Medtronic, Inc. and other medical device makers are reaping huge financial rewards from spinal-cord stimulator implant systems designed to treat chronic pain disorders.
However, a new investigation conducted by the Associated Press and other media outlets throughout the world found that spinal-cord stimulators have actually injured many patients, suggesting the devices are far more dangerous than previously thought.
Spinal-cord stimulator systems generally consist of a lead implanted in the spinal cord’s epidural space, as well as a pulse generator placed into the back or buttocks. Once implanted, the stimulators emit low-voltage electronic pulses to block pain signals to the brain.
At the moment, four medical device companies dominate the market for spinal-cord stimulator implants: Abbott/St. Jude, Boston Scientific; Medtronic, and Nevro.
According to Nevro, that market has grown from just $300 million in 2001 to nearly $2 billion in 2017.
Medicare, major insurance plans, and most state workers’ comp programs cover the devices, making the United States the biggest market for spinal-cord stimulator systems.
According to the Associated Press, medical device makers lay out big money to protect that lucrative market. In 2017 alone, the four companies spent a combined $22 million lobbying to advance their overall business interests.
A significant portion of that spending went to an industry group called AdvaMed, which worked to advance legislation that promoted spinal-cord stimulators as a solution to the opioid crisis.
Unfortunately, some medical device companies may have also flouted the law to promote their pain-therapy implants.
In 2015, for example, Medtronic agreed to pay $2.8 million to settle a whistleblower lawsuit filed by a former employee just four years earlier. Among other things, the complaint accused the company of providing doctors with powerful financial inducements to push spinal-cord stimulators on their patients. Medtronic did not admit guilt when the case settled.
In 2011, a whistleblower lawsuit alleged that Boston Scientific had engaged in multiple unlawful schemes to drive sales of its Precision Plus SCS spinal cord stimulation system. These schemes allegedly included paying kickbacks to physicians and promoting the system for off-label, unapproved indications. That case remains pending.
Most importantly, the Associated Press investigation suggested that spinal-cord stimulator implants often do more harm than good.
Among other things, the article noted that the U.S. Food & Drug Administration (FDA) has received more than 80,000 injury reports involving spinal-cord stimulator systems since 2008. In fact, metal-on-metal hip implants and insulin pumps were the only medical devices associated with more complaints.
According to many of the FDA reports, a spinal-cord simulator implant had burned or shocked a patient. In other cases, the devices actually worsened chronic pain.
At least 500 patients had died after receiving a spinal-cord stimulator implant. However, it’s not clear if the devices or complications from the implant surgeries caused the deaths.
In addition, medical device makers frequently recall these systems. In fact, the companies have announced 50 spinal-cord simulator recalls since 2005. That’s an average of four per year!
About half of those spinal-cord stimulator implant recalls involved Medtronic devices. However, none of the recall notices warned of a risk of injury or death.