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Shoulder Pain Pumps and FDA Alerts

The U.S. Food and Drug Administration (FDA) recently released a safety information notice reporting chondrolysis, or breakdown and death of cartilage, in the shoulder after the use of continuously infused local anesthetics following Arthroscopic surgery.

Arthroscopic refers to a type of minimally invasive surgery that is common today for operating upon joints without having to make a large incision. It involves inserting into the joint a small tube-like device with a camera attached. This allows surgeons to see the inside of a joint on a monitor and enables them to watch as they manipulate surgical instruments inside the joint.

The FDA report was issued to patients and health care providers in February 2010 as an update to a previous November 2009 report. The warning regarded the use of pain pumps to deliver anesthetics directly into the shoulder joint following arthroscopic shoulder surgery. The shoulder pain pumps are called elastomeric infusion devices.

Complications Associated with Shoulder Pain Pumps

The FDA said it reviewed 35 reports of chondrolysis in otherwise healthy young adults. The youth of the patients was of particular concern to the FDA. Ninety-seven percent of the patients suffered cartilage damage after having shoulder surgery. More than half of them needed further surgery, including joint replacement.

Patients reported the following shoulder problems on average about eight and a half months after receiving the anesthetics by infusion:

Joint pain
Loss of mobility
Stiffness

In some patients, these symptoms occurred as soon as two months after surgery. These post-surgery symptoms have been labeled Postarthroscopic Glenohumeral Chondrolysis (PAGCL). Glenohumeral refers to the shoulder joint.

The safety notice said the causes of the chondrolysis are not known specifically. Possible causes include:

The anesthetics used
The materials in the device used to infuse the drugs
A combination of these or some as yet unknown factors

Safer Alternatives?

The FDA made a point of noting that single injections of local anesthetics into joints have been used for many years without any occurrences of chondrolysis. The government agency emphasized that the injection of local anesthetics has FDA approval.

But, neither local anesthetics nor infusion devices have received FDA approval for continuous injection into joints. The notice urged health care professionals to avoid using elastomeric infusion devices to deliver anesthesia following orthopedic surgery.

Because of these unprecedented infusion injuries to the shoulder, the FDA is requiring the makers of these anesthetics to update their product labels and caution doctors and patients about the possibility of the occurrence of PAGCL. Doctors are advised to be aware that these continuous flow infusion devices do not have FDA approval.

The FDA noted that their information is currently relevant, but that as additional data become available, it would issue further notices.

For more information or if you believe you’ve suffered a shoulder pain pump injury, contact a shoulder pain pump attorney today.

Product Liability Breaking News

"Shoulder Pain Pump Does More Harm Than Good"

According to recent reports, patients who had surgery for dislocated shoulders are saying the product they used to control the pain caused more harm than good.

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