A customizable medical implant surgically inserted into patients to alleviate chronic pain was allegedly nothing more than a “dummy component” of inert, useless plastic, according to new legal filings from the FBI.
Medical startup Stimwave touted its StimQ Peripheral Nerve Stimulator (PNS) device as an effective, safe, minimally invasive alternative for patients suffering from chronic pain. In a surgical procedure, doctors implanted the device next to problematic nerve areas near the spinal cord via a cannula, according to past descriptions of the procedure. A PNS delivered tiny electrical pulses powered by a small wearable patch adhered to a user’s shirt, which supposedly enabled the brain to “remap specific pain signals” as described by the FBI. The implant was approved for use by the FDA in March 2017.
[Related: The Theranos trial exposes issues with FDA review.]
“You know you are making a positive impact on people’s lives when some of these people call you up and say, ‘You know, I was going to kill myself before this,’” Laura Tyler Perryman, Stimwave CEO, co-founder, and co-inventor, told Engadget two months after FDA approval. “We had one the other day, someone who had facial pain for 15 years, was bedridden. This person said their pain was zero after receiving our system.”
Soon after approval, however, the FBI reports some doctors began complaining that the PNS device’s approximately 23-centimeter implantable “Pink Stylet” receiver component could not fit in certain regions of patients’ bodies. According to the agency’s timeline, to maintain financial viability, the company introduced a “White Stylet” variant not long after its initial Pink Stylet approval. This alternative could be cut to a desired length before insertion into the body, but in actuality, cutting the implant would render it useless, the FBI reports.
For years, medical professionals continued to suggest Stimwave’s roughly $16,000 products were a possible solution to their chronic pain. According to the FBI, Perryman herself oversaw training for doctors in which she referred to the White Stylet as a “receiver” for the wearable patches’ electrical charges, despite it containing no conductive component. Stimwave continued charging doctors and medical professionals for the device, according to the FBI, which insurance providers—including Medicare—would then reimburse.
[Related: A little known form of medical pollution is costing Puerto Ricans their health.]
Federal officials are charging Perryman with conspiracy to commit wire fraud and health care fraud. In their statement, the FBI also revealed Stimwave filed for bankruptcy in June 2022, a legal move that remained under seal pending the ongoing federal investigations. Stimwave representatives have admitted to wrongdoing, and are entering into a non-prosecution agreement requiring a $10 million fine.
“As a result of her illegal actions, not only did patients undergo unnecessary implanting procedures, but Medicare was defrauded of millions of dollars,” FBI Assistant Director Michael J. Driscoll said in their press release. Perryman could face as much as 20 years in prison if convicted.