FDA Asks For Shoulder Pain Pump Safety Label Updates

By Michele Wallace

Published on December 02, 2009

The U.S. Food and Drug Administration is requiring the manufacturers of shoulder pain pumps to update safety labels to include a warning about the dangers of anesthetics on cartilage.

The FDA says that between 2006 and 2008 it received 35 reports of cartilage damage after pain pumps were placed in the shoulder following joint surgery.

In addition, three separate studies have linked placement of pumps in the shoulder joint with postarthroscopic glenohumeral chondrolysis (PAGCL), a condition in which cartilage begins to deteriorate. Experts believe that the direct delivery of anesthetics to the shoulder joint results in destruction of cartilage.

The companies that manufacture the pain pumps and the anesthetics used in pain pumps will have to revise the safety labels on their products this month to warn consumers and medical professionals about the potential risk of cartilage damage.

Several shoulder pain pump lawsuits have been filed against the makers of shoulder pain pumps, as well as the companies that manufacture the anesthetics used in pain pumps.

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