Benefits and Risks
The PRESTIGE® Cervical Disc is an artificial disc replacement that was designed to maintain motion and offers patients an alternative to cervical spinal fusion. The benefits of treatment with the technology, however, should be weighed against the risks.
Once you have discussed your condition and your treatment options thoroughly with your doctor, you must weigh the benefits and risks associated with each treatment plan. It's important that you consider the impact your condition has on your daily life and on your ability to participate in the activities you enjoy. You may decide the risks associated with a particular treatment are greater than the potential benefits, or that the benefits to be gained may outweigh any possible risks. Discuss these issues thoroughly with your family and your health care team.
The PRESTIGE® Cervical Disc: Potential Benefits
Your doctor may recommend surgery if non-surgical treatment fails to provide relief from the symptoms of radiculopathy/myelopathy related to degenerative disc disease (DDD) in the cervical spine, which may include pain, numbness and/or weakness in the arms. The benefits of surgery can outweigh the risk.
Traditionally, an anterior cervical discectomy with fusion (ACDF) has been the "gold standard" for surgically treating DDD in the cervical spine. Using bone grafts and instrumentation such as metal plates and screws, this procedure fuses, or creates a bond between two or more adjacent vertebrae, ideally stabilizing the segment and providing relief. Many patients have achieved excellent results with ACDF; however, a potential disadvantage associated with spinal fusion is the loss of motion and flexibility in the treated vertebral segment.
The PRESTIGE® Cervical Disc offers patients with DDD and associated neurologic symptoms an alternative to ACDF. The device is made of two-piece stainless steel components, which are secured to the vertebral bodies via a flange and screw locking mechanism. A round "ball" located on the superior (upper) component sits within an elongated cavity, or "trough" located on the inferior (lower) component to create a unique ball-and-trough articulation.
The PRESTIGE® Cervical Disc is FDA approved for safety and effectiveness.
The PRESTIGE® Cervical Disc: Potential Risks
As with any spine surgery, surgical treatment with the PRESTIGE® Cervical Disc is not without risk. A variety of complications may occur, either alone or in combination. It also is important to remember that surgery is a human endeavor, and that errors and unforeseeable outcomes may occur.
Potential risks associated with surgery include anesthesia complications, blood clots, allergic reactions and adverse effects due to undiagnosed medical problems, such as silent heart disease. Potential complications associated with spine surgery and the PRESTIGE® Cervical Disc may include:
- Allergic reaction to the implant material
- Bending, breaking, movement or migration of implant material
- Local and/or systemic infection
- Pain
- Nerve or spinal cord injury
- Numbness or tingling in extremities
- Tear in the protective membrane of the spinal cord
- Loss of motion or fusion at the treated cervical level
- Development or progression of disease at other cervical levels
- Bleeding and/or blood clotting, possibly resulting in hematoma or stroke
- Swelling
- Adverse reaction to anesthesia
- Altered mental state
- Pregnancy complications, including miscarriage and/or fetal birth defects
- Inability to resume normal activities, including sexual activities
- Death
Most of these complications happen very infrequently and can be treated once they are detected. However, this may require a longer period of hospitalization and recovery, more medications and in some instances additional surgery.
Please discuss the risks associated with your specific surgical procedure and the PRESTIGE® Cervical Disc thoroughly with your surgeon. Your doctor also will have a specific recovery plan for you to follow after your procedure. It is important that you follow your doctor's instructions carefully, so you can recover as quickly as possible and increase your chances of a successful outcome.
Find out if you are a candidate for the PRESTIGE® Cervical Disc.
Talk with your doctor to learn more about the PRESTIGE® Cervical Disc.
For more information about the PRESTIGE® Cervical Disc, talk to your spine surgeon. To find a doctor near you, visit our physician locator.
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 physician\'s judgment. Only your doctor can determine whether you are a suitable candidate for this treatment.
Important Safety Information
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