[4604948]
Pt received 5 treatments every other week with the vaser shape ultrasound unit as part of a study (b)(6) supported by sound surgical technologies (sst), now solta medical. After the 5th treatment and before results of the pop's were back as well as other labs, the pt was hospitalized unable to get out of bed w/severe back pain and has been in a nursing home ever since then. Initially, i did not see any connection between the vaser shape treatments and the back pain, but after seeing the results of the (b)(6) study, i feel that there is a definite relationship. The pt's blood and urine were obtained approximately 1 hour post treatment and sent to (b)(6) for evaluation. His heavy metal test results showed uranium in his urine at the level 90th percentile compared to (b)(6). He also had multiple other toxins that were liberated from his fat by the diathermic energy that could have caused tissue, organ, and/or nerve damage. The other diabetics/metabolic syndrome patients tested also had uranium 90th percentile as well as other toxins. Sound surgical technology failed to support the research after being purchased by solta medical and when confronted about the dangers of liberating these toxins w/o educating the doctors purchasing the vaser shape and giving the patients informed consent about the release of toxins into their lymphatics and ultimately into the circulation, i received a nasty letter from solta lawyer. I advised them that their toxins were dangerous. After a vaser shape treatment, if not mitigated with liver detoxifying supplements like n acetyl cysteine aka mucomist, and fiber to bind the fat soluble toxins going out of the body and increased amounts of water to flush water soluble toxins out the kidneys, these toxins could recirculate through the blood stream into other fatty tissues like the brain and breast tissue or other organs like the heart, pancreas, liver, muscle, and/or kidneys. The level of uranium alone was serious! I am asking that solta medical issue a voluntary recall of all their ultrasound equipment, until they can prove that the release of these toxins from their fat storage sites into the general circulation is not harmful both short term and/or long term as the toxins that i measured could cause cancer, metabolic syndrome/diabetes, hypertension, chronic fatigue syndrome/fibromyalgia, migraine headaches, liver and/or kidney damage if not mitigated beforehand w/ training the doctors that have the equipment and giving the patients a full informed consent about the possible toxins that are being released into their bodies from the fat storage sites and that mitigating those toxins after treatment needs to be done with liver detox herb/nutrients, increased amounts of fiber and fluids to help the body detoxify naturally. Dates of use: (b)(6) 2012 - (b)(6) 2013. Diagnosis or reason for use: body contouring external w/ultrasound diathermy. Event abated after use stopped or dose reduced: no. Dose or amount: 1 treatment; frequency: every other week; route: transdermal. F: pt was on multiple dietary supplements and diabetic and blood pressure and pain meds which would not come into the tissue with the ultrasound equipment.
Patient Sequence No: 1, Text Type: D, B5