May 8, 2012 — Medtronic, the company responsible for the Medtronic Infuse Bone Graft, is currently under Congressional investigation following journalist reports that the company paid doctors to falsify reports and inflate safety data to promote their product. The company is also accused of illegal off-label promotion of the Infuse Bone Graft for uses that were not approved by the FDA.
The Medtronic Infuse Bone Graft is a new type of medical device that is designed to be implanted after spinal surgery, and is used to promote bone growth. The FDA approved it in 2002, only for use after lower-spinal surgery. The device consists of a sponge-like carrier, which is soaked in a biological agent that stimulates bone growth.
Unfortunately, one major side effect of the device is that it is often a little too effective — an estimated 75% of patients suffer from ectopic bone growth, a condition in which the bone grows too much. This can cause severe problems in the spine, a sensitive area of the body. Over-grown bones have caused severe nerve damage to some patients.
The FDA has received at least 250 adverse event reports related to side effects of the Medtronic Infuse Bone Graft. Most of the reports come from people whose doctors implanted them with the devices in an off-label use. Some of these adverse events include reports of patients who have died.
The Senate Finance Committee has asked Medtronic to explain why doctors who were paid tens of millions of dollars produced clinical studies that were favorable to the Infuse Bone Graft, while independent studies of the product found high risks of side effects. The company has been accused of falsifying reports in clinical trials, as well as downplaying the risks of serious, potentially life-threatening side effects.
Medtronic Infuse Bone Graft side effects include, but are not limited to:
- 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)