What Is INFUSE Bone Graft?
INFUSE Bone Graft is a medical technique used to alleviate spinal problems by encouraging the natural process of bone formation. The INFUSE Bone Graft is a two-part system where bovine collagen is used to create a framework for new bone tissue to form. The INFUSE Bone Graft was designed to be a replacement for the conventional idea of using donated material from the patient’s bones. This way, patients would be able to undergo a quicker bone graft surgery with minimized inconvenience, pain, and recovery time.
How Does the INFUSE Bone Graft Work?
The INFUSE Bone Graft technique works by placing a human recombinant morphogenetic protein into a bovine collagen mold, or graft. In the bone graft, protein is released while replacing the degenerated bone tissue.
Which Company Created INFUSE Bone Graft?
INFUSE Bone Graft is a procedure created by Medtronic, that employs a synthetic protein during spinal and other types of surgery to encourage new bone growth. Infuse Bone Grafts have been used in millions of procedures but may have caused serious complications in many patients.
Can Bone Grafts Be Artificial?
While bone grafts are typically made of real bone taken from either a cadaver or from other bones in your body. However, it’s possible for a bone graft to be artificial, which would eliminate the need to take bone from somewhere else in your body where it might still be needed. The INFUSE bone graft by Medtronic is an example of a synthetic bone graft.
What Is the INFUSE Bone Graft Made of?
The INFUSE Bone Graft is made up of two materials:
- Recombinant human Bone Morphogenetic Protein-2 (rhBMP-2)
- Absorbable collagen sponge (ACS)
Together, these form a manufactured bone graft that is designed to simulate a natural bone. The idea was that the use of the protein in creating the bone graft would result in the bone successfully grafting onto the natural bone it was attached to and healing with it.
How Does the INFUSE Bone Graft Work?
Infuse is a recombinant human bone morphogenetic protein (rhBMP) produced by Medtronic Inc. This bone grafting technique is used to treat patients with bone-deteriorating conditions associated with degenerative disc disease, skeletal trauma, and oral maxillofacial surgery. Infuse is a popular alternative to other bone graft techniques because it does not require the harvesting of the patient’s own bone for grafting. Instead, it creates a platform for the bone to grow on, while stimulating the patient’s natural bone growth. This is meant to reduce pain and recovery time.
What Bone Graft Surgeries Can the INFUSE Bone Graft Be Used for?
Medtronic’s INFUSE Bone Graft can be used for the following:
- Open tibia shaft fractures
- Certain types of oral and maxillofacial surgery
- Treatment of degenerative disease, affecting the lumbar portion of the patient’s spine
When Was the INFUSE Bone Graft Approved by the FDA?
The INFUSE Bone Graft was approved by the FDA for the above three purposes in July of 2008.
What Is a Bone Graft?
A bone graft, or bone grafting, is a medical procedure that treats a damaged or diseased bone with bones that come from either elsewhere in your body or from cadavers. This type of procedure can repair or even replace bones anywhere throughout the body.
How Does Bone Grafting Work?
Your bones are made up of what is called the bone matrix. This is the part of your bones that makes up most of their mass and is also the part that gives your bones their strength and hardness. The cells inside the bone matrix are living bone cells that both create the bone matrix and help to maintain the bones. These bone cells do this by healing damage that has happened to the bone.
However, if the damage is too great or a large chunk of bone is missing, then it’s too much for the bone cells to repair. In cases like these, bone grafting replaces the missing bone with bone taken from either elsewhere in your own body or with bone donated from a cadaver. During surgery, your surgeon would insert that donated piece of bone. Then, your bone cells would seal to the new bone, making it a part of the existing bone.
Why Might Someone Need a Bone Graft?
There are a variety of reasons that you might need a bone graft, including:
- You have a new bone fracture that won’t heal properly on its own
- You have an older bone fracture that didn’t heal properly on its own
- You have a bone disease like cancer or osteonecrosis
- During spinal fusion surgery to support an unstable spine
- During dental implant surgery to replace any missing teeth
- You have a joint replacement like a hip replacement or knee replacement to help the artificial joint bond to your bones
What Are the Risks of Bone Grafting?
Typically, bone grafting is a safe procedure, but there are some risks, including:
- Blood clots
- Nerve damage
- Anesthesia complications
- The bone failing to heal well
What Is Spinal Fusion?
Spinal fusion is a type of surgery that fuses two vertebrae in the spine together so that there isn’t any space or possible motion between the two. Typically, a surgeon performs a spinal fusion by placing a bone graft in between two vertebrae. They usually will also use metal rods, screws, and plates to fasten the vertebrae to each other so that they don’t move while the bones are healing and fusing into the new chunk of bone. Eventually, the vertebrae and the bone graft will heal together as one unit.
When Is Spinal Fusion Needed?
Generally, a spinal fusion surgery is needed in one of the three following scenarios:
- The spine is deformed
- The spine is weak or unstable
- There is a herniated disk in the spine
What Is a Herniated Disk?
A herniated disk occurs when there’s an issue with the disks in between the vertebrae of the spine. These disks are rubbery cushions that help to protect the vertebrae from each other by preventing them from rubbing against each other. This disk can slip out of place, which is sometimes called a slipped disk or a herniated disk.
What Is the Controversy with INFUSE Bone Graft?
According to a study in The Journal of the American Medical Association (JAMA), there was a 15-fold increase in the number of spinal fusion surgeries from 2001 to 2007. This was apparently a direct result of the INFUSE Bone Graft since doctors no longer needed to perform bone harvest surgeries before spinal fusion. During this time, Medtronic Inc. spent millions of dollars in consulting fees and royalty payments. Several officials believe this was an effort to suppress safety concerns from the INFUSE Bone Graft.
What Type of Surgery with INFUSE Bone Graft Had Complications?
The INFUSE Bone Graft appears to be safe for use in lower back, or lumbar, surgery, however, the procedure has been used in fusions involving the cervical spine, or vertebrae of the neck, which may have resulted in complications. This is considered an “off-label use,” since the Infuse Bone Graft is not federally approved for use in the cervical area of the spine.
Numerous injuries may have resulted from Medtronic illegally promoting off-label uses of the Infuse Bone Graft. As a result, Medtronic faces a number of Infuse lawsuits.
What Is Off-Label Use?
If something is used off-label, this means that it is used in a way that it wasn’t approved for. The term off-label can apply to a wide variety of things in medicine, from medicines being prescribed to treat a condition they weren’t approved for to the INFUSE Bone Graft being used in spinal fusion surgeries involving the cervical spine when it was only approved by the FDA for back surgeries that are located in the lumbar area of the spine, which is in the lower back.
Has the FDA Issued a Warning for the INFUSE Bone Graft?
The U.S. Food and Drug Administration (FDA) issued a statement in July 2008 regarding life-threatening complications associated with INFUSE bone grafts. Between 2004 and 2008, the FDA had received 38 cases of patients experiencing complications during their INFUSE cervical spine fusion treatment. At the time, INFUSE was not approved for cervical spine fusion. The INFUSE FDA warnings were specifically targeted toward this unapproved use of INFUSE.
What Are the Side-Effects of INFUSE Bone Graft?
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 on the neck. Off-label uses of the INFUSE Bone Graft have caused 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 side effects. However, patients have mentioned numerous other problems from INFUSE Bone Grafts.
What Are Common Side Effects of INFUSE Bone Graft?
Among other symptoms of the INFUSE Bone Graft, the conditions developed can affect bones and muscles, heart, and lung systems, and cause nervous system complications. The effects from the INFUSE Bone Graft can affect areas near the surgery site or can cause other bodily harm.
The side effects can include:
- Swelling and inflammation
- General discomfort
- Difficulty swallowing, speaking, or breathing
- Uncontrolled bone growth
- Nerve injuries or paralysis
- Radiating pains in arm or leg
- Male sterility due to retrograde ejaculation
- Urogenital injuries and swelling
- Kidney failure
- Pulmonary embolism
- Tears in spinal cord tissue, or dura
- Allergic reaction
- Excessive bleeding
- Vascular complications
In some cases, severe side effects or complications of INFUSE may be life-threatening.
Is the INFUSE Bone Graft Life-Threatening?
The complications in the INFUSE FDA warnings included the constriction of airways and nerves due to the swelling of throat tissues. Other reported problems involved difficulty breathing and swallowing, described in the FDA warning statement as “severe dysphagia.” The anatomical proximity of the cervical spine to the airways contributed to the severity of the side effects.
The majority of these life-threatening symptoms detailed in the FDA warnings were experienced between 2 and 14 days following the procedure. In the event of airway constriction, patients often required medical intervention. Intubation, anti-inflammatory medication, tracheotomies, and additional surgery were often needed to treat the complications.
The FDA warnings further suggested that patients treated with any recombinant human bone morphogenetic protein (rhBMP) in the cervical spine should know:
- The signs and symptoms of airway complications. This includes difficulty breathing or swallowing, swelling of the neck, tongue, mouth, throat, and shoulders or upper chest area.
- To seek immediate medical attention at the first sign of an airway complication.
- To be especially watchful between 2 and 14 days after the INFUSE cervical procedure, when airway complications would be most likely to occur.
Why Was the INFUSE Bone Graft Investigated?
In 2010, a collaborative investigation between the Journal Sentinel and MedPage Today found that physicians with financial ties to Medtronic reported suspiciously optimistic results with Infuse treatments. The reports occurred during the period prior to the FDA’s approval of the procedure in 2002. Doctors financially connected to Medtronic recorded significantly better INFUSE results than doctors that worked independently of the company’s financial influence.
In the years leading up to the Infuse Senate investigation, side effects missing from Medtronic-affiliated doctors included:
- Male sterility
- Neurological complications, due to entropic bone development
- Radiating leg pain
- Potentially fatal swelling of the throat and neck
Why Did the Senate Investigate the INFUSE Bone Graft?
In 2011, the United States Senate launched a formal investigation of Medtronic’s possible involvement in the publishing of biased articles. These biased articled falsified information regarding the potential safety issues of INFUSE treatments. Physicians with known financial ties to Medtronic published articles omitting serious Infuse risks and side effects associated with treatment.
What Were the Results of the Senate Investigation?
After a 16-month investigation of Medtronic’s financial records, the INFUSE Senate investigation yielded evidence that Medtronic had been privately paying physicians to write articles promoting INFUSE products. Over a 15-year period, Medtronic paid $210 million to these doctors for confidentially promoting their products and was estimated to have profited by $900 million from the Infuse Bone Graft system.
The medical authors promoted INFUSE by downplaying health risks while dismissing other alternative bone graft treatments. INFUSE Bone Graft lawsuits are largely based on financial ties between Medtronic and researchers supporting the technique. Researchers claimed there were no risks but developing health problems suggest otherwise.
What Is the Grassley-Kohl Physician Payments Sunshine Act?
The findings of the Infuse Senate Investigation resulted in the passing of the Grassley-Kohl Physician Payments Sunshine Act. This act was included in the Patient Protection and Affordable Care Act of 2009, which was signed into law on March 23, 2010. The Physician Payments Sunshine Act demanded that royalties paid to physicians by corporate businesses must be recorded and made public starting January 1, 2012.
What INFUSE Bone Graft Lawsuit Settlements Have There Been?
Medtronic, the manufacturer of the INFUSE bone graft, agreed to pay $85 million as a settlement of a shareholder lawsuit. Accusations allege that Medtronic is guilty of making misleading statements about the Infuse Bone Graft. This illegal marketing strategy is believed to have increased sales by approximately 85 percent.
In 2014, Medtronic settled a lawsuit involving 950 people for a total of $22 million. Then, in 2017, Medtronic paid out $12 million to resolve lawsuits claiming that the company had engaged in deceptive marketing practices
What INFUSE Bone Graft Lawsuits Are There?
Medtronic has faced more than 10,000 lawsuits for complications caused by the treatments including infections, sterility, and bone problems. The company set aside more than $300 million to settle many of the INFUSE Bone Graft Lawsuits.
How Do I Find an INFUSE Bone Graft Attorney?
If you have had a bone graft surgery, particularly a cervical spinal fusion, that involved an INFUSE bone graft and have suffered medical complications as a result, you may be eligible for a lawsuit against Medtronic. Contact Seeger Weiss for a free consultation to discuss your case. You won’t have to pay anything unless your case is successful.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.