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*Treatment results may vary

Nerve study results & neurologist commitment on cause.

I felt I should add these med documents /results so those who feel this nerve damage isn't possible, can see that opinion isn’t shared by all doctors. These are copied from my personal medical records. Im sharing these nerve studies, and doctor’s assessment in hopes that other docs/providers and potential clients better understand the potential damage HIFU can cause. This should serve as a cautionary measure prior to getting Ultherapy on your neck (or anywhere for that matter), as it can injure nerve trunks and cause permanent nerve damage distal to the trauma/injury...Neurologist understand nerves/ nerve damage and this is what my neurologist concludes.please know that those that are injured suffer a great deal. In my case, the Manufacturer emailed me they had nerve heard of this (paraphrasing) but their FDA Maude database reports prove they were not being truthful, as they had multiple similar injuries reported by the compliance officer (handling my complaint) prior to my injury-(aka lied to me /my provider as best I understand & I don’t think I misread their emails)-know that this can happen to anyone that has 160-170’ heat applied to their body-and that could be you! If u had this w no adverse events great-consider yourself fortunate! Educate yourself and go beyond the Manufacturer’s marketing materials... no one else should go through this...it’s horrifying on ALL human levels. These r my opinions and results. I’m not defaming anyone (but clearly not a fan for obvious reasons) - just stating facts as I have personally experienced them.

MAUDE EVENT ABOUT ARM INJURY (possible AE) after ultherapy- Event dated 4-23-19...Please seek the hlep of an experienced neurolo

On 5-14-19 the FDA MAUDE data base posted an Adverse event from a patient stating they are experiencing "severe pain in my right arm after therapy to my lower face and neck..." after Ultherapy 4-23-19. PLEASE seek medical assistance from a neurologist/ someone with experience with brachial plexus injuries/ upper extremity specialist. I am NOT a doctor (I have my Master's degree in Occupational Therapy so my educational background includes a lot of anatomy and neurology, etc...). Based on your description your experience seems similar to my experience. If this individual is on real self and reads this...PLEASE carefully explain Ultherapy to your doctor (use the manufacturer's information to explain what you had done, and show them where the device was placed on your NECK. Injury on the neck CAN and DOES present in the arm and hand. Think spinal cord injury-an injury to the spinal cord will impact body parts below the level of the injury (CNS vs PNS), While the manufacturer's "white paper" states anti-inflammatory meds may interfere with the results of the Ultherapy procedure, bc Ultherapy's stated mechanism of action is via the body's inflammatory reaction to the multiple wounds (burn healing process), and consequent healing (scar tissue-My words)- I strongly urge you to discuss steroids/ anti-inflammatory meds to calm the inflammatory process your body is going through, with your doctor. Again, I am NOT a doctor but you must properly explain to your doctor what your body has gone through so they understand what they are dealing with.....Note:" Ultherapy White Paper (1001504DOC Rev D, 1000674DOCB, 1002845A, 1002845B)". Ulthera/ Merz has been made aware of serious, permanent nerve events impacting major motor and sensory nerves the arm, that occur after Ultherapy "neck"/ "face and neck"/ arm treatments. I have yet to see any warnings regarding this issue. Forget about looking young(ER) or refreshed....you may be permanently paralyzed, have palsy/ partial use of your extremity (arm and/or hand). If the phrenic nerve (in neck) is impacted the diaphragm could be injured (we need this to breath). IF nothing else; let my experience and pictures provide a platform for discussion and education about what CAN GO WRONG.I am not writing this to upset or scare anyone. If someone had great results, good for you; I'm happy for you. My goal isn't to engage in a debate about good or bad aesthetic results- it is to educate about POTENTIAL ADVERSE EVENTS, as adverse events DO occur and this issue should not be brushed off as if it is a non issue. Why this issue is not more proactively and fully disclosed is beyond my (ethical) comprehension. PLEASE HELP ME TO HELP THIS PERSON (and others)....This could be a serious, permanent nerve injury that requires not only specialized care, but timely care because nerve injury healing is TIME dependent and informed decisions need to be made within timely guidelines. PLEASE TAKE THIS INJURY SERIOUSLY and tell your doc(s) what you did. At the time of my injury, I did not think of "Ultherapy" as "trauma" so when asked, I said NO trauma, but approx. 170' F heat to your tissue IS TRAUMA....It does not matter that it came from a so call "medical device"....it IS TRAUMA and causes injury. I hate seeing this happen to yet ANOTHER person. Shameful!

Pictures of arm

Pictures to help understand what happened. These pictures are of my shoulder area pre and post treatment. If you “google” brachial plexus” you will see the nerve fibers in the neck and better understand how this can happen. Very life changing event.