FDA Panel to Evaluate Side Effects of Restylane, Juvederm and Other Dermal Fillers
A panel of outside advisers to the FDA will meet this week to review reports of dermal filler side effects, and to consider whether the regulatory agency should place new warnings or instructions on the injections used to reduce wrinkles and scarring.
According to an FDA document posted Friday on the agency’s website, there have been 930 reports of dermal filler side effects received between 2003 and September 20, 2008. Some of the problems were associated with administration of the injections by untrained professionals or in a setting other than a doctor’s office.
Although no specific products were identified by the FDA, the more popular dermal fillers available include Restylane and Perlane from Medicis, Juvederm from Allergan Inc. and Radiesse from Bioform Medical.
Dermal fillers, which are also known as wrinkle fillers, are injections given to smooth wrinkles for a younger look or to reduce the appearance of scarring. According to the American Society for Aesthetic Plastic Surgery, about 84,000 men and 1.36 million women received a wrinkle filler injection in 2007.
The FDA advisory panel is scheduled to meet tomorrow in Washington, D.C. to review the safety of these products and whether any regulatory actions, such as strengthened warnings or additional instructions, may be necessary to protect the public.
The FDA review indicates that some people given dermal fillers suffered “serious and unexpected” side effects, such as facial palsy, disfigurement and rare life-threatening allergic reactions or anaphylactic shock. In some cases, surgical procedures have been required to treat these problems, such as draining abscesses.
Other wrinkle filler side effects have included inflammation, pain at the injection site, numbness, bleeding, blistering, bruising, migration, formation of lumps or nodules and infection. Minor problems, such as a small amount of swelling or redness, are known and expected side effects and are currently described in the product literature.
The FDA is attempting to determine whether additional studies are necessary and whether any updates should be made to the product labeling. Although the FDA is no required to follow the recommendations of their advisory committees, they often do.
200 comments
I had Juvederm Plus injected into my tear troughs under my eyes May 6, 2013. Eight weeks later, I still have swelling and some pain near my left cheek bone. I went back to the doctor who happens to be a surgeon, complaining about the bags under my eyes a month later and he claimed that everything looked good. He suggested I go to an allergist to help with the headaches and swelling around the eye area. After reading all of the comments on injectable side effects, I am completely mortified regarding the health consequences I may have to endure in connection to these injectables.
I was getting dermal injections (reystalene mostly & some juvederm) for about 1 year. Suddenly I developed an autoammune disease callled morphea scleroderma. My body is producing too much collagen. Maybe coincidental, however, I don’t think so. I think it was a reaction to the dermal fillers. I wish more research could be done on dermal filllers and autoammune diseases.
I want to know if anyone has started a class action lawsuit regarding injectibles or the doctors who do the injections? This practice should be stopped or reimbursements should be made if something goes wrong. Or a free “corretion” should be given.
Yes, I had under eye juvederm done about a month ago. The results are not worth the $600.00 I paid. I had brusing under one eye and I don’t see that this juvederm ultra really fixed the hollowness under my eyes much. The bruise went away but now I have a deep wrinkle under that same eye that the doctor said could possibly be fixed with more juvederm for another $300.00. So, for $600.00 I didn’t get the results that I expected and now I would have to pay even more money to get it fixed, which might not work. This is riduculous!!!
Would I do it again….NO WAY. Why would anyone pay a lot of money for something that doesn’t work or needs to be fixed for more money? This practice, with the tease and anticipation that you could look better, younger, more rested, etc, should be stopped. Or the fix should be FREE…..like when you return something to Macy’s that didn’t fit. You get your money back.
There should be a money back guarantee and/or a free fix for any problems that can be fixed. The people who do these injectibles need to have more responsibility put on their shoulders or this practice should be stopped, period.
I had a terrible problem with restylane . It was injected into a very small depression I had on my cheek; in fact the assistant who was sent to mark it asked me to point out where it was because she could not find it. I noticed the doctor injected into several areas and was going to question him but I had had good results with him on one previous occasion on the other cheek.
Well immediately it caused lumps in the area. He said it would die down overnight but it did not. Not only was the depression not corrected but it made the cheek area look like a lumpy mountain range. It has been over 6 months now and has not changed. I had that hydraulic acid dissolver injected several times to no avail. I don’t know what this doctor did to me really.
So I have this depression in the middle of two raised areas, and then general lumpiness in surrounding area. My cheek area was very smooth previously, in fact I sent him several photos of now and before and he said maybe the befores were the ‘light’. It is amazing they don’t recognize how they botched up.
I don’t know what to do, I am severely depressed about it. I even started to wear a bandaid over the area, until my children asked if I was going to wear it the rest of my life. I really wonder if it will eventually dissolve or not.
I know someone who had the same restylane injected very deep into the same area and I guess it broke down the previous restylane nd smoothed out the lumpiness. But I’m afraid to do it, if it makes it worse I will become suicidal. I don’t know what to do.
I am in my twenties and had juvederm injected to my cheeks. Right after i felt so sick and tired ,felt like im a walking dead body. My face was swollen and my eyes shrinked to tiny holes in my face. I couldnt walk .. I looked deformed like an ailen or someone that just was beaten up in face by world’s boxing champion. 2 days after, i woke up to a disaster! since then, I have saggy skin on lower face and two big hollow under eyes like black tear through deformity, hollow cheeks. Lost half the volume i had in my face in just 2 days plus saggy skin and hollow eyes. Here we think fillers gives you volume !!I had a lot of
pain in my eyes and face a month. Regret it so bad ,wish i could turn the time bavk because i look 15 years older and $600 poorer i just 10′. I too hear the good lies and juvederm scam commercials in Dr office that how it gives volume no risk blah blah … I want them pay for what they did to me but i can see FDA approved means nothing,you can pay FDA and sell dangerous stuff . Its all about money and politics..
I went for a Resytlane injection (1 syringe) to a highly reputable, “top doctor” (M.D.) and the results have been problematic.
We discussed that the Restylane would be placed along the nasolabial fold areas. It has always been done closer to the mouth than high up around the nose. My other doctor never went so high. As a result, I have large, firm masses on each side of my nose high up where the nasolabial crease begins. One side has been decreasing but the other side is getting larger and migrating towards my eyes and cheekbones. My eyes and skin are irritated, too. It has been painful to the touch. I cannot sleep. I have been icing the area. I am trying to sleep with my head upright in an effort to hopefully prevent further migration towards my eyes.
Two days after the procedure I went back to the doctor. She said the lumps were a concentration of the filler in the area around my nose but it was nothing to worry about and it was not uncommon (although I never experienced anything like this after 5 years of using Restylane). She told me it should resolve.
It’s now 10 days since the procedure, so I will go back again, but for a diagnosis only. I may not allow her to inject me, if she cannot do a routine Restylane injection competently. She might further injure the area. Especially now that it is migrating away from the crease up into the cheekbone area: Scary!!!
Over the last few years I have used Restylane. Have have had only mild lumps and swelling that have resolved in a few days. Results have been outstanding. I get injections every 2.5 years. I will likely not proceed with another Restylane injection given what I am learning on this site. It’s not worth the risk. The doctor I went to is supposed to be one of the top docs in the country (to the rich and famous). This seems like a botched job.
I just hope I don’t have anything worse and that it will resolve in time.
I had perlane L injected in Sept. 2011. It was around the mouth. That night my lips swelled up huge. Within days I started feeling like I had the flu, aching all over. Then I went to barely being able to walk,getting out of bed or doing anything. I went back to surgeons office and they said they had never heard of anything like this. I\\\’m thinking \\\”why are you doing these injections and don\\\’t know the worst side effects?\\\”. I then went to my primary care doc and he put me on prednisone for a week . It did help. After I came off all pain was back so he put me on it for another 10 days. So nice to be pain free for a bit. Then I saw a neurologist ( worthless visit) who did a nerve and muscle test. He tried to say possibly fibromyalgia. I knew NOT. Next doc was a Rheumatologist that told me to go back on prednisone until my symptoms left. Maybe autoimmune. I wasn\\\’t happy with this so I scheduled myself for a muscle biopsy with the neuro muscular dept. at Duke Med. Cntr. They did an MRI first and then told me my tendons were inflamed throughout my body. I\\\’m thinking those injections hit a vein and went all over. The neuro doc. said there was nothing they could do for me. I was amazed hearing that at Duke. People go from all over there for diagnosis and treatment. I left so depressed. They sent me to another Rheumatologist at Duke and she was a Total WASTE. She said maybe you should try Celebrex. I had already tried Cymbalta and no help. I asked her if she could give me a prescription and she said I would have to get it from my primary care doc. I did not get it b/c I knew what the real problem was. NO Doc wants to hear about the injections causing the problem.
Then tried acupuncture and it didn\\\’t help. I knew a girl that went to a kinesiologist /chiropractor that figured her problem out so being desperate and fed up with traditional medicine, I went there. He put me on a special diet, no sugar, white flour , dairy etc. , also on some supplements. It has not helped so back to square 1 and frustrated. My symptoms are flu like all over, stiffness, achiness all over. I\\\’m coming off the prednisone and symptoms are all worse. The inflammation is still there after almost 2 yrs.
I was totally healthy and active before all this and I like most of you regret the day I was talked into the perlane injections. Telling you totally safe and you trust that…..that\\\’s my case. Help I can\\\’t live like this.
Artefill Nightmere! Got artefill 1-2 years ago to help with what I called a drool river.Hated that moist feeling in corners of my mouth . But now granulomas rearing their ugly head Lumpy heavy face. Dr trying to help by injecting steroids of some sort now it is very lumpy,itchy RED blood vessels. Now he is refilling with juvederm and working on redness all for free. But then what ? How long will I need to go through this and how long will it be free? They blamed it on stress from my dad passing away.
I got restylane injected in my lips 4 days ago. These have been the worst 4 days of my life. The left half of my face is completely paralyzed. I can’t smile on the left side or blink my left eye. I’m shaky, I’m nauseous, my eyesight is ailing and, above all, I’m struggling to adapt to paralysis. Of course. The doctor who administered this saw me today & assured me that the injections were not the impetus for the symptoms I’m having. She and the nurse practitioner offered me the consolation that I’m probably “having a stroke,” never mind that I’m 27 years old & I’ve never had health problems. Idiots. Healthy 27-year-olds don’t have strokes. Restylane paralyzed me!!
There is an attorney I know of that takes Botox lawsuits. That would be against Allergan. I had perlane and the company is Medicis which has now changed to Valiant I believe. I have to talk to this attorney but would be good to have people wit my same problem, so severe it has ruined my life. Its been 2 yrs doc to doc and no resolution. Life is depressing. Before Perlane I was biking, golfing, running……no more and it\’s sad. I HATE MY LIFE.
I am needing help in resolving my not being able to walk, do stairs,
bend or anything basically due to being lied to like everyone else. I was also told , totally safe and a natural product that\’s in your body.
You are trusting what they say….now I know better. Too late and have spent thousands out of pocket. The company needs to compensate and be banned from injecting this garbage.
ladies and gents, if you have a purplish, graying bruise that wont go away and it may or may not be accompanied with a rash of tiny pussy blisters and rash, GO TO A BOARD CERTIFIED SURGEON!!! Or a dermatologist!!! The filler may have gotten into a blood vessel (or is pressing on a vessel) which causes blood flow to be restricted and you’ll only get WORSE if you don’t have it treated IMMEDIATELY!!! It can lead to permanent soft tissue damage and horrible scarring. I have a very mild case of this right now… but the world “mild” doesn’t make me feel much better. My PS has me on antibiotics and additionally some meds to increase blood circulation. fingers crossed.
wow!….the stories here are really shocking!!…makes you wonder just how much damage these fillers have done to people as we can only be skimming the surface here!!…..it\’s a disgrace that these companies can ruin people\’s lives by selling harmful products. IF YOU WANT TO HIT THEM WHERE IT HURTS, TRY AND MAKE AS MUCH PUBLICITY AS YOU CAN ABOUT THE DAMAGE THESE PRODUCTS HAVE DONE TO PEOPLE!!!!……it\’s all about money…..that\’s why they go out of their way to promote their products through slick advertising campaigns and why you have to did a lot deeper to see the ugly side of what these products can do!!!
People have died from complications from these injections. I read where a little girl had them for some med problem and she died. Of course the company insists they are not at fault. You all are right. These fillers need to be banned but of course not , too much $$$ to be made. They don\’t care as long as they live in luxury.
I had fillers 2 yrs ago and can barely walk now and in horrific pain. Everything has been ruled out. before that I was running, golfing, exercising and now can\’t even bend over to get something or getting dressed is a major chore. Also steps are hard. I\’m too young to be dealing with this and these sorry A _ _ companies could care less. let them go through this hell. Like I said I WAS a healthy 50+ yr old.
4 months ago my doctor injected juviderm ( which he has injected with no issues before) But because I was a repeat customer he said he was going to mix a little something with the juviderm to make it last longer.
I thought he was just blowing smoke. The next morning I was so dilopitated and had enourmous flaps on the sides of my mouth. I immediately went back and instructed him to dissolve them as I knew Vitrase could do that. Well, he was able to reduce it to some extent, but for the most part it stayed in certain areas. He then tried convincing me that I already had these huge flaps and was this assymetrical. I asked him what he used to supposedly have it last longer and he said “just purified water” I am not sure if he was telling the truth or if the added water added volume and took away the ability to dissolve the juviderm with the vitrase. I had quite a bit of vitrase injected and I am fearing what will happen to my skin once the juviderm actually starts dissolving on it’s own. I absolutely hate this Doctor for what he did as the only reason I was using Juviderm was because he told me it was reversable and was very specific in that I only needed a little bit for my frown lines. He just went injection happy and literally told me to throw my mirror away if I don’t like what I see. Hoping it eventually goes back to normal after the year ends.
I received an injection of Restylane to my tear troughs without any sort of block. I felt immediate numbness on the right side of my face. I had some trouble speaking, complete numbness and pain. My board certified dermatologist tried to reverse the procedure 2 weeks later with Vitrase. When she injected the Vitrase I felt a strange, heavy feeling in the right side of my nose running down to the right side of my mouth. I lost the ability to move the entire right side of my face. Now I have partial paralysis and cannot smile or speak clearly. I’m extremely concerned and my doctor stated this has never happened and she really didn’t know what to do. I’m trying to find a nerve specialist somewhere that can assess the damage and help my face to heal FASTER. If anyone has any suggestions I’d greatly appreciate it. This has been a nightmare. I’ll never seek a filler injection ever again. I’d rather look old and be able to smile. My job requires me to be client facing constantly and this is seriously impacting my professional and personal life.
I went in to get juvederm injected into the middle of my upper lip due to two deep lines. Doctor talked me into injecting a little in my smile lines as well. After putting numbing cream on and a few minutes after beginning injection, I began to sweat and feel nauseous. I had to lay down with a wet rag, and doctor brought me juice. I felt a little better so Dr. began again. I got nauseous and went to bathroom and threw up. The doctor struggled to smooth out lip lines and I believe ended up over injecting. Thinking it must me scars, she moved on to my laugh lines. She injected there and then asked if it would be ok to do a little on my bottom lip to help compensate for the amount she put in upper lip. As we were finishing I still felt flushed and a migraine came on. I was not prepared nor prep talked that these symptoms could come on. Dr. did say it could just be my adrenaline. I’m two weeks post and not only do I have a nodule on my lip, one side is fuller than the other and now I have two odd parallel lines on the upper right lip that weren’t there before. It looks as if she only put some in the middle of upper lip as the sides of my upper lip slope down to the corners. Think Leela from Futurama. The upper parts of my smile lines I hope are still swollen as they protrude out and make me look like the joker when I smile. I’m really disappointed and completely regret my decision. In looking on many websites of pics, many woman have had issues/complications. I feel that the Juvederm pamphlet and website play down the side affects and time it takes for recovery/symptons to subside. All of my friends were interested in getting injections, I have honestly advised them to steer clear. Also, I have a high tolerance for pain, but it was still unbearable even with the numbing cream. Steer clear of this stuff!
iHAD JUVADERM VOLUMA XC INJECTED BY A BOARD CERTIFIED PLASTIC SURGEON ON MAY 5,2014. I BECAME VHE CALLED THE AMBULANCE AND I WAS TRANSPORTED TO THEERY HYPER ACTIVE AND HYPER VERBAL THAT PM AND THE NEXT DAY THEN ON MAY 8, MY HUSBAND COULD NOT AWAKEN ME, WHEN HE DID MY PUPILS WERE DILATED AND MY EYES LOOKED LIKE “THEY WERE POPPING OUT OF MY HEAD “, AND I WAS CONFUSED. I WAS TRANSPORTED TO THE NEAREST HOSPITAL. I LOST CONSCIOUNESS AND MY PUPILS PINPOINT AND I COULD NOT BE AWAKENED. THE CT OF HEAD WAS NEGATIVE. I BEGAN AGONAL,CHENE STOKES RESPIRATIONS. MIRACULOULY I CAME OUT OF IT; HOWEVER I WAS STILL CONFUSED AND WITH SLURRED SPEECH AND FOCAL TREMORS. I WAS KEPT OVERNIGHT FOR OBSERVATION, HAD AN MRI THE NEXT MORNING WHICH WAS NEGATIVE BUT THEN I DEVELOPED PARALYAIA OF MY LOWER EXTREMITIES AND THEN LOST MY SWALLOWING REFLEX. I SPENT ANOTHER NIGHT IN THE HOSPITAL AND THEY CONSULTED A NEUROLOGIST, A SWALLOWING STUDY AND THE PHYSICAL THERAPIST. I HAD TO WALK WITH A WALKER AND WAS SENT HOME WITH OXYGEN BECAUSE MY O2 SAT WAS ONLY 87. I WAS DISCHARGED BUT HAD TO RETURN TO THE ER THAT EVENING BECAUSE MY BP WAS 230/110. I RECEIVED CLONIDINE A
I went to a Beverly Hills plastic surgeon 2/19 of this year for Botox & Restylane injections for my lines & dark circles. I had Restylane once before, about a year ago & it helped. He suggested Voluma for my cheeks since I have a thin face & said I would love it & lasted 2 years. He injected 1 syringe along with1 of Restylane. I had to go back on the 26th because it wasn’t even. I should mention he left me waiting in the reception area while talking to someone who had no appointment & had never been a patient. I thought it was very rude when he knew I was sitting there & mentioned it to him. He said he just came in his office and sat down, perhaps you can say you have a patient. I felt rushed & every time I’d point something out he would say, oh, your crazy, not in a mean way but flippant & didn’t appreciate it.
My face had a bubble like lump, extreme redness & had never looked like that. I was very upset by the whole incident & emailed him explaining how I felt along with photos. He assured me that there was nothing to worry about. It did finally subside but by the first week of May, I noticed a lot of bruising, redness & the same blister like lump plus the left cheek was very swollen.
JUVÉDERM VOLUMA™ XC is a Hyaluronic FDA approved (10/13) filler for the cheek area to correct volume loss. I would think it’s important to know all the possible side effects & how to treat a patient in case of an infection or reaction. He never mentioned anything about a Biofilm infection or that it was harder to dissolve if there was a problem because it is a thicker substance. I left a message that night and went in May 8th. I don’t know if he was annoyed by my email but felt he minimized my concerns & said he didn’t feel any lump. I actually had to place his hand on the lump and finally said he felt it. There was no way you could miss it. He explained the redness as rosacea which I’ve never had. I asked specifically if I might have a biofilm infection. He said I didn’t but the tone implied I had no idea what I was talking about. I also asked about dissolving it but he said not to do anything at the moment. I left the office feeling very uneasy & asked if I could send him pictures since he brushed it off which bothered me.
I sent more on the 12th since it was mother’s day weekend showing how the redness had spread down my cheeks. He called at the end of the day & said he really didn’t know what to do & should find a doctor who had experience with adverse reactions. He did confer with a dermatologist who suggested I be put on antibiotics for a possible BIOFILM infection, the same one he so readily dismissed when I asked. I told him I called Allergan, the company & there had been some reports & even found some cases where doctors explained the specific symptoms & treatment. He wasn’t aware of anything like that & even asked me to forward the site to him. He prescribed Biaxin for 10 days & gave him my pharmacy to call but they hadn’t received it 15 minutes before closing. I was anxious to start & had to email him the name of a 24 hr. pharmacy. Why make a patient wait who is so nervous? He said to follow up next week. I think a doctor should be the one to follow up, not ask your patient to give you a call. I spent the next 48 hours researching every doctor to find the right one.
I feel it’s best to err on the side of caution & make sure the patient is taken care of even if that means bringing in another doctor. It’s a very frightening experience, especially anything around the eyes and felt so alone. I’ve had 3 injections to dissolve this & shouldn’t have been sent home with a lump in the first place. I can’t fathom why he thought it was fine but doctors need to listen to their patients. I may not be the expert, but I do know when something is wrong. If you don’t know how to deal with an adverse reaction, perhaps it’s not a good idea to inject these fillers until you do & make sure your patients are aware of all possible risks BEFORE any procedure.
I requested a refund on 5/15 since he told me I should find another doctor that can deal with this but asked me to sign a release which I can’t since I haven’t finished treatment. He has known me for years & feel a caring physician would have offered not only to reimburse me but also to pay to have this corrected. It wasn’t a large amount of money but regardless, it’s the right thing to do instead of running to an attorney or malpractice insurance company.
I’ve heard NOTHING from him, not a call, an email to see how I’m doing, could he help in anyway or follow up on my progress. IT DOESN’T COST ANYTHING TO CARE BUT IS INVALUABLE IF YOU DO. IF you’re inexperienced with reactions to these cosmetic fillers & tell your patient to find someone else, why should they pay the cost? I want people to be aware of what can happen & to be extremely cautious!
UPDATE AFTER 3 INJECTIONS TO DISSOLVE FILLER
After reading everything possible to learn about infections and complications with facial fillers, I’ve learned some of the causes can be; how the doctor does the injection, the product itself, not cleaning the area properly which can allow bacteria in or how it was stored. the doctor had to go down the hall for the product since he didn’t have it in his office. I’m not saying this caused my reaction but you do have more control if it’s in your office at all times. The photos I sent the next day clearly showed a blister like lump and redness which should have triggered enough concern to want to check it out.
This has been a nightmare and having his wife write such slanderous comments on Facebook, such as accusing me of extortion is deplorable. The fact that he allowed it, speaks volumes. It will be interesting to see how the medical board views this. What happened to patient/doctor confidentiality? I asked for a reimbursement because he said he didn’t know what to do and to find someone who was experienced with complications so now I’m paying to have this fixed. I think it’s wrong to wash your hands of the situation and keep the money!
DEFORMED AND DISAPPOINTED. … May 12th, 20014th I made the BIGGEST MISTAKE of my life. Voluma XT was injected under my eyes for dark circles. I had two black eyes, lumpinesd, and 2 months later instead of less darkness I look like Lurch from The Adams Family. I have been back the my board certified plastic surgeon twice now. Even tried arnica montana. DEVASTATING RESULTS. Terrible!!!!
5 months after my restylane injection which had entered my venous blood supply causing “venous congestion” and “venous stasis” a series of symptoms and pathologies began. From muscle twitching and muscle spasms, to adhesive capsulites, tendinopathy, bursopathy, tendinosis, and bursitis ensued. My TSH thyroid levels began “swinging” as high as 17.2 but prior to this, my hashimotos thyroiditis had been stable for 10 years without problem or significant change. My body tremored intermittently for no reason. I felt sensations of heat in my left arm. My heart rate was erratic sometimes reaching 145 from just simply walking across a room. My primary complaints one year later from onset of symptoms are limited movement of my shoulders, buring and discomfort in my elbows and stiffness in my left hip and cervical/thoracic spine. The twitching and electric rumbling that goes on throughout my body is everpresent. A year ago, before the onset of these symptoms, I was in excellent shape. I did pilates twice a week and was strong and extremely flexible. I am now taking Plaquenil for “Undifferentiated Connective Tissue Disease”. I believe that I know these problems came from the restylane (bacteria dervided hyaluronic acid) has triggered an autoimmune response in my body. Perhaps Autoimmune Inflammatory Syndrome (ASIA) or perhaps I have begun producing antibodies to my own hyaluronic acid. I am not a doctor and do not know. It is unfortunate, that NO doctor around knows anything about this. I just want to recover and be given proper treatment. I have become old before my time. Please help me. I would be a guinnea pig, and you could perform any and al tests necessary for a definitive answer. Histology, CSF, whatever it takes because I know my body and I truly believe this has occurred after being primed with restylane in my systemic circulation. I am a biology teacher teaching both high school level and college level biology. I have a great deal of understanding regarding many of these matters. I just need someone to listen and run the appropriate tests. I have been unable to achieve this, despite much of the medical literature I have found regarding ASIA from hyaluronic acid injections/acting as adjuvants. I have been suffering. Please help me!
I had Radiesse injected into my nasolabial folds and in the tear troughs under my eyes by a trained plastic surgeon in Chevy Chase, MD. According to all of the doctors I have seen since then who have been able to look at the photos of my infection, it is believed that a blood vessel was occluded. I developed a severe infection that lasted for months and was treated with antibiotics as well as antivirals. I was left with permanent scarring. That was 2 years ago. A few months after the infection from the Radiesse I developed vitiligo around my eyes and in the area where the infection was the most obvious. I lost all of the pigment around my eyes including my eyelashes and have suffered from breathing issues since then as well. I was a very healthy 34 year old at the time. The decision to receive that filler changed my life. The FDA doesn’t care about people. They care about the pharmaceutical companies.
Has anyone had any experience with Artefill? I am so angry that my doctor (who I trusted) injected it under my eyes for lines. The Artefill rep was even there to monitor it and NEVER ONCE said that the filler was too thick to apply in that thin area under the eyes. They charged me $500. It didn’t look right from the start and I called the Doctor and Artefill to complain. Finally the doctor tried to resolve the problem and then tried to charge me another $500. I went back to her at least 5 times and each time it looked okay for a few weeks and then back to looking bad. I NEVER had ANY BAGS prior to this and now have permanent bags under both eyes from this PERMANENT filler. I talked to many other professionals who said that they would NEVER inject ARTEFILL under the eye as this area is way too thin for it. I believe that artefil was supposed to be used only in areas that are very thick (naso-labial folds?). Now I have these bags that make me look OLDER when the whole reason I went in was to look YOUNGER. I am not new to fillers, botox or even plastic surgery, but feel as if this doctor should PAY for me to get this filler removed. Otherwise to look normal again I have to PAY for filler to fill up the areas above where the bag is every 3-4 months! HELP! Are there any class action suits yet against Artefill?
I had received Juvederm a few times over the past couple of years. I tolerated it well, but in only small amounts. Recently, I had a very small amount (not even 1/2 syringe) of Juvederm Voluma. After a couple of minutes, I had sudden onset of throat tightness, warmth and tingling down my arms, legs and across my chest, as well as chest heaviness. I thought I was going to die. My whole face became swollen and beet red. I was treated for anaphylaxis, and ended up on steroids and antihistamines for a week. In the contraindications, it states to not give it to anyone with a history of anaphylaxis. They all knew I was anaphylactic to bees. I should not have received this, and am angry with myself for not catching this in the product insert online. I don’t think the injector and doctor even recognized it. In fact, for every HA filler, the same contraindication is given. As it turns out, Voluma has the highest degree of cross linking, which may be why I reacted to that one, and not others. No more fillers for me!!
I have had juvaderm a few times around my lips and smile lines and I now have a line of hyperpigmentation freckles lining my lips my boyfriend actually randomly asked me if I ever had my lip liner tattooed !!!! No Never!!! I also have tons of little mila and light rash around my mouth I been trying to cure for 2 years!!! I was told it’s perioral dermatitis and got put on doxicycline 100mg but I still have bumps…it did help w the rash…I just went to an allergist and wasn’t allergic to any foods or the environment…I now have chemical patch testing in september. I to have suffered migraines, loss of breath, loss of vision, have been diagnosed with adrenal fatique, dizziness, chronic exhaustion:(
I began getting juvederm about 5 years ago. The first time it had lidocaine in it and I was bruised for over a month, but after the bruises healed, the result was great. So I continued to get juvederm about once a year. About 3 years ago I began getting Morphea Scleroderma lesions on my abdomen and calf. It never occurred to me that the juvederm may have had something to do with it. In April 2014, I again received Juvederm on my lower face and in early June, my entire chin turned red, blue & lumpy. I also began getting depressed areas that look to me like Morphea lesions – Morphea cause over-production of collagen, resulting in areas of hardened, discolored skin. Even if the lesion stops flaring up, the skin may not return to normal. My chin now looks disfigured, as though I have a deep scar in two areas, and the redness has continued. Tomorrow I am getting injections to try to dissolve the juvederm but am pretty anxious about having even more stuff injected into my chin. I am convinced the juvederm has had an effect on my immune system because I have also developed hyperparathyroidism (secondary type) and high cortisol levels. No more fillers for me!
One month ago I had 2 syringes of Juvederm Voluma injected into my cheek area. Less than a week later, I woke up dizzy, nauseaus and could not get out of bed. As the day progressed, I realized that the sensation worsened whenever I looked down. The next day, the nausea subsided, but I could not look down without getting dizzy. I then called both Allergan and my plastic surgeon. I was told by both that this sensation was not a known side from Juvederm. I tolerated the situation for two more weeks in the hope that the dizziness would subside. It was a difficult time because I felt quite disabled. Three weeks after the injections were done, I went to the doctor for my follow-up visit. When I told him my symptoms were still there, he repeated that he didn’t see how the injections could be the cause. I said “Well, there’s only one way to know, if you would be able to dissolve the filler. He then injected me with a dissolving solution, and fortunately, the dizziness began to subside and has been lessening a little more every day. I can add, that before the Juvederm was removed, my cheeks felt rock hard and I felt continual pressure there. I am so glad it’s out of me, and NEVER AGAIN!!!
I went to a reputable dermatologist complaining at age 49 of dark circles. She injected Restylane and after the injections saying it looked wonderful. I went home and hours later I had massive burning and swelling. One month post op and I have the Tyndall effect. I did not go in for the under eye hollows to be filled that did not bother me it was the under eye circles I wanted fixed. The under eye result? Under my eyes are darker and twice the size after one and a half syringes full of Restylane. I went to get my dark under eyes fixed and they got darker and worse! I hope the Tyndall effect resolves within a year because I am not going in ever again for more injections. Live and learn.
Radiesse. The initial study to approve this, if I am reading the FDA papers correctly was 117 people over one year. The thing is that granulomas may develop, while not the most common side effect, after one year. The FDA showed none during the sole one year study prior to approval. A granuloma appeared on my chin about 12 months or more (had several Radiesse injections at a few different times) and was surgically excised, only internal scarring. It grew back larger and was surgically removed leaving a visible indentation and scar as well as internal scarring. Over the course of a year, it’s been treated with antibiotics to control the inflammation a few times as well as monthly steroid injections to break up the internal scarring. It looks awful, like a knife slash.
A diffuse granuloma on the hollow area of my left cheek has appeared. A steroid shot and a course of antibiotics has done nothing, it’s in an area where the scar will be tremendous (it’s a large granuloma, they grow quickly) and I am therefore consulting with a dermatological surgeon who is experienced with cosmetic surgery as well. There will be internal scarring as well as a new scar in the most prominent area of my face with no place to hide it,
I’m devastated and stunned at the lax approval process and lack of follow through. I adore my doctor who did the injections so carefully and beautifully. This is a big deal and it doesn’t dissolve as the hyaluronic fillers do.
Horrified. Like a science fiction movie run amuck.
I have not had any real problems with juvederm that I can directly contribute it to. I have noticed depression and lack of energy since I received .my last treatment. But its hard to determine if this is a result of juvederm. or just stress from holiday and anxiety about up coming move. Plus a break up ….so many variables could be causing this. However I have noticed that taking olive leaf extract, vitamin B3 and anti inflammatory herbs have dissolved the the juvederm somewhat. May not work for everyone but just thought I’d throw it out there for a possible gentle reduction of the product without completely dissolving all of it while making you feel a little better physically. Again it’s just working for me and just wanted to share, not sure it would work for everyone and of course not intended for medical advice.
On September 17,2014, I received one injection as a trial for future reconstruction of area on the nose indented from biopsy. We used the lip area because I am 58 and of course mild aging. Extremely painful. I am tuff and have tolerated pain in past, I gave birth naturally without anything. It hurt very bad on every poke. Then my whole face swelled up and the congestion, uncomfortable feelings began. And they are still happening after 5 months. Severe headaches, a cyst on spine, pain at base of skull. Labs are normal, Head CT is normal. I am having a clear reaction to restylane. 20 yrs ago I had Silicone Breast Implants. I had a major reaction to them also and they had to be removed because of it. Before the FDA approves such dangerous money making products perhaps they should require proper Education in immune response and treatment first. This is unacceptable, dangerous. NO md should be allow to use this stuff if they do not have training in reversing or being able to safely dissolve the “sugar water” The greed is abundant in restylane land. I intend to sue the used car salesman. That is what it is like. Some shady used car salesman saling garbage for profits. It is just sugar water, its nothing. An elephant could stand on your chest and the implant would not break are just 2 sale pitches that I have heard. Seriously I want NO part of this clown show or to look like fish wanda. I will use my own fat thank you. Derma Fillers are dangerous and I would bet that many women do not realize that the head cold congestion feeling they have had for a long time is a reaction. It was the same thing with breast implants. Women did not put together the side effects with the breast implants causing a immune reaction to foreign substance/object in the body. The studies are flawed. The FDA has a blind eye. A people are dying because of it. It is not worth it. Find a different way. Don’t fall for the deceptive dangerous marketing of greedy restylane salesman.
I believe that Juvederm Voluma should be taken off the market until further testing. I found it to produce side effects that did not occur when I was injected with regular juvederm. It seems to me that it is unstable in the way it spreads into areas that were not intended for volume. Also, this instability seemed to manifest itself in the way that it moved into the upper layers of my skin even though it was deeply injected. Not unlike spray foam insulation when released into a crack, it is hard to tell just where the residual product goes after filling the crevice. I ended up with dark discoloration and large hard lumps in the cheek area and up under my eye even though the area around my eye had not been injected.
i have had juvaderm, juvaderm voluma and restalene injections over past 8 years with only general soreness and slight bleeding/bruising first few days. happy with results each and every time.
I do admit, at times juvaderm did cause knots but they dissolved over a few week’s time. years ago i did have one dr. use juvaderm that was old, it never softened up and i had thick massess under my skin in my smile folds for 4 months or so… but it was due to being dated we found. i hate so many people are having so many issues… i suppose i’m blessed.
Sheri’s message is so poignant. She is an informed consumer who knows what she’s talking about and the doctors still won’t listen to her. That is the story of modern medicine: doctors who are not even willing to try. If the symptoms don’t immediately fall into a pattern with which they are familiar they are far too quick to write the patient off as imagining things. What good is across the board coverage if doctors won’t listen? It’s like being thirsty and surrounded by water but all the water is shut up behind glass.
I was injected with jeuvederm in the throat area after a vocal cord injury. Right after i had flu symptoms , tired achy then my feet and hands started swelling and became so painfull i went to the emergency room twice and was admitted the second time for thee days to get the swelling down.Its beed2 yrs and i still have pain in my feet and hands. i was a very athletic women and now its very difficult to do be active. i did follow up many times with my doctor that injected me only to be ignored
I had Juvederm injected under my eyes to fill in the hollow sunken look in Nov 2014. Under my left eye was ok for a little while but under my right eye I have had a big bulge that makes me look deformed. I asked the doctor to fix it and he kept telling me it would dissolve, he tried charging me 1000.00 and then decided to forgive 500.00 due to the big bulge. It has been almost a year and the bulge is still there, and now I am noticing 2 bulges forming under my left eye. This doctor has had his license pulled for other reasons, does anyone know what recourse we all have? Maybe we should start a class action suit due to all these issues that we were not informed of. I’m tired of looking at this horrible disfigured mess when before I could at least look in the mirror and feel confident. Now I am embarrassed and self conscious.
I would like to get in touch with “Betsy W.August 26, 2013 at 11:55 am”. I have literally the exact situation plus many other symptoms. I have been so so many doctors that I lost count and no one can help me. I am ready to give up and losing all hope. Betsy W. if you are still checking this post can you please contact me? I would love to know if you have gotten better or if anyone was ever able to help you. Thank you!
In April of 2014, I had HA injected into my left knee, which has subchondral edema, which was one of several contraindications Dr Michael Alexeides of the Hospital for Special Surgery ignored. He literally laughed as I cried out in pain as the third injection went outside the capsule and into my bloodstream.
I have asked my insurance company to investigate, as they have picked up the tab for, so far, two broken fibula and a sudden onset of spinal stenosis that kept me in a wheelchair until I demanded an EMG that showed no signals were getting past my spine.
The neurologist who performed the exam said the results were consistent with a relapse of shingles, which I ‘ve noticed is another side effect of HA. But an MRI also showed that nearly every disc in my spine is distorted, so that the vertebra look like a stack of bricks falling down.
Knowing the risks, I specifically took the HA from the prescribing physician to HSS, hoping they would be more prudent. But Alexeides said, “It can do no harm.”
Oh boy, was he ignorant. The manufacturer says they’re not responsible for the off-label use – I corrugated my patella during a quick kick in a nightmare. I just wish I could wake up from this one; it’s nearly cost me my job and made it impossible for me to interview for a new position.
In 2010 a plastic surgeon injected artefill in my face all over to help with acne scarring. The first year it was in my face I didn’t have any problems. In 2011 I started having extreme pain in my face and flare ups hard nodules all over my face. I did not understand what was going on at this point. I also was diagnosis with fibromyalgia and I had a constant low grade fever at all times. My entire body including my face was always hurting. It started to actually break through the skin and reject I saw countless doctors trying to figure out what was going on. I have had countless surgeries to remove the aretifill and biopsies and they come back with foreign material as the result. My face has many scares. Recently I spent 3 days in the hospital. The aretifill has got so bad that above my eye it has got into the muscle tissue. I had a ct scan to make sure that it was all localized and not into the bone. I have to have major reconstructive surgery and possibly skin grafts. This has been a nightmare. I can not do a malpractice case in ohio because it’s been over a year. Something needs to be done this has caused my face severe disfigurement and I have suffered extreme pain. I have had to pay out of pocket for many of these procedures. Someone needs to be held accountable!!
Artefill nightmare! I too received injections of Artefill under my eyes which I’m now learning should never be done. I now have large visible lumps under both eyes now… Looks awful! They get larger as time goes on. Also lumps along my jaw line from the injections. Help. Anyone have success with lawsuits??
We need to join together to get a class action law suit!!! My life has been destroyed by aretifill and I am not stopping someone needs to pay!!!
I had juvederm injected in top my cheeks in 2013, posted here at that time. I’m in my twenties & had hollow lower eyelid genetically. I look years older right after injection, loose skin & atrophy of while face! Some 2013, I have lost a lot of fat & muscle. Hyperpigmentation, dry thin skin & hair, dry eyes, Crooked smile, i look like a dead body (skin on the bone no other tissue left in my body the day i injected changed my health upside down) Juvederm dont accept it even with before after pictures. They basically can say you have an autoimmune condition not related to Juvederm!
I had voluma 10 days ago. It was fine until the 5 th day. I woke up with my eyes swollen. Next day I called the doctor went in and they put me on methypredesilone .Started that an was beginning to see improvement. Went to my pa and he said a shot of kenalog would bring the swelling down. It did ju d t the opposite. Wound up in the emergency room I was so scared. Th ed y sent me home with only a ibuprofen. Went back to my injector and they took pics and put me on an antibiotic. I am still having cheek pain and two nodules on top of my cheeks make me look deformed. I am going to see if I can resolve this with a dissolver. I am very unhappy with my results.
I have been living a nightmare after being injected with Sculptra in 2012 under the eyes by an uncaring dermatologist. Her answer was to give me a steroid pack and tell me my nail polish was contributing to an allergic reaction. By 2014 both eyes were showing large lumps, bumps and granulomas. I had an incredibly brilliant plastic surgeon remove this poison from under my eyes in March of 2015. Every looked great until December of 2015. The residual Sculptra has now risen to the surface in the form of new lumps, bumps and granulomas. My plastic surgeon is horrified we will have to repeat this tricky removal surgery again. I do have a surgical pathology report to verify what what extracted from under my eyes that the plastic surgeon submitted for me. It is my mission to now inform the public how disfiguring and dangerous Sculptra is. Galderma has a new marketing campaign that just started regarding mothers and daughters. It makes me sick. My poor daughters have NO interest in looking anything like their deformed mother!
I just read all the above stories,all true ,and so many more through out the westernized world,any Dr. who does any fillers should be made to take a course in autoimmune problems ,biofilms which develop in people that have lyme disease but dont catch it early enough and treat it with antibiotics, or people that have been exposed to toxic mold,most dont even realize it because it can be in your house ,but you cant see it,once you devlop a biofilm you need anti biotics and antifungals to try to get rid of them.They also can cause severe nerve damage,fibro,and your immune system goes to hell and unless you are rich or have amazing insurance,the physical mental ,emotional pain goes on and gets worse ,ihave lost my urinary and bowel continence,nerve damage and other things that bring tears to my eyes,the mighty pharmaceuaticals,like allergan and the ignorance of the doctors that do these quick fix procedures should be prosecuted,but they wont be,if you want volume anywhere inyour face your own fat is the only thing you should do,It is more expensive but lasts for 2-5 years and will renew blood vessel and grow more of your own collagen ,i know enough people who have had it and nothing compares,our bodies are already filled with toxins,pollution that our lymph system tries to filter,putting in a something your own body doesnt recognize will damage it,think of YOLONDA ,from housewives of B.Hills.If you do have any ofthese fillers injected document any symptoms ,urinary tract infections bowel problems sinus,pain breathing ,pain merve problems,see an autoimmune Dr, they start with bloodwork and refer for as to the results and then get a good lawyer and sue,if you can get bloodwork done from your primary care Dr.not difficult to due ,and inexpensive just before you get injectables and then have problems,then you really have a lawsuit;all this info is avalible-search can i have an mri and facial injectables,restylane,juverderm etc, onthe internet and GOVPUDMED willcome up and their is so much information about the dangers and what the treating Dr. should do All of these issues have been well documented for years by the drug companies trials ,evidence that is undisputable , pleasecheck it outt this is hard science and research that started some time ago to the present,pub.med.gov. best wishes to everyone
I had artefill put into my smile lines in 2007 and everything seemed ok but in 2012 I started having health issues, not ever putting a connection with the artefill until much later. The filler became so hard and seemed to lift to the surface and has become so visible and now painful to the touch. It literally is like little miniature marbles all over. They are visible. I feel it is my own fault. I have ruined myself for being vain. I am so upset and discouraged.
Went in to a board certified plastic surgeon and walked out also with injections of voluma he thought u needed. Five weeks later the hard knots had not subsided but he said not to worry.
I returned to him the next week to show him my swelling and lumps, especially a small hard one near the inner corner next to my nose. He gave me an antibiotic, allergy presc and Flonase. My symptoms continued and three days ago I had a severe headache and my right eye was encircled in blue. The small lump seemed to be pressing against a vein. These lumps have shifted and up and down but remained very hard on the right side. The left side has somewhat softened. I am saddened by these shared horrific experiences and also frightened about my outcome. I am very afraid to have this doctor inject a dissolver but also to let this continue. This product is dangerous and no doctor should encourage its use. The company and doctors should be held accountable. I was charged 1800 for this voluma nightmare.
I had Restlyn injected under my eyes. My right eye developed a lump after 2 days. I contacted my Dr and sent her pictures, she told me I was fine just put hot towel on it and take Advil. It was going away it was worse , I called her on Monday and told her I think I have an infection she told me to come over… Sure enough she said I had a biofilm!! I lost it, it has been a month a my eyes are still very black underneath. I am sick over this I don’t know what is going on!! Does anyone have answers?? Help!! This shot should be off the market!! Is there a lawyer out there to help with this?
I have and auto-immune condition call Ankylosing Spondylitis . My spondylitis was mild and no flare since 3 years.I had a juvederm injection on 11 july and an hour after the injection, my hole body was flaring and burning. After 2 week, the pain is always there and very intense. I just don t Know what to do . I m in pain.
I’ve had two syringes of juvederm
Ultra injected into my lips over the past few months. My body suddenly began feeling achey and stiff. Been feeling this way for months! Not sure if it has triggered an auto immune disease. Very freaked out!
I had Botox and Juvederm injected into my face about 5 months ago by a gal that worked out of a lash spa. 2 weeks later, ptosis of my eye lid and swelling. Shortly there after, my fingers slowly started to swell. A month later my fingers were so swollen I could not get my rings off. I didn’t think there was a relation to the injections. 3 months into it, my fingers were so swollen I could not bend my fingers. The swelling was throughout my whole hand. 4 months into it, my arms, legs and feet swollen and numb. It’s now been 5 months and my whole body is swollen. My hands and feet hurt the most. I’ve been to see my PCP doctor, Neurologist, Rheumatologist. None of these doctors understand what is going on and claim that the Botox nor Juvederm had anything to do with the swelling. I am hoping that once the Juvederm wears off, the swelling will too. I pray that the injections did not trigger a autoimmune disorder.
Has anyone had this experience with Botox and or Juvederm?