THE FORT LAUDERDALE PERSONAL INJURY ATTORNEYS AT MADALON LAW FIGHT FOR THE RIGHTS OF PEOPLE WHO ARE SUFFERING FROM MEDTRONIC BONE INFUSE

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.

2. 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

3. 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.

4. 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

5. 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.

6. 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.

7. 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

8. 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.

9. 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.