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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.

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241 comments

  1. Linda Reply

    It’s been more than 11 years since I had Fascian injections into acne scarring. The doctor I was working with refused to give my antibiotics prior to the procedure though I had read that was standard according to the doc that first used the injections. Two days after the procedure I developed large boils and fever on both sides of my face. This carved out large “pockets” and the Fascian slipped down my face – it was no longer under the acne scars. The doctor then prescribed antibiotics but it was too late to rescue my face. It was very lumpy and the doctor said to “massage” and they would go away eventually. They never went away and two years later I had sculptra to fill in the hollows these lumps have created in my cheekbone – my doctor refused to do this at cost in spite of the lumps on my face. Looking back I should have taken him to court, but he kept saying they will be absorbed eventually. I can’t afford the Sculptra upkeep and 11 years later I am left with large lumps on both side of my face. These give me a “hound-dog” look and make me look 10 years older than my age. At least the fact that it was injected so far under my skin means I can only feel the many separate lumps in my mouth. The small lumps formed to make one large lump on each side and I have been told there’s not much that can be done. They are permanent and I have been extremely depressed about them for many years. It will cost a fortune to keep the hollows on my cheekbones filled in. Please don’t do Fascian if you are considering it. These lumps are far worse than the scars I was trying to correct. I realize the statute of limitations has run out on my lumps unfortunately.

  2. Michelle Reply

    Had juvederm it has ruined my life..

  3. Judy Reply

    I was severely harmed by a juvederm injection in my nose.. I didn’t go in for any injection on any part of me and was talked into it by a nurse.. found out it isn’t FDA approved for noses.. the dr came in and said he had to go deep in noses.. I should have stopped him but he went so fast I didn’t have the chance, now I have juvederm in my sinus.. blocked.. burns.. throbs.. my mouth is on fire and throbs..has severe pressure on the roof,, eyes and mouth are day.. nose is numb.. my throat is tight and I can hardly swollen.. didn’t sleep for 3 years at all. My brain is fogged..memory shot..can’t drive or leave house. My heart is rapid.. arms and legs buZZING.. i am in hell.. digestive system shot.. my digestive system is shot..no appititie.. i was 55 and looked 35″” can’t leave the house and am going crazy with pain.. can’t drive.. my parents love me to the moon and did everything for me and are beyond grieving, I have called juvederm and when they answer they say if you are poisened go to poisen center. I asked why do they say that if they are safe.. they have a staff to answer people who have reactions but insist they have never heard of my issues.. this. Log has tons of my symptoms. Doctor said at the time there are no allergic reactions, my life is over and they don’t care.. they tape your calls .. I cry all day.. I can’t help anyone.l.. I know the doctor hit a nerve since I flew thru the ceiling and also a vein as I had blood in my mouth.. I went to doctors and they all made it worse,, I never believed in any injections but for some reason ti wasn’t thinking that day and the nurse said it is wonderful. Has anyone known anyone who has died. I dropped off the earth and all my friends don’t know what happened to me.

  4. Sara Reply

    Michelle .. I wish you would tell us what happened to you with the juvederm.. you posted today. Will you let us know.. juvederm ruined my life too

  5. Julie Reply

    I would like to hear back from people who have posted and give an update.. I have been badly injured and my health is so bad from juvederm and there is no life left in me.. I believe that there are more people out there hurt from fillers that the FDA doesn’t have an accurate counting of people injured. First. The doctor will never report it. Second,, who do you call.. I called the FDA and they didn’t even care.. people are so sick and no doctor believes them so at a dead in. We did it to ourselves cause I didn’t research and the famed doctor said there were no allergies to juvederm… it is produced in our bodies .. please people.. give us an update,, my family and I are forever ruined,, never thought the end of ,y life would be from something I didn’t even want and was talked into

  6. Dennis Reply

    Has anyone tried to get a lawsuit. My wife is bed ridden and I don’t know where to turn to.. she had
    Botox and she had a stroke.. please let me know if you hand a stroke with botox

  7. Donna Reply

    I had juvederm and when I left I knew I made a mistake.. how can I get ahold of these people.. the reply button doesnt work,. Who manages this website,l please help me

  8. Jeff Reply

    Linda.. PLEASE GIVE US AN UPDATE.dont you read this webpage .. you just posted in dec.. everyone please call juvederm 1 800 433 8871″” please tell them your story.. my wife is dying from juvederm ? She is bed ridden PLEASE CALL JUVEDERM .. PLEASE EVERYONE WRITE HOW YOU ARE DOING.. I A, LOSING MY WIFE BEFORE MY EYES.. JUVEDERM IS A MURDEREE.. PLEASE CALL PEOPLE. I call and they just write it down like a robot.. I hate them and hope they lose a loved one like I am.. please write your updates..I am grieving my loss.. she can’t get out of her bed..I love her .. screw those bastards..

  9. Suszie Reply

    In had a juvederm injection in my nose my a palm desert highly regarded plastic surgeon but obviously not on fillers,,.. I didn’t go in for this just a consult for something I wasn’t going to do .. I really just went with my friend,, the bastard nurse brought up fillers and talked me into it.. well juvederm injected into nose is not FDA approved.. they convinced me it was so safe .. I must have been out of my mind cause I did it.. I asked the doctor if I could be allergic and he said., no., it is already in my system, .. he did this to me.. hit a triginial nerve., hit a vein,, after I had blood coming down in my mouth.. liquid running from my nose,, came home and called nurse,, she said all normal.. this is what happened.. burning mouth with pain level 1000″” pressure on the top of my roof.. nose plugged with sinus plugged .. heightened fast and smell. Couldnt sleep for 3 fricken years.. awake ever second,, brain fog,, putrid smell in my nostrils,, smells like a dead body”,, clenching my mouth., I am dying,,thank you for ruining my life .. I hope the doctor has a family member near death from the same thing, and his little nurse witch too ..

  10. Petricia Reply

    Please update your posts.. I would love to hear from people.. are you okay

  11. Perry Reply

    I had botox and I left with a headache and dizzy.. does anyone have this side effect .. please tell me if either go away. I wish I had seen this website.

  12. Robert Reply

    Can we get everyone together and do a lawsuit .. my wife went blind in one eye and now her smile is crooked.. please pray for us.. I will call an attorney and we can see if he will take our case.. is anyone gone or still alive

  13. Payton Reply

    I had botox and my face became numb and burns.l please don’t have these fillers.. no one can help me

  14. Darla Reply

    Why don’t we hear updates from these people,, maybe they have died..i a, in constant pain.. i a, bed ridden.. i scream to the Lord for relief,. This is poisen and I am sure most people don’t report it to the FDA cause they are too sick to even fill out the report. I have ruined my family. Me. All my friends don’t know what happened to me.. I didn’t sleep for three years and used to sleep like. Log.. please update us on your condition, I am sure most are dead,I was so cautious with my life and ended up being poisened wit juvederm,, I can’t. Near the pain,l only now sleep 3 hour and wake up to my face burning and throbbing. My heart beats fast and hard,, my body is void of muscle and I lifted heavy weights the week. Before I was killed ? Help. The needle hit an nerve.l I can’t go on

  15. Pammy Reply

    I am in pain. Is everyone in pain.. I can’t go on,, the doctor hit a bad nerve,l didn’t sleep for three years.. can’t go on, please let’s talk because I can’t go on and writing takes the mind off my pain., I never thot this could happen and I didn’t want this injection.. the nurse brought it up and said.. you should do this,, I hope she goes to somewhere other than heaven,, I am beyond pains for four years

  16. Paddy Reply

    My symptoms came on immediately.. and my death is near.. why do they keep this poisen on the market.i just pray I don’t die today,, the suffering is overwhelming,. I have burning to tongue, mouth, eyes.nose.sinus.poundinf in face,mouth. Blood blister in my mouth. Eyes dry. Mouth dry. Heart rate hard and fast. Can’t sleep. Bones hurt. Feet hurt, aching all over.. Jesus help me all cause a nurse talked me into it .. JUST WENT IN FOR CONSULT ON A DIFFERENT DEAL .. PLEASE CALL THE FDA EVERYONE

  17. Sassy Reply

    I had botox and I had a seizure,, please stay away from this poisen .. please email me when the attorney want to help me,l thanks. Now I am going blind and shake all over my body

  18. Darrin Reply

    I had juvederm put into my forehead.. immediately I had a seizure and was in hospital a month.. doctors see white stuff In my brain,, please.. doctors can’t identify it.. I am bed ridden,, will anyone else with this please let us know.,

  19. Shannon Reply

    Hi.. thanks for taking my email. I watched my best friend die from restylane. Please help me. Why do they have this on the market with deadly side effects.. there are hundred on the website.l I am devastated.. she choked to death from an injection around her mouth and it paralized her throat which for worse.. she sent a comment and you refuse to post them.. what is this blog for if you won’t post.. I will call the attorney above and tell them.. I believe this is their webpage. Have you ever watched a person. Turn blue to black.. thank you., allergen sounds like allergy. They know people are dying from this and do nothing, I hope they all go to you know where

  20. Perilla Reply

    Is there any product that will flush out restyane out of my sinus cavities,. It is plugged. A doctor injected my nose and was told it would fill in a swoop. I am bed ridden and need to get the burning out of my mouth,l the doctor is crazy and will find his own hell someday,..

  21. Tina Reply

    I am in hospital with face parasites with resytane injections,, I have them in my nose and sinua.. they took a cat scan and could see the worms .. i am scheduled for surgery but my face is red and inflamed.. they say I may not make it through the surgery.. please pray.. I a, going crazy with the itching in my nose.. another way of doing it would be for them to let me stay awake and go up and pull the worms out,, please pray for me.. I a, I’ll ans sugery is my only way to live., they injected restyane in my nose to fill out a dent,, now I am sick and have hepatitis..

  22. Donna Reply

    Hi.. my sister is bed ridden AND NEEDS TO GO TO MAYP CLINIC FROM BOTOX.. HER FACE IS HARD AS A ROCK.. HER MUSCLES ARE PARALIZED.. I AM GOING TO START A FUND FOR GO FUND ME.. SHE IS GOING TO MAYO FOR INTENSIVE THERAPY OF WATER INJECTIONS, PLEASE.. WE NEED 50,Oooo dollars to reverse what the nanstard doctor did to her.l pray for her.. we need to pay for an ambulance for 3500 miles. Pray for protection

  23. Serra Reply

    I am so sick from juvederm and was poisened and the doctor hit a nerve and vein in my nose,, but reading these sick people made me cry.. who put this website on and why don’t they take theses issues to the FDA and get something done. I had injection into my nose which I learned is not FDA approved.. I have burning mouth.. on fire.. throbbing in mouth like a heart beat.. brain fog,. Nose plugged,, sinus plugged. Nervousness not steaming from anxiety.. can’t drive.. can’t hardly eat,, nose and eyes dry.. face muscles tense.. numb nose.. horrible stench coming from nose liquids.. nose is plugged.. can’t sleep.. didn’t sleep for three years.. now I sleep maybe 4 hrs.. I was talked into this from the bastard nurse., was there for a consult on perhaps pulling up my cheeks in 5 years.. was on vacation and heard is was the top I. Faces but obvious not injections, my head is blurry and sore spots on scalp.. my arms and legs vibrate and pounds., my jaws are tense and I grind my teeth.. my neck is vibrating, my mom is beyond upset.. she cries all the time.. I am a nervous wreck and house bound.. can’t drive., Jesus help me.. I am in pain and don’t want to die.. I was perfectly healthy.. lifted weights for years.. did eliptocal every day.. now I am bed ridden and live on hardly any food cause my body can’t process it.. I lay I. Bed at night crying why God didn’t protect me from a lying bitch nurse and a doctor that didn’t know what he was doing., please me postman,, why don’t you post newer blogs.. I am sure you get them every day” the FDA should stop this poisen,. But people are too sick to go after the doctors,, i a, in so much pain and can’t take it.. the doctor hit a trigenial nerve in my nose and it will never go away.. half of all people with that damage kill themselved

  24. Riley Reply

    I had botox injection in my forehead and my face is red,,burning and half paralized .. I am in a state of depression,, has anyone tried to sue these doctors and won. I am a professional and am on disability. Please let me know who has succeeded in the courts, my heart is also affected.. I don’t know what to do,,

  25. Janice Reply

    My best friend was severely injured with juvederm and wrote her sad story here and the people who run this site has not printed her story. Why are people’s life changing injections banned from this site,, I believe this site is not wanting to know the truth,, allergen knows of all the people whose slices have been injured and keep letting it on the market. I dare you people who read this to post it, why don’t you believe in freedom of speech.. my friend is so sick and her life has ended all because her doctor lied and told her there was no side effects..please publish..

  26. Wilber Reply

    Ok.. I have a friend who is on her dearth bed and has written and no one will post her post,,is this a scam website,.please advise.i will keep writing until I get some action,. My attorney is watching..please.. if this is legitimate webpage when why don’t you let people express their death. Ed wishes .. Is this a scam

  27. Sarah Reply

    Why don’t they not publish my friends letter with the things she has gone through,, please look into the eyes of her children left without a mom.. I will be willing to bet we will never see her again

  28. Petree Reply

    I am 50 years old and was talked into an injection that left me blind in one eye.. please people.. I also have red rash all over my face and legs..why do they not take this off the market..

  29. Patsy Reply

    Juvederm caused me hell. I am bed ridden and have so many horrific ailments.. juvederm put into my nose cause some idiot nurse talked me into.l I wasn’t there for anything but a consult on nothing I planned on doing for years.. I was 55 and looked 40″. I had never heard of juvederm.. I asked the doctor if I could be allergic and he said it is already in your body.l he hit a nerve and o shot to the ceiling.. that was the first injection. Next he hit a vein.. I had blood in my mouth.. I nave blocked and numn sinus..burning sinus that also throbs. My mouth is dry and on fire., it throbs.. I didn’t sleep at all for three years,,my throats is restrictive and can hardly swallow.. half paralized,, my brain has foggy,, no memories or names .. can’t visit with people.. I was out going and loved people. Now I lay in bed for over theeenyeara I ONLY SLEEP IF YOU CAN CALL IT THAT.. my mom is carrying for me. Doctors made it worse,, i worked out on weights 3 times a week.. loved my life. Now I can’t breathe cause my nose is plugged and my heart beats so fast I have to lay down and try to slow it.. I used to do elliptical for 45 minutes and not even breathe hard,, I am dying and every day I wonder when it will be my last.. o love my family and everyone is beyond grief.. I can’t drive or cook … i loved Christmas. And birthdays. It now we don’t have any birthdays cause I can’t make my usual cakes.. this doctor did this and it wasn’t FDA approved for noses., that bastard and his wicked nurse killed me .

  30. Betty Reply

    Where are all the people .. why don’t they update us on their condition,, please someone,, are you still alive,, let us know

  31. Janis stone Reply

    I had some botox injected into my lines over my mouth and now I can move my upper lip., I am very upset and also have been getting migraine headaches I never had before. When will this end. The lines are still there ,, please don’t use fillers, my life and face is ruined, I can’t laugh as I look like a freak,,when I laugh it also hurts,,

  32. Perry Reply

    Why do they let these products like juvederm exist, my friend is permently harmed,, she had facial inject
    Ions and was told it was safe.. now she is blind in one eye,, heart is damaged,, please tell me why do they have this product..

  33. Linda Reply

    Help me. Juvederm is killing me., please somebody.. call juvederm and tell them about your pain,, please

  34. Patsy Reply

    I had an injection or restylane and my face became swollen and red. I also got a high fever with chills, now I can’t feel my face and my throat is constricted, I can’t leave the house, please don’t do this,, I am home riddenand my face is hard,, help.. has anyone recovered from injections, I also can’t sleep .. it has poisened me.. I cry all the time

  35. Jennifer Reply

    I hate Juvederm a few weeks after a nose injection I got severe burning in eyes and it’s still burning on and off I have dry eyes now and never had it before those are my only symptoms but it’s never ending pain

  36. Priscilla Reply

    Will someone please tell my why with all the people getting physically ruined and allergen is still producing this poisen. Why is it we can’t stop them,, please anyone here write a blog on why you don’t think we can stop them . Please call their company and complain

  37. Robbins Reply

    Don’t get any filler injections, my brother got some and is dying, please. He has facial paralysis, can’t breathe,, face burns.. face is purple, please. His throats is paralyzed, his face burns, please don’t do kt

  38. Paula Reply

    Juvederm has ruined my daughters life . swelling bags under the eyes. They are also hard. Bruising and knots or lumps on forehead . plastic surgeon is putting
    Shots in under eyes but has not fixed it. Has to wear sunglasses everywhere . stays home mostly skipping nieces shower today looks so bad. Her life is on hold. Can anyone help?

  39. Brie Reply

    I had all of these symptoms from Juvederm. My throat swelled up, excessive dry throat, and lungs burned. Nose was numb, throat paralyzed, and didn’t sleep for a month. Thought I was dying and no one could give me answers.

  40. Brie Reply

    Does anyone have info on where and how to file a lawsuit for this drug?

  41. Jenn Reply

    Hi did anybody’s dry eyes from juvederm go away? After it’s dissolved from body? I had it done in nose region and was diagnosed with dry eyes a few weeks after never had any problems with my eyes prior? How long for symptoms to resolve if they did thank you

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