Overview: Medtronic’s spinal division continues to suffer a decline, as more negative news emerges about its controversial Infuse Bone Graft product. Infuse gained notoriety last June, when The Spine Journal published a report showing that Medtronic-funded researchers omitted the presence of serious side effects among Infuse users. Now, a recent Senate investigation reveals that Medtronic manipulated a number of Infuse studies.
- Medtronic’s market share has declined 5% following the Infuse controversy, and is expected to drop further
- Medtronic Infuse is an artificial bone graft; last year a spinal publication reported serious side effects associated with the product
- A recent Senate investigation showed that Medtronic edited medical journals to hide side effects such as male sterility and cancer
Product: Medtronic Infuse Bone Graft
Manufacturer: Medtronic, Inc.
Side Effects & Complications
- Difficulty breathing, swallowing
- Uncontrolled bone growth
- Nerve injury
- Male sterility
- Retrograde ejaculation
Medtronic Spinal Division Struggling
According to a report in Trefis.com, Medtronic’s spinal division has suffered in the wake of the Infuse controversy. From 2008 to 2011, the company’s market share dropped from 40% to 35% following the Spine Journal publication. Analysts expect Medtronic’s market share to decline even more, below 30%, with the continual release of negative news surrounding Infuse. A recent report by the U.S. Senate Finance Committee dealt a blow to the company’s stock value, stating that Medtronic edited at least 11 medical journals over Infuse to hide side effects. Furthermore, the report found that the Medtronic has paid millions to the authors of these studies; these financial ties were not disclosed in any of the studies.
Infuse is used to regrow bone in the spine using a synthetic protein known as BMP-2. It was approved in 2002 for use in the lower spine (L4 to S1) and later for two types of dental surgery. However, reports indicate that Infuse is mostly used for unapproved uses, or “off-label”. According to the U.S. Food and Drug Administration (FDA), using Infuse off-label in cervical spine can lead to life-threatening complications, such as difficulty breathing, and swelling of the neck and throat.
Recent news also indicates that Infuse is used in 9 to 10 percent of spinal fusion surgeries performed in kids. Given the current safety issues associated with use in adults, the statistics among pediatric patients is unsettling for many.