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. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-80).BMP Infuse ® Bone Graft is comprised of two main active ingredients, the protein that stimulates bone growth and the collagen sponge. The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. Need Legal Help Regarding Medtronic Infuse Bone Graft? Medtronic has also been sued over allegations of off-label promotion with Infuse. The publication prompted several investigations later on, a Senate report found that Medtronic employees helped write and edit studies promoting Infuse. In an entire issue of the Spine Journal they criticized Medtronic-paid researchers for failing to mention a number of side effects, including male sterility. In 2011, a group spine experts made a bold and unusual move by publicly rebuking Medtronic-funded research on Infuse. Medtronic Infuse has become a controversial product in general. Patients under the age of 18 who have undergone a procedure with this type of product should be closely monitored for complications, which may include problems with skeletal development, excess growth of other tissues and tissue swelling or fluid accumulation that could put pressure on nearby organs or tissues. The agency stated in its notification that it “recommends against routine use of these products in patients under age 18 because their safety and effectiveness has not been reviewed or approved for use in this population.” The FDA also recommends considering autograft or allograft bone as alternatives in patients younger than 18. No such protocol was implemented for patients under age 18. For these products, manufacturers are required to submit clinical data to show that they are safe and effective. Medtronic Infuse and other similar products are classified as high-risk (Class III) medical devices. “Any product that affects bone growth could have the potential to negatively impact skeletal development by altering normal bone formation and growth, especially if implanted near open growth plates.” the alert states. According to the safety alert, however, these issues are even more pressing in patients under age 18 because they tend to be smaller and their bones are not done growing.
The product is already controversial in adults, with similar adverse events reported. The FDA never approved Medtronic Infuse for patients under the age of 18. This type of bone graft is meant as an alternative to autograph bone, where bone is harvested from another part of the patient’s body, and allograft where bone is transplanted from another individual. The agency said it was aware of reports of serious injuries, such as excess bone growth, fluid accumulation, inhibited bone healing and swelling, linked to using the bone graft substitutes in patients under the age of 18.īone graft substitutes containing recombinant proteins or synthetic peptides such as Medtronic Infuse are used to promote bone growth in patients with a bone defect. Food and Drug Administration (FDA) warned that bone graft substitutes containing recombinant proteins or synthetic peptides, such as Medtronic Infuse, should not be used in patients younger than 18. Medtronic Infuse Bone Graft substitutes containing recombinant proteins or synthetic peptides In a safety alert issued Jan.
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