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Shezad Malik MD JD
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Medtronic Infuse Bone Graft System Linked to Serious Risks

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What is Infuse?

The Medtronic Infuse bone graft is a genetically engineered liquid protein that helps the body to grow its own bone. It includes a bioengineered protein manufactured by Wyeth, called bone morphogenetic protein (BMP).

Scope of the Infuse Problem

Medtronic’s Infuse Bone Graft is used in about a quarter of the estimated 432,000 spinal fusions performed in the U.S. annually, according to the New York Times.

The Infuse system involves three steps:

Small collagen sponges are used to absorb in bone morphogenetic protein (known as rhBMP-2), a substance that encourages bone growth. Sponges are then placed in small, hollow metallic cages. The cages are then implanted in the spine between vertebrae to support the spine while new bone grows between the vertebrae.

FDA Approved Infuse only for Anterior Lumbar Surgery

Medtronic’s Infuse Bone Graft system was FDA-approved in 2002 for anterior approach lumbar fusion surgery. Infuse was not, approved for other types of spine surgeries, including lateral or posterior approach lumbar fusion surgeries or for those on the cervical spine.

Medical research has demonstrated that both approved and off-label uses of Infuse Bone Graft system may cause serious and potentially fatal injuries, such as:

Cancer
Infertility/Sterility
Uncontrolled/Ectopic Bone Growth
Airway Swelling and Compression

Questionable Behavior by Medtronic Infuse Manufacturer

Medtronic, maker of Infuse Bone Graft System, should have conducted thorough and competent research into all possible risks of Infuse. But according to the Spine Journal, Medtronic caused the endangerment of patients who received the Infuse system.

The Spine Journal review found that the 13 original Medtronic-funded studies overestimated the usefulness and downplayed the risks of Infuse component rhBMP-2.

The authors of these studies received an estimated $12 million to $16 million each from Medtronic, and their studies frequently revealed absolutely no Infuse complications.

Other studies that weren’t funded by Medtronic have revealed serious and potentially fatal injuries associated with Infuse Bone Graft system.

Medtronic to Pay $85 Million Lawsuit

Medtronic has agreed to settle a shareholder lawsuit for $85 million, regarding accusations that the company made misleading statements about Infuse.

Shareholders claim that Medtronic failed to disclose that 85.2% of Infuse sales depended on off-label uses that are not approved by the FDA.

They allege that Infuse sales began to drop after the U.S. Department of Justice and the U.S. Senate launched investigations into whether Medtronic was illegally promoting off-label uses of Infuse to doctors.

2 Comments

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  1. Chris says:
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    Let me tell you about Infuse. When use on-label this product is just as pathogenic as any invasive, destructive microorganism. It causes increased post-op pain, in decreased quality of life, and increased use of pain medications even 2 years after surgery. When the injured patient looks for answers as to why Infuse increased post-operative pain there are no answers. No surgeon wants to admit that this is an inferior product that should be pulled from the market. The hospital where I had my surgery charged about $40,000.00 per cage (right and left). Since the surgery in 2010 I have had nothing but excruciating pain. Instead of paying the shareholders, Medtronic should be paying the patients who had this device inserted into their spine

  2. Jon says:
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    I had Cervical spine surgery after a work related accident in 2000 by Dr. Mark Kabins while living and working in Las Vegas. I do not know if Kabins used a graft and am wondering how I can find out the truth if he did use this product and it was off label use. I moved from Nevada in 2001 and I have recently found out that Kabins dubbed by the Las Vegas press during the Federal trial as a member of what they called the “Medical Mafia” was found criminally guilty of fraud in a malpractice case covering up the truth about his work. I am asking about this because I am dying of a unknown mitochondrial disease and unusual symptoms that were undiagnosed and ignored by doctors after the spine surgery. I now wonder if my Neurological symptoms are related to the procedure that was performed upon me. I was a patient of the NIH in Bethesda MD to find out what is wrong with me and they could not definitively identify what is killing me. I has always wondered why after I had complained about my unusual symptoms to include hospitalization for 5 days after ” 7 Grand Mal seizures” I almost died during this attack. I was treated very poorly by any doctor in Vegas that I asked if the surgery could have caused the seizures; to the point that Dr.Kabins wouldn’t see me again after I asked him if the the seizures were cause by the surgery just 3 months prior. I had no history of any neurological disorders before the surgery. I would like to know if instead of dying in poverty as i haven’t been able to work now for over 4 years, I should be compensated for the unusual disease that is killing me. I appreciate any information. Thank you.