The Boston Scientific Spinal Cord Stimulator lawsuit was filed by the family of a child who was paralyzed from the neck down. The medical community at that time was not yet ready to use this type of treatment to effectively reverse the damage that had been done to their child. The lawsuit claims that the company did not have enough data to show that these VESD treatments were effective.
This particular device was developed around the time when Boston Scientific was considering a leader in spinal cord research. There have been other lawsuits and claims regarding the quality of the Boston Scientific Spinal Cord Stimulator.
Boston Scientific Spinal Cord Stimulator Lawsuit
In 1997, Doctor Timothy Sheffrin of Tufts University came up with a revolutionary device called a spinal cord stimulator (also known as a vestibulocular electric stimulator). He named it the Boston Scientific Spinal Cord Stimulator. The device has been used to treat severe spinal cord injuries for over fifteen years.
However, on March 4th, in a federal court in Seattle, Washington, the FDA announced that they would be banning the VESD device due to safety concerns. In an eight-page letter addressed to the FDA, the agency cited a number of cases where patients had died or had permanent nerve damage as a result of using the Boston Scientific device.
The Boston Scientific model was the first of its kind to treat spinal cord injuries and return function to patients.
Patients that suffered injuries from stroke, carpal tunnel syndrome, tumors, or birth defects that affected the spinal cord were treated through the Boston Scientific model. According to the company, they invested a great deal of time and money into testing the VESD before deciding to approve it. They received approval in March of 1998. At the time of the FDA’s announcement, approximately twenty patients had undergone procedures using the Boston Scientific spinal-cord stimulator.
The FDA cited a number of factors that they said led to their decision to ban the stimulator.
One was that the company said that the devices that they were manufacturing did not properly meet the clinical guidelines required by the Food and Drug Administration. Another was that the devices caused a number of negative side effects. According to the FDA, one patient experienced infections and pain while another required an operation after the device was implanted. The FDA also cited animal studies in which mice had tumors implanted under the skin in order to determine whether the device would cause cancer in humans.
Many patients and their families are upset with the FDA’s decision.
For a medical device manufacturer to get their medical device approved, the medical facility that is conducting the research needs to make sure that everything is safe and adequate for human use. Medical device manufacturers need to conduct clinical trials for at least two years before they can be released onto the market.
This is to ensure that the product is safe and efficient before being offered for use by patients. The FDA cited numerous instances in which Boston Scientific was negligent in its conduct of clinical trials.
In addition to the Boston Scientific spinal-cord stimulator lawsuit, there is a lawsuit from the Center for Safe Surgery, which is seeking compensation for medical malpractice.
The center is also looking into whether or not Boston Scientific should be held liable for the injury of a former employee who died of asphyxiation after having surgery with one of their devices. The death of the man has prompted a number of lawsuits against the company. If these lawsuits prove successful, it could force medical devices manufacturers to develop more safety features for their products. Right now, all spinal-cord stimulators sold in the US are not approved for home use, although some devices are approved for use in hospitals.
I had Boston Scientific WaveWriter Spinal Cord Stimulator implanted September 2019 and then after one year of torture and pain I had it removed in September 2020. Now, two years since removal I still have not only my original back pain but constant burning pain, pins and needle pain where the battery was located. They kept saying it would go away after time. Well it’s been two years and I still have the same pain. Nothing helps it. This company needs to be sued because there are hundreds and possibly thousands of people who have suffered while they fill their pockets with big insurance funded implants. Makes me sick and I wish I would have refused the thing like my instinct told me. On a side note, my aunt had one put in and the day after she came home from surgery she collapsed and died, she had no serious health issues either outside of back pain