After many women suffered medical problems from an intrauterine device, Congress passed a Medical Device Amendment Law in 1976 in hope to prevent medical devices from being used on patients without an appropriate approval process. The Food and Drug Administration became the government department that provided oversight and approval for medical devices. One representative of the FDA stated that as many as 12 devices or modifications to previous devices are approved on a daily basis. Residents in Massachusetts may be interested to learn that some patients are experiencing negative side effects and decreased quality of life following a device implant. One man in another state may have experienced medical malpractice after an implanted spinal-cord stimulator left him bedridden.
The 45-year-old man had an existing injury to his arm that resulted in significant pain. The man was under the care of a pain management physician when he was introduced to the possibility that an implanted device could help reduce his occurrence of pain. A spinal-cord stimulator was implanted, but it malfunctioned. The device produced severe shocks, resulting in insomnia and a fall downstairs. The man reports that he remains in his bed the majority of his days and requires assistance for daily activities.
Unfortunately, the man is not the one who has suffered from implanted spinal cord stimulators. Reports of injuries from spinal-cord stimulators are the third highest reported to the FDA. Only reports of injuries from artificial hip joints and insulin pumps have more reported injuries. Adverse reactions from spinal-cord stimulators include shocks, burns, spinal cord never damage, muscle weakness and paraplegia. It is unclear if there are any deaths directly related to injuries from the devices.
Some individuals are beginning to question the process by which the FDA approves medical devices and the ethics of medical device companies providing compensation to physicians to promote patient use of the new technology. When a device fails for a patient, the patient bears the burden of the pain, loss of quality of life and medical expenses for any additional treatment. Massachusetts medical malpractice attorneys understand the difficulty some patients face and can offer advice on options to seek compensation for financial losses.
