Medtronic InFuse Bone Growth Side Effects
Medtronic’s Infuse BMP has been promoted as an new alternative bone graft product, allowing individuals to avoid harvesting bone from a different part of the body or using donated bone. However, side effects of Medtronic Infuse may cause excessive bone growth, also known as ectopic bone growth, which may cause severe nerve damage, inflammatory reactions and other serious health problems.
The product liability lawyers at Saiontz & Kirk, P.A. are reviewing potential Medtronic Infuse bone growth lawsuits for individuals who experienced complications from uncontrolled bone formation around the site of spinal surgery following off-label use of this product.
Medtronic Infuse Bone Morphogenic Protein (BMP) involves an aborbable collagen sponge treated with the bone growth agent and then placed inside of a cage that is implanted into the spine to promote fusion of vertebrae. It is a genetically engineered substance, which the FDA has only approved for limited types of spinal surgery, involving a single-level anterior lumbar fusion.
The FDA limited the types of spine surgery where the device may be used due to the potential risk of Medtronic Infuse bone growth side effects that may result if the BMP migrates out of the cage-like structure it is supposed to be contained within.
When used off-label, such as during a cervical spine fusion, posterior lumbar fusion or multi-level spinal fusion, users may face an increased risk of unintentional and excessive bone growth, which can cause nerves to become compressed or potentially lead to:
- Pain
- Paralysis
- Spasms
- Leg Cramps
- Airway Compression
- Retrograde Ejaculations
- Urinary Retention
- Cancer
MEDTRONIC INFUSE BONE GROWTH LAWSUITS
Although the manufacturer knew or should have known about the risks with off-label use of Medtronic Infuse, the company illegally and aggressively promoted such applications, placing their desire for profits before patient safety.
Financial compensation may be available through a Medtronic Infuse lawsuit for individuals who have experienced ectopic bone growth that following surgery, which may have been caused by side effects of the graft.
All cases are reviewed by our Medtronic Infuse bone growth lawyers under a contingency fee agreement, which means that there are no fees or expenses unless a recovery if obtained for injuries caused by side effects of Medtronic Infuse. To review a potential claim for yourself, a friend or family member, request a free consultation and claim evaluation.
5 Comments • Add Your Comments
Mark says:
I had my first spinal surgery, a partial lamanectomy in December of 1998. I have then since had spinal fusion in 2005, L5-S1 where I was giving the choice of eiter harvesting bone from my hip, requiring what eould be an additional surgery, or a single surgery utilizing a serum new to fusion surgery. I chose the serum. I again had spinal surgery for, T3-T4 fused wit a plate &the four screws, note; ive been on pain meds every since 98. In this fusion was performed in 20211. The pain in lower back was severe enough to promt another mri of lower back yet again in 2012. The results showed my L3-L4 blown. Surgery again using a new serum. This surgery was performed in 201220211 by the same surgeon. After the surgery I was told the old hardware had to be cut out to to bone growth at the L5-S1 level. I still am fighting the pain . The first serum used was no longer available do to growing to much bone. Is this a founded case? I can be reached by phone at 615-318-8446
Thank you
Mark
Posted on May 27, 2013 at 9:59 am
Mary says:
I have concerns about a C1-C2 Screw Fixation with Fusion intentions post-op 2 months. Dr. says that fusion material has moved and infers it is my fault, that I must not have worn hard neck brace. My concern is that this probably occurred day of surgery from leaking CSF or blood and now that I have researched this, I don’t know if this material was used legally, and now I have bone chips which may be growing in my neck with swallowing, swelling, headache, nausea issues and a host of problems since the surgery. As of the day of surgery, Xray and CT reports “small bone chips posteriorly at C2-C3 and C1-C2 levels, Subcutaneous air inferior to the area of surgery and small amount of air in the site of surgery. There appears to be some immediate postoperative possible bleeding vs CSF leak tracking down posterior to the spinous processes in the soft tissues of the posterior neck.” “We prepared bilateral burritos which consisted of special Medtronic infused sponges soaked in BMP and wrapped around a combination of the autograft material from the craniectomy. We placed the burritos and then the free bone material.” Please let me know if there is a problem here. I am now scared these things are growing and will order my latest xray for comparison. I saw the latest in the Drs office, but the bone fragments looked like they were bigger than the very 1st xray, possibly growing!
Posted on August 10, 2013 at 12:57 am
kenneth says:
In 2008 the material was used without my knowledge. Since then I have suffered terribly and now want the material removed. No one should have to live with such excruciating pain for as long as I have. If there is a doctor out there, I would like his name so this shit can be taken out of me
Posted on December 2, 2013 at 10:40 pm
Anne says:
I had fusions on June 19.Dr.has me off work until Dec.had headaches for 5weeks after surgery-have them on and off now-a lot more than before.have have ALOT of stomach issues I’ve never had before now.I can’t bend over or move around to do my job-my Dr.says I’m not disabled and he won’t help me getting disability-
Posted on September 7, 2014 at 7:05 pm
Donna says:
I had bilateral ( sacroiliac Illiacjoint)fusions. One was in 06 the other in 07. In 2009 I had to have the screws taken out. The doctor noted in 09 that the bone fusion (bmp) had overgrown. He chipped away the excess bone and removed the overgrowth. I am now having so much more pain in the region of the surgeries and down the legs and feet. I am having severe difficulty with walking. I am waiting to hear back from my doctor but I have 2 questions. 1) is the bmp able (or are there cases) of it growing back again? 2) Does this sound like a case involved with the recall?
Posted on April 14, 2016 at 11:56 am