When Michelle discovered her insurance company did not yet cover spinal disc replacement surgery with the PRESTIGE® Cervical Disc, she decided to take action. Today, she's free of her neck pain and back pain and "feels like a new person."
There are times in life when "no" just isn't — and shouldn't — be an option.
When Michelle's doctor recommended spine surgery to ease the debilitating neck pain she'd endured for months due to a herniated disc, she felt confident the procedure she'd elected to undergo — cervical arthroplasty, or spinal disc replacement — with the PRESTIGE® Cervical Disc was the right one for her, and looked forward to the day when she could finally play with her little boy again, pain-free.
But when Michelle learned her medical insurance provider didn't yet cover the procedure, leaving spinal fusion her only surgical option, she decided to take action — and learned that persistence can indeed pay off.
At the age of 26, Michelle already felt like a medical industry insider. A nursing support coordinator at a major Minneapolis hospital, she spent her days taking care of patients in the pre- and postsurgical departments. The previous year, she'd undergone gall bladder surgery, and spent several months recovering not only from her procedure but a serious case of meningitis she developed soon after.
Her illness finally behind her, Michelle felt overwhelming gratitude and relief. Her happiness was soon cut short, however, when she developed acute back pain between her shoulder blades that extended into her neck. "My back and neck pain was constant, and it intensified really quickly," she recalls. "There was a lot of pressure — it was aching and sharp all at the same time. It felt so bad, the pain was just incredible." It didn't take long for Michelle to make an appointment with her general practitioner. Diagnostic testing, including x-rays and magnetic resonance imaging (MRI), revealed the cause of Michelle's pain to be a herniated disc between the C5/C6 vertebrae of her cervical spine. This is a condition in which the jelly-like inner core of the disc bulges out through a tear in its outer, fibrous layer. If the disc material presses on a spinal nerve, it can cause pain, numbness and weakness, both in the neck and other parts of the body.
Under the guidance of her doctor, Michelle initially tried to manage her symptoms with nonsurgical treatments, including physical therapy, cold packs, and pain relief medication, including epidural steroid injections. She sought the help of an acupuncturist and chiropractor, but over several months experienced no lasting relief with any of these. "I did it all, but the pain just continued to get worse," she says. "I have a seven-year-old son, and it affected everything I did with him, my ability to function as a mom. Every day, I'd come in from work and have to immediately lie down to recover. My son got to where he knew the routine — he knew when Mom got home, it was time for him to go play quietly in his room so she could ice her neck. We'd have a quick dinner, then I'd get right back in the recliner with more ice packs. I had to help him with his homework from there, and read to him. My personality suffered; I was agitated and short-tempered all the time, because I was in such pain. It was no way to be a parent."
After a few months, in addition to the pain she also started to feel shooting pains down her left arm, along with numbness and tingling, and eventually lost sensation in her left hand. Because these symptoms can signal serious nerve involvement, which can possibly lead to potential nerve damage, and because all the conservative therapies she'd tried hadn't provided any relief, Michelle's doctor felt it was finally time for her to consider spine surgery, and referred her to a spine surgeon. "Once I knew I was a surgical candidate, I started exploring my options," she says. "I knew I didn't want spinal fusion, and wanted to see what else was out there."
After looking over Michelle's diagnostic and physical exams and considering her particular spinal condition and overall general health, Michelle's surgeon, Dr. Mahmoud Nagib with Neurological Associates, Ltd., in Minneapolis, recommended spinal disc replacement surgery with the PRESTIGE® Cervical Disc as a possible alternative. "Until Dr. Nagib mentioned it, this was something I'd never heard of," Michelle admits. "He gave me a lot of information on the procedure, and I did an extensive amount of research into it on my own. Learning more about it, what I really liked was the possibility for preserving the range of motion I was used to in that part of my spine. Not losing this is huge for me, in terms of what that means for my future, and for my spine."
When considering spine surgery with the PRESTIGE® Cervical Disc, Michelle weighed the possible benefit of maintained range of motion against the technology's potential risks, which include anatomical or technical difficulties, early or late loosening of the components, tissue reaction, or component sizing issues. Additional risks include the formation of bone that may reduce spinal motion or result in a fusion, either at the treated level or adjacent levels, and/or new radiculopathy, myelopathy, or pain. For more information, please click here for links to important safety information or the patient information brochure which contains the complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.
Traditionally, spinal fusion has been the "gold standard" for surgically treating spine conditions such as Michelle's. Many patients achieve excellent results with fusion; however, a potential disadvantage associated with the procedure is the loss of motion and flexibility in the treated vertebral segment. "I'd learned that this could put more stress on the vertebrae next to it, and that I could possibly need another fusion in a few years," Michelle explains. "Being as young as I am, with a herniated disc due to degenerative disc disease, I wanted to do whatever I could to avoid any more surgery, if at all possible."
By the time Michelle was ready to have spinal disc replacement surgery with the PRESTIGE® Cervical Disc, she'd been living in almost constant pain for more than seven months, and was more than ready to get her life back on track. "My days were nothing but work, parenting and school; everything else — my volunteer work, time with friends — was out." There was only one remaining obstacle to overcome: her insurance company's initial decision to deny coverage of her procedure.
In some cases, an insurance company may not be willing to cover a treatment or surgery because it involves technology that it considers new or experimental, even though it may be approved by the U.S. Food and Drug Administration. When Michelle requested coverage of her procedure, the PRESTIGE® Cervical Disc, released in Europe in 2004, had only been on the market in the United States for about three months.
If an insurance provider denies a claim, the company is, however, required to take another look at the case and reconsider its decision when the policy holder resubmits the claim in accordance with the rules and regulations of that particular insurance company's appeals process. By providing the right information and "dotting their i's and crossing their t's" through the proper channels, policy holders are often able to overturn a claim denial.
With the help of her doctors and her employer's human resources department, Michelle successfully convinced her insurance provider to cover her procedure with the PRESTIGE® Cervical Disc. "I got it covered, but it did take a while, about eight months," she says. "Three doctors, including my surgeon and referring doctor, submitted appeal documents, and I received a lot of help from my hospital's (employer's) benefits staff in navigating the process, as well."
Data from clinical studies supporting the technology's safety and effectiveness also helped turn the decision in her favor. Approved by the FDA in July 2007, the implant has been studied in the most rigorous manner possible, evaluated in a Level 1 multicenter, prospective, randomized, controlled study that involved 541 patients — the most extensive clinical study of its kind ever conducted for the cervical spine.
"Eventually, my case was presented at a meeting, and I got a phone call saying my surgery was approved," Michelle says. "It was so great to finally get that call!"
Her insurance company now on board, Michelle scheduled her surgery for the following month. To replace Michelle's damaged intervertebral disc with the PRESTIGE® Cervical Disc, Dr. Nagib made a small incision in the front of her neck and created a narrow opening through the muscles for access to the cervical vertebrae. He then removed the damaged disc material pressing on Michelle's spinal nerves and, through the opening, inserted the PRESTIGE® Cervical Disc and closed the incision. The procedure was performed under general anesthesia, and Michelle was released from the hospital the day after her surgery.
Michelle admits that before her surgery, she was nervous, but waking up, knew she'd made the right decision. "As I came to, I realized I could feel my hand again, and the pain I'd had before in my back, neck and all down my arm was gone. It was a night and day difference."
To manage her incision pain, Michelle took medication for about a week; after two weeks, she was cleared to drive again, and started a month-long course of physical therapy. "I was advised not to do any heavy lifting, but other than that there really wasn't much else I couldn't do," she says. "I felt really good. The only time I had any flare-up of my old symptoms was during the first few weeks; if I pushed myself too hard, I'd get a little tingling in my fingers. But after taking it easy a few hours, it would go away. Of course, I was on the phone to Dr. Nagib immediately, scared the pain was coming back, but he explained that this was normal, an after-effect of the nerve damage. Now that never happens at all."
Following her procedure, Michelle took several weeks off work, in part to "make up for lost time" with her son, she says. "He was a big part of my recovery. He was really into keeping up with my range of motion — the day I could finally turn around to look at him in the back seat of the car, he started clapping and cheering, saying 'Mom, you finally turned your head all the way!' And whenever somebody would ask how I was doing, he'd say "Look how far she can turn her head now!'"
Today, Michelle is symptom-free, and having a great time reconnecting with the world around her. "I feel like a new person," she says. "I keep hearing from everyone that it's great to see me smile again — they'd forgotten what it was like. I can concentrate again, and I no longer want to break down in tears on my way out the door at the end of the day."
Even though her symptoms possibly could have been resolved earlier had she chosen to undergo spinal fusion, Michelle says she's happy she stuck by her decision to have spinal disc replacement surgery with the PRESTIGE® Cervical Disc, and that the time and effort she invested convincing her insurance company to cover it was worth it. "I'm so glad I was able to have this kind of surgery, that the technology was available and that I could finally get it covered," she says. "Of course, I wish I could have had it sooner. But I'd advise anyone else in the same situation to just hang in there, because I truly believe disc replacement saved me in the long run from having to have spine surgery again.
"And I feel fabulous. I've got my full range of motion back, and life has turned around 100 percent from where it was before. Thanks for such a great product!"
Read more about the PRESTIGE® Cervical Disc and cervical artificial disc replacement at www.prestigedisc.com.
It is important that you discuss the potential risks, complications and benefits of the PRESTIGE® Cervical Disc with your doctor prior to receiving treatment, and that you rely on your doctor's judgment. Only your doctor can determine whether you are a suitable candidate for this treatment.
As you read this please keep in mind that all treatment and outcome results are specific to the individual patient. Results may vary. Complications, such as infection, blood loss, or nerve damage are some of the potential adverse risks of spinal surgery. Please consult your physician for a complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.