Provided below is the risk information for the United States.
The iFuse Implant System® is intended for sacroiliac joint fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruptions 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. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life.
- Deformities or anatomic variations that prevent or interfere with iFuse 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.
- 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.
- Carefully read and follow all instructions prior to use.
- Patient adherence to post-operative physical activity instructions is important to support long-term service life of the implant.
- Pay careful attention to selection of implant size. Pre-operative X-rays and/or CT scan may be helpful in selecting implant size.
- Appropriate patient selection is necessary as patient factors such as size and weight may make use of iFuse more difficult or impossible.
- Inspect iFuse Implants and delivery instruments for damage prior to use. Do not use if damaged or worn. Do not attempt to repair.
- Do not use any component from an opened or damaged package.
- Do not use implants after the expiration date.
- If placing the iFuse Implants in conjunction with an open procedure, the surgeon should take care not to destabilize the joint prior to placing the implants.
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)
- Local swelling
- Radiation exposure
Potential risks specifically associated with the iFuse Implants or Delivery System include, but are not limited to the following:
- 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 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 of device to fuse your SI joint
- Potential difficulty in delivering fetus vaginally due to device-related restriction of SI joint stretching