Ultherapy/ Permanent Nerve Damage/ Brachial Plexus

I received Ultherapy on the "full face and ext (extended) neck" in March 2016. Soon after the treatment I began to notice a nagging achy/pain in my right neck and right arm. Days later my arm developed a very intense painful episode, to include numbness and lack of movement in the arm. I had to go to the ER, then a neurologist the following day--then multiple specialist....To make a LONG story short, the brachial plexus (nerve fibers) in my neck were injured and I have an neuropathy. My arm was not treated, but the nerve fibers in the neck, that eventually form a nerve in my upper arm, were severely and permanently damaged. This neuropathy has left me with partial use of my right arm-an atrophied and distorted arm with partial function. I have motor and sensory loss,and always in pain. I reported the event to the manufacturer. The only treatment I had on my neck was Ultherapy. I did NOT know this was off label treatment at the time; actually the full face and neck indication was denied by the FDA, as best I understand in the submission papers. The manufacturer stated to me that they can not "substantiate" my event without a peer to peer discussion with my neurologist and/or my medical records-(given the fact they report social media events, i find this puzzling??). They were provided the Ultherapy treatment records. My event was NOT reported to the FDA. The compliance manager at Ulthera also told me they had never heard of anything like what I was explaining, but on 3-10-16 (6 days before my treatment) this same compliance manager reported an event that is very similar to my event. PLEASE read the updated IFU/ Instructions for Use (Rev B), prior to this treatment. On the very bottom of the IFU they list post market events-Neuropathy is a known side effect and is now in this IFU. I am not the only patient that has lost motor and sensory stimulus in an arm, after a Ultherapy treatment. I have consulted with approx 10 medical professionals /specialists over the past 3 years; I have had multiple MRIs/X-rays/C-scan, physical therapy and 4 nerve studies (showing the acute to the chronic stage). All other causes for this permanent Neuropathy have been ruled out by my treating neurologist. It is not my job to tell people what treatments they should or should not get, but I SINCERELY recommend that if you are considering this procedure you read up on it, prior to having it done. I have constant ringing in my ears-hearing tests conducted and I have Sensory Neural hearing loss, which is permanent NERVE damage. After years of reading about this device, my personal belief is that it is more problematic than advertised. Physicians and potential patients need to properly respect what approx 165' F is actually doing to tissue (my bad for not converting C' to F' years ago). I have also viewed online training videos that state visualizing the nerve fibers on the DEEPSEE technology is problematic (paraphrasing)...this is just my story, my outcome and my opinion. I was not warned that this could happen. I have severe and permanent damage....and will never have the full use on my right upper arm. PLEASE EDUCATE yourself BEFORE this treatment and know this risks/benefits. Non-invasive does not mean Non-injurious. I am not disparaging the manufacturer, I am simply stating the facts of my situation, as I continue to experience them....

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.

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!