Medtronic Infuse Problems from Off-Label Use
The Medtronic Infuse is a surgically implanted medical device that contains a genetically engineered protein, known as recombinant human bone morphogenetic protein (rhBMP-2), which is designed to stimulate bone growth.
Although it was only tested and approved for one type of lower back surgery, an Anterior Lumbar Interbody Fusion, which involves approaching the spine from the front through an incision in the abdomen for a single level fusion, it has been widely used “off-label” during different types of spine surgery.
Medtronic Infuse “off-label” use may include neck surgery, upper back surgery, lower back fusion where it was not an anterior approach (such as a posterior lumbar fusion) or any multiple level fusion.
As a result of such procedures, individuals throughout the United States have experienced a number of different serious and potentially life-threatening Medtronic Infuse complications, such as:
- Bone Overgrowth
- Inflammatory Reactions
- Nerve Damage
- Breathing Problems or Respiratory Compression
- Sterility in Men
- Sudden Death
It appears that Medtronic knew or should have known about the risk of these problems, but failed to adequately warn consumers or the medical community. The Lawyers at Saiontz & Kirk, P.A. are no longer reviewing new cases. This page is maintained for informational purposes only.
▸ Bone Overgrowth
Many of the more serious problems following Medtronic Infuse spine surgery involve the growth of bone in areas of the body where it is not desired. This may be referred to as herotopic bone growth or bone overgrowth.
When the bone morphogenic protein (BMP) contained in the Medtronic Infuse leaks into other areas of the body, it may result in this unwanted bone around the spinal cord, which could lead to:
- Additional surgery to remove excessive bone from the spinal canal
- Neck or back pain similar to what the original fusion was designed to eliminate
- Severe inflammatory reactions, which typically develop within 2 to 14 days after surgery
- Other potentially life-threatening complications
In 1999, several years before the device was introduced to the market, a study involving use of the Infuse bone graft during posterior lumbar surgery was halted when unwanted bone growth problems were found in a number of patients.
It has been known to Medtronic that bone overgrowth from the Infuse bone graft during “off-label” procedures can cause serious health problems, yet they failed to adequately warn consumers or the medical community about the risk of these side effets.
▸ Cervical Fusion Breathing Problems
Off-label use of the Medtronic Infuse during cervical fusion surgery, or neck surgery, has been linked to a number of serious respiratory problems, nerve injuries and deaths.
Although Medtronic never established that the Infuse was safe or effective during cervical spine surgery, they have encouraged such off-label use and in some cases even had a sales representative in the operating room during such neck surgeries to provide instruction and assistance to physicians.
In July 2008, the FDA issued a public health notification specifically warning against use of the Medtronic Infuse during cervical spine fusion, as it could cause severe inflammatory reactions within a few days after surgery, which may compress the airways and nerves. This could result in:
- Breathing Issues
- Difficulty Speaking
- Trouble Swallowing
- Hospitalization with the need for Feeding Tubes, Tracheotomies
- Additional Surgery
▸ Medtronic Infuse Cancer Risk
Substantial concerns have emerged in recent years about an increased risk of developing cancer following Medtronic Infuse bone graft surgery.
According to research involving a proposed higher dose formulation of the Medtronic Infuse, known as Amplify, a significantly higher number of cancers were found among individuals who received the BMP bone graft when compared to a traditional bone graft. The risk of developing cancer within the next year after surgery was found to be 2.5 times higher and the risk increased five-fold after three years.
The types of cancer that may be associated with the Medtronic Infuse BMP bone graft include:
- Breast Cancer
- Pancreatic Cancer
- Prostate Cancer
- Other Cancer or Tumors
▸ Male Sterility from Medtronic Infuse
Some studies have also linked the Medtronic Infuse bone graft and male sterility after spinal surgery, with some men developing retrograde ejaculation, where semen is pumped into the bladder instead of the urethra, making the male sterile.
Although Medtronic-sponsored studies have found no link with sterility and Infuse, multiple problems have been revealed with these studies, including a lack of disclosure about substantial consulting fees received by the researchers and failure to adequately report cases where man developed sterility problems from Medtronic Infuse.
LAWSUITS FOR MEDTRONIC INFUSE COMPLICATIONS AND WRONGFUL DEATH
Many individuals received a Medtronic Infuse BMP bone graft without knowing the complications associated with the device or understanding the risk. Therefore, financial compensation was puraued for those who experienced problems resulting in hospitalization or death following Medtronic Infuse bone graft surgery.
The product liability attorneys at Saiontz & Kirk, P.A. reviewed potential Medtronic Infuse injury lawsuits and wrongful death lawsuits as a result of the manufacturer’s failure to adequately warn about the risk of side effects. New cases are no longer being accepted. This page is maintained for informational purposes only.