FDA Demands Danger Warnings from Makers of Shoulder Pain Pumps

By Jim Greene

Published on December 28, 2009

Saying it never cleared them for use on joints, the U.S. Food and Drug Administration (FDA) has demanded that makers of pain pumps and the anesthetics used in them warn patients of the possibility of severe cartilage damage. The devices were approved to deliver a steady supply of painkillers directly to the site of surgery for the first few days of recovery.

The FDA said it has received 35 reports of irreversible cartilage damage, primarily in shoulder surgery patients. The agency said some victims reportedly required joint replacements, including otherwise young, healthy adults.

Pain pumps supply anesthetics through small plastic tubes temporarily implanted at the site of the surgery. Makers of the devices include Stryker Corp., Orthofix, Inc., I-Flow, Inc., Moog, Inc., Sgarlato R.P., Inc., Breg, Inc., Linvatec Corp., and DJO, Inc. Anesthetics used in the devices include lidocaine and bupivacaine, the latter marketed as Marcaine® or Sensorcaine®; makers include AstraZeneca, Abbott Laboratories, APP Pharmaceuticals, and Hospira Worldwide.

The FDA noted that the single injections of the painkillers have been used for years without any reports of cartilage damage. Several lawsuits filed against the pump and anesthetic makers claim it was the steady stream of medication that led to damage.

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