What is Infuse?
Infuse is a permanently implanted medical device sold by Medtronic that makes bones grow together as a way to treat chronic back pain.
The system started out as a three-part product – a cage that held a sponge coated in a laboratory-made bone morphogenetic protein (BMP) that helped bones grow together after lower spine surgery.
But since its introduction in 2002, the name Infuse has come to be associated with the protein alone. It is sold separately from the cage and sponge and used the vast majority of the time in ways the FDA never judged safe or effective.
How is it supposed to be used?
For spine surgery, Infuse only has Food and Drug Administration approval for procedures entering from the front of the body, known as the anterior approach, to fuse no more than two vertebrae in the L4, L5 and S1 sections of the spine.
Most spinal surgeries enter from the back of the body, known as the posterior approach. Infuse is not FDA-approved for this or for uses in the chest and neck areas of the spine. The device is also FDA approved for use in the tibia, the long bone between the foot and the knee, as well as a few dental procedures.
How is Infuse usually used?
In the 13 years since its release, Infuse has been used in unapproved or “off-label” procedures in 85 percent of more than 1 million surgeries. Doctors have inserted it primarily from the back in the lower spine. It has been used in the neck area of the spine and in some cases in children, despite specific wanings from the FDA not to do so.
What can happen with “off-label” use?
The most common complications include uncontrolled bone growth that can lead to painful, permanent nerve damage. Other patients have experienced male sterility, swelling of the throat, bowel and bladder problems. The North American Spine Society says Infuse carries a small but significant cancer risk.
Do we know how many people have been adversely affected by “off-label” use?
Medtronic says it faces 1,500 personal injury claims related to Infuse, and lawyers have informed the company of another 4,600 claims expected to be filed. Since 2002, the FDA has received more than 10,000 reports of complications related to Infuse. In 2012, an FDA researcher found that 99.5 percent of publicly reported injuries related to Infuse stemmed from off-label procedures.
What does the law say?
Doctors are free to use FDA-approved devices in unapproved ways so long as they believe it will help patients. Doctors do not have to inform patients of off-labe uses and their risks beforehand. Federal law requires medical-device companies to make a public report whenever any of their employees gets information suggesting that one of their devices may have caused or contributed to a death or serious injury. The law says the report must be filed within 30 days, and each adverse event is supposed to have its own report.