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AM I A CANDIDATE?

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Barricaid® is indicated for patients at greater risk of a new disc herniation, disc collapse and return of sciatica (back and leg pain). Your surgeon can identify you as a potential candidate for the Barricaid before surgery by measuring your posterior disc height on an MRI scan. A minimum of 5mm posterior disc height is required. During surgery, fi your anular defect size (hole in the disc) is between 4-6mm tall, and 6-12mm wide, you are considered at greater risk for developing a new herniation over time.

The final decision about placing a Barricaid will always be taken during surgery.

You can download a patient brochure for the Barricaid device here.

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INFORMED CONSENT

Informed consent means that as a patient, you are given all available information so you can understand what is involved in this procedure. Your doctor will explain the treatment to you, including its possible benefits and risks. You will be given an informed consent form to read and consider carefully.

WARNINGS AND PRECAUTIONS

There are a number of health risks that have been linked with standard discectomy surgery. They include:

  • Breakdown of bone in the spine (vertebral bone resorption)
  • Bulging or leaking of the soft material inside the spinal disc into the epidural space through the hole the surgeon made in the disc’s outer ring during the discectomy procedure, which may compress or damage neural elements (reherniation).
  • Problems from anesthesia
  • Problems with how blood moves about the body (circulatory problems)
  • Blood clots                                                                  
  • Heart attack
  • Stroke
  • Death
  • Pneumonia
  • Spinal fluid leaks
  • Blood vessel damage/bleeding
  • Infection
  • Leg pain
  • Back pain
  • Bruises
  • Bladder problems
  • Problems related to nerves

There are also health risks that could occur after the Barricaid device is placed in your spine. These risks include:

  1. Movement of some or all of the device from its original location into the epidural space, which may compress or damage neural elements.
  2. Bulging or leaking of the soft material inside the spinal disc into the epidural space through the hole the surgeon made in the disc’s outer ring during the discectomy procedure, which may compress or damage neural elements (reherniation).
  3. Sinking or settling of some or all of the device into the backbone.
  4. Movement of some or all of the device from its original location into the disc space.
  5. Separation of the mesh part of the device from the part that holds it in place.
  6. Loosening of the part of the device that holds it in place from the bone.
  7. Decrease in bone density due to less stress in the area.
  8. Fracture of bony structures.
  9. Fracture of the device.
  10. Sensitivity to the implant material or allergic reaction to a foreign body.
  11. Discomfort or abnormal sensations due to the presence of the device.
  12. Irritation of the nerve root, damage from placing or removing the device, or both.
  13. Excessive scar tissue formation.
  14. Operation to remove the device.
  15. Increased breakdown of bone in the spine (vertebral bone resorption).