Patient Safety Information

Information for Patients Considering SI Joint Surgery

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

WHAT IS THE iFUSE IMPLANT SYSTEM®?

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.

WHAT IS THE iFUSE IMPLANT SYSTEM USED TO TREAT? 

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

WHAT ARE THE MOST IMPORTANT CONSIDERATIONS PRIOR TO CHOOSING TO HAVE THE iFUSE PROCEDURE?

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

WHAT ARE SOME RISKS ASSOCIATED WITH THE iFUSE PROCEDURE?

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
catastrophic or fatal bleeding
7. Neurovascular injury
8. Damage to lymphatic vessels and/or lymphatic fluid
9. exudation
10. Injury to intra-pelvic structures
11. Infection of the wound, deep infection, peritonitis
12. Wound dehiscence
13. Pulmonary or systemic embolism
14. Thrombosis, thrombophlebitis
15. Death
16. Bruising
17. Local swelling
18. Radiation exposure
19. Loss of fracture fixation
20. 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.