Medtronic Infuse Bone Graft was initially approved by the FDA as an alternate choice for people wanting to avoid grafting bone from the hip. Surgeons use the product while performing their procedures in order to help the bone to grow. Ultimately, the growth of the bone replaces the previously injured section. Medtronic Infuse Bone Graft was only given approval for certain use and had never been given approval to be used in procedures to correct cervical spine injuries.

Medtronic received approval from the Food and Drug Administration in 2002. In doing so, the FDA limited the product for use on procedures involving lower back injuries to the lumbar spine, as well as for a few dental scenarios. The FDA, in particular, gave Medtronic its approval to assist with problems involving degenerative disc disease.

Through genetic engineering, Medtronic created this bone graft product which houses recombinant human Bone Morphogenetic Protein. This protein is a version of the protein that our bodies release naturally. When surgeons apply Bone Morphogenetic Protein to the spine, it helps to start growing bone in the specified regions of the spine. Surgeons are able to gain some control as to where re-growth of the bone will take place.


Though Medtronic Bone Infuse was granted approval to be used in certain surgical situations, it has been demonstrated that is can drastically cause severe problems when used for off-label purposes. There have been a multitude of accounts where Medtronic Bone Infuse was used for procedures involving upper neck injuries. When Medtronic Bone Infuse is used for cervical spine injuries the risk of dangerous outcomes increases. The main reason that using Medtronic Bone Infuse on the cervical spine creates such a problem is because the genetically manufactured protein that promotes the bone growth has shown possibilities of leaking. It has been indicated by research, that problems arising from the use of Medtronic Infuse have developed in approximately half of the patients who have been treated with the product. Issues with the use of Medtronic Infuse Bone Graft range from continuous pain in the region of surgery, all the way up to death. The reality of such a severe problem becomes even more increasingly concerning when considering the possible effects, including:

  • Uncontrolled and/or excessive bone growth
  • Nerve Damage
  • Chronic radiating pain in the legs or arms
  • Cancer
  • Respiratory Depression / Compression of the Airway

Consequently, a seemingly “helpful” product has become a nightmare for so many people. Medtronic has been accused of promoting off-label use of its product as a stimulator to doctors; more specifically, with regards to the cervical spine. The encouragement of off-label use from Medtronic to its physicians has created mass sales, clearing the $3 billion dollar mark. To date, around 700,000 units of Infuse Bone Graft have been used in the United States.

Madalon Law understands that when you are considering whether you have a valid claim for damages, it can sometimes be overwhelming. Allow our legal team in Miami and Fort Lauderdale assist you in determining the most effective way to approach the injury you may have sustained as a result of a Medtronic Bone Infuse Graft. Contact us today, so your questions and concerns can be answered.

Infuse Bone Graft Problems – Signs and Symptoms


The most important thing for people to be aware of who have been treated for neck injuries using Medtronic Bone Infuse is that symptoms are not immediately recognizable. The symptoms of such bone grafting complications which involve Bone Infuse have a wide range of distinguishing signs. The FDA asserts that many problems that can be directly attributed to the use of this product on the cervical spine. Issues that arise from Bone Infuse will generally present themselves within the first 14 days after the surgical procedure; however, there have been cases where symptoms stemming from the use of Bone Infuse remained dormant until after the typical 14 day mark.

The earlier studies done on Medtronic Bone Infuse, as well as the FDA’s review of the product, have illustrated that Bone Infuse can potentially inflame the tissues and bone near the surgical region. It can also cause urinary issues, and has been shown to encourage the growth of cancerous cells. These types of products have been linked to an overall 43 percent complication rate.

Medtronic has presented Bone Infuse Grafts as a more effective way to graft bone as opposed to the conventional bone grafting methods, because it helps to avoid secondary procedures of grafting from the hip. Historically, this type of follow up procedure is linked to major complications. That being said, there have been studies showing that the use of Medtronic Bone Infuse as an alternative, creates risks of serious problems post-surgery which are equal to or greater than the conventional method of grafting from the hip.

As a risky procedure on its own, grafting bone can be extremely terrifying for a person to undergo. When a patient entrusts their surgeon to perform any type of procedure on them, they have expectations that they are in good hands. The reality has been, however, that surgeons who have used Medtronic Bone Infuse for grafting in off-label procedures have left some of their trusting patients with severe complications and side effects. It is important to be able to recognize some of the side effects so that treatment can been immediately administered. Many of these side effects include, but are not limited to:

  • Swelling of the Neck
  • Trouble Swallowing
  • Issues with Breathing
  • Problems with Speech or Speaking
  • Chronic Radiating Pain throughout areas of the body
  • Injury to Nerves
  • Sterility / Retrograde Ejaculation
  • Uncontrolled Bone Growth

If you or a love one have been a patient of a surgeon who has used Medtronic Bone Infuse, it is imperative that you seek medical treatment for any signs of possible side effects. The complications that result from the off-label use of the product have been as severe as death. Long term side effects of some from complications have not been fully calculated as the product is still relatively new to the market. If you are in the state of Florida, you need to contact the Fort Lauderdale office of Madalon Law today to speak to an injury attorney who can explain to you your options during this most unfortunate time. Legal representation will allow you to recover damages from the injuries you sustained as a result of the off-label use of Medtronic Bone Infuse.

Medtronic Infuse Bone Graft: Frequently Asked Questions


  1. What is Medtronic Bone Infuse used for?

The company Medtronic, created, promoted and sold Bone Infuse graft kits as an alternative method for fusing together damaged vertebrae to encourage growth of the human bone.

  1. Originally, what procedures was Medtronic Bone Infuse performed on?

Initially, surgeries involving the use of Medtronic Bone Infuse were intended procedures involving situations where:

  • There was presence of degenerative disk disease
  • Only one disk space was being fused and only between lower back vertebrae
  • Placing the product would only occur through entry to the front of the body.

Later on, Medtronic Bone Infuse was approved for additional use. The new uses included:

  • Acute, open tibial fractures
  • Sinus augmentation involving dental implants
  • Roof of the mouth augmentation post socket extraction procedures
  1. What is the specified use on the product’s label?

First, the Bone Infuse product in bottle is supposed to be extracted by the doctor by using a syringe. Next, the doctor dispenses the Bone Infuse onto a sponge-like piece of gauze until the product saturates the sponge. Following that, the doctor places the sponge into a device (cage) used to house the product for insertion. The doctor then places the cage in the area, or disk space, which is intended to be fused. The cage is then fastened by the surgeon to the desired location using plates and screws in most cases.

  1. What situations have surgeons used Medtronic Bone Infuse for off-label purposes?

Unfortunately, there have been many cases where doctors have improperly used the product Bone Infuse in surgical procedures. These off-labels uses by surgeons include:

  • Using the product to fuse discs outside of the approved range of vertebrae (L1 through S1)
  • Using inaccurate dosages of the product for the intended procedure
  • Using the product on areas which were NOT approved by the FDA
  • Using of incorrect devices used to house the sponge containing the product
  • Placing the product directly on the desired location of fusion
  • Using the product to fuse together more than one vertebrae at a time
  1. How often does off-label use of Medtronic Bone Infuse occur?

There have been updated reports that indicate that over eighty percent (80%) of procedures using Medtronic’s product, Bone Infuse, have been improperly used.

  1. Are there any issues that result from the off-label use of Medtronic Bone Infuse?

As an alternative to grafting bone from the hip in surgeries involving fusions, initially, Medtronic’s Bone Infuse was looked at as an extremely positive product compared to what needed to be done previously. The idea was to encourage the bone to grow without having to have an invasive procedure such as grafting bone from a person’s hip. The issue that developed is that Medtronic’s product worked a little too well in that, the stimulated growth became excessive in certain situations. The overgrowth of bone causes many problems associated with the impingement of the spinal cord and nearby nerves.

  1. What type of injuries can be associated with using Medtronic Bone Infuse for off-label purposes?

There have been many serious injuries that have resulted from using Medtronic Bone Infuse for off-label purposes. Some of those injuries are, but are certainly not limited to:

  • Cancer
  • Respiratory / Breathing Issues
  • Swelling of the Neck
  • Paralysis
  • Sensations of Burning
  • Growths of Cysts on area of Procedure
  • Extreme Pain / Long-lasting Pain
  • Ectopic Bone Growth
  • Death
  1. What additional issues can be attributed to Medtronic Bone Infuse which can help in a lawsuit?

Medtronic has been accused on multiple occasions of paying lab companies to write positive findings on investigations of their product, Bone Infuse, and withhold any negative findings. The FDA did its own investigation and concluded that all negative findings found through their own studies were never mentioned by any of the previous reports made.

Medtronic has also been accused of encouraging the off-label use of its Bone Infuse. The degree to which Medtronic promoted this type of use of its product, it has been said that it is like no other in the industry. Accusations of paying personnel in the medical industry to promote the off-label use, is one of the biggest concerns that surrounds Medtronic today.

  1. How do I know whether I have a claim against Medtronic?

Laws which govern these types of claims are generally similar from state to state. Compensation can be collected when there is a loss resulting from defective medical devices, unreasonably safe procedures or misuse of the intended manufacturer. The costs that you may be able to recover include:

  • Medical Expenses (Past & Future)
  • Loss Wages & Lost Ability to Earn Wages
  • Out-of-Pocket Expenses Incurred as a Result
  • Pain & Suffering damages

Additionally, if it can be proved that Medtronic recklessly or intentionally failed to provided a physician or patient with the associated risks of harm, there may also be a claim for punitive damages.

If you or a loved one underwent a procedure involving the use of Medtronic Bone Infuse and are now suffering because of it, you need to hire an attorney. Contact the Medtronic Infuse Bone Graft attorneys at Madalon Law for your free consultation and start getting answers to your questions today.

Uncontrolled and/or Excessive Bone Growth Lawsuits


There are currently a large number of people actively involved in litigating cases against the company Medtronic, and the number continues to grow. The purpose for the majority of these lawsuits stems from experienced post-surgery complications after surgeons used the company’s product, Bone Infuse, to assist with stimulating bone growth during the surgery. The problem with the product is that its initial intended use, approved by the FDA, was not how these surgeons were using it. Medtronic has been accused of promoting off-label usage of their product, which subsequently, has caused very serious side effects to patients it was improperly used on.

The very serious allegations that continue against Medtronic claim that the company minimized the severity of risks involved pertaining to the uncontrolled growth of bone in the spine. The lawsuit against the company alleges that the number of these types of excessive bone growth cases exceeds that of which Medtronic discloses as the factual number.

The severity of the complications involved with the off-label use of Medtronic Bone Infuse is so great, that the FDA has advised doctors, by issuing an alert, of the complications. Specifically, doctors were warned that using Medtronic Bone Infuse in upper regions of the spine during fusion procedures could attribute to extreme neck swelling, breathing issues and other life threatening side effects.

Excessive bone growth in the spine due to using Medtronic Bone Infuse can have long lasting effects which can leave a person permanently disabled. The uncontrolled growth of the bone has caused damage to nerves, which generally cause residual issues throughout the body. Additionally, the uncontrolled growth of bone in undesired areas of the body can create very serious issues.

The medical term used to describe excessive bone growth is Heterotopic Bone Growth. The manufactured protein that Medtronic uses in its product has been shown to find its way into other unintended areas of the body. When the BMP, or bone morphogenic protein, leaks into areas of the spinal cord, the effects can be devastating.

Issues that result from Medtronic Bone Infuse excessive bone growth can be, but are not limited to:

  • Inflammation of affected area post-surgery
  • Necessary second procedure to rectify the complications of the spine
  • Continued and worsened pain which surgery was intended to alleviate
  • Problems post-surgery leading all the way to death

There are reports that years before the problems with off-label usage of the product became known, studies were done which demonstrated the possibility of excess growth in using Medtronic Bone Infuse on the lumbar spine. The unfortunate truth is that Medtronic has known for many years that there was potential for uncontrolled bone growth. By promoting off-label use of their product, they placed serious risk of severe complications on the patients who had Bone Infuse used on them. It is important to know that if you or a loved one has been the victim of Medtronic Bone Infuse off-label grafting, you may be entitled to recover for any injury that resulted from the product, as well as a possible pain and suffering.

Contact the Medtronic Bone Infuse attorneys at Madalon Law for your free consultation and get a better understanding of what options you may have. We are based out of Fort Lauderdale and fight for the rights of victims throughout the state of Florida.

Why Do People Get Bone Grafts?


There are many types of crippling injuries out there. Many people would be willing to do whatever it took to eliminate these injuries and the effects they cause on day to day activities. When a person has an injury to a bone or a joint in their body, or they suffer from a diseased bone or joint, bone grafting can be the cure for their pain. Essentially the damaged area of bone can be replaced by pieces of good bone or bone like material.

There are an increasing number of people who are forced to deal with pain stemming from degenerative disease of the spine and additional forms of arthritis. With as many grafting procedures that have been conducted, it has been calculated that more than eighty percent (80%) of them have been done in a procedure known as a spinal fusion. Generally, these spinal fusions are done to help the patient eliminate pain in the back.

Spinal fusions are performed by surgeons on more than four hundred thousand (400,000) patients every single year. The price for such a procedure can vary depending on the doctor, but average costs for these types of surgeries have been estimated at around thirty-six thousand dollars ($36,000.00). The goal of the surgeon performing the procedure is to repair the damaged part of the spine, or the vertebrae, by fusing that area of the spine. Once the fusion is completed, the vertebra forms back to a whole piece of bone. By fusing the bone back to its condition prior to being damaged, the pain that the patient was enduring is generally eliminated because there are no longer nerves in the spine being irritated.

Bone grafts are generally done by removing bone from one part of a patient’s body, most of the time from the hip, or bone which is provided by a done. There are problems that can arise from taking bone from the hip in a grafting procedure. Many times, complications that come from harvesting bone from this sensitive area of the body include, but are not limited to:

  • Residual pain in that area
  • Surgical infections
  • Bone bruising
  • Fracturing of the pelvic bone

If a patient were to receive bone which was donated, there are chances that the bone may bring in infections and/or diseases. Additionally, it is extremely difficult for a surgeon to control the quality of bone being used.

With the uncertainties and complications that come along with bone grafting, there have been companies like Medtronic who have created alternatives to this procedure. Ultimately, the alternative that was created was a synthetic generated version of a bone protein that is normally produced in the body. The protein’s role is to help form bone where it needs to be reinforced. Though the synthetic version has shown positive attributes in its use in certain areas of the body, it has also shown terrifying results when used for off-label purposes.

If you have had a bone graft performed on you with the use of Medtronic Bone Infuse, it is extremely important to be evaluated by a physician concerning your well-being. If you are currently suffering pain as a result of Medtronic Bone Infuse being used during your bone graft procedure, contact the trained legal team at Madalon Law to find out how you can be compensated for your injuries.