Medtronic Infuse Bone Graft: FDA Approval and Warnings

When the bioengineered bone graft developed by Medtronic was approved for U.S. markets in 2002, it was for procedures in the lumbar spine. The FDA had approved the Infuse Bone Graft specifically for patients requiring spinal surgeries for scoliosis, spinal fractures, and other spinal injuries affecting the lower back.

Based on the data presented by Medtronic-paid researchers, no one ever anticipated the dangers associated with this product. Since its approval, and thirteen papers published by doctors and researchers with financial ties to Medtronic, independent researchers and doctors using the Infuse found several alarming side effects associated with the product, including:

• Ectopic or uncontrollable bone growth;
• Cancer;
• Male sterility;
• Nerve damage;
• Severe inflammation;
• Infection;
• Bone loss;
• Fatality.

Depending on how the product was used, Infuse patients were 10 to 50 times more likely to suffer from an adverse event than other patients who had not been treated with the Medtronic product.

2008 FDA Safety Alert

In 2008, after receiving dozens of reports of injury by patients who had been treated with Infuse, the FDA issued a safety alert: warning doctors against using the Infuse Bone Graft in neck procedures. The Infuse was more likely to cause inflammation, which can contribute to a number of respiratory problems, including respiratory failure. Infuse patients required unplanned tracheotomies and intubations nearly four to five times more than non-Infuse patients, and were at risk of higher fatality rates.

FDA Rejects a Similar Product

Amplify was a product similar to Infuse, but with a higher concentration of Recombinant human Bone morphogenetic protein 2 (rhBMP-2), the active ingredient in Infuse. However, the FDA rejected the product because of the cancer risks associated with such high concentrations of rhBMP-2. However research has shown that many Infuse patients have been exposed to concentrations of rhBMP-2, much higher than that of Amplify. In fact, within one year, average patients who underwent Infuse treatments, more than doubled their chances of developing cancer.

Seeking Help for Your Infuse Bone Treatment Injuries

Infuse Bone Grafts alone generates hundreds of millions of dollars to the billion-dollar medical technology company. A company like Medtronic, especially as the world’s largest provider for medical devices, has a responsibility to its patients, to ascertain the safety and efficacy of their products before releasing it to the public, and thoroughly test the product with unbiased observers before marketing it to consumers. As a product used in one of the most complicated and delicate surgeries, Medtronic must be held accountable for releasing an obviously dangerous product under the misleading papers conducted by doctors with financial ties to the company. If you have developed complications after being treated with the Infuse Bone Graft, please be sure to contact a skilled Medtronic Infuse Injury lawyer regarding your potential case. Having experienced legal representation for your defective product liability claim can help you protect your rights and ensure you receive the compensation you deserve.

ABOUT THE AUTHOR: Estey & Bomberger, LLP
The law firm of Estey & Bomberger, LLP provides experienced legal representation to victims of defective products. Specializing in severe injury and wrongful death cases, our qualified defective medical device lawyers can help victims protect their rights against large corporations that are willing to aggressively challenge their injury claims.

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Disclaimer: While every effort has been made to ensure the accuracy of this publication, it is not intended to provide legal advice as individual situations will differ and should be discussed with an expert and/or lawyer. For specific technical or legal advice on the information provided and related topics, please contact the author.

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