July 4, 2008
Off-Label Warning for Graft Material — FDA: Bone Products Not for Neck Surgeries
By Daniel Connolly
The Food and Drug Administration is warning doctors against using Medtronic's Infuse bone graft product in surgeries on neck bones, an off-label practice the agency never approved.
The warning issued this week also covers OP-1 brand bone graft products from Kalamazoo, Mich.-based Stryker Corp. For unknown reasons, using these products in the neck can cause dangerous complications, the FDA says.
Infuse is a genetically engineered protein that causes the body to grow its own bone. It is meant to eliminate the painful procedure of harvesting bone from elsewhere in the patient's body to fill gaps.
Infuse has been a hot seller for Medtronic's Memphis-based spinal unit since it was introduced in 2002. The firm doesn't break out sales figures, but said the product contributed to the $3 billion in sales the spinal unit reported in the most recent fiscal year.
Because the FDA warning focused on an off-label use, it is unlikely to affect Medtronic's sales or stock price, said Phil Nalbone, an analyst with RBC Capital Markets in San Francisco.
"This advisory from the FDA is important for patients and doctors, but it in no way should be seen as a negative for Medtronic," he said.
Infuse is approved for use in some fusion surgeries in the lower back, for some serious leg fractures and for some oral and dental uses.
The complications were related to the use of Infuse and OB-1 in spinal fusion surgery of the neck, a procedure in which a doctor bonds spinal bones to keep them from moving against one another. Doctors use spinal fusion to treat a variety of problems.
The FDA has received at least 38 reports of complications in the past four years related to use of Infuse and OB-1 in neck fusion surgeries.
The neck and throat tissue of some patients swelled, the agency said. Some patients had difficulty swallowing, breathing or speaking. Some required a second surgery to resolve the issue, and in some cases, health-care workers inserted tubes to keep them breathing, the FDA said.
The term "off-label" refers to the practice of using a medical product beyond what regulators approved. For instance, Botox is approved for smoothing wrinkles, but health care workers are using it to treat many other conditions, including bladder problems, the New York Times recently reported.
In a statement, Medtronic said it issued a safety alert to spine surgeons in September 2004 after it received reports related to neck surgery procedures; in early 2005 it added a warning to product packaging.
Medtronic said the FDA had not requested any other action.
Contact Daniel Connolly at 529-5296. To read more stories by this reporter, click on "Contact Us" at commercialappeal.com, then click on the reporter's name.
How it works
In lower-back fusion surgery, the surgeon mixes Infuse powder with sterile water and applies it to collagen sponges.
The surgeon then puts the sponges in small metallic cages and places them between the vertebrae. The thimble-like cages stabilize the spine while bone tissue grows between the vertebrae.
Originally published by Daniel Connolly [email protected] .
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