Medtronic’s InFUSE bone graft system is both groundbreaking and unique in many aspects. The FDA approved InFUSE/LT-CAGE in 2002 as a combination device comprised of InFUSE, a collagen sponge used as a carrier for InFUSE, and a spinal cage called the LT-CAGE to hold all three components together1. While the cage and collagen matrix don’t necessarily represent a groundbreaking discovery, the development of InFUSE changed the landscape of spinal surgery.
Arguably more accurately described as a new drug or even biologic, InFUSE is a recombinant human bone morphogenetic protein (rhBMP-2) which stimulates new bone growth by mimicking a protein naturally produced by the human body. To put this in perspective, most, if not all, previous spinal fusions required either harvesting the patient’s own iliac crest bone or the use of cadaver grafts, in order to gather enough BMP to stimulate bone growth and achieve spinal fusion. As both autologous and cadaver bone grafts have their own inherent drawbacks, such as graft rejection or pain at the site of harvesting, Medtronic found themselves in a wide open market once the system was approved by the FDA. Unfortunately for Medtronic, the FDA also implemented a number of very stringent controls on the use and marketing of InFUSE.
Since FDA approval of InFUSE, Medtronic has captured the majority share of the spinal fusion market, and has realized billions in profit from sales. However, while some of their sales are certainly a result of developing a new, groundbreaking treatment, recent findings show much more was at work driving those sales.
Perhaps the most egregious actions undertaken by Medtronic are allegations, and findings, that Medtronic not only sponsored many of the studies touting InFUSE for both on- and off-label procedures, but also wrote and published the studies and paid the authors tens of millions of dollars in return. Worse yet, when these studies were critically reviewed by The Spine Jounal, which dedicated an entire issue to the topic, unbelievable ethical violations came to light. For example, in 13 studies funded by Medtronic, encompassing over 700 patients, not a single adverse event was reported. In one study at Walter Reed Army Medical Center, the author simply made up data. In another, adverse events previously reported to the FDA during the approval process disappeared when published in a scientific journal. In yet another, Medtronic authored an article and purposefully excluded adverse event data. With such glowing reviews permeating the literature, it’s no wonder surgeons throughout the country began using InFUSE in off-label procedures. These surgeons were denied the full story.
By reporting perfect or near perfect safety, the original studies might have led others to widespread off-label use of the product with some potentially catastrophic outcomes. Revised estimates of adverse events are:
- Posterior lumbar interbody fusion techniques: 25-50% risk of associated adverse events.
- Anterior lumbar interbody fusion: 10-15% risk of adverse events.
- Anterior cervical fusion: 40% greater risk of adverse events in the acute postoperative period including potentially life-threatening complications.
- Posterolateral fusions: equivalent or greater early postoperative risk of morbidity compared with ICBG harvesting for this dosage; 16-20% of rhBMP-2 subjects had adverse back and leg pain events, a probable two to threefold increase in the first three months after surgery over control groups.
Identified Risks and Injuries
While we still don’t know the full extent of injuries associated with InFUSE, some of the risks being reported to the FDA include:
- Severe inflammation
- Severe infections
- Massive bone loss
- Graft migration
- Loss of fixation
- Epidural Hematoma
- Retrograde ejaculation
- Persistent bladder retention
- Severe back and/or leg pain
- Overgrowth or uncontrolled bone formation (ectopic bone growth)
- Male sterility
In many cases, patients will need revision surgery to correct adverse events associated with InFUSE. Further, it now appears that many of these associated risks may be untreatable.
If you or a loved one have undergone spinal fusion using Medtronic’s InFUSE bone graft, and have experienced any side effects, please contact Daniel P. Kondos today. Attorneys are available by phone, e-mail, or by clicking here.