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Infuse Bone Graft

The Infuse bone graft injury attorneys at the Drug Law Center fight aggressively for their clients who have suffered injury caused by the bone growth promoting device.

What Is Infuse Bone Graft?

Infuse Bone Graft RecallsSpinal surgeries to repair damaged or degenerating discs are common procedures in hospitals and medical centers throughout the United States. Nearly four-fifths of all spinal surgeries involved bone grafts. Originally, surgeons harvested the bone they needed from the patient’s own chin, hip, skull, or jaw bone. While the grafts were effective, the procedure created painful problems including secondary infections at the harvesting site. Nearly two decades ago, medical device manufacturers created synthetic versions of Infuse bone graft material that provided both positive results and horrific outcomes.

As far back as 2000, many doctors have used Infuse bone graft devices during spinal surgical procedures to treat lumbar degenerative disc disease, a painful deterioration of spinal discs. In 2002, the Food and Drug Administration (FDA) initially approved the use of Infuse bone graft material as an interior approach to fuse lumbar discs by stimulating new bone growth. Some doctors have also used the product in dental genitive procedures. At the time of the FDA approval, the federal agency defined the use of Infuse bone graft as “a device to help fuse vertebrae in the lower spine in order to treat degenerative disc disease.”

During routine procedures, doctors place a synthetic liquid protein-filled metal device between degenerating vertebrae in the sacral and lumbar regions. The liquid protein is designed to promote bone growth and fuse the damaged area together. While the initial clinical trials were highly successful device manufacturers began promoting the product for off-label uses creating horrific adverse reactions and life-threatening side effects.

Infuse Bone Graft Side Effects

Because an artificial product is implanted inside a patient, the device has the potential of causing serious side effects and dangerous adverse events. While some patients never experience any side effect, others may suffer from one or two that could negatively affect their procedure’s outcome. The possible complications, side effects, and reaction events occurring in individuals with a newly implanted Infuse bone graft include:

  • Severe allergic reaction to the synthetic material
  • Nearby tissue damage
  • Bone fractures
  • Abnormal, unintended, or excessive bone formation
  • Loosening, breakage or bending of the implant
  • Migrating implants
  • Gastrointestinal issues
  • Bladder or bowel problems
  • Infections
  • Acute severe swelling
  • Difficulty speaking or swallowing (Dysphagia)
  • Male sterility
  • Sexual dysfunction
  • Uro-genital injury swelling
  • Breathing (respiratory) issues
  • Ectopic bone formation
  • Severe discomfort or pain
  • Nerve damage
  • Spinal cord damage
  • Severe reaction to anesthesia used during the procedure
  • Neurological issues including paralysis
  • Postoperative change to the discs’ height
  • Improper spinal curvature
  • Dura tissue layers tears
  • Airway compression
  • Complications and fetal development
  • Vascular problems
  • Disabilities
  • Wrongful death

Common contraindications when using Infuse bone graft involve:

  • Pregnant women, and women wanting to become pregnant, should avoid using an infuse bone graft
  • Individuals with sensitivity to Type I collagen, titanium alloy, titanium, or recumbent human bone morphogenetic protein-2 should not use an infuse bone graft
  • Individuals with immature bone growth
  • Individuals with a surgical incision-related infection
  • Those who have the removal of the tumor close to the implantation site

Pregnancy and Infuse Bone Graft

Pregnant women should avoid using an infuse bone graft because these devices have yet to be tested to determine if it is harmful to the mother or fetus. Studies on infuse bone graft and nursing mothers have also not yet been conducted. That said, comprehensive testing has been performed on female rabbits who were given the synthetic protein.

These test results revealed that the mother rabbit had transferred her antibodies built-up from the synthetic protein to the developing fetus. Of these, a few of the rabbit fetuses developed bone formation abnormalities. Some of these abnormalities continue to develop after birth. The device manufacturers have warned pregnant mothers and women of childbearing age to avoid using the product during pregnancy or immediately before becoming pregnant.

Infuse Bone Graft and the FDA

In July 2008, the Food and Drug Administration released a safety warning notifying patients of problems associated with cervical (neck) surgery procedures using infuse bone graft material. The public health notification was a response to nearly 40 reports of severe complications that patients had experienced in neck fusion procedures that had yet to be approved by the FDA.

This warning came two years after Medtronic, a major Infuse bone graft manufacturer, agreed to pay plaintiffs more than $40 million in settlement costs for marketing their device for off-label uses. Numerous lawsuits have revealed that almost 15 years ago, Medtronic had known of the specific problems of using an Infuse bone graft where nearly one out of every four patients required hospitalization due to difficulty swallowing and breathing because a “swelling” reaction after having the procedure performed.

Infuse Bone Graft Lawsuits

Since the Food and Drug Administration first use of the device in early 2000, thousands of individuals have filed Infuse bone graft lawsuits, alleging that the device manufacturer was negligent in their design, marketing, promoting and selling their medical product. Information and news involving lawsuits filed against Infuse bone graft manufacturers include:

  • S. Congress Gets Involved in Infuse Bone Graft Manufacturers Surgical Outcomes
    April 2016 – Medtronic Inc. was recently asked by US Sen. Al Franken of information concerning the reports of adverse reactions in individuals who have received the implanted device. The initial article, first published in the Minnesota Star Tribune detailed information of outcome studies were nearly 3600 patients receiving Infuse bone graft suffered 1000+ adverse events. The senator wanted information to determine whether the injuries suffered by the patients could have been caused by FDA approved or non-approved uses of Medtronic’s devices
  • Medtronic Facing Lawsuit Filed by Humana over Infuse Bone Graft Device
    December 2015 — Medtronic, Inc. is facing one more lawsuit, this time filed by Humana, one of the nation’s largest managed healthcare companies. The man made claims that Medtronic’s falsely represented their product as being effective and safe for use in spinal fusion surgical procedures.Attorneys working on behalf of the plaintiff are alleging that Medtronic their product through paid academic literature information making claims that the infuse bone graft devices were both effective and safe, even for off-label uses. Humana cover the costs for their patients undergoing a more expensive procedure instead of using traditional bone grafts because of the strength that had given to the academic literature.

    Medtronic’s response to Humana was that the Food and Drug Administration labeling clearly specified the risks that had been known since the device first received approval in 2002. While numerous independent reviews have shown that the device produces nearly identical outcomes to traditional bone graft, their safety might not be the same.

  • $22 Million Set Aside by Medtronic to Settle Infuse Bone Graft Injury Lawsuits
    Nearly 1000 Infuse bone graft injury lawsuits filed for financial compensation will be settled using the $22 million that Medtronic set aside to cover complaints that their medical device produces serious injuries. This is in addition to the $140 million that will be used to settle future claims. Since the device was first approved by the FDA in 2012, more than a million individuals have used the medical product. Of those, many have had the device implanted for off-label purposes.While Medtronic’s has denied any wrongdoing, over the last 15 years, the company has paid more than $210 million to surgeons who illegally promoted their device for off-label uses. Attorneys filing lawsuits against Medtronic have made allegations that the company has been attempting to hide the complications and potential risks their product creates.
  • Two Florida Plaintiffs File Infuse Bone Graft Injury Lawsuit against Medtronic
    August 2014 – Medtronic, Inc. is facing one more Infuse bone graft injury lawsuit, this time filed by a Florida, who claim that the wife suffered serious injuries after the Infuse bone graft device was implanted during spinal surgery. The female plaintiff claims that she “would not have consented to be treated with the off-label use [of the product) had she been informed by Medtronic or their spine surgeon of the true infuse risks.” The woman indicates that she was not informed and that the company “did not adequately inform her implanting surgeon of the true incidence of ectopic or uncontrolled or unusual bone growth resulting from the use of infuse bone graft off-label procedures, or of other risks area.”The company’s failure to inform the plaintiffs caused the woman to undergo “posterior approach lumbar fusion at levels 4 and 5 without the requisite LT-cage in October 2006.” A few years after the surgery, the plaintiff began suffering severe continuous pain that was reported to her doctors. At that time, she had been undergoing rehabilitation treatment to tackle her back issues for many years.

    Upon hearing her complaints, her doctors x-rayed the Florida woman’s back to show a significant amount of “bone overgrowth”. The implant apparently had caused her nurse to compress causing significant pain. By the middle of 2013, the plaintiff “have reason to suspect that her chronic pain was caused by infuse-induced bone overgrowth.”

    In fact, it was not until approximately the spring/summer of 2013 that [the] plaintiff even learned that [the medical device product] was used in her 2006 lumbar fusion surgery and that it was causing her multiple complications and injuries.” This lawsuit has been filed in the Circuit Court of the 13th Judicial Circuit in and for the County of Hillsboro, the State of Florida for the Circuit Civil Division.

Patients suffering severe complications after spinal surgery that involve Infuse bone graft devices are likely entitled to receive financial compensation for their damages. However, these cases are often very complex and require the skills of a competent personal injury attorney who specializes in medical malpractice and product liability cases. An attorney can handle every aspect of the case including filing a lawsuit before the expiration of the statute of limitations and present supporting evidence in court or a negotiated settlement hearing.

Experienced Legal Assistance Available

The Infuse bone graft injury attorneys at the Drug Law Center is standing by to provide immediate legal assistance to patients who have suffered injury after complex spinal surgery. Our law firm has handled many cases for clients who have life-threatening, permanent injury as a result of having an Infuse bone graft implant.

We are currently reviewing, evaluating, and accepting defective medical device cases including those involving infuse bone graft materials. Contact us today to schedule an appointment to discuss the merits of your case during a comprehensive case evaluation at no charge to you. We accept all product liability, personal injury, medical malpractice, and wrongful death cases through contingency fee agreements. This means we postpone accepting your payment for legal services until we successfully resolve your case in court or through a negotiated out of court settlement.

Sources:

http://www.infusebonegraft.com/healthcare-providers/bone-grafting-options/fda-approval-pathways/index.htm

http://www.startribune.com/franken-pushes-medtronic-fda-for-infuse-study-details/375474141/

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?start_search=1&sortcolumn=do_desc&PAGENUM=500&pmanumber=P000058