![]() ![]() Medtronic calls Infuse “revolutionary,” but there are serious concerns over patient outcomes. It has been used in various types of bone surgeries over the last 20 years (over 1 million surgeries, according to Medtronic), but it is most noted for its use in complicated surgeries on the spine. Infuse uses special protein (Bone Morphogenetic Protein-2, rhBMP-2) and a sponge-like substance made from collagen to act as “scaffolding” for the remodeling and natural formation of new bone. However, in 2002 Medtronic, an Irish-American medical devices company, launched a new type of system, Infuse Bone Graft (often shortened to Infuse). The treatment often requires the harvesting of bone from the hip to repair bones elsewhere, often in the spine. Furthermore, there were accusations that Medtronic manipulated studies on the safety of Infuse Bone Graft.īone grafting is a type of surgical treatment to repair damaged or diseased bones. Medtronic disputes this interpretation of FDA regulation, claiming there is scope within the rules to use off-label products. The underlying allegation of the Medtronic bone graft lawsuits is that the company’s product, Infuse Bone Graft, was used “off label”, meaning it was unapproved for use in that particular type of procedure by the FDA, and this unregulated product caused injury to many bone graft patients. In total, Medtronic said they put aside $300 million to settle claims for the Infuse Bone Graft lawsuits. As a result, Medtronic agreed to pay millions of dollars to settle a large number of lawsuits from various claimants, including individual plaintiffs, Medtronic shareholders, several states, and the U.S Department of Justice. The plaintiffs claim that Infuse Bone Graft, a synthetic protein treatment used to repair diseased or damaged bones, caused severe side effects, serious injury, and even death in some cases. Please see our Notice of Privacy Practices.Since the late 2000s, the medical device company Medtronic plc has been hit with 1000s of lawsuits from people who claim the company’s Infuse Bone Graft system caused serious injury. The results depicted in “before” and “after” pictures and stated by any “patient testimonial” illustrate results you may or may not achieve if you choose to have a cosmetic surgery procedure. Individual results will vary and no guaranteed result is stated or implied by any photo use or any statement, testimonial, or video on this website. This website and its contents do not represent or claim to provide the information needed for a patient to give his or her informed consent to any dental or surgical procedure or are a reflection of individual patient results, as they may vary from patient to patient. By no means should the information contained on this website be considered as a substitute for consultation with a qualified physician and it does not constitute a second opinion. *Disclaimer: The information contained on this website is intended to be purely educational in nature and does not create a physician-patient relationship with Staten Island Oral & Maxillofacial Surgery or any agent, servant, or employee thereof. by calling 718.226.1251 for our Staten Island location or 718.261.2790 for our Forest Hills location. How can I find out more about BMP Infuse ® Bone Graft?įor more information on a BMP Infuse ® Bone Graft, please contact Staten Island Oral & Maxillofacial Surgery to schedule an appointment with oral and maxillofacial surgeons surgeons David Hoffman, D.D.S., F.A.C.S., Lydia J. Our oral surgeons will discuss which method of building bone density is best for you during your personal consultation. Dental implants are a permanent solution to missing teeth, and building sufficient bone density, whether through BMP Infuse ® Bone Graft or bone grafting, may be necessary. Once sufficient bone has grown in the needed sites of the jaw, our dental implant specialists may then insert dental implants. The specific protein used in BMP Infuse ® Bone Graft in New York is rhBMP-2, which is a synthesized version of a natural protein found in the body. Eventually, the collagen sponge will be absorbed into the body, and new, dense, natural bone will remain. The collagen sponge releases the protein over time and acts as a mold for new bone growth to form against. BMP Infuse ® Bone Graft is comprised of two main active ingredients, the protein that stimulates bone growth and the collagen sponge. ![]()
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