Bioengineered liquid bone protein meant to encourage bone growth inside a thimble-sized cage is implanted into the spine in the Infuse bone graft process, but uncontrolled bone growth and other “side effects” have wreaked havoc on many people who have been “Infused.”
Manufacturered by Medtronic, Inc., the nation’s largest medical device maker, Infuse is implanted in some 100,000 people in the U.S. yearly, mostly for spinal fusion surgery. Problems have arisen for InFuse, however, when it has been used off-label, for purposes for which it was not approved. Medtronic, meanwhile, has been accused by a U.S. Senate committee of not properly revealing InFuse’s off-label problems, and the company has gotten into more hot water as it has tried to silence a Medtronic whistleblower lawsuit.
In late November 2012, Medtronic, Inc. filed a motion to dismiss a whistleblower lawsuit alleging the medical device manufacturer used a spine surgeon, who was being paid by the company, as an editor of a medical journal to promote its Infuse Bone growth device. That case has not been dismissed.
InFuse is a system which consists of the (thimble-sized) LT-Cage meant to hold a bone grafting substance derived from recombinant bone morphogenetic protein-2.
The FDA approved InFuse in 2002 only for one type of spinal surgery – an anterior approach lumbar fusion. InFuse was not and is not approved for other types of spinal surgeries, such as lateral- or posterior-approach lumbar fusions. The FDA has also never approved Infuse for surgery on the neck or cervical spine.
When any drug or device – such as Infuse – is used off label, the surgeon must fully disclose the risks of the off-label use, so the patient may make an informed decision before proceeding.
Infuse “Side Effects” not Disclosed
In 2012, The Spine Journal devoted an entire issue to reviewing earlier Infuse studies, which it characterized as “biased or corrupted research” – research which had been conducted by physicians on Medtronic’s payroll.
The Spine Journal noted that in 13 Medtronic-funded trials (of more than 700 patients), the company never disclosed any adverse events. Meanwhile, data accessed by U.S. regulators and other publications showed that as many as 50 percent of patients implanted with InFuse suffered adverse events – complications and side effects that included ectopic bone growth, uncontrolled bone growth, inflammatory cyst formation, cancer and infertility in men.
Medtronic must now answer for its apparently slanted (and well-paid-for) research, and the company must also respond to the whistleblower suit regarding Medtronic’s questionable business practices and the company’s apparently putting profits before people.