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Editor: Marc Jay Bern
Profession: Defective Medical Device Lawyer

Category: Medtronic News

The FDA recently issued a warning to doctors against using Medtronic's Infuse bone graft product in neck surgeries, an off-label use never approved by the agency.

The agency is unsure why, but using Infuse bone graft products in the neck can cause dangerous health complications.

Over the last four years the FDA has received 38 reports of complications related to the use of Infuse and OB-1 in neck fusion surgeries.

Infuse is a bone graft material used in some spinal surgeries. Infuse bone graft releases a protein found naturally in the body into the location that it is placed and helps to produce new bone growth. After surgery the Infuse bone graft is absorbed and replaced by new bone.

The complications were related to the use of Infuse and OP-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.

Medtronic first introduced Infuse in 2002. The company says the product contributed to the $3 billion in sales the spinal unit reported in the most recent fiscal year.

The warning is unlikely to affect Medtronic's sales or stocks due to the warning focusing on off-label use. Infuse is approved for use in fusion surgeries in the lower back and in some serious leg fractures and dental uses.