Articles tagged: Infuse

At this time, medical technology giant Medtronic is being investigated by the Department of Justice as well as several Senate members due its failure to report associated complications with its Infuse synthetic bone graft product. Medtronic is also being accused of promoting non-FDA approved uses of the same product. Recently, Medtronic’s Amplify failed to be approved by the FDA entirely, due to its association with increased cancer risks. Many lawsuits have been filed against Medtronic in relation to these various problems with their bone graft treatments. Common complications with Medtronic’s Infuse include: cancer, leg pain, infection, sterility (in male patients), unwanted bone growth, as well as bone loss.

Medtronic Infuse Bone Graft Studies Publicly Refuted

A collection of spine experts have gathered to publicly refute the findings of research studies that supported Medtronic’s Infuse Bone graft product. These specialists referred to existing research as both biased and misleading, and an entire issue of The Spine Journal was devoted to repudiating research studies about Infuse (June 2011). Infuse is a bone growth product that contains a genetically engineered version of a natural protein called rhBMP-2(recombinant bone morphogenetic protein-2). This protein is controversial in the medical community due to a link with increased cancer risks in high doses. Medtronic, which made nearly $900 million last year from Infuse alone, still maintains that its product is not related to any complications. However, other experts estimate an adverse event rate between 10-50%, depending on how the product is used.

FDA Rejects Medtronic Amplify Bone Graft

Amplify, a Medtronic bone growth product, failed to be approved by the United States Food and Drug Administration due to studies linking the product with higher number of cancers. Interestingly, the active ingredient in Medtronic’s Amplify bone growth product is the exact same synthetic protein used in its Infuse bone graft product. Cancer risks can be even greater in patients who smoke or with genetically higher cancer risks as well.

File a Medtronic Bone Graft Lawsuit: Speak to an Attorney

Have you experienced complications or adverse effects following treatment with a Medtronic Bone Graft product? If so, you may want to consider a Medtronic Bone Graft Lawsuit. Call the Willis Lawsuit today, and we will gladly help you evaluate your potential Medtronic claim with no charge or further obligation. You may be entitled for considerable financial compensation in relation to the physical, emotional, and financial suffering associated with your injuries. At this time, our firm is accepting Medtronic clients in all 50 states; furthermore, all bone graft cases are handled via Contingency Fee Basis.

Medtronic Infuse Lawsuit

The largest medical technology company in the world, Medtronic, Inc. is currently the subject of multiple lawsuits in response to its Infuse bone graft product. Infuse is a bone graft product that contains rhBMP-2 (recombinant human bone morphogenetic protein). This protein occurs naturally, but is used in Infuse to initiate bone growth in specific areas of the spine. Infuse has been approved by the FDA for lumbar spine procedures, however at this time, Medtronic is being investigated by the Department of Justice as well as the Senate for promoting off-market uses for Infuse, including cervical spine (neck) procedures. The FDA also failed to approve Amplify, a stronger version of Infuse citing possible cancer risks.

Medtronic Infuse Conflicting Studies

In June of 2011, a group of spine experts joined together to publicly refute the findings of several research studies performed by people with financial ties to Medtronic. In the most recent fiscal year, Medtronic made nearly $900 million from Infuse alone, which is used in ¼ of all spinal fusions in the United States. The findings of this independent group of spine specialists was published in The Spine Journal. Basically, the researchers who have received any money from Medtronic deny the presence of any risks or complications associated with the Infuse product. These financial interests of the researchers created a conflict of interest, and the result was detrimental to the safety of patients. In all of these studies, the existing interest conflicts were either unclear of not reported at all. As a result, many recipients of Infuse treatment were not informed regarding any potential risks; as a result, some choose to file an Infuse Lawsuit against Medtronic, Inc.

Medtronic Infuse Complications

Several research studies related to Medtronic Infuse have been accused of significantly overstating its benefits, as well as denying that the product has been linked to any adverse effects or complications. Several other experts have suggested that the actual rate of complications after treatment with Infuse ranges from 10-50% of cases depending on how it was used. Some of the reported Medtronic Infuse complications include:

  • Sterility in males
  • Bone loss & Unwanted bone growth
  • Cancer
  • Infection

Medtronic Infuse Lawsuit: Speak to an Attorney

If you or a loved one has been treated with Medtronic INFUSE Bone Graft and experienced any complications or adverse effects, call the Willis Law Firm today. You may be eligible for a substantial amount of financial compensation through filing a Medtronic Infuse Lawsuit. When you call, our experienced team of legal professionals will provide you with an Infuse lawsuit evaluation, free of any charge or obligation. Currently, we are reviewing Medtronic Infuse lawsuits nationwide; all bone graft clients are taken on a contingency fee basis, meaning that you will not be billed any legal fees unless a successful recovery is obtained.

Medtronic Infuse Cancer

Medtronic, the world’s largest medical technology company, is currently under scrutiny due to an increased cancer risk associated with its Infuse Bone Graft Device. Infuse, which accounts for an estimated $900 million of the company’s annual profits, contains a controversial ingredient called recombinant bone morphogenetic protein-2 (rhBMP-2). Medtronic claims that Infuse does not pose any risk of harm to patients; however, other experts believe that between 10% and 50% of Infuse patients suffer complications ranging from infections and leg pain to unwanted bone growth, and even cancer. Previously existing studies regarding Medtronic Infuse are believed to be biased and misleading due to undisclosed financial ties between the doctors leading the studies and Medtronic. In addition to the Infuse cancer controversy, Medtronic has also been accused of promoting off-market uses for Infuse, for uses that are not FDA approved.

Medtronic Infuse Cancer Risk Higher Than Previously Believed

A new research study reveals that the already controversial Medtronic bone graft product Infuse may carry with it a higher risk of cancer than previously suggested. Dr. Eugene Carragee, a professor at the Stanford University School of Medicine, believes that patients who received treatment with Infuse increase their cancer risk by more than two times as much within one year of treatment. In the three years following treatment, this risk is increased by nearly 5x. Carragee, who is also the editor of Spine Journal, dedicated an entire issue of the journal to exposing issues with Infuse and its use of synthetic growth proteins.

Medtronic Amplify Failed to Obtain FDA Approval Due to Cancer Risk

In July of 2010, an advisory panel of the United States Food and Drug Administration failed to approve Medtronic’s Amplify product because a vote determined that the product’s harm outweighed any potential benefits. Interestingly, Amplify contained the same active ingredient as Medtronic Infuse: rhBMP-2. This genetically engineered growth protein has been linked to the increased risks of cancer present in Infuse treatment, but in a higher dose.

File a Medtronic Infuse Cancer Lawsuit: Speak to an Attorney

When complications occur due to a negligent or defective medical treatment, like Medtronic’s Infuse Bone Graft, the associated expenses can quickly escalate and become extremely overwhelming. If you or a loved one has experienced an adverse effect following Medtronic Infuse treatment, you may want to consider a lawsuit. Call the Willis Law Firm today, and we will provide you with an initial case review completely free of cost or obligation. Although our firm is based in Houston, we are currently accepting Medtronic cases in all 50 states; all Infuse clients are taken on a contingency fee basis.

The world’s largest medical technology company, Medtronic, has become the center of controversy due to claims regarding its Infuse bone graft product. Many of the recipients of Medtronic Infuse Bone Graft treatment have filed lawsuits against the company after experiencing complications and adverse events related to the device. Medtronic claims that its Infuse bone growth treatment has no risks of complications and cites several research studies, which were conveniently conducted by people with significant financial ties to the company. In each of the Infuse research studies, financial conflicts of interests were either not clear or entirely left unmentioned.

What is Medtronic Infuse Bone Graft?

The Medtronic Infuse Bone Graft is a bone growth treatment used to help repair complex bone fractures, as well as fractures that do not heal correctly or those with increased risks to the patients. Medtronic Infuse bone graft products utilize a synthetic version of a naturally occurring protein, which is supposed to initiate and encourage bone growth in specific areas of the spine. Unfortunately, high doses of this ingredient, called recombinant human bone morphogenetic protein (rhBMP-2), have been linked to various complications, including an increased risk of cancer. Amplify, another Medtronic bone graft product, contained rhBMP-2 as well and failed to obtain FDA approval as a result. Despite these risks, Medtronic continues to claim that its Infuse product carries with it no risks or adverse effects.

Medtronic Infuse Off-Market Promotion

Although doctors have the prerogative to use medical devices as they see fit, medical technology companies are prohibited from promoting their products for uses other than the uses that are approved by the United States Food and Drug Administration. Although Infuse bone grafts are only FDA approved for lumbar spine procedures, Medtronic is suspected of promoting its Infuse products to doctors for non-FDA approved cervical spine procedures as well. As a result of this alleged promotion, Medtronic is under investigation by both the Department of Justice as well as several members of the Senate.

Medtronic Infuse Bone Graft Lawsuit: Speak to an Attorney

If you were treated with a Medtronic Infuse Bone graft and experience complications, contact the Willis Law Firm today for your free lawsuit evaluation. Medtronic infuse bone graft has been linked to all of the following complications:

  • Cancer
  • Male Sterility
  • Unwanted bone growth & bone loss
  • Infection
  • Leg pain

File a Medtronic Bone Graft Lawsuit

If you or someone you know has experienced complications after being treated with a Medtronic bone growth product, call the Willis Law Firm today. You may be entitled to financial compensation through a Medtronic bone graft lawsuit. Our law firm is currently reviewing these Medtronic lawsuit cases across the nation, and all of our bone graft clients are taken on a contingency fee basis, meaning that you will not be billed legal fees unless a recovery is obtained. Call us today, and let us help you get the settlement you deserve.