Things to ConsiderThings to Consider

WARNINGS

Possible Danger

Implanting an artificial disc in the spine is serious surgery. There are blood vessels and nerves very close to where the implants enter the body. Your doctor will take care to find and protect the blood vessels and nerves.

Potential Consequences

  • A small cut to a blood vessel could cause dangerous or even fatal loss of blood (hemorrhage).
  • Damage to a nerve could cause long-term loss of movement (paralysis) or feeling.

Possible Complication

As with any artificial disc surgery, there are steps your doctor should take to make the surgery safer. The activL® Artificial Disc should only be used by doctors, who:

  • Are skilled in back surgery.
  • Are specifically trained in the proper use of the activL Artificial Disc including who it should be used in, how it works, how to choose the correct size, and how to implant it correctly.
  • Understand the risks and complications of lumbar disc surgery.

Potential Consequences

  • If your doctor does not have enough experience or training, there may be a higher chance of problems during and after surgery.

Possible Complication

Bone could grow outside the vertebrae (heterotopic ossification (HO)). HO can happen after lumbar artificial disc surgery and may cause less lumbar motion.

Potential Consequences

  • If HO forms, the potential consequences are not fully understood.

What are the WARNINGS and PRECAUTIONS associated with using the activL Artificial Disc?

There was a clinical trial in the United States to evaluate patients treated with the activL Artificial Disc. To participate in the clinical trial, patients had to meet certain criteria. For example, patients could not be included in the trial if they were older than 60 years, if they had undergone previous low back surgery, or if they were taking steroids. As a result, it is unknown if the activL Artificial Disc will perform as well in other types of patients compared to those included in the trial.

Take time to understand the possible dangers from lumbar artificial disc surgery.

Talk to your doctor about the possible dangers and complications of activL Artificial Disc surgery.

PRECAUTIONS

Because the clinical trial only evaluated patients who met certain criteria, the safety and effectiveness of the activL Artificial Disc has not been tested in patients with the following conditions:

  • More than one lumbar spine level that is damaged and needs surgery
  • The young (younger than 18) and the elderly (older than 60)
  • Patients whose bones are still growing
  • Previous lumbar spine surgery
  • Back or leg pain from an unknown source
  • Disease of the bone caused by low mineral levels or genetic problems (Paget’s disease, osteomalacia, or other metabolic bone diseases)
  • Very overweight/obese (Body Mass Index (BMI) greater than 35 based on NIH Clinical Guidelines)
  • Pregnancy
  • Taking medicine that is known to get in the way of bone or soft tissue healing (such as steroids)
  • Diseases that cause the vertebrae to swell or grow together and limit movement, such as rheumatoid arthritis, lupus or other autoimmune diseases
  • Whole body (systemic) diseases, including AIDS, HIV, and hepatitis
  • Active cancer (malignancy)
  • Diseases that affect muscle movement because of problems with nerves or muscles (neuromuscular disorders). Disease examples include: Parkinson‘s disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis.
  • Serious mental illness or drug abuse
  • Insulin dependent diabetes

What are the potential RISKS and ADVERSE EFFECTS associated with using the activL Artificial Disc?

Complications may occur when you are treated with the activL Artificial Disc, as with any surgery. Although many of the major risks are covered in this patient information, a full list is provided in the package insert for the implant, which your doctor has received. Please ask your doctor for more information about any additional risks that could be related to your planned surgery.

Possible complications may include, but are not limited to the following:

Risks associated with low back surgery:

  • Injury to surrounding organs and structures including nerves, surrounding spinal bones, structures that carry lymph (lymphatic vessels), blood vessels, soft tissue, the membrane that surrounds the spinal cord (dura), intestines, kidneys and ureters
  • Problems controlling bowel or bladder function
  • Sexual and reproductive problems including ejaculation of semen into the bladder (retrograde ejaculation)
  • Muscle weakness or loss of movement (paralysis)
  • Numbness or tingling
  • Back or leg pain
  • Swelling from a mass of clotted blood inside the spinal canal (epidural hematoma) or in the region next to where the abdominal organs are located (retroperitoneal hematoma)
  • Scarring in the belly (adhesions)
  • Weakness in the belly muscles (hernia)
  • Swelling or infection in the outside cover of the spinal cord or brain (meningitis)

Risks associated with any surgery:

  • Problems with anesthesia including an allergic reaction
  • Infection involving the wound, near the wound, or elsewhere in the body
  • Problems with the wound including wound opening (dehiscence) or unhealthy tissue within the wound (wound necrosis)
  • Swelling (edema)
  • Soft tissue damage or a fluid collection (hematoma or seroma)
  • Pain around the surgical cut including in the muscles or skin
  • Heart or vascular problems including bleeding, deficient blood supply to a body part (ischemia), abnormal blood pressure, heart attack, stroke, formation of a blood clot, or obstruction of a blood vessel by a clot or abnormal particle in the blood (embolism)
  • Lung complications, including lung collapse or pneumonia
  • Gastrointestinal complications including slowing of the intestines (ileus) or blockage of the intestines (bowel obstruction)
  • Problems with controlling bowel or bladder function including incontinence or other dysfunction
  • Sexual or reproductive problems
  • Nerve problems including nerve damage, loss of movement (paralysis), seizures, changes to mental status, or burning nerve pain with swelling and motor and sensory changes (reflex sympathetic dystrophy)
  • Problems with pregnancy including miscarriage or birth defects
  • Inability to return to daily activities
  • Death

Risks specifically associated with implanted artificial discs including the activL Artificial Disc:

  • An issue with the implant including poor positioning of the implant, movement of the implant out of place, sinking of the implant into the bone resulting in loss of disc height, breakage of the implant, disassembly (coming apart) of the implant, or early or late loosening of the implant. Any of these issues may cause pain or injury to surrounding organs and structures including nerve or spinal cord compression or damage (which could cause paralysis) or damage to blood vessels (which could cause a lot of bleeding).
  • Worsening (deterioration) in neurological status including muscle weakness or loss of movement (paralysis) or numbness or tingling
  • Development of new pain
  • Failure of the artificial disc to improve symptoms or function
  • Problems during placement of the implant including trouble sizing the implant or issues with the implant instruments including the possibility that part of an instrument may remain in your body
  • Reaction of your body to wear debris from the implant (particles of either plastic or metal that come off the implant) or a reaction to the entire implant which may lead to loosening of the implant, bone loss (osteolysis), tumor formation, autoimmune disease, inflammation around the implant because it is made of metal (metallosis), scarring, or other symptoms
  • A change in the alignment or curvature of your spine including abnormal movement of one vertebra compared to the vertebrae below it (spondylolisthesis, instability) or development of an unnatural curvature of the spine
  • Degeneration of other parts of your spine including the joints that connect the vertebrae together in the back of the spine (facet joints) or adjacent discs
  • Narrowing of the spinal canal (spinal stenosis) which may cause symptoms
  • Breakage (fracture) of the surrounding spinal bones
  • Formation of extra bone (heterotopic ossification, anular ossification) which may reduce movement and may result in unintended fusion at either the treated level or another lumbar spinal level
  • The need for additional surgery which could include removal of the activL Artificial Disc

ADVERSE EFFECTS

In addition to the risks listed previously, there is also the risk that the surgery may not be effective in relieving your symptoms, or may cause worsening of your symptoms. If this occurs, you may need another surgery in order to help you feel better.

The activL Artificial Disc was studied by enrolling patients into a clinical trial in the United States approved by the Food and Drug Administration (FDA). The FDA-approved Investigational Device Exemption (IDE) clinical trial included 218 randomized patients who were treated with the activL Artificial Disc and 106 randomized patients who were treated with either the DePuy Spine Charite or the DePuy Synthes Spine Prodisc-L Artificial Disc (other FDA-approved lumbar total disc replacement devices) in the control group. Throughout the FDA clinical trial, patients reported health related problems to their doctors. Some of the events listed on the previous page occurred in the FDA trial. During the U.S. clinical trial, some of the notable events were:

  • Continued lower extremity (leg) pain in 27% (58 out of 218) of activL patients and 21% (22 out of 106) of control group patients.
  • Continued lumbar (low back) pain in 22% (47 out of 218) of activL patients and 33% (35 out of 106) of control group patients.
  • Continued lumbar (low back) and lower extremity (leg) pain in 18% (39 out of 218) of activL patients and 21% (22 out of 106) of control group patients.
  • Complications related to the ability to move (motor function) in 5% (10 out of 218) of activL patients and 7% (7 out of 106) of control group patients.
  • Complications related to feeling (sensation) in 11% (24 out of 218) of activL patients and 16% (17 out of 106) of control group patients.
  • Thirteen patients (5%) treated with the activL Artificial Disc and 6 patients (5%) in the control group had additional surgery at the same level as their original surgery within the first two years.

A complete list of risks is provided in the package insert for the implant, which your doctor has received. Please ask your doctor for more information about any additional risks that could be related to your planned surgery.