 arthroscopic shoulder surgery patients. All but 12 of the patients who used shoulder pain pumps developed PAGCL.
In October 2007 the American Journal of Sports Medicine (AJSM) published a study by Dr. Charles Beck, an orthopedic surgeon and senior author of the study. Dr. Beck stated that there is a, ââ¦strong association between the intra-articular (inside the joint space) use of high volume pain pumps following arthroscopic shoulder surgery and an otherwise unexplainable loss of hyaline cartilage in the shoulder joint.â He also said that âThe complication, known as PAGCL, is permanent and can lead to extreme pain and lifelong suffering in 63 percent of the patients that use them. The medical records of numerous other patients suggest the complications may occur following open surgery as well.â
Have shoulder pain pump lawsuits been filed against the pain pump manufacturers?
There have been more than 30 shoulder pain pump lawsuits filed nationwide against the shoulder pain pump makers, including Stryker, DJO Inc., I-Flow, BREG Inc. and others, alleging that the devices caused the development of a painful and debilitating condition where the cartilage in the shoulder is destroyed.
Dr. Charles Beck (above) claims that the manufacturers knew about the problem years ago, but did nothing. According to Dr. Beck, hundreds of patients are at risk for PAGCL, " which results in severe pain, debilitating stiffness and eventual joint replacement surgery for many of those affected.
Beck says he sent the results of the October 2007 study to the shoulder pain pump manufacturers some time ago, " but their response has so far been minimal to non-existent. It is time to get the word out and stop these devices from ruining any more lives."
The shoulder pain pump lawsuits claim the pain pump manufacturers failed to instruct or warn the US medical community that the safety of using the pain pumps in the shoulder joint had not been established and that the continuous injection of commonly used anesthetics by these devices may cause permanent injury.
In May 2008 a petition was filed by a number of attorneys to consolidate all federal lawsuits filed on behalf of individuals who developed PAGCL after using a shoulder pain pump following arthroscopic shoulder surgery. But in August, 2009 the United States Judicial Panel on MDL (multi-district litigation) denied the petition. The panel decided a MDL was not appropriate in shoulder pain pump litigation, mainly because an indeterminate number of different shoulder pain pumps made by different manufacturers are at issue; consolidation would not help the parties, and it could also be a drain on judicial economy. A request to consolidate shoulder pain pump lawsuits was again filed in November, 2009.
How can I proceed with a shoulder pain pump lawsuit?
First, it is important to obtain all your medical and billing records--they belong to you. Having those medical records in your hand definitely speeds up the process.
Next, you can take the necessary actions to win your shoulder pain pump case with the help of an experienced shoulder pain pump attorney who can determine if you indeed have a claim and if the statute of limitations is applicable in your state: LawyersandSettlements.com makes it easy for you to find the right attorney because we work with shoulder pain pump attorneys throughout the US and Canada who specialize in this case.
As well, LawyersandSettlements.com provides comprehensive news coverage about shoulder pain pump lawsuits that aim to keep the public informed. We also provide an online legal news source that includes interviews with attorneys who discuss their shoulder pain pump cases.
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Last updated on Mar-15-10