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.
For Patient Safety Information outside of the U.S., see below:
If you are a Healthcare Provider, please view the Indications for Use here.
Information for Patients Considering SI Joint Surgery
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 to treat certain types of sacroiliac joint dysfunction, which can cause pain in the lower back, buttocks, hip, and down the leg. The iFuse Implant System’s indication for use statement reads 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.
- Sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
- Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
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 all surgeries, the risks associated with the iFuse Procedure include, but are not limited to:
- Adverse reactions to anesthesia;
- Hemorrhaging or bleeding which is difficult to control and may become dangerous;
- Muscle and/or nerve damage;
- Localized bruising or swelling;
- Dangerous blood clots;
- Wound site infections, wound re-opening and damage to the tissues surrounding the surgical site;
- Excessive radiation exposure;
- Lung damage; and
Potential risks specific to the iFuse Implant include, but are not limited to:
- Local injury to the pelvis;
- Increased pain in the sacroiliac joint or surrounding tissues and joints;
- Allergic reaction to or rejection of the implants;
- Migration, loosening, breakage or failure of the implant;
- Muscle pain due to the change in function of the SI joint;
- Stress to and fracture of the bones in the pelvis surrounding the implants; and
- Need for additional surgery to remove or adjust the positioning of one or more implants.
If you have any questions or concerns about any of these risks, contact your doctor.