(NEW YORK) — Helen Bertelli, a mother of two young girls from Raleigh, N.C., has been crippled with weird symptoms — electric shocks, muscle cramps and the sensation that water is running down her legs — all since she received an epidural steroid injection for back pain in 2011.
Three months after a medical “fellow” administered the shot at a pain clinic, she had trouble urinating, then both her feet went numb.
“I had this feeling I was connected to the end of a guitar string and someone was plucking it,” said Bertelli, 36, a former runner and hiker. “My legs just exploded like there were fireworks in them. My muscles twitched like they were boiling.”
For months doctors told her the knife-like pains were in her head, but six months later, Bertelli was diagnosed with arachnoiditis, an incurable condition that can be associated with epidural steroid injections.
Arachnoiditis is not fungal meningitis. The outbreak that killed 23 and infected 308 patients nationwide was linked to contaminated steroid solution prepared by a Massachusetts compounding pharmacy.
What Bertelli has is a pain disorder caused by the inflammation of the arachnoid, a delicate spider web-like membrane that surrounds and protects the spinal nerves, spinal cord and brain. The three most common causes are surgery, infection and chemical irritation.
“It’s rare,” said Dr. Ray M. Baker, an anesthesiologist and president of the International Spine Intervention Society.
But advocates, including Baker, say that the rising number of epidural steroid injections — many performed by untrained clinicians — signals the need for better medical and patient education about risks.
There is some evidence linking the preservatives in steroid medication to arachnoiditis, when the medication is accidentally injected into the spinal fluid. Fluoroscopic (x-ray) guidance is useful with spinal injections, as it confirms needle placement outside of the spinal fluid and allows for safe injection, according to Baker.
“With the right hands, the right skill set and the right patient and the right conditions, they are safe and quite effective,” said Baker. “We don’t have a lot of policing or oversight to say what are the standards and the rules.”
And consumers don’t know what a “quality job” is, he said.
“Although the fungal meningitis outbreak is a horrible tragedy, we need to be looking at lessons learned,” he told ABC News. “If any good can come from this, in addition to shining a light on the need for greater oversight of compounding pharmacies, it might be that the media attention on steroid injections will allow patients to become better-informed consumers. For patients, it is buyer beware.”
A patient group, led by Bertelli, has urged the Food and Drug Administration (FDA) to provide more comprehensive training of the practice, better oversight of physicians and better patient consent forms that include arachnoiditis as a potential complication.
She also wants better tracking of adverse events and better guidelines for doctors on contraindications.
FDA spokesman Sandy Walsh said “the practice of medicine” does not fall under FDA regulation, but is regulated by the states.
“That being said, in a broader sense, FDA does review adverse event reports and notify the public of safety warnings as we learn new information,” she told ABC News. “And we do often work with physicians groups and external partners.”
She acknowledged that complications from these epidural injections can include, in addition to arachnoiditis, bowel and bladder dysfunction, headache, meningitis, paraparesis/paraplegia, seizures and sensory disturbances.
Copyright 2012 ABC News Radio
Emanuella Grinberg, CNN