Medtronic accused of misleading doctors over spinal stimulator effectiveness

Medtronic is accused of misleading patients and doctors regarding the effectiveness of its Intellis spinal cord stimulator, an implant used to treat back pain. According to confidential reports from Australia’s Therapeutic Goods Administration (TGA) obtained via freedom of information laws, the company’s claims of significant pain reduction may be unsupported by real-world data.

While Medtronic’s website cites a 2021 study of 128 people claiming the device reduces pain by more than half for most patients, unpublished data from a much larger group suggests the device may provide no meaningful benefit while exposing users to serious risks. A TGA government auditor noted that the performance data is “substantially worse” than the manufacturer’s published studies and that the improvements were so minimal it was unclear if they constituted a benefit at all.

The regulator concluded that the studies used to back the device were poorly designed and small. The report further stated that it is “impossible to see how patients can give meaningful informed consent in this setting, nor how prescribers can make reasonable recommendations about care.” The Intellis device was approved for sale by the TGA in 2018.