The Infuse Bone Graft is approved by the Food and Drug Administration (FDA) for use in dental bone grafting procedures, open fractures of the tibia, and Degenerative Disc Disease. However, it is also used “off-label” (not approved by the FDA) for surgeries of the neck. Off-label uses of the Infuse Bone Graft have caused Infuse side effects for many patients.
Infuse side effects come as a result of the artificial protein inflaming nearby tissue. The material must be inserted properly or it might leak and cause bone growth outside of the surgical site. There were over 200 adverse events that were reported to the FDA for off-label uses causing harmful Infuse side effects.
Senators from the Senate Finance Committee contacted Medtronic about three specific Infuse side effects. Abnormal bone growth, swelling of the neck and throat, and sterility were frequently reported Infuse side effects. However, patients have mentioned numerous other problems from Infuse side effects.
Common Infuse Side Effects
Infuse side effects will typically affect the surgical site but it is also possible for material to translocate to other parts of the body. Health problems can become very severe if the artificial protein material used is moving freely through a patient’s body.
The Infuse side effects include:
- Acute severe swelling
- Inflamed tissue
- Severe neck swelling
- Difficulty swallowing
- Difficulty speaking
- Difficulty breathing
- Impaired speech
- Ectopic bone growth
- Uncontrolled bone growth
- Nerve injuries
- Chronic pains
- Severe pains
- Radiating pains
- Radiating chronic leg pain
- Radiating chronic arm pain
- Retrograde ejaculation in male patients
- Sterility in male patients
- Urogenital injuries and swelling
- Supraventricular tachycardia
- Confusional state
- Post procedural infection
- Synovial fluid crystal
- Altered mental state
- Acute renal failure
- Pulmonary embolism
- Surgical failure
- Cauda Equina Syndrome
Side Effects in the ER
Infuse side effects can be sudden and severe and must seek medical help immediately. Several patients were forced to the emergency room from Infuse side effects. Patients would often require tracheotomies, feeding tubes, and additional surgery in order to correct the problems from Infuse side effects. Many of the problems from Infuse side effects are from unwanted bone growth aggregating near nerves.
Drug Interaction Side Effects
Another problem from Infuse side effects is using medications that can adversely interact with the Infuse Bone Graft. Drug interactions can be difficult to predict since patients will experience them based on personal circumstance.
Drug interactions symptoms from Infuse side effects include:
- Fish oil – cholelithiasis, immunoglobulin increase, increased body temperature, auditory hallucinations, balance disorder, sinus bradycardia, constipation, gait disturbance, reduced visual acuity
- Metoprolol succinate – cholelithiasis, contusion, immunoglobulin increase, auditory hallucination, pain in extremities, sinus bradycardia, gait disturbance, constipation, balance disorder, pain
- Prinivil – cholelithiasis, contusion, immunoglobulin increase, asthenia, pain in extremities, sinus bradycardia, pain, chills, chest pain
- Infed – coagulopathy, syncope, traumatic brain injury, palpitations, gastrointestinal hemorrhage, heart valve incompetence, tricuspid valve prolapse, tachycardia, mitral valve prolapse, pericardial effusion
- Levothroid – insomnia, post procedural infection, hip fracture, abdominal pain, iron deficiency anemia, dizziness, gastrointestinal pain
- Oxycodone/acetaminophen – cholelithiasis, immunoglobulin increase, sinus bradycardia
- Fosamax – pneumonia, anxiety, chest pain, injection site pain, eye pain, neck injury, visual impairment, asthenopia, head discomfort, pruritis
- Methotrexate – pyrexia, decreased appetite, diarrhea, engraft failure, liver disorder, hypomagnesaemia, cerebral toxoplasmosis, brain oedema
- Ambien CR – insomnia, weight decrease, ovarian disorder, oral disorder, sensation of pressure, chills, fallopian tube disorder, upper abdominal pain, hyperhidrosis
Failure to Report Serious Health Risks
Shortly after being approved, doctors began questioning the Infuse Bone Graft’s safety. It was discovered later that the manufacturers, Medtronic, failed to disclose serious health problems associated with Infuse side effects. Doctors were misled about the medical device’s safety profile which caused unwarranted overutilization of the Infuse Bone Graft.