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"&amp;lt;h3&amp;gt;Ectopic Bone Formation Definition&amp;lt;/h3&amp;gt;&amp;lt;p&amp;gt;Ectopic refers to an object or human tissue that forms or is located where it does not belong. Ectopic bone formation is the laying down of new bone material (via a process called ossification) in areas, again, where this material does not belong.\u00A0 This ossification process is performed by cells called osteoblasts.&amp;lt;/p&amp;gt;&amp;lt;p&amp;gt;The word ectopic comes from the Greeks, and means \u201Caway from a place.\u201D\u00A0 Its antonym, which is \u201Corthotopic\u201D bone \u2013 also derived from Greek \u2013 refers to bone that is formed in its correct anatomical location, according to Scott, et. al., in their article entitled \u201CBrief Review of Models of Ectopic Bone Formation.\u201D\u00A0 The article was published in the March 2012 issue of the journal, &amp;lt;em&amp;gt;Stem Cells Development.&amp;lt;/em&amp;gt;&amp;lt;/p&amp;gt;&amp;lt;p&amp;gt;&amp;lt;strong&amp;gt;Learn More:&amp;lt;/strong&amp;gt; &amp;lt;a href=&amp;quot;https://www.verywell.com/bone-spurs-osteophyte-definition-2548492&amp;quot; data-component=&amp;quot;link&amp;quot; data-source=&amp;quot;inlineLink&amp;quot; data-type=&amp;quot;internalLink&amp;quot; data-ordinal=&amp;quot;1&amp;quot;&amp;gt;Bone Remodeling&amp;lt;/a&amp;gt;&amp;lt;/p&amp;gt;&amp;lt;p&amp;gt;Ectopic bone formation can be present at birth, be due to genetics or arise as a complication of certain medical conditions such as paraplegia and/or traumatic injury (to name just a few.) Scott, et. al. say that ectopic bone formation is thought to be caused by local inflammation followed by a gathering of skeletal progenitor cells.\u00A0 According to Boston Children\u2019s Hospital\u2019s website, a progenitor cell is much like a stem cell except that it is more limited in terms of the types of cells it can become as it divides. Progenitor cells come from stem cells but are not adult stem cells.&amp;lt;/p&amp;gt;&amp;lt;h3&amp;gt;Ectopic Bone Formation Due to Spinal Surgery&amp;lt;/h3&amp;gt;&amp;lt;p&amp;gt;Scott, et. al, say that up to 10% of patients who undergo invasive surgery - and back surgery certainly falls into this group - \u00A0will develop ectopic bone formation.&amp;lt;/p&amp;gt;&amp;lt;p&amp;gt;In the spine, the term &amp;amp;#34;ectopic bone formation&amp;amp;#34; is sometimes used to describe unwanted bone tissue that gets laid down in the\u00A0&amp;lt;a href=&amp;quot;https://www.verywell.com/spinal-ligament-anatomy-296462&amp;quot; data-component=&amp;quot;link&amp;quot; data-source=&amp;quot;inlineLink&amp;quot; data-type=&amp;quot;internalLink&amp;quot; data-ordinal=&amp;quot;2&amp;quot;&amp;gt;spinal canal&amp;lt;/a&amp;gt;. \u00A0In 2002, the FDA approved a bone protein manufactured by Medtronic \u00A0called Infuse for use in lumbar spine surgery.\u00A0 The use criteria specified by the FDA was very specific:\u00A0 As bone graft for single level Anterior Lumbar Interbody Fusion (ALIF) within the Lumbar Tapered Fusion Device system (LT-Cage.) Whew!&amp;lt;/p&amp;gt;&amp;lt;p&amp;gt;But soon after the approval many surgeons began to use the material \u201Coff-label,\u201D which means for purposes other than what\u2019s been approved by the FDA. \u00A0Off-label uses included cervical spine surgery that resulted in a number of \u201Cadverse events,\u201D or AE being reported to the FDA.\u00A0 Ectopic bone formation was one of the AE\u2019s, but the list included other very serious things like &amp;lt;a href=&amp;quot;https://www.verywell.com/arachnoiditis-296628&amp;quot; data-component=&amp;quot;link&amp;quot; data-source=&amp;quot;inlineLink&amp;quot; data-type=&amp;quot;internalLink&amp;quot; data-ordinal=&amp;quot;3&amp;quot;&amp;gt;arachnoiditis,&amp;lt;/a&amp;gt; increased neurological deficits, retrograde ejaculation, cancer and more.\u00A0 Not pretty!\u00A0&amp;lt;/p&amp;gt;&amp;lt;h3&amp;gt;Medtronic Controversy&amp;lt;/h3&amp;gt;&amp;lt;p&amp;gt;The Milwaukee Journal Sentinal Watchdog Report, which has followed this story since 2011 (and continues to do so), says that within weeks of the first clinical trial for Infuse, ectopic bone formation was found in 70% of the study\u2019s patients.\u00A0 Some of these patients required one or more surgeries to correct the unwanted bone and/or the medical complications that arose from it.&amp;lt;/p&amp;gt;&amp;lt;p&amp;gt;In her review of evidence published in the 2013 issue of &amp;lt;em&amp;gt;Surgery Neurology International&amp;lt;/em&amp;gt;, Epstein compared the 13 industry fueled studies to other studies subsequently published in journals, as well as to FDA documents and information located in databases.\u00A0 She reports finding \u201Coriginally unpublished adverse events and internal inconsistencies\u201D with the Infuse studies.\u00A0 She also reports that 40% of the \u00A0adverse events were attributable to ALIF (the \u201Coff-label\u201D neck surgery that was done,) adding that some of these events were life threatening.&amp;lt;/p&amp;gt;&amp;lt;p&amp;gt;Meanwhile, the Milwaukee Journal Sentinel reports that Medtronic either under-reported or did not at all report these adverse effects to the FDA in a 2004 report written by Medtronic-funded doctors. \u00A0MJS says the \u201Cdoctors who wrote the 2004 paper would go on to receive millions of dollars in royalties and other payments from Medtronic.\u201D&amp;lt;/p&amp;gt;&amp;lt;p&amp;gt;In May of 2014, the MJS followed up this story with another article saying Medtronic had agreed to pay $22 million to settle 1000 claims against their Infuse.\u00A0 The story also mentioned that &amp;lt;a href=&amp;quot;https://www.verywell.com/what-is-spinal-fusion-2552315&amp;quot; data-component=&amp;quot;link&amp;quot; data-source=&amp;quot;inlineLink&amp;quot; data-type=&amp;quot;internalLink&amp;quot; data-ordinal=&amp;quot;4&amp;quot;&amp;gt;Medtronic&amp;lt;/a&amp;gt; is setting aside another $140 to cover \u201Cexpected claims.\u201D&amp;lt;/p&amp;gt;&amp;lt;p&amp;gt;&amp;lt;strong&amp;gt;Related: &amp;lt;/strong&amp;gt;&amp;lt;a href=&amp;quot;https://www.verywell.com/yoga-for-discogenic-low-back-pain-296372&amp;quot; data-component=&amp;quot;link&amp;quot; data-source=&amp;quot;inlineLink&amp;quot; data-type=&amp;quot;internalLink&amp;quot; data-ordinal=&amp;quot;5&amp;quot;&amp;gt;Take Care of Your Spinal Discs&amp;lt;/a&amp;gt;&amp;lt;/p&amp;gt;&amp;lt;p&amp;gt;&amp;lt;sub&amp;gt;&amp;lt;strong&amp;gt;Sources:&amp;lt;/strong&amp;gt;&amp;lt;/sub&amp;gt;&amp;lt;/p&amp;gt;&amp;lt;p&amp;gt;&amp;lt;sub&amp;gt;Boston Children&amp;amp;#39;s Hospital. What are Progenitor Cells? Adult Stem Cells 101 page. Boston Children&amp;amp;#39;s Hospital website. Accessed Dec 2015.&amp;lt;/sub&amp;gt;&amp;lt;/p&amp;gt;&amp;lt;p&amp;gt;&amp;lt;sub&amp;gt;Epstein, N. Complications due to the use of BMP/INFUSE in spine surgery: The evidence continues to mount. Surg Neurol Int. 2013: Accessed Dec 2015.&amp;lt;/sub&amp;gt;&amp;lt;/p&amp;gt;&amp;lt;p&amp;gt;&amp;lt;sub&amp;gt;Fauber, J., Infuse cited in patients&amp;amp;#39; painful bone overgrowth. Side Effects. A Journal Sentinel Watchdog Report. Journal Interactive. June 2011.&amp;lt;/sub&amp;gt;&amp;lt;/p&amp;gt;&amp;lt;p&amp;gt;&amp;lt;sub&amp;gt;Fauber, J. Medtronic to pay $22 million to settle legal claims over spie product. Watchdog Reports. Milwaukee Wisconsin Journal Sentinel. May 6, 2014.&amp;lt;/sub&amp;gt;&amp;lt;/p&amp;gt;&amp;lt;p&amp;gt;&amp;lt;sub&amp;gt;Scott, M., A., Levi, B., ASkarinam, A., Nguyen, A., Rackohn, T., Ting, K., Soo, C., Brief Review of Models of Ectopic Bone Formation. Stem Cells Dev. 2012 Mar 20; 21(5): 655\u2013667.&amp;lt;/sub&amp;gt;&amp;lt;/p&amp;gt;"^^<http://www.w3.org/2001/XMLSchema#string>
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