• Skip to primary navigation
  • Skip to main content
  • Skip to footer

Madalon Law

  • (877) IT-MATTERS
  • (954) 923-0072
  • Home
  • Legal Team
    • Joseph Madalon, Esq.
    • Leandro Carvalho, Esq.
    • Susan Lee, Esq.
  • Practice Areas
    • Property Damage
    • Hurricane Damage
    • Roof Damage
    • Water Damage
    • Amusement Park Accidents
    • Aviation Accidents
    • Bar / Nightclub Accidents
    • Bicycle Accidents
    • Birth Injury
    • Boating Accidents
    • Burn Injury
    • Bus Accidents
    • Car Accident
    • Construction Accidents
    • Head and Brain Injuries
    • Horse Riding Accident
    • Lyft Accident Attorneys
    • Maritime Attorneys
    • Medical Malpractice
    • Motorcycle Accidents
    • Negligent Security
    • Nursing Home Abuse
    • Pedestrian Accidents
    • Premises Liability
    • Product Liability
    • Sexual Harassment
    • Slip and Fall
    • Spinal Injury
    • Swimming Pool Accident
    • Theme Park Injuries
    • Truck Accident
    • Uber Accident Attorneys
    • Vacation / Hotel Accident
    • Wrongful Death
    • Class Action Lawsuits
    • CPAP Recall Lawsuit
  • Results
  • Videos
  • Blog
    • Articles
  • FAQs
  • Contact
  • En Español
  • Inicio
  • Nosotros
    • Equipo Legal
    • Biografia de Joseph Madalon
  • Lesiones Personales
  • Resultados
  • Videos en Español
  • Contacto
  • En inglés

Medtronic Infuse Bone Graft: Frequently Asked Questions

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.

  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.

Areas of Practice

roller coaster ride with trees in foreground

Amusement Park Accidents

plane on runway getting ready for takeoff

Aviation Accidents

people drinking and dancing at a bar

Bar and Nightclub Fights

woman ready to get on a bicycle

Bicycle Accidents

emergency room sign at the entrance of hospital

Birth Injury

cruisde ship at dock

Boating and Cruise Ship Accidents

fire burning and burned skin

Burn Injuries

school bus picking up kids at bus stop

Bus Accidents

two cars in car crash at intersection

Car Accidents

constuction worker that got hurt working on job site

Construction Accidents

woman with head injury from a car accident

Head and Brain Injury

person riding a horse

Horse Riding Accident

cruise ship sailing on the sea

Maritime and Cruise Ship

medical professional with stethascope helping a patient

Medical Malpractice

motorcycle accidient with rider on the ground with injury

Motorcycle Accidents

security personnel at a concert

Negligent and/or Inadequate Security

nursing home patient laying in bed

Nursing Home Abuse and/or Negligence

man injured on ground from car that went through intersection

Pedestrian Accident

broken fence and cracked sidewalk

Premises Liability

sign wih the word defective spelled out

Product Liability

beach and palm trees at a vacation resort

Resort/Vacation Injuries

womans hands pushing away a man that is grabbing her

Sexual Harassment

yellow caution sign on floor with a person that slipped on the floor next to it

Slip and Fall

medical image of body and spine

Spinal Cord Injury

swimming pool with people jumping in the water

Swimming Pool Accidents

sign of walt disney world theme park entrance

Theme Park Injuries

semi truck driving on road

Truck Accidents

lady justice statue

Wrongful Death

Video Library

Blog

Understanding the Law

Fort Lauderdale

Main Office
100 N. Federal Hwy #CU5
Fort Lauderdale, FL 33301
Map for Fort Lauderdale address
Phone: (954) 923-0072
Toll Free: (877) 486-2883
Fax: (954) 923-0074

West Palm Beach

By Appt. Only
515 N Flagler Dr Suite P-300
West Palm Beach, FL 33401
Map for West Palm Beach address
Phone: (561)-243-1003
Toll Free: (877) 486-2883
Fax: (954) 923-0074

Miami

By Appt. Only
150 SE 2nd Ave, Suite 300
Miami FL 33131
Map for Miami address
Phone: (786) 401-5059
Toll Free: (877) 486-2883
Fax: (954) 923-0074
  • Home
  • Disclaimer
  • Privacy Policy
  • Contact Us
  • Site Map

Footer

Facebook

Twitter

Linkedin

Google Plus

YouTube

Instagram

Pinterest

We serve the following localities:
BROWARD COUNTY including Fort Lauderdale, Hollywood, Pembroke Pines, Pompano Beach, Plantation, Coral Springs, Davie, Sunrise, Weston, Deerfield Beach and Miramar;
MIAMI-DADE COUNTY including Coral Gables, Cutler Bay, Doral, Hialeah, Homestead, Kendall West, Miami, Tamiami, The Hammocks, and Westchester;
PALM BEACH COUNTY including Belle Glade, Lake Worth, and West Palm Beach;
ORANGE COUNTY including Orlando and Winter Park;
OSCEOLA COUNTY including Kissimmee, Poinciana, and St. Cloud.
Areas Served

Copyright © 2023 · Madalon Law · Powered by: USAttorneys.com
Areas Served

X

Contact Madalon Law

    Contact Us

    Please prove you are human by selecting the Flag.