Know the Risks | SI-BONE
For Patients

Patient Safety Information

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.


The iFuse Implant System is a surgical system designed to stabilize and fuse the sacroiliac, or SI, joint.  At least two, and generally three or more, triangular titanium implants are placed through the ilium, or wing bone of the pelvis, across the SI joint, and into the sacrum, the large bone at the base of the spine, to immediately reduce the motion of the joint and facilitate long-term fusion of the ilium to the sacrum. Studies have shown that the iFuse Implant, which has been commercially available since 2009, generally reduces the pain caused by SI joint dysfunction, reduces disability, and improves the quality of life of patients who have undergone the iFuse Procedure™.  The surgeon can use either the iFuse Implant or the 3D-printed iFuse 3D Implant™, which was introduced in 2017.


The iFuse Implant System® is intended for sacroiliac joint fusion including use in high and low energy fractures of the pelvic ring.


You will need to undergo a careful diagnosis and evaluation by your physician before undergoing the iFuse Procedure.  Lower back pain (LBP) is complex and may be challenging to diagnose.  Some patients may have multiple problems causing their lower back pain and the iFuse Procedure alone will not resolve all of their pain.  It may not be appropriate for all patients and all patients may not benefit.

You should try non-surgical management of your SI joint dysfunction and consult carefully with your surgeon before choosing to have the iFuse Procedure.  Women who may in the future want to undergo childbirth should consult with their surgeon prior to undergoing the procedure or prior to delivery if they have had an SI joint fusion procedure.

It is important to develop and follow an appropriate post-operative rehabilitation plan with your surgeon and other healthcare providers, such as your physical therapist. 

Patients who are allergic to certain metals, have tumors or active infections in or around the sacroiliac joint should not be treated with iFuse.  Patients with certain types of fractures of the pelvis should have those fractures stabilized with standard internal fixation, prior to treatment with iFuse.

Patients who have had the iFuse Procedure can likely still undergo magnetic resonance imaging, but should notify their healthcare providers prior to doing so as the imaging procedure needs to be performed in certain ways to adjust for the implants


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

  1. Adverse reactions to anesthesia
  2. Hemorrhage
    Muscle damage
  3. Hematoma or seroma
  4. Neurological deficit, nerve root or peripheral nerve
  5. injury, irritation or damage
  6. Vascular injury or damage that may result in
  7. catastrophic or fatal bleeding
  8. Neurovascular injury
  9. Damage to lymphatic vessels and/or lymphatic fluid
  10. exudation
  11. Injury to intra-pelvic structures
  12. Infection of the wound, deep infection, peritonitis
  13. Wound dehiscence
  14. Pulmonary or systemic embolism
  15. Thrombosis, thrombophlebitis
  16. Death
  17. Bruising
  18. Local swelling
  19. Radiation exposure
  20. Loss of fracture fixation
  21. Fracture of the sacrum and/or ilium

Potential risks specifically associated with the iFuse Implant System 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, loosening or fracture of the implant
  • Pain in muscle(s) due to altered biomechanics
  • Nerve root or peripheral nerve irritation due to local swelling or altered biomechanics
  • Loss of fixation / stabilization
  • Metal sensitivity or allergic reaction
  • Failure to improve symptoms and/or function
  • Increased pain at treated or adjacent levels
  • Need for re-operation or removal of the implant(s)
  • Implant rejection
  • Response to wear debris
  • Decrease in bone density due to stress shielding
  • Failure to achieve SI joint fusion
  • Potential difficulty in delivering fetus vaginally due to device-related restriction of SI joint motion

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

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