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FDA Orders Change to Pain Pump Warning Labels.

Federal regulators are demanding changes to labels on devices that deliver pain killers directly to joints after surgery, in response to numerous reports of irreversible cartilage damage.

The Food and Drug Administration said from 2006 to 2008 it received 35 reports of severe cartilage damage in patients who were given pain pumps after joint surgery. Nearly all the reports involved patients who had shoulder surgery; more than half needed additional surgery, including joint replacement.

Companies making pain pumps include I-Flow Corp. and Stryker Corp. Makers of the anesthetics used in pain pumps, such as APP Pharmaceuticals Inc. and Hospira Inc., will also have to update their labels. The firms have 30 days to propose language that includes a warning about the potential for cartilage destruction, according to the FDA.

“The significance of this injury to otherwise healthy young adults warrants notification to health-care professionals,” the FDA said in a notice to doctors and other health care professionals Nov. 13.

APP and Hospira declined to comment, citing ongoing litigation. Stryker hasn’t yet responded to requests for comment. In a statement, I-Flow said its On-Q PainBuster has been used successfully for over 10 years in two million patients in the U.S. The company said it couldn’t comment further, citing ongoing litigation.

Pain pumps are small plastic tubes that deliver and regulate pain medicine constantly, usually for two to three days. The anesthetics in the FDA’s alert include bupivacaine, marketed as Sensorcaine or Marcaine, and lidocaine. These anesthetics, the FDA noted, have been used safely in single injections for many years without any reports of cartilage decay.

The new notice says the FDA did not clear pain pump infusion devices using the anesthetics for “intra-articular” or joint surgery. The pumps are approved to be used after abdominal and other surgeries, such as hysterectomies. They are considered a better way to deliver pain-relieving medications because they target specific areas and don’t involve narcotics.

But reports about decaying cartilage after shoulder surgery began surfacing several years ago, followed by studies in medical journals on orthopedic surgery and sports medicine. In January, the Canadian government alerted surgeons about potential cartilage decay when the pain pumps are used for joint surgeries.

If you or a family member has been personally injured because of the fault of someone else: by the use of dangerous and defective drugs, bad products, or toxic injury etc then please contact the Dallas Texas Defective Product Liability Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 817-255-4001 or Contact Me Online.

The Dr. Shezad Malik Law is currently evaluating and accepting Pain Pump cartilage damage cases.

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