Attorney Robert K. Jenner says new FDA report confirms that pain pumps were never approved for use in joints.
Baltimore, MD (PRWEB) November 21, 2009 -- Baltimore personal injury attorney Robert K. Jenner is applauding the decision by the Food and Drug Administration to require new safety warnings for pain pumps and the anesthetics that are used for pain management after shoulder surgery.
In announcing the new warnings requirement, the FDA analyzed 35 reports of shoulder chondrolysis reported to the FDA from 2006 to 2008. Each of the patients developed severe cartilage damage in following the use of pain pumps after shoulder surgery. Most patients who suffered cartilage damage required additional operations, including joint replacement.
An October 2007 article in the American Journal of Sports Medicine reported a link between intra-articular pain pumps following arthroscopic shoulder surgery and an extremely painful, debilitating condition known as Postarthroscopic Glenohumeral Chondrolysis (PAGCL). Pain pump manufacturers were slow to react. In fact, the drug companies steadfastly maintained that they were not required to change their labels, at all. Now, with the FDA’s directive, both the pain pump manufacturers and the drug companies must promulgate safety warnings for patients regarding the possibility of irreversible cartilage damage.
Pain pumps have been approved for the direct delivery of pain medication following other surgeries, but not orthopedic surgeries. The Nov. 13 report from the FDA states explicitly, “(t)he FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics.” The term intra-articular means inside the joint.
“Pain pumps that were placed into shoulder joints were done so in a practice not approved by the FDA, and irreversible injuries occurred as a result.” Mr. Jenner said. “The companies and health professionals responsible should know they will be held accountable for these injuries.”
About Janet, Jenner & Suggs, LLC
The law firm of Janet, Jenner & Suggs, LLC is a nationally recognized law firm dedicated to representing victims of defective medical devices, prescription drugs and medical malpractice. Each of the firm's principals is named in The Best Lawyers in America® and Super Lawyers®. The firm has offices in Baltimore, Maryland and Columbia, South Carolina. The firm accepts clients and referrals from patients and attorneys throughout the country. For more information on shoulder chondrolysis, contact the firm through its pain pump Website.
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