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If you are reading this right now, there is probably a good chance that you or a loved one received a Medtronic Infuse Bone Graft and have been experiencing side effects and/or complications from your surgery. Even if your procedure dates back to the early 2000’s, you should read the rest of this document very carefully as you may be entitled to financial compensation from the active class action lawsuit filed against Medtronic.
Medtronic Infuse Bone Graft was first approved by the FDA in 2002 for only anterior approach lumbar fusion and two types of dental procedures. The FDA was quite specific, defining the Medtronic Infuse Bone Graft as: “A device to help fuse vertebrae in the lower spine in order to treat degenerative disc disease.’’ In a proper procedure, a small metal device filled with synthetic bone material is placed between two vertebras in the lower back to enhance bone growth and fuse the two together. This procedure was very successful, but Medtronic got greedy and started to market the device for different kinds of surgeries without proper warnings to surgeons or patients. And after these improper surgeries, patients developed horrific side effects.
Initial medical studies that found Infuse to be risk-free were discredited because of financial ties between these researchers and Medtronic. Later, independent studies found a link between the implant and a higher risk of cancer, as well as a host of other issues, including uncontrolled bone growth.
By July 2008, the FDA issued a warning about the use of Medtronic Infuse Bone Graft in cervical or neck surgery, specifically citing excessive bone growth in the neck.
If you’ve had back or neck surgery since 2002 and are concerned that you may have side effects from the Medtronic Infuse Bone Graft, don’t delay in getting an ethical, legal opinion about whether you have a valid case. Call John Foy & Associates at 404-400-4000. We’re one of Atlanta’s most well established Medtronic Infuse Bone Graft firms.
This synthetic bone graft implanted in you may have been causing you serious medical problems for years.
Read the full FDA Summary of Safety and Effectiveness Data dated Match 9th 2007.
What is a Medtronic Infuse Bone Graft and why is it used?
Spinal surgery is one of the most common orthopedic procedures performed today. And 80% of all bone grafts in the United States are performed to support the spine during vertebrae fusion surgery. Bone grafts traditionally have come from the patient’s own jaw, skull, hip or chin, requiring a second surgery to harvest the bone. These kinds of surgeries can be very painful and lead to secondary infections. Surgeons also use allogenic bone grafts come from cadavers or cow bones. So, it was with great excitement when Medtronic introduced its new product in 2002 to treat degenerative disc disease.
Medtronic Infuse Bone Graft is a combination of cow collagen and synthetic human protein, rhBMP-2, that is injected into the graft area to promote re-growth of the bone.
More than 1 million people have used it. This synthetic implant was touted as a great way to replace the pain that comes with harvesting the patient’s bone. It does work, but the FDA only approved it for use on the lower spine.
Unfortunately, over the years Medtronic encouraged doctors to use this drug for different purposes. Studies showed, however, that 80% of its usage was for “off-label” procedures. Off-label means that the drug is being used for something other than what the FDA has approved it for.
Why is there a class action lawsuit against Medtronic?
A class action suit against Medtronic was filed because the company misstated and misled doctors about the drug’s benefits and played down its risks. In 2012 Medtronic paid $85 million to settle a shareholder’s lawsuit that stated the company had misled its shareholders about the amount of revenue that came from the use of Infuse in non-FDA approved procedures.
U.S. lawmakers found that Medtronic-sponsored research had overstated the benefits and downplayed the risks. In 2014 the med-tech firm also paid $22 million to almost 100 claimants, and set aside $140 million more for other expected settlements.
What are some of the injuries, side effects and complications linked to the use of Medtronic Infuse bone graft?
Medtronic Infuse Bone Graft when given in high doses may increase the risk of cancer in patients. Patients with spinal fusion procedures are often given high dosages.
A Stanford University study found that when the drug was given in high doses, it increased a risk of cancer in patients 2.5 times after one year and 5 times after three years. Other side effects include:
- Uncontrolled bone growth, especially if the surgery was done of the neck.
- Difficulty breathing
- Difficulty swallowing
- Difficulty speaking
- Acute severe swelling
- Severe neck swelling
- Speech impairment
- Severe and/or chronic pain
- Nerve damage and pain to legs, spine and arms
- Chronic radiating pain, chronic radiating leg and arm pain
- Male sterility
- Retrograde ejaculation (semen enters the bladder)
- Uro-Genital injuries swelling
- Ectopic bone formation, specifically bone growth in the spinal canal
- Neuritis (inflammation of the nerve, chronic pain)
- Radiculopathy and Radiculitis
- Cauda Equina Syndrome (CES)
- Death and disability
When used from neck treatment, the problems increased by 40 percent.
What rights do I have if I think I have been injured by a Medtronic Infuse Bone Graft?
If you think you, or your loved one, have been injured by a Medtronic Infuse Bone Graft, you have the right to add your name to a Mass Tort case that allows a personal injury lawsuit to be filed for more than one defendant at a time. If a judgment is found against Medtronic, you will be eligible for a portion of the settlement so that you can seek medical treatment or simply be compensated for your pain and suffering. You have a right to hire your own attorney to keep you posted on any trial events and to represent you in this massive lawsuit. We urge you to call our attorneys at John Foy & Associates at 404-400-4000 to get a free and confidential consultation on your rights on your case.
What should I do if I or a loved one have been experiencing some of the side effects and complications where the Medtronic Infuse Bone Graft was used?
If you think that you or a loved one have been experiencing side effects and complications after Medtronic Infuse Bone Graft surgery, we urge you to visit your physician and be candid about your symptoms. And, call a personal injury attorney at John Foy & Associates to look at your legal rights. These sorts of lawsuits are complicated with multiple defendants with varying complaints going up against a cadre of highly paid attorneys. You need a local personal injury attorney by your side that can help manage the legal side while you and your physician concentrate on your health.
Is there a time limit to file a claim against Medtronic?
Time limits, or statute of limitations, to file a claim against Medtronic are quite complicated. Your deadline is tied to the first time you hear that you may have side effects relating to this drug. That’s why it’s so important to reach out to an attorney as quickly as possible or you risk losing out on this important compensation.
What am I entitled to in a Medtronic Infuse Bone Graft lawsuit?
In a Medtronic Infuse Bone Graft, you are entitled to a portion of any large Mass Tort settlement that is decided. The court uses a complex legal matrix to decide your portion of any settlement.
How can John Foy & Associates help me?
If you are a resident of Georgia, you need a strong, local attorney who has experience with filing Defective Medical Devices lawsuits. In a Mass Tort case, a single law firm is designated to try the case in court. By employing a local attorney, you will have an educated advocate who stays abreast of lawsuit changes and verdicts and who will make sure you get your fair share of any settlement. There are no fees unless you receive a settlement.
This is a quite serious breach of medical ethics. Let us represent your legal rights while you and your doctor concentrate on getting better. Give our Medtronic Infuse Bone Graft Lawsuit attorneys a call at 404-400-4000 for a free and confidential consultation.