Infuse Bone Graft: Side Effects, Risks & Lawsuit Information
The Infuse Bone Graft, a Medtronic product, has been linked to severe complications, including abnormal bone growth, nerve damage and cancer concerns. FDA warnings and lawsuits allege the company failed to disclose risks and promoted unapproved uses.
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What Is the Infuse Bone Graft and How Does It Work?
The Infuse Bone Graft stimulates bone remodeling and formation, preventing doctors from needing to harvest bone from other parts of your body. It is approved for use in spinal fusion procedures, certain dental surgeries and open fractures in your shinbone.
- Recombinant human Bone Morphogenetic Protein-2 (rhBMP-2): A protein that encourages the growth of new bone cells.
- Scaffold (collagen sponge/carrier): A structure that holds the protein in place so that new bone can form.
Medtronic received U.S. Food & Drug Administration (FDA) approval in 2002 for the Infuse Bone Graft in certain lumbar spinal fusion surgeries. The graft was later approved for use in acute, open tibial shaft fractures and dental surgeries, such as jaw restorations.
However, there are many controversies associated with these bone grafts that stem from hidden risks and improper marketing.
Infuse Bone Graft Side Effects and Complications
Infuse Bone Grafts come with common side effects, like pain and infection, as well as serious risks like excess bone growth and a possible increased cancer risk.
Alert your doctor immediately if you think you have any side effects after receiving an Infuse Bone Graft.
Common Risks Reported by Patients
Some of the most common adverse reactions reported by patients who received an Infuse Bone Graft are typical surgical complications. These can include infection, pain and swelling.
- Abnormal gait
- Bronchitis
- Facial swelling
- High blood pressure
- Infection
- Nausea
- Pain
- Rash
- Skin discoloration or redness
- Swelling
Additionally, roughly 6% patients develop antibodies to the rhBMP-2 protein, while around 20% develop antibodies to the anti-bovine Type I collagen carrier. The potential dangers of these antibodies are not fully understood.
Severe or Long-Term Complications
While rare, Infuse Bone Grafts may come with dangerous complications like abnormal bone growth, an increased risk of cancer and even death.
- Airway or throat swelling:
- When Infuse is used in neck or spinal fusion, tissue swelling can compress your throat or airway. You may experience trouble breathing or swallowing.
- Abnormal or excess bone growth:
- This is when bone grows in places it shouldn’t. This can press on your nerves or organs, causing pain or nerve damage.
- Cancer concerns:
- Some studies have suggested a possible increased cancer risk when using rhBMP-2, but the data isn’t conclusive. The manufacturer claims there’s no proven causal link.
- Death:
- Infuse Bone Grafts have been linked to patient deaths in off-label cases.
- Other risks to certain populations:
- Women who are pregnant or may become pregnant, people who have tumors, children or those with an active infection are at a higher risk when using this product.
One study evaluated adverse events reported in the FDA’s Manufacturer and User Facility Device Experience Database (MAUDE) and found that some patients required an additional surgery to address complications they experienced from their bone grafts.
FDA Communications
While the Infuse Bone Graft has received three different FDA approvals, it has also been the subject of warnings and communications.
In 2004, the FDA warned that the risk of rhBMP-2 in “women of childbearing potential” had not been properly researched. The warning recommended waiting one year to become pregnant after receiving an Infuse Bone Graft.
The FDA issued physician labeling updates in 2007, highlighting the risks of Infuse Bone Grafts when used in oral surgery. Complications mentioned included allergic reactions, problems with fetal development, tissue or nerve damage and death.
In July 2008, the FDA issued a public health notification warning about life-threatening complications when the bone graft was used in neck or cervical spine fusions. These uses were considered off-label. Adverse events listed included swelling in the throat and neck, breathing difficulties and death.
In 2013, Yale University led a review of data provided by Medtronic and others. This review added clarity to the product’s known risks and benefits. The study confirmed that, for many approved uses, Infuse was effective. However, it also highlighted concerns with off-label use.
Scientific Studies Linking Infuse To Harm
Several studies have evaluated the risks of Infuse Bone Grafts. A Yale-led review looked at over 2,000 patients and post-market adverse event reports. Researchers in this review collaborated with Medtronic to gain access to clinical trial data.
The study found that there is a slightly increased risk of cancer with the use of rhBMP-2, as well as higher rates of complications. This includes bone growth in areas where it is not supposed to occur.
A separate study published in Surgical Neurology International found that complications like cancer, infection, neurological deficits and more are among the dangers of Infuse Bone Grafts.
Researchers from an additional study published in The Spine Journal wrote, “Despite the excellent spinal fusion rates promoted by this powerful molecule, the increasingly reported adverse outcomes associated with bone morphogenetic protein usage have created real concerns.”
This research helped to fuel litigation from patients who experienced complications from the Infuse Bone Graft.
Why Infuse Bone Graft Lawsuits Were Filed
Some patients have filed Infuse Bone Graft lawsuits against Medtronic because they were injured after receiving a bone graft.
The allegations include:
- Failure to adequately warn patients and surgeons about the serious risks of the bone grafts, especially for off-label uses.
- Promotion of off-label uses even though safety and effectiveness had not been established for those uses.
- Concealment or under-reporting of adverse event data or negative study findings.
In May 2014, Medtronic agreed to settle roughly 950 Infuse Bone Graft lawsuits for around $22 million. The manufacturer also agreed to a $12 million settlement in Massachusetts for deceptive marketing strategies related to the bone grafts.
If you had an Infuse Bone Graft and were injured, you might be eligible to file a lawsuit. Having your medical records, imaging, documentation of any warnings you received before surgery and whether the use was approved or off-label can help an attorney determine if you have a case.
Alternatives To the Infuse Bone Graft
If you are concerned about Infuse’s risks, there are alternatives. Each one has its pros and cons, so it’s important to speak with your doctor about the best option for you based on your health, the location of bone damage and your potential risk factors.
| Autograft | Bone is harvested from somewhere else in your body | Pros: Less risk of rejection or infection, stronger transplant
Cons: Extra surgical site, increased recovery time |
| Allograft | Bone from a cadaver | Pros: No extra surgical site, widely available
Cons: Can take longer to incorporate into your body, transplant may not work |
| Synthetic grafts/bone substitutes | Materials made in a lab that resemble bone scaffolding | Pros: Sterile, less chance of illness, readily available
Cons: May have less capacity to stimulate bone formation |
| Watchful waiting/non-surgical treatment | Physical therapy, pain control, bracing | Pros: Avoids surgery risks
Cons: May not work if bone loss or instability is severe |
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