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Texas Fusion Surgery Cancer Lawyer and Fusion Suffocation Lawyer Is Reviewing Medtronic Infuse Bone Graft Cases Where A Fusion Surgery Has Resulted in Cancer, Nerve Damage, Suffocation, or Death by Texas Fusion Cancer Lawyer and Fatal Back Fusion Surgery Lawyer Jason S. Coomer  

Medtronic Infuse Bone Graft has been used in numerous fusion surgeries and may cause an increased risk of cancer, nerve damage, or death.  Persons that have had fusion surgery where Infuse has been used and then been diagnosed with cancer or nerve damage should report the health issues to their physician and the FDA.  Additionally, families that have lost a loved one to cancer, nerve damage, organ failure, or respiratory failure after a fusion surgery should also contact the FDA regarding the death.    

For information regarding a potential Fusion Cancer Lawsuit, Fusion Nerve Damage Lawsuit, or Fusion Death Lawsuit, please feel free to submit an inquiry or send an e-mail to Texas Fusion Cancer Lawyer and Texas Fatal Back Fusion Lawyer Jason Coomer.  He is a Texas defective product liability lawyer and commonly works with other failed back surgery lawyers and failed neck surgery lawyers throughout the nation to investigate and handle failed back surgery product liability lawsuits.

FDA Adverse Reports and Post Fusion Surgery Adverse Health Events

Medtronic Infuse Bone Graft is a product that has been commonly used in back fusion surgeries since 2002.  The product contains recombinant human Bone Morphogenetic Protein (rhBMP) which is a genetically engineered protein that initiates bone growth.  The Infuse Bone Graft was approved by the FDA for use in some specific back surgeries, but has not been approved for neck surgery.  The FDA has received more than 200 adverse reports from the Infuse product including patients that have suffered swelling of the neck tissue, which constricted their airways, requiring an emergency tracheotomy, feeding tube, and more surgery.

Persons who have had a back fusion surgery which included the use of Infuse Bone Graft and families of these people should be aware of and report any of the following post surgery adverse health events:

  • Cancer

  • Difficulties swallowing, speaking, or breathing

  • Angioedema (swelling of the neck and throat, which can cause fatal suffocation)

  • Compression of airway

  • Impingement of nerves and nerve damage

  • Unwanted bone growth

  • Male sterility

  • Paralysis

  • Emergency surgery

  • Disability

  • Death

Metronic Infuse Bone Graft Lawsuits

The Manufacturer of the Infuse Bone Graft product is Medtronic.  Medtronic is facing over 3,000 lawsuits alleging adverse health events from the Infuse Bone Graft product. These Infuse Bone Graft lawsuits have not been consolidated into a MDL or class action lawsuit. Instead, the cases are individual lawsuits filed by plaintiffs with severe injuries. In May 2014, Medtronic agreed to settle 950 lawsuits for $22 million. They have set aside $120-140 million to settle thousands of additional claims. The Infuse Bone Gaft lawsuits include allegations that Medtronic sales personnel encouraged doctors to use the Infuse Bone Graft for off-label procedures that were not approved by the FDA.  Further, these lawsuits allege that Medtronic paid physicians to fraudulently create false studies regarding the Infuse Bone Graft product in an effort to mislead doctors and the public about the use of the product and that Medtronic failed to adequately warn of the dangerous side effects associated with the Infuse Bone Graft product.

Spinal Fusion Surgery

Spinal Fusion Surgery uses a bone graft to stop motion and impingement in the spine, thus reducing the patient's pain.  A Lumbar Spinal Fusion uses a bone graft in the lumbar or lower part of a person's back to stop the motion at a painful vertebral segment for the purpose of decreasing pain generated from the damaged part of the lumbar or lower back.  A Cervical Spinal Fusion uses a bone graft in the cervical or neck/upper back to stop the motion at a painful vertebral segment for the purpose of decreasing pain generated from the damaged part of the cervical back, upper back, or neck. 

Unfortunately, spinal fusions can fail for several different reasons.  A common reason for a failed fusion is that the patient's spine does not properly fuse.  An example of this type of fusion failure occurs when there is not enough support to hold the spine, while the spine is fusing.  These failed fusions can be caused by hardware failures.  In these situations, spinal hardware such as pedicle screws can be misplaced or can be defective causing the internal splint to fail.  The internal split is intended to hold the spine while the fusion takes place after spine surgery.  Its failure can cause spinal instability and prevent the fusion from being able to fully fuse.  Other potential reasons for a failed fusion include that the fusion does not stop the impingement or the fusion causes problems in other areas of the spine. 

In general, surgeons estimate that it takes at least three months to get a solid fusion after surgery, and it can take up to a year in some patients to get a solid fusion after the spine surgery.  Therefore, in some patients with unstable spines, after surgery it can sometimes be a race between the spine fusing (patient’s bone providing support for the spine) and the metal failing (causing fusion failure).  It is therefore important to have follow up care after surgery and for the patient to be advised as to the potential dangers of applying too much stress on the back during the healing process.  It is also important for the hardware that is implanted in a patient to be able to last long enough for a solid fuse to occur.

Also, it is important to keep in mind that even if a solid fusion is not obtained through the spine surgery, the hardware if it does keep intact and provides good stability to the spine, the patient may still achieve effective back pain relief with the spine surgery. In many cases, achieving spinal stability alone is more important than obtaining a solid fusion from the spine surgery.

Spinal Decompression and Fusion Surgery, Lumbar Decompression and Fusion Surgery, Cervical Decompression and Fusion Surgery, Failed Lumbar Decompression and Fusion Surgery, Failed Cervical Decompression and Fusion Surgery, and Failed Spinal Decompression and Fusion Surgery

In some patients, the decompression surgery will sometimes de-stabilize the spine and create the need for a fusion to add stability. In these cases spinal instrumentation (such as a small plate) can also be used to help add stability to the spinal construct.  Depending on the patient's cervical impingement an Ananterior Cervical Decompression Surgery (Discectomy) or a Posterior Cervical Decompression (Microdiscectomy) and Fusion Surgery (Discectomy) or a combination of operating from the front and back of the patient may be used. 

 The decompression and fusion surgeries are often used together because decompression surgery involves removing a small portion of the bone which will often result in spine instability.  Thus, decompression surgery or a laminectomy will sometimes de-stabilize the spine and create the need for a fusion to add stability. In these cases a internal splint or spinal instrumentation (such as a small plate and pedicle screws) can also be used to help add stability to the spinal construct. This decompression and fusion surgery includes Cervical Decompression and Fusion Surgery as well as Lumbar Decompression and Fusion Surgery. 

Unfortunately, some careless surgeons will fail to stabilize the spine during a decompression surgery resulting in spine instability that can result in severe pain, paralysis, or disability.  Other surgeons can fail to remove the bone or anatomical lesion (injury) that is causing the impingement and pain.  Both of these failures can result in the need for additional surgeries.

Fusion and Decompression Surgery by its nature involves incisions into and manipulation of the spine, surrounding nerves, and tissue, any mistake by a surgeon during the surgery can have potentially serious injuries and damages for the patient. These injuries and damages can include permanent nerve injuries, blood clots, incontinence, and even death if the surgery does not go as planned. Additionally, a medical professionals’ failure to monitor patients for potentially crippling and/or fatal side effects can be medical malpractice should these injuries occur.

In addition to the above back surgeries, there are numerous implants and spinal devices as well as injections that can help people recover from back and spinal cord injuries.  These procedures and devices can reduce pain caused by back injuries as well as help reduce impairment.  However, it is extremely important when considering back surgery or other spinal procedures to make sure that you have a competent doctor and medical staff that you trust.  A failed back surgery or defective medical device can cause more impairment, pain, and health problems than none at all.  It is important to understand the risks of any back surgery or medical treatment.

Further, it is important to understand that some medical doctors feel that too many surgeons are using back stimulators for treating back pain when the indication is for neuropathic pain instead.  It is extremely important to have a medical doctor and surgical team that understands the cause of your back pain and properly treats the underlying cause rather than uses an implant or improper surgical procedure to mask pain.  Further, it is also important for the surgical team to understand the proper methods for implanting any back stimulator.  Improper implantation of a back stimulator can cause serious problems.

Medtronic Fusion Infuse Bone Graft Lawsuits Include Fusion Cancer Lawsuits, Fusion Nerve Damage Lawsuits, Fusion Suffocation Lawsuits, and Fusion Death Lawsuits

For information regarding a potential Fusion Cancer Lawsuit, Fusion Nerve Damage Lawsuit, or Fusion Death Lawsuit, please feel free to submit an inquiry or send an e-mail to Texas Fusion Cancer Lawyer and Texas Fatal Back Fusion Lawyer Jason Coomer.  He is a Texas defective product liability lawyer and commonly works with other failed back surgery lawyers and failed neck surgery lawyers throughout the nation to investigate and handle failed back surgery product liability lawsuits.

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Law Offices of Jason S. Coomer
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Texas Lawyer Jason Coomer

Texas Lawyer, Jason S. Coomer, has extensive experience in practicing law and handles legal matters in a variety of practice areas. These practice areas include the following: