Federal regulators are urging doctors to conduct a trial stimulation period for patients before implanting permanent spinal cord stimulators, following reports of hundreds of patient deaths linked to complications with the devices.
In some cases, patients can experience serious side effects from spinal cord stimulators, including pain from the device and even death, which is why the agency issued a letter to healthcare professionals on September 2, advising doctors to conduct test implant before permanent spinal cord stimulator (SCS) is placed in the body.
Spinal cord stimulators are offered as an aid to cope with unmanageable chronic pain, including pain associated with failed back surgery syndrome, or unmanageable low back and leg pain. Roughly 50,000 of these devices are implanted every year in the U.S.
In many cases, the SCS implants are offered to patients who are not eligible for other devices or who have failed other therapies. This is an opportunity for the patient to experience significant improvement from debilitating symptoms.
An SCS trial period is typically done for three to seven days. Success is defined by a 50% reduction in pain symptoms.
The FDA reviewed more than 107,000 medical device reports for SCS implantation, including nearly 500 reports that lead to death, 80,000 that caused injury of some kind, and 30,000 involving device malfunction.
The most common problems from spinal cord stimulators, occurring in 28% of cases, was inadequate pain relief. Roughly 15% of cases caused pain to the patient. Problems in the other injury reports included infection and discomfort.
Patients also reported other problems with the device, included charging problems, device migration, or battery problems.
The FDA letter called on doctors to conduct a trial stimulation before permanent implantation to not only ensure adequate pain relief, but also help prevent some serious side effects. Additionally, permanent implantation should only be conducted among patients who have undergone and passed stimulation trial.
The agency advises doctors to inform patients of serious side effects and what to expect during the trial. Doctors should also discuss the benefits and risks of different types of implants and treatment options, including MRI compatibility.
Doctors should also provide the manufacturers labeling and any other educational materials for the device that will be implanted and inform the patient of the risks and benefits and what to expect during use. They should also provide the patient with the name of the device manufacturer, model, and unique device identifier of the implant.
Conducting a trial stimulation before permanent implantation is not only crucial for safety and proper pain relief but can help provide doctors with additional medical recommendations.
Doctors and patients should report any side effects or adverse events to the FDA’s MedWatch Adverse Event Reporting program.