The problem is that some doctors who promote the off-label use of Infuse Bone Graft allegedly received money from Medtronic. That money was listed as consulting fees, but a whistleblower lawsuit claims that the money was actually payment for promoting the Bone Graft for unapproved uses.
Usually, companies like Medtronic are investigated for their actions—after all, it is illegal to market a drug or device for off-label use. However, more and more frequently, individual doctors are being taken to task for their actions. Investigators are angry that doctors are accepting illegal kickbacks, while patients are upset that they were not informed that their doctor had financial incentives to use a particular device in their surgery.It is not abnormal for a doctor to prefer a particular brand of medical device over another. Often, the doctor is more familiar with the means of implanting one device or feels more comfortable with its success rate. But when the doctor uses one device over another because he or she has a financial incentive, the patient is the one who loses—especially if that device turns out to be faulty. In the case of the Medtronic Infuse Bone Graft, patients have reported swelling necks and compressed airways, causing trouble breathing and swallowing—most of those problems have occurred after the Infuse Bone Graft was used for off-label purposes.
According to the Minneapolis Star-Tribune, medical device companies look for surgeons who will use a high volume of their devices and surgeons who are known as "Key Opinion Leaders." The opinion leaders are people whose opinions on medical devices are held in high regard: If they are willing to promote the use of a certain device, then other surgeons are likely to follow suit and use that device. The company then pays the "Key Opinion Leader" a consulting fee and the doctor promotes the use of a particular medical device.
Congress is attempting to pass a bill, the Physician Payments Sunshine Act, that would force medical companies to reveal how much money they give to doctors, including gifts and travel. That information would then be made public on a government website. Whether or not it would affect how much money is given to doctors is not yet known. Of course, it is important to note that not all of these arrangements between device makers and doctors are illegal—it is the use of kickbacks, or payments for use of a specific device, that is illegal.
Medical devices are often a mystery to patients. We rely on our doctors to make the best decision regarding medical devices for us because we cannot possibly understand how all the devices work and how they differ from one another. Most doctors will absolutely make the right decision for us, based on our unique situations and needs. However, some doctors may make this decision not because it is best for us but because it is financially profitable for them—because the company that makes the device is giving them money. So the question then is: "Would you have used this device if you were not receiving money from the device maker?" Of course, the even scarier follow-up question is: "Do I actually need this surgery, or am I having it because you want to implant a device that you profit from?"