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FDA Requires Change to Pain Pump Labels

November 17th, 2009

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. Now, federal regulators are demanding changes to labels on the devices.
The Companies making pain pumps have 30 days to propose language that includes a warning about the potential for cartilage destruction, according to an FDA spokeswoman.
“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, Stryker and Hospira all make the pain pumps. 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.
Reports about decaying cartilage after shoulder surgery, when the pumps were involved, began surfacing several years ago, followed by studies in medical journals on orthopedic surgery and sports medicine. If you have suffered severe cartiledge damage as a result of these pumps, contact a Jacksonville Personal InjuryAttorney.

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