Treatments

Know the Risks

With any surgery, there are potential risks of complications. We've collected information that patients should understand before undergoing an iFuse procedure. Talk to your doctor to learn more.


Information for Patients Considering SI Joint Surgery

If you are a Healthcare Provider, please view the Indications for Use here.

INDICATIONS

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

CONTRAINDICATIONS

If any of the following apply to you, you may not be a candidate for iFuse.

  • Deformities or anatomic variations that prevent or interfere with implant placement.
  • Tumor of sacral or ilial bone.
  • Active infection at treatment site.
  • Unstable fracture of sacrum and or ilium involving the sacroiliac joint.
  • Allergy to metal components.
WARNINGS

Women of childbearing potential should be cautioned that vaginal delivery of a fetus may not be advisable following SI joint fusion. If pregnancy occurs, the woman should review delivery options with her obstetrician.

PRECAUTIONS

Patient adherence to post-operative physical activity instructions is important to support long-term service life of the implant.

RISKS

As with other surgical procedures used to treat SI joint conditions, the risks associated with the iFuse surgical procedure include, but are not limited to the following:

  • Adverse reactions to anesthesia
  • Hemorrhage (internal bleeding)
  • Muscle damage
  • Hematoma (blood pooled under the skin) or seroma (clear fluid under the skin) at the implant site
  • Neurological deficit, nerve root or peripheral nerve injury, irritation or damage (damage to nerves, permanent or temporary)
  • Vascular injury (damage to a blood vessel) or damage resulting in catastrophic or fatal bleeding
  • Neurovascular (blood vessel and nerve) injury
  • Damage to lymphatic vessels and or lymphatic fluid exudation (leakage)
  • Injury to intra-pelvic structures
  • Infection of the wound, deep infection, peritonitis (infection in the abdomen)
  • Wound dehiscence (the surgery incision opens up)
  • Pulmonary or systemic embolism (clot in lungs or blood vessel system)
  • Thrombosis, thrombophlebitis (blood clot and swelling of blood vessels)
  • Death
  • Bruising
  • Local swelling
  • Radiation exposure

Potential risks specifically associated with the iFuse Implants and instrumentation include, but are not limited to the following:

  • Infection
  • Pain, discomfort, or abnormal sensations due to presence of the implant
  • Instrument failure resulting in a complication
  • Migration (moving), loosening or fracture of the implant
  • Pain in muscle(s) due to altered biomechanics (the positioning of your hip, leg and foot during normal daily activities)
  • Nerve root or peripheral nerve root irritation due to local swelling or altered biomechanics (changes in position of your hip, leg and foot during normal daily activities)
  • Loss of fixation / stabilization (implant becomes loose from the bones)
  • Metal sensitivity, or allergic reaction
  • Failure of device to improve symptoms and/or function
  • Increased pain at treated or adjacent levels (lumbar spine above and hips below)
  • Need for re-operation or removal of the implant(s)
  • Implant rejection
  • Response to wear debris (small metal particles that come loose from the device causing a tissue response)
  • Decrease in bone density due to stress shielding (loss of bone mass due to the implant assuming some of the normal daily load of the SI joint)
  • Failure to achieve SI joint fusion
  • Potential difficulty in delivering fetus vaginally due to device-related restriction of SI joint stretching

If you have any questions or concerns about any of these risks, contact your doctor.

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