Up To 85% Of The Times This Infuse Device / System "Hybrid" Product Is Used By Surgeons, It Is For Some Surgery Type Not Approved By The FDA
(Posted by Tom Lamb at DrugInjuryWatch.com)
An April 2013 Wall Street Journal news report about the Medtronic Infuse Bone Graft ended with this rather startling statement:
The Justice Department is also looking into its use for procedures beyond those officially approved by the FDA. Research indicates Infuse is used off-label in about 85% of cases, [Eugene Carragee, chief of spine surgery at Stanford University] said.
Essentially what this means is that while the Infuse Bone Graft medical device / system is approved by the FDA for a few specific surgical procedures, in the vast majority of surgeries when some or all of this Medtronic Infuse product was used in recent years it was for some "other" surgery type, i.e., so-called "off-label" use.
In today's article, here, we will deal with the foundation for this rather astounding problem, namely: What type of surgery is the Infuse Bone Graft approved for by the FDA?
In the coming weeks will address the the following related points:
- Some of the non-approved surgical procedures where surgeons have utilized the Medtronic Infuse product; and,
- Reports of adverse events that have caused serious injury to patients when there has been "off-label" use of Infuse Bone Graft.
In July 2002 the FDA approved this Medtronic Infuse Bone Graft product as a "medical device" containing an absorbable collagen sponge that is treated with rhBMP-2 for certain limited uses. The FDA’s limited-use approval of the Infuse Bone Graft product was based on concerns about potential adverse events that already had been reported with the product at the time of approval. In effect, the FDA approved Medtronic's Infuse "system" for only a small percentage of overall spinal fusion surgeries, with the Infuse label specifying
the limited surgical applications for which the product was to be used.
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In more detail, as approved by the FDA this Medtronic Infuse medical device / system consisted of two components:
(1) the LT-Cage® Lumbar Tapered Fusion Device Component, a thimble-sized hollow metal cylinder which keeps the two vertebrae in place and provides a frame that contains and directs the development of new bone growth; and,
(2) the Insfuse Bone Graft Component, which includes (a) an absorbable collagen sponge (“ACS”) that acts as a carrier and scaffold for the active ingredient in Infuse Bone Graft, and (b) rhBMP-2, the actual active ingredient that is reconstituted in sterile water and applied to the ACS.
The initial FDA-approved labeling for the Infuse product indicates that the rhBMP-2 active ingredient must be used with the LT-Cage device. However, as these two components are sold separately by Medtronic, it was easy for a surgeon to use one component part of the Infuse Bone Graft system without the other. And, as we will see later, this is what often happened when the Infuse product was used in an "off-label" surgery type.
When first approved by the FDA in July 2002, the Infuse Bone Graft could only be used for an Anterior Lumbar Interbody Fusion (“ALIF”) procedure, involving a single-level fusion in the L4-S1 region of the lumbar spine. This ALIF procedure is performed by approaching the spine from the front through an incision in the abdomen and is primarily used to treat pain resulting from disc collapse. Moreover, the original FDA-approved Infuse product labeling also provided directions about the specific manner in which both components -- the rhBMP-2 active ingredient and the LT-Cage device -- are to be used in the ALIF fusion procedure.
While Medtronic's label for the Infuse Bone Graft has remained substantially the same as the one approved in 2002, over time the FDA has made some limited and minor amendments to the Infuse label through post-approval supplements. For example, in July 2004 the FDA allowed the Infuse label to be revised to show an expanded "indicated" spinal region for the ALIF surgery, going from L4-S1 to L2-S1. And at a later time the FDA granted approval for using the Infuse system in certain oral maxillofacial surgeries.
However, as we saw at the start of this article, some ten years after the FDA approved this Infuse Bone Growth product limited types of surgical procedures, about 85% of the sales for this now controversial Medtronic product had to do with various "other" surgeries.
In our next Medtronic Infuse article we will take a look at how and when surgeons have used the Infuse Bone Graft product in these non-approved or "off-label" surgical procedures, as well as the associated reports of adverse events from patients.
Previously in this Medtronic Infuse series of articles we have covered these topics:
- Investigative news reports looking into the serious medical complications and side effects associated with the Infuse Bone Graft that were essentially ignored in Medtronic-funded studies;
- A U.S. Senate Finance Committee investigation led by Senators Charles Grassley and Max Baucus concerning the revelations made by those press reports as well as The Spine Journal June 2011 edition featuring the Infuse safety issues; and,
- Lawsuits being filed against Medtronic on behalf of patients who have suffered ectopic / excessive / unwanted bone growth, neurological impairment, and other severe side effects of the Infuse Bone Graft product.
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