Overview: Medtronic Infuse has become a product clouded in controversy; amongst accusations of off-label marketing, the product has also received a lot of negative attention after researchers discovered an increased risk of cancer. In particular, studies have looked at pancreatic, prostate and breast cancers.
- Medtronic has been accused of off-label promotion over Infuse
- Last June, The Spine Journal published an entire issue discussing the side effects of Infuse, and how fellow doctors were paid to hide the risks
- Medtronic is under investigation by the U.S. Senate over Infuse
- The protein used, rhBMP-2 (also BMP-2), is associated with an increased risk of pancreatic, prostate and breast cancer
Product: Medtronic Infuse Bone Graft
Manufacturer: Medtronic, Inc.
Side Effects & Complications
- Difficulty breathing, swallowing
- Uncontrolled bone growth
- Nerve injury
- Male sterility
- Retrograde ejaculation
Although Medtronic Infuse litigation has been taking place since 2009, the issue became truly sensationalized last June, when Dr. Eugene Carragee published an exposé in the Spine Journal. The piece highlighted numerous side effects associated with the products, pointing the finger at fellow health professionals who were allegedly paid to hide these facts in their research. Dr. Carregee and his colleagues cited side effects such as male sterility, swelling of the neck, difficulty breathing, infection, increased leg and back pain and cancer.
Last November, Dr. Carragee also presented his findings about Amplify, a high-dose version of Infuse, at the North American Spine Society (NASS) meeting. His research further demonstrated the link between BMP-2 and cancer; specifically, pancreatic, prostate and breast cancers. Dr. Carregee discovered that Amplify patients were 2.5 times more likely to develop cancer in one year and five times more likely after five years.
Carragee had emphasized the severity of these findings, telling Reuters that “Almost certainly this is cancer promoting and not a carcinogenic,” with the latter taking much longer to develop.
The original lawsuits against Medtronic were shareholder suits alleging that the company participated in illegal off-label promotion of the product, falsely inflating their stock value and misleading their investors. While Infuse is only approved for the lower spine and jaw, Medtronic was paying doctors to use it in areas such as the cervical spine, allegations say. When the Spine Journal piece was published, the subject was thrust into media spotlight. Medtronic found itself investigation by the U.S. Senate. The U.S. Department of Justice also conducted an investigation, which Medtronic chose to settle last December for $23.5 million. Last month, it also settled the class action suit for $85 million.