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I had a two-level, l4-s1 alif with medtronic mbmp-2, autograft and nuvasive formagraft on (b)(6) 2015 followed by a two level, l4-s1 laminectomy and foraminotomy, posteriolateral gutter fusion with nuvasive formagraft, lifenet frozen allograft bone chips, and morselized autograft lamina on (b)(6) 2015.Nuvasive rods and screws added for stabilization.I had three large posterior, lumbar seromas on different dates, two of which were drained and the third left as is, by my spine surgeon.I do not know if the serous fluid was analyzed for bmp-2, in solution.I also had significant leg, ankle and foot swelling, for 1-2 months postop that was described to me by the vascular surgeon as an extension of my posterior seromas, similar, and that it would subside gradually.I became disabled after the surgery and subsequently was diagnosed with an arthritic l hip that was totally replaced (b)(6) 2016 and identified as a potential source of my continuing radiculitis, pelvic pain "girdle" and low back pain.The hip replacement has worked out well, no complaints, but i still have big problems walking and standing for more than 15 - 20 plus minutes and must sit down upon exertion.I take vicodin 5/325 for pain, 2 plus 4 pills, as needed.I sit and stay in bed a lot.I noticed a number of reported complaints and adverse events in the medical literature and popular press about bmp and several nuvasive products referred to, supra.I note that the nuvasive brigade hyperlordotic system was not fda-approved until (b)(6) 2015 while it was used, off-label, in my body on (b)(6) 2015.It must have been marketed to my surgeon, who is also a paid consultant, by (b)(4), and has accepted a trip to (b)(6) to do charitable back surgery with (b)(4).He also has transferred his interest in a patent for pedicle screw inserts to nuvasive, and received (b)(4) dollars in payments from nuvasive in 2016 as found by (b)(4) search.I am covered by (b)(6) (and was in 2015) for the back surgery., and understand that off-label use and marketing is illegal and not reimbursed by (b)(6).I do not know if (b)(6) was billed by the companies for formagraft and the brigade system and for bmp-2, but suspect that they were, given the known history and litigation.I have had a number of problems and pain complaints that i am still trying to work through 2 1/2 plus years later, and am contemplating additional back surgery, and a permanent spinal cord stimulator.I would like to know from the fda if the brigade system was illegally marketed for two-level use in my body prior to its official approval, if medtronic infuse was ever tested with formagraft and approved by the fda for use and if use of bmp outside of the cage would likely come into contact with seromous fluid, or otherwise migrate to my muscles, nerves and other soft tissues? i have walking problems with my psoas, gluteus and iliacus muscles.I did not give informed consent, as i knew nothing about the off-label uses or potentially damaging adverse events associated with the products described above.I think there has also been a breach of the dr's fiduciary duty to me and other potential allegations to be raised in due course.There are additional details about my complications and (b)(4), to be left for another day, for the proper venue.Sincerely, (b)(6).
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