Jim Taft had long suffered from nerve damage when his doctor discussed a possible solution using a spinal cord stimulator. He was told that it would offer potentially dramatic results. After the device was implanted it began malfunctioning. He began experiencing shocks that prevented him from sleeping and once caused him to fall down the stairs. He underwent an operation to fix the device; however, it was unsuccessful. Today Taft is partially paralyzed from complications associated with the device. Medical device companies have heavily marketed these products in recent years. Many patients have since had poor results.
Taft has been on worker's compensation for several years after his right arm was smashed while hauling materials at work. Taft's doctor had told him that the spinal stimulator could eliminate his dependency on pain medications. Now Taft feels that his condition is hopeless. His doctor said that some of his patients had excellent results. The AP interviewed Taft and dozens of other patients who have had similar results with product defects.
Stimulators as Alternative to Opioids
Pete Corby, who worked as a stuntman for films, has since endorsed the stimulator as an effective alternative to the pain medications he was addicted to. Doctors are increasingly under pressure to transition their patients away from the pain medications that those with chronic pain become addicted to. In order to obtain coverage from Medicare or Medicaid for the stimulator, doctors must go through a process that makes it a medical necessity. Many of those who have had the implant feel they were pressured to do so because they feared their doctor would stop prescribing their painkillers.
The U.S. Food & Drug Administration (FDA) is largely responsible for the regulation of the medical device industry. Related data is as follows:
- Since 2008 they are said to have received over 80,000 complaints regarding spine stimulator devices
- Complaints have included being shocked, burned and weakness in the muscles
- Only metal hip implants and pumps for insulin have received a higher volume of complaints
- Spinal cord stimulation devices have a relatively high number of complaints despite being less common than hip implants
Manufacturer Response & Potential Liability
Boston Scientific is a manufacturer of the Precision™ Spinal Cord Stimulator (SCS) systems. Legal representation from the company wrote a letter stating that they are protected from civil injury claims based on federal law that covers FDA approved devices. The AP reported that the company stated that the situation involving Mr. Taft was related to his “activity level”, but did not get into specifics. They also stated that many longer-term opioid users may have problems associated with “hyperalgesia”. This condition is described as one where the individual is ultra-sensitive to pain.
Medical Device Industry Influence
Manufacturers of medical devices spend money marketing their products to the medical community. U.S. drug and medical device companies are required to divulge any payments that are made to physicians. Over an estimated $500 million is spent annually by the industry to educate, consult and entertain physicians and hospital personnel. Some device companies have had fines imposed for inappropriate promotion of their products in the past.
Spinal Cord Stimulators
The American Association of Neurological Surgeons classifies SCS systems in three categories:
- Conventional: Have minimal maintenance requirements
- Radiofrequency: Maintain high-output levels of therapy for lengthy time periods
- Rechargeable: Patients recharge these devices regularly