• 11
  • November
    2011

Infuse is a bone morphogenetic protein made by Medtronic Inc. for use in spinal surgeries. BMP's purpose is to induce bone and cartilage growth and limit the need for surgeons to harvest bone from elsewhere to use during spinal surgeries. Since Infuse's approval in 2002, it has been utilized in thousands of surgeries to help aid spinal fusion - but now there are indications that Medtronic provided inadequate warnings about its product.

Off-Label Use

Infuse was approved by the FDA for use in surgeries where there is a single-level anterior lumbar spinal fusion of degenerative disc disease from L2-S1. Many surgeons, however, have used it "off-label," or in ways other than its intended one. Off-label usage of Infuse has had significant impacts, both negative and positive. Studies have suggested that off-label use of BMP could increase complications, prompting the FDA to issue warnings.

Controversy

A study published in the Spine Journal indicated that Medtronic's initial release of data from the Infuse studies may have lacked complete information about its complication rates.

And another controversy surrounding Infuse is the fact that several positive studies were not random, double-blind, controlled studies, which is the highest standard for producing legitimate results - many Infuse studies were sponsored by Medtronic, which had the most to gain from positive outcomes.

Dosage

Many doctors agree that, although knowledge of BMPs is limited, a key aspect of BMP usage is the dosage. Complications are more likely to occur when a patients receives too much BMP.

Learning Process

As with most innovations, there are setbacks and leaps forward, and BMP usage is no different. The conversations regarding Infuse and its issues will serve as a catalyst for more research and development of similar products, likely producing a more refined product and different usage guidelines.

Source: Becker's Spine, "Where Infuse Stands: 6 Points on the Controversial Spinal Fusion Product," by Laura Miller, 10/25/11