A FAKE NEUROSTIMULATOR IMPLANT!!! FINALLY, AFTER FIVE YEARS OF DOING NOTHING, THE GOVERNMENT ACTS
The company is called StimWave. It claimed to have an innovative product for pain management. In 2014, it proclaimed its advantages:
The device differs from existing SCS (Spinal Cord Stimulator) systems in that it contains no leads or implanted pulse generator, relying instead on power and telemetry provided by an external RF transmitter. Stimwave is touting the device’s simplicity and cost savings for payers and patients. While traditional SCS systems can cost upwards of $20,000, the Stimwave Freedom system will be available in configurations costing as low as $10,000. Also, unlike existing SCS therapy, which requires a trial period with percutaneous leads, the microstimulator serves as its own trial device, enabling more clinicians to maintain care of their chronic pain patients.
This week, the Department of Justice made a startling revelation. They arrested
Laura PERRYMAN, the former Chief Executive Officer (“CEO”) of STIMWAVE LLC, a Florida-based medical device company, in connection with a scheme to create and sell a non-functioning dummy medical device for implantation into patients suffering from chronic pain, resulting in millions of dollars in losses to federal healthcare programs.
The device had an important component and, early on, doctors implanting the device discovered a critical problem.
Soon after the Device was released, physicians informed STIMWAVE that they were having trouble implanting the Pink Stylet in certain patients because the Pink Stylet was too long. STIMWAVE and PERRYMAN knew that the Pink Stylet could not be cut or trimmed to shorten it without interfering with the functionality of the Pink Stylet as a receiver, and without a receiver component for doctors to implant and seek reimbursement for, doctors would incur a substantial financial loss with every purchase of the Device, thereby making it more difficult for STIMWAVE to sell the Device to doctors and medical providers at the approximately $16,000 price.
The company created a “fix” of criminal and horrifying dishonesty:
Instead, PERRYMAN directed that STIMWAVE create the White Stylet — a dummy component made entirely of plastic that served no medical purpose but which STIMWAVE misrepresented to doctors as a customizable receiver alternative to the Pink Stylet. The White Stylet could be cut to size by the doctor for use in smaller anatomical spaces and was created solely so that doctors and medical providers would continue to purchase the Device for use in those scenarios and continue to bill for the implantation of a receiver component. To perpetuate the lie that the White Stylet was functional, PERRYMAN oversaw training that suggested to doctors that the White Stylet was a “receiver,” when, in fact, it was made entirely of plastic, contained no copper, and therefore had no conductivity. In addition, PERRYMAN directed other STIMWAVE employees to vouch for the efficacy of the White Stylet, when she knew that the White Stylet was actually non-functional.
According to a current MedPageToday article:
The alleged scheme was initially brought to the attention of the government by a whistleblower in 2018.
2018?!?!? By my math, that was FIVE YEARS AGO!!!!
Think about this: An IMPLANTED device has a problem and the company simply swaps out the offending piece with a useless chunk of plastic. Patients wonder why their pain implant is not taking care of the pain. The hapless pain doctors reassure the patients it is helping, but they just need to give it time. The company representatives all encourage the concerned pain doctors to give it time. Yet, the device will never work because it is no better than implanting a pain device made from LEGO BLOCKS!
Someone calls the government with details of the fantastic crime and with Barney Fife speed and efficiency, HALF A DECADE passes while vulnerable patients are CRIMINALLY ASSAULTED for no possible good reason so everyone can charge the government huge amounts of money.
FIVE YEARS?!?? Did anyone even attempt to give the pain doctors and their unhappy victim patients a “heads up?” The criminal documents note the devices were implanted from 2017 to 2020, years after the government was notified the company was implanting useless garbage into the bodies of patients. By the time the criminal complaints were created, the company had already filed for bankruptcy.
Reading between the lines, it becomes obvious the implants were not even halted by the government, but by the company’s bankruptcy! Appallingly, the documents note the supposedly favorable actions made by the company, including a “Company-wide compliance program”to reduce the criminal penalties. Excuse me? Isn’t that like letting off a mass shooter because he decides to take a gun safety class?
Do I have any implant patients who have received this device? How would I even know? The level of fraud, harm and abuse here is impossible to overstate. Forget assessing fines that will never be paid. How about bringing back Firing Squads!!!
CAVEAT EMPTOR: Let the Buyer beware… Research, DOCUMENT, DOCUMENT,DOCUMENT.
ALL those Facilities, all the Doctors, have a duty to research the products, make sure they are Valid, then carefully study their RESULTS. Does it work in my patient?..
OH YEAH, THAT TAKES TIME AND WE DON’T HAVE TIME,GOT TO CRANK THOSE PATIENTS THRU, CHARGE THAT PERSON OR THEIR INSURANCE AND GET THOSE BUCKS….
I wait to see if something works.. I did not get the Covid Vac, cause I waited to see if it works, So far never had covid, Never got burned in the Opiod epidemic,working clinics, urgent care and ER’s. Why, cause you got to have standards, Would I give Narc’s to this patient if they were my parent,my wife,my child? I worked chronic pain clinic, seeing people who had “Failed back or other surgery for their pain problems. Often massage therapy, accupuncture, PT, OT, INTENSE WORK HARDENING PT or OT..Course those take time and are not reimbursed as well as all the crap that does not work..Yep Miracle elixir, magic Pill are alive and well in this science based modern world.. LOL,LOL,LOL….. Such are Humans,gotta love them,even the crooks.. Course we should make sure they spend lots of time in a “Loving Jail”….
Work for insurance company and have had pain docs requesting prior auths for new SCS devices because of the bankruptcy, NOT because of non-working fake “receivers”! 🤦🏼♀️
Feel so bad for these patients, many elderly and who may have had to pay out of pocket costs.