May 8, 2012 — Congress is currently investigating whether Medtronic, the company behind the Medtronic Infuse Bone Graft, paid physicians and experts to produce inflated positive endorsements for their products.
Media reports allege that Medtronic paid these experts to intentionally downplay the risks of severe side effects, which may have misled physicians into using the product.
The Medtronic Infuse Bone Graft is a medical device that is intended to stimulate bone growth after a spinal surgery. It is intended to be used instead of the traditional bone grafting techniques, which involve invasive bone harvesting. The Medtronic Infuse Bone Graft consists of a sponge-like carrier soaked in a biological agent that promotes bone growth.
The Senate Finance Committee is calling on Medtronic to explain discrepancies in clinical trials. Media researchers have reported that the clinical trials that were funded by Medtronic may have included falsified results, and downplayed the risks of potentially fatal side effects. The Infuse Bone Graft may cause angioedema (potentially fatal swelling of the mouth and throat), cancer, chronic pain, and infertility in men. Furthermore, 75% of people who have been implanted with the Infuse Bone Graft have had ectopic bone growth, in which bone grows outside of the intended area. Severe bone growth can damage nerves in the spine, causing pain and debilitation.
The risk of severe side effects is not the only problem — Medtronic is also being investigated for illegal off-label promotion of the Infuse Bone Graft for uses that were not approved by the FDA. In 2002, the FDA approved the Medtronic Infuse Bone Graft for a specific procedure: spinal surgery in the lower back.
Unfortunately, since 2002, hundreds of people have reported serious injuries after their doctor used the Infuse Bone Graft for off-label use. More than 250 adverse event reports have been submitted to the FDA, with the vast majority of them resulting from off-label use of the Infuse Bone Graft. Some of the reports include patient deaths.
Experts are concerned about the following Medtronic Infuse Bone Graft side effects:
- Ectopic Bone Growth
- Nerve damage
- Pain that radiates to other parts of the body (arms, legs) after surgery
- Male sterility
- Angioedema (potentially fatal swelling of the mouth or throat, which can cause suffocation)