Epidural Steroid Injection Risks Include Incurable Arachnoiditis

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FDA Cannot Regulate 'Practice of Medicine'

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 ABCNews.com. "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.

This year, the FDA launched the Safe Use Initiative, working with experts from anesthesiology, orthopedics, neurology/stroke neuro-radiology, pain medicine, and physical medicine and rehabilitation to create guidelines for best practices for transforaminal steroid injections -- those that are administered closest to the spinal arteries.

Experts say the rising number of epidural procedures is due to an aging population that wants to remain more active; an increase in physicians willing to offer them; and word of mouth from patients who say they get relief.

But Bertelli and others who suffer from arachnoiditis say that in hind sight, the risks were too great.

Doctors recommended she get steroid injections in the facet joints on either side of her spinal column after an MRI showed a bulging lumbar disk.

A good friend advised Bertelli not go to a teaching hospital where she had experienced a severe headache after a student administered her epidural.

Instead, Bertelli went to a pain clinic, but when she lay on the examining table a "fellow" gave the injection as her doctor, an osteopath, watched.

"What can you say when there is a needle in your back," Bertelli said. "After several attempts of stabbing around he found the right place."

"Turns out he had been there for three months and it may have been his first injection," she said. "I cried and was in so much pain."

A week after the procedure she experienced, "a burning in the back," and it got worse, preventing her from sleeping. Within three months her entire saddle region went numb.

Despite medications for nerve damage, the pain continued. Doctors misdiagnosed Bertelli with fibromyalgia, and even her husband didn't believe her symptoms were real.

Eventually, she found support from other patients on Facebook -- Life With Arachnoiditis -- and got a diagnosis from Dr. Antonio Aldrete, professor emeritus from the University of Alabama and an authority on arachnoiditis.

Aldrete estimates that as many as 10 to 15 percent of all patients who have epidural steroid injections experience dura perforation. These adverse incidents are "grossly unreported," he said. Aldrete said he bases his findings on clinical work with more than 3,000 patients over 22 years.

"I have personally examined these patients and their radiological images and have their medical records on file," he said. "I can state that all pain management patients whose dura is accidentally punctured during attempted epidural and when steroid (Depomedrol, Kenalog) is deposited subarachnoid, develop arachnoiditis."

"It's not a new disease," he said. "They have found it in mummies in Egypt, caused by TB, syphilis and infections to the spine."

Epidural steroid injections make patients "feel better for awhile," but are being abused in the field of pain management, he said.

"Most go alright, but the ones that go wrong can cause tremendous injury," said Aldrete. The preservatives in steroids can be "toxic" to spinal nerves.

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