cialis online

Medtronic-Paid Docs Encouraged Unapproved Use of Infuse Bone Graft

AddThis Social Bookmark Button

Infuse Bone Graft has caused serious complications in some patients when it has been used in approved ways, and now some are wondering if its maker, Medtronic Inc,. may have encouraged frequent off-label use of the product. Apparently, off-label use of the Infuse Bone Graft is quite common. According to a report in The Wall Street Journal, at least three-quarters of the roughly 200 “adverse events” reported to federal regulators involve off-label uses of the product.

Medtronic has been named in three “whistleblower” lawsuits filed by former employees that alleged the company paid doctors to use Infuse Bone Graft and other Medtronic spine products. Medtronic agreed to pay $40 million to settle two of the cases, but admitted no wrongdoing. The third lawsuit alleges that Medtronic illegally paid doctors inflated consulting fees and bogus royalty payments to promote off-label uses Infuse.

Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body. It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia. It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation. According to Medtronic’s Website, the Infuse Bone Graft provides a scaffolding where new bone can grow.

In July, the Food & Drug Administration (FDA) warned that the use of the Infuse Bone Graft had caused serious problems when it was used off-label in cervical spine (neck) surgeries. The agency said it received 38 reports over four years of side effects, mainly swelling of neck and throat tissue, which resulted in compression of the airway and other structures in the neck. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.

But according to The Wall Street Journal, the Infuse Bone Graft has injured many patients after it was used in other off-label situations. The Journal said that most these complications cases involve unwanted bone growths near nerves or in areas outside targeted fusion sites. That can lead to pain, repeat surgeries and, in some cases, emergency intervention.

« »

Leave a Reply

You must be logged in to post a comment.

NEWS CATEGORIES

GOVERNMENT NOTICES

ARCHIVES


Defective Johnson & Johnson Depuy ASR Hip Implants

The Johnson & Johnson Depuy ASR Hip Implant is suppose to last 15 years, but can fail in only a few years after surgery. Victims with faulty hip implants endure excruciating pain, pain in the groin, death of tissue in the hip joint and loss of surrounding bone. GET ALL THE FACTS NOW! CLICK HERE!
defective-hip-replacement.com

CAT Scans Radiation Exposure

If you had a CT or CAT scan and now have a band of missing hair, skin reddening or any other problems possibly related to a radiation overdose, you may have been exposed to much radiation due to incorrect settings on these machines. CONTACT US TODAY!
CAT-Scans-Radiation-Exposure.com

Water Contamination From Fracking

Hydraulic Fracturing of Fracking a way to extract natural gas from shale is contaminating water supplies across the country. Get the facts to keep your drinking water safe for your family.
WaterContaminationFrom Fracking.com

Overexposure to PCBs

Many people unknowingly have been exposed to high levels of PCBs. Recently 3 schools in NY City were found to have dangerous levels of PCBs throughout. Many workers for Monsanto, General Electric, and Westinghouse were exposed to high levels of PCBs. PCBs are a dangerous toxic substance that doesn't break down easily and can cause chloracne, bleeding and neurological disorders, liver damage, spontaneous abortions, malformed babies, cancer, and death. GET THE FACTS!
Overexposure to PCBs.com

Great Photography

Tallis Photo, the number one photographer for great corporate, wedding, and special occasion photos. CONTACT US TODAY!
TallisPhoto.com

Poligrip Lawsuit

Super Poligrip or Fixodent May Cause Nerve Damage. 800-LAW-INFO
Poligrip-Lawsuit.com

Personal Injury Lawyer Nassau County

If you or someone you love was injured CONTACT US TODAY!
Nassau-Personal-Injury-Lawyer-Online.com

Nursing Home Blog

When a loved one is abused at a nursing home, it is time to take action. STOP nursing home abuse!
nursing-home-blog.com

Car Accident Lawyer Nassau County

If you or someone you love was injured in an auto accident CONTACT US TODAY!
www.nassau-car-accident-lawyer-online.com

Suffolk County Auto Accident Lawyer

If you or someone you love was injured in an auto accident in Suffolk County, NY CONTACT US TODAY!
www.suffolk-car-accident-lawyer-online.com

Don't Be Denied Veterans Benefits

If you or someone you love was denied veterans benefits CONTACT US TODAY!
www.veterans-benefits-denial.com

Oil Rig Spills Lawyer

Oil Rig Spills harm the environment and cause heavy losses to coastal game and fishing industries, as well as a loss of waterway usage, resulting in a loss of income to individuals and businesses, and a loss of beach front usage. Don't let a spill cause you harm, CONTACT US TODAY!
www.oil-rig-spills.com

Whistle Blower

Stand up and say what you think is right. See something, say something.
whistlebloweradvisor.com