But Smith’s doctor, Bryan Wall, an orthopedic surgeon at the Core Institute of Phoenix, Ariz., wasn’t giving up. He suggested Smith have a new procedure, a reverse shoulder replacement. Approved by the Food and Drug Administration (FDA) in 2004, the procedure offers relief to some patients who suffer long-term rotator cuff tears with arthritis. During the procedure, surgeons place an implant in the shoulder that is designed so that the ball portion of the shoulder is attached directly to the shoulder blade. The socket is then placed at the upper end of the arm bone. The procedure essentially reverses the anatomy of the shoulder.

“What it does is it allows us to not only replace the joint that has become arthritic, but it puts the shoulder in a better mechanical position and changes the mechanics of the shoulder to allow people to elevate their arm,” Dr. Wall explained.

The result was life-changing for Smith, who said he no longer has pain in his right arm and is able to get on with an active retirement. However, Dr. Wall warns, the procedure is not recommended for all patients. The best recipients are older patients who are less likely to put extreme stress on the shoulder joint.

SOURCE: Pain Pumps › New procedure may prove effective for some shoulder injuries

The nine are among a growing number of lawsuits filed against the makers of shoulder pain pumps that were used in patients following shoulder surgery. The devices have a catheter that is implanted into the surgical site and delivers regular does of anesthetics to the wound for up to 72 hours. Doctors soon began to see a connection between the use of the devices and a painful and debilitating condition known as chondrolysis.

The pain pumps were approved by the Food and Drug Administration (FDA) with the catheters placed in the shoulder tissue, but in the 1990s pain pump manufacturers sought approval from the FDA to have the catheters placed directly in the shoulder joint.

“To the FDA’s credit, they said no,” says Frank Woodson, shareholder with Beasley Allen Law Firm. “The FDA said, ‘If you want permission to do that, you’re going to have to do safety studies to determine whether or not that is a safe practice or a safe method to use your product.’ The companies did not do that and just went ahead and started advising physicians to place the pain pump catheter in the joint space.”

When the catheters were placed in the shoulder joint instead of the tissue, the medication began to eat away at the cartilage in the joint, causing the painful condition known as chondrolysis.

As a result, more than 140 lawsuits have been filed in state and federal courts against manufacturers of pain pump devices. “I hope this litigation will continue to educate the medical community to use pain pumps in a proper manner because if it is done in that way, then we should stop seeing these injuries occur,” Woodson said.

SOURCE: Pain Pumps › Lawsuits seek more than $68 million from pain pump manufacturers