Drugs & Medical Devices
Shoulder Pain Pumps
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Further shoulder damage may result after insertion of pain pumps following surgery
Did you sustain additional shoulder damage after implantation of a pain pump? Discuss your situation with our lawyers.
Pain pumps are used to manage post-operative shoulder surgery pain. They should be placed in the muscle or outside the shoulder joint. However, with little or no study regarding safety, the surgical approach of inserting pain pumps directly in the shoulder joint has been extensive over the last 7 years. This treatment is now linked to "chondrolysis" or PAGCL, an excruciating condition for which there is no cure.
On November 13, 2009, the Food and Drug Administration (FDA) informed the public and health care professionals that it has reviewed 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices to control post-surgical pain.
The significance of this injury to otherwise healthy young adults warrants notification to health care professionals.
The local anesthetics (with and without epinephrine) were infused for extended periods of time (48 to 72 hours) directly into the intra-articular space using an elastomeric pump.
Chondrolysis was diagnosed within a median of 8.5 months after the infusion. Almost all of the reported cases of chondrolysis (97%) occurred following shoulder surgeries.
Joint pain, stiffness, and loss of motion were reported as early as the second month after receiving the infusion.
In more than half of these reports, the patients required additional surgery, including arthroscopy or arthroplasty (joint replacement).
Local 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.
Health care professionals are encouraged 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.
Based on the reported cases of chondrolysis, following continuous intra-articular infusion with local anesthetics, the FDA is requiring the drug manufacturers to update their product labels to warn healthcare professionals about this potential serious adverse effect.
In addition, the FDA will require the manufacturers of pumps that may be used to infuse local anesthetics, including elastomeric infusion devices, to have similar warnings for their products.
Those with chondrolysis are likely to need additional surgeries, and often must have complete shoulder replacements.
Legal resources for shoulder damage
People who have been harmed by pain pumps may contact our lawyer for a free lawsuit review via the form below.
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see also:
Pump Anesthetics
Shoulder Pain Pump Anesthetics | Weitz & LuxenbergDid you sustain further shoulder damage after surgery? Legal options
FDA
FDA Report Shoulder Chondrolysis Pain Pump | Weitz & LuxenbergDid you develop chondrolysis after shoulder surgery? Free legal review
