Marti Conger now has two artificial cervical discs in her neck. Her own discs had degenerated, causing spinal cord compression, severe numbness and pain. She traveled to England for the surgery since her insurance would only cover spinal fusion and not disc replacement.
"Even though it's FDA-approved and even though it's got 30 years track record on it, we consider it investigational," she told ABC7. "And, Dr. Chou even helped me fight them but, I lost every battle along the way."
"It's a really frustrating situation as a physician because you know that once you fuse someone's neck, you can't unfuse their neck," Chou said.
UCFS neurosurgeon and spine specialist Dr. Dean Chou supported Conger's decision to travel abroad for the surgery when the State of California upheld her insurance company's decision.
"I was shocked," she said. "I was shocked that my government wouldn't stand behind me."
She ended up choosing a surgeon in England who was using discs not yet FDA-approved in this country, but manufactured by Sunnyvale-based "Spinal Kinetics." A company animation demonstrates the product's range of motion. Preserving motion is believed to protect surrounding discs from degeneration, a problem with fusion.
"The recovery from a fusion is months. And, with an artificial disc, plunk it in, I'm ready to go," Conger explained.
In fact, three days later, she and her husband were sightseeing in England before heading home. Now that she is back, she is on a mission to change the system. She is focused on the FDA.
"All we need to know... is the product safe? Then, let us decide whether we want to use it and get it out there quickly," she said. "No more of this starting from scratch and having to do trials over again. They should be able to start with the data on hand."
She wants a fast track for medical devices with proven track records in trusted countries.
Neurosurgeon Dr. Charles Branch is President of the North American Spine Society. He understands patient frustration, but believes clinical trials in this country are critical.
"The FDA is always wrestling with this. What's too quick? What's too slow?" he said. "I'm also bound by this ethical need to make sure that if I'm going to use it on a patient, it needs to be as safe and effective as it can be."
He points to the need for change within the insurance regulatory system.
"Why shouldn't we have a standard that says if the FDA has approved a product for commercial use and marketing, why shouldn't very insurance company be obligated to cover that?" he asked.
But, as Congers pointed out, "Instead, insurance companies are allowed to say oh no, we consider it investigational. No, once it's approved, it's approved."
Conger has already applied to the FDA to become a consumer advocate on its Medical Device Advisory Committee. She is also lobbying Congress and the insurance industry for change.
"I think she's made a phenomenal effort and kudos to her for all that she's done to really try and push this," Dr. Chou said.
And, she is just getting started.
"You got what you needed. Help someone else…. This is not a one-time gig," she said.
Marti Conger can be contacted at: marti@congerresources.com.
