Have you had Bone Graft Surgery?
Medtronic Inc., manufacture of the Infuse Bone Graft System a medical device used to unite the vertebrae after undergoing a spinal surgery, is currently facing a rising number of lawsuits. Allegations that the manufacturer inadequately did research to study the side effects, as well as warn the general public regarding the risks. Medtronic failed to warn people that surgery may result in severe and irreversible injuries to both nerves and spinal cord. They are also being accused of using the product for other procedures that were not include in their initial research, or approved by the FDA called “off label” procedures. The device is from cow collagen made into an absorbable sponge that is soaked in a genetically-engineered bone-growth protein also known as rhBMP-2. It was promoted as a substitute to the traditional bone grafting techniques. Its biggest promotional point that patients could avoid the pain and any other problems that are associated with the older, traditional ways of bone grafting.
In 2002, the FDA approved the use of Medtronic Infuse Bone Graft. After a few years, there were reports stating that more than 80% of its use was “off-label”, and never studied or evaluated by the FDA for the use in the following procedures:
- cervical fusion,
- posterior fusion
- lumbar fusion
- thoracic fusion
Medtronic Infuse Bone Graft was only tested and approved for an anterior lumbar fusion that involves a single level fusion. In 2008 the FDA announced that serious life-threatening injuries can occur after infused bone graft surgery. This was announced when researched showed that after 2-14 days patients who underwent surgery experienced difficulty in speech, swallowing and problems breathing.
Some of the most common side effects for Medtronic Infuse Bone Graft are:
– Excessive bone growth
– Nerve damage
– Chronic pain
– Swelling in the neck
– Male sterility
– Radiated leg pain
– Retrograde ejaculation
Medtronic Infuse Bone Graft, when used for unapproved procedures may cause growth of bones in unwanted areas which may lead to:
- Severe Inflammatory Reaction
- Nerve Impingement Resulting in Severe Back or Neck Pain
- Hospitalization with ICU Treatment
- Airway Compression Associated With Breathing Problems
- Additional Surgery to Remove Excessive Bone from the Spinal Canal
- Need for a Feeding Tube or Tracheotomy
Victims are highly encouraged to seek medical and legal advice immediately. If you or anyone you know suffered complications and injuries caused by Medtronic Infuse Bone Graft, you may be qualified to receive financial compensation. Please Contact Us and provide any details along with contact information. If you prefer to leave a voicemail you can call 1.858.236.9020. GetClassActionMoney.com can then forward these requests to our network of attorneys that may contact you if a Class Action Lawsuit is to be pursued.
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