Senators Investigate Medtronic Spine Implant, Payments to Doctors
The Senate Finance Committee is investigating whether Medtronic and physicians with "substantial financial ties" to the company were aware of complications associated with the company's Infuse bone graft product and failed to report them in published clinical trials.
In a letter requesting a host of documents from the medical device manufacturer, Senate Finance Committee Chairman Max Baucus (D-Mont.) and Senior Member Charles Grassley (R-Iowa) write that they are "extremely troubled by press reports" suggesting that in its own funded clinical trials, Medtronic and its paid consultant physicians may have "unreported or under-reported" potential risks associated with the use of Infuse, a recombinant human bone morphogenetic protein 2 (rhBMP-2) treatment used in spinal fusion surgery. The product is used to stimulate bone growth and, by Medtronic's estimates, has been used in more than 500,000 patients.
Despite its widespread use, Infuse has come under scrutiny for alleged off-label use and accusations of falsified research funded by Medtronic.
Several independent studies have identified risks ranging from sterility in men to " life-threatening complications ," such as neurological impairment and swelling in the neck and throat.
The senators have given Medtronic until July 11, 2011, to provide "all documents and communications pertaining to adverse post-operative events and/or medical complications relating to the use of" rhBMP-2 treatments, as well as details of all payments made to clinical investigators of the Infuse bone graft. They warn Medtronic not to destroy or modify any of the requested documents.
In an e-mailed statement, Medtronic spokeswoman Marybeth Thorsgaard said the company has received and will respond to the senators' request. She also noted that the FDA-approved product labeling for Infuse warns users of several of the complications listed in the letter. "Medtronic provides PMA clinical study adverse event data to the FDA irrespective of any financial relationship between the company and the clinical investigator or study author," adds Ms. Thorsgaard.
Another statement on the company's website specifically addresses the allegations that Medtronic has not disclosed the risk of sterility associated with Infuse.
Bone Morphogenic Protein - News
Medtronic and its paid consultant physicians may have "unreported or under-reported" potential risks associated with the use of Infuse, a recombinant human bone morphogenetic protein 2 (rhBMP-2) treatment used in spinal fusion surgery.
Infuse, also known as bone morphogenetic protein-2, is a bioengineered protein; it is used instead of real bone in a significant number of graft operations. It was approved by the FDA for limited purposes in 2002 - the fusing together of vertebrae in
What makes it worse is that the bone tissue surrounding his teeth have become too weak for him to endure an implant operation. But thanks to a new technology using a bone morphogenetic protein, or BMP, graft he is now able to have dental implants.
Bone morphogenic protein could cause male infertility, other complications. A study published in North American Spine Society's The Spine Journal shows a correlation between the use of rh-BMP-2 for spinal fusions and infertility among male patients.
Smad interacting protein-1 is a transcription factor that is implicated in transforming growth factor-beta/bone morphogenetic protein signaling and a repressor of E-cadherin and human telomerase reverse transcriptase.
Bone Morphogenic Protein-4 Impairs Endothelial Function Through ...
From the Institute of Vascular Medicine, Li Ka Shing Institute of Health Sciences, School of Biomedical Sciences (W.T.W., X.Y.T., Y.C., F.P.L., L.L., X.Y., Y.H.); and Departments of Chemistry (H.K.L.) and Surgery (C.F.N.), Chinese University of Hong Kong; and Departments of Medicine (A.X.), Pharmacology (A.X., P.M.V.), and Anatomy (G.L.T.), University of Hong Kong, China.
Bone Morphogenic Protein - Bookshelf
Bone Morphogenetic Protein and Collagen, An Advances in Tissue Banking Specialist Publication
All these aspects are logically and scientifically described in this volume.Bone morphogenetic proteins, from local to systemic therapeutics
Completing the PIR series, this volume summarizes the major advances made in the local and systemic use of bone morphogenetic proteins (BMPs).Advances in skeletal reconstruction using bone morphogenetic proteins
Today, the extract of the BMP originating from bone tissue as well as genetically modified BMPs, particularly BMP-2 and -7, can be used.Though the BMP as an ...Bone morphogenetic proteins, regeneration of bone and beyond
In the field of structur/function analysis of BMPs new discoveries have been made improving our understanding of interactions with receptors and antagonists ...Acceleration of bone formation in distraction osteogenesis by bone morphogenetic protein-7
The manipulation of the molecular mechanisms that govern distraction osteogenesis (DO) in order to increase the biomechanical strength of new bone and to ...View Information Directory
Bone morphogenetic protein - Wikipedia, the free encyclopedia
Bone morphogenetic proteins (BMPs) are a group of growth factors also ... Bone morphogenetic protein 4 expressed in esophagitis induces a columnar phenotype in ...
Bone Morphogenic Protein
protein powder and is mixed with bovine bone collagen and sterile saline solution to form ... The use of bone morphogenic protein is considered investigational for all other ...
Bone morphogenetic protein: Definition from Answers.com
bone morphogenetic protein abbr : BMP; any of several zinc metalloendopeptidases belonging to the sub-subclass EC 3.4.24, and having an EGF motif
BMP | ProSpec
ProSpec's BMPs include: BMP, Bone Morphogenetic protein, BMP-2, Pro-BMP-2, BMP-4, BMP-6, BMP-7, Bone Morphogenetic protein Receptor-1A
Bone morphogenic proteins
Bone morphogenic proteins - BMPS. Introduction. The first implantations ... Recombinant Bone Morphogenetic Proteins. Initially BMP's were derived from purification of ...