Spinal implants have become popular in Florida and around the United States, because they offer a way to reduce pain for those with ongoing back pain. But, when a spinal implant goes wrong, is it medical malpractice? In this case, a 66-year-old man had the implant attached only to have it backfire and result in his paralysis from the waist down. He is only one of over 100 people who have had partial or permanent paralysis due to the spinal-cord stimulators, according to the report.
In these cases, the patients' injuries are reportedly due to the stimulator electrodes puncturing or compressing the spinal cord. Who is to blame? That's what's being debated. The FDA has a database with 58 reports of paralysis in 2013, and it has 48 from 2012. The patients had all received the spinal stimulators from a number of companies, with the three most popular being Medtronic, St. Jude Medical, and Boston Scientific Corp.
Doctors claim that the frequency of paralysis may come down to the implanters' experience and skill levels. But, this isn't well understood, because there isn't enough data. However, researchers at Duke University Medical Center have found that around one in every 100 patients will have some degree of spinal-cord or spinal nerve-root damage. That can range from muscular weakness to paraplegia.
Doctors who have been working with the items claim that there is a problem that may cause risks to patients. That problem is the poor physician awareness of the risks of operating near the spinal cord and the techniques they could be using to help eliminate the risks. With insufficient training and guidelines, this has left some doctors without enough knowledge to perform the procedure safety.
So far, there has been a lawsuit in 2011 after a woman alleged she became paralyzed after a surgeon implanted her with the St. Jude Medical stimulator. She claims the doctor hadn't been trained enough to use it and was negligent. She also claimed that St. Jude Medical was negligent for selling the item to someone without the proper training. She settled out of court in 2012, but the issue is once again being highlighted by new cases.
Source: The Wall Street Journal, "When Spine Implants Cause Paralysis, Who Is to Blame?" Joseph Walker, Apr. 15, 2014