FDA’s Warning About Intra-articular Elastomeric Infusion Devices

Although arthroscopic surgery is supposed to carry less risk and involve less pain than open procedures, these surgeries still require pain killers. For arthroscopic shoulder surgeries, doctors have long favored intra-articular infusion pain pumps for pain management. These flexible plastic catheters deliver pain medication directly to the joint. They are typically used for two-three days following surgery. The most common pain medication used with a pain pump is bupivacaine with epinephrine (Marcaine).

Unfortunately, these shoulder pain pumps have been associated with Postarthroscopic Glenohumeral Chondrolysis (PAGCL), a serious condition where shoulder cartilage begins to deteriorate. Without cartilage, joints are not protected from friction, causing extreme pain and loss of mobility. The only alternative to the damage for many sufferers is costly shoulder replacement.

In November 2009, the Food & Drug Administration (FDA) released a warning saying that it had received 35 reports of chondrolysis in shoulder surgery patients. The FDA was particularly alarmed because the reported cases involved significant injury to otherwise healthy young adults (the average patient age was 25).

Those injured shoulder patients had allegedly been given intra-articular infusions of pain medication through elastomeric pain pumps. In an intra-articular infusion, medicine is pumped directly into the joint. The FDA stated that it had never approved the use of pain pumps in this manner. The agency is now requiring the manufacturers of these elastomeric infusion devices to warn healthcare professionals about the increased risk of developing chondrolysis.

Several state and federal lawsuits have been filed against those pain pump manufacturers whose devices were inserted directly into the shoulder joint. Several pain pump manufacturers applied to the FDA to alter their package inserts to include an indication for placement of the pain pump catheter in the shoulder joint space, but the FDA repeatedly denied these applications. The manufacturers allegedly ignored the FDA’s denial of their applications for intra-articular placement approval and instead assured the medical community that shoulder pain pumps were safe to use for placement in the joint space.

Some of the intra-articular elastomeric infusion devices that have been linked to shoulder cartilage toxicity include:

  • Stryker PainPump
  • Stryker PainPump Blockaid
  • BREG Pain Care Infusion Pump
  • Donjoy Pain Control Device
  • Donjoy Accufuser Plus Pain Pump
  • I-Flow On-Q PainBuster

If you or someone you love has been injured by an intra-articular pain pump infusion, or have the symptoms or diagnosis of PAGCL, you may have valuable legal rights. If you have developed continuous pain after having received a pain pump, the knowledgeable lawyers at our firm can help you immediately by investigating your legal rights. The MedLaw Legal Team of Janet, Jenner & Suggs, LLC has filed cases against pain pump manufacturers across the United States and has retained some of the nation’s leading experts.

Please contact the MedLaw Legal Team of Janet, Jenner & Suggs, LLC by filling out the contact form or calling us at 1-888-4-MED-LAW for an evaluation of your case.

Janet, Jenner & Suggs, LLC

Cohen & Malad, LLP