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.

Spinal-Cord-Stimulation-Lawsuit
Spinal-Cord-Stimulation-Lawsuit

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 โ€œserious and unexpectedโ€ 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.


249 Comments


Ann
i was injected in December of 2009 with Juvederm. I was at my Dermatologist to have my last follow-up after having basal cell skin cancer next to my eye. I had been interested in these fillers for some time, having seen the brochures at his office for quite some time. I’ve had other basal cell Moh’s procedures. I decided to treat myself to botox on the forehead and Juvederm injections where noted below. The botox has worn off and that was no big deal. I prefer my forehead the way it is. The area injected with Juvederm is what the Dermatologist referred to a Marionette lines. The area beneath each corner of the mouth and going south towards the jaw bone area. I read the brochure and saw the Juvederm was used on these Marionette lines. He’s a well known Dermatologist in Philadelphia and I put my trust in him after having had four MOH’s procedures done by him over a period of years. I expected the swelling and bruising. Put up with the discomfort and did the required icing. Covered it with make-up to the best of my ability. In August I developed what looked like Mumps. Doctors are still trying to figure out why my face has a lumpy area extending from the cheekbones down to where the injections of Juvederm were given. I now need to see a maxo-facial specialist to see if my parotid glands have become infected, inflamed and if this is another situation where Juvederm has migrated. I’m a side-sleeper and sleep on both of my sides throughout the night. It looks like the Juvederm went along the side of my face. Seems where the side of my face meets the least resistance with the pillow the juvederm found a route towards the cheekbone area.. I amm in the midst of having tests to rule out something serious with the parotid glands but they are definitely affected by somethig. Even the area where the parotid glands drain in to the mouth are quite blocked. Antibiotics, warm compresses and anything else I have been told to do by my GP has worked. I am experiencing pain and it isn’t going away. Of course I want to rule out a tumor in the parotid glands and I am hoping it isn’t that. I read the brochure and saw that this juvederm is suppose to dissolve away in 9 months to a year. Well it is 9 months and I hope this Juvederm starts disappearing. I have a gut level instinct that what the doctors find after tests will turn out to be Juvederm which has migrated. If I had seen any mention of the possibility that it could migrate…I would never have had Juvederm injected.

Lisa
I am in Portland, OR and was getting Botox when the doc suggested I have Restalyne injected into my tear troughs to get rid of the dark circles. This one done by “the biggest provider of Botox and Restalyne in the state” and I assumed she knew what she was doing. Wrong! she over injected and I had to look over the giant bumps to see my feet. I still have lumps. This was 4 years ago and she did two free laser treaments after two years to try to get rid of the lumps and it did nothing. If anybody has had success getting rid of this permanent, disfiguring sludge, please post about it.

Tami
I had radeisse injections in my nasal labia lines a week ago. It was done by a PS. He also decided to inject my cheeks. I have purple bruises on both sieds of my face. My left side looks like a big birthmark. I had no idea of any of these possible side effects. I was hoping to smooth out some smile lines and now just want my face back. Every day I see new bruising and there is no sense to any of it. I would NEVER have anything put in m face again. Just praying for healing and no further side effects. Praying for all of you as well. What a nightmare!

vivian
Had artefill procedure and am at wit’s end. I passed the patch test, then had one application end of June and was fine. Then a second one on first of August. Woke up during the night after 12 hiurs with a feeling of poison going through my body – numbness and tingling. No eruption on the face but these past 5 weeks have been hell – have been diagnosed with hypersensitivity by internist and now have been told it was nerve damage due to injection. The company says it is not the product!! One doctor says bovine collagen allergy. Have no idea. Artefill is bad news.

SculptraDamage
2 years ago a board certified FACS plastic surgeon recommended sculptra. I ended up with clumps of product and chronic cellulitis (multiple drug resistant bacterial infection) and chronic granulomatous inflammation. The FDA had no business approving Sculptra without any histology, mode of action or safety data in 2004 for people with HIV and then to grant wider approval for cosmetic use in 2009, when the panel stated there was a “paucity” of safety data but would recommend approval based on compassionate use in HIV individuals. Then Daniel Shultz resigned. The FDA is corrupted by big pharma and incompetent scientists. They have an obligation to assure medical devices are safe. Sculptra is NOT safe. Just look on the MAUDE database. But Sanofi is laughing at us because of the Supreme court FDA medical device approval immunity. The world we live in!! Never use Sculptra it is a dangerous product that can not be corrected.

Alisha
I worked for a group of plastic surgeons for over 6 years. I just want to advise anyone considering injectable/fillers to do their research on the injector. I wouldn’t suggest any other type of doctor, besides a PS to administer injections, however, even better than that is a PA or RN that has extensive training & certification in injectables & fillers. They are typically the best & most thorough at the decision making involved in which treatment plan is best for each individual. Most MD’s do not feel like they need to obtain this type of certification & even though these injections are expensive to the patient they actually do not equate to much profit for the surgeon. The MD had much rather be doing surgery, but will default to injections if you are too hesitate to procede to the operating table. A certified injector is your best choice, having worked with an amazing group of plastic surgeons, I wouldnt hesitate to let them operate on me, but I l would never let anyone of them inject me. It might seem llike simple needle injections, but I have learned that this is definitely not the case, it is a specialized science that borders on artistic technical skill. Just want to share my knowledge. Hope this helps. The FDA needs to begin requiring a certification for anybody administering these injectable/fillers.

Josie
I consulted with a board certified plastic surgeon and he recommended Radiesse. He stated that there may be some bruising but no downtime from work. The Radiess was injected into the naso-labia fold on both sides of my face and around the mouth on Monday. One hour after the procedure I noted a small bruise on my cheek, by the next morning thebruise had traveled down my face to my upper lip and chin. I expected the Phycisian to call the next day to see how I was doing and never got a call. By Wednesday the bruising became worse, it turn to a very deep purple and people started asking questions a work. Of course nonone wants to let co-workers about cosmetic procedure one is having done but since it looked like someone beat the hell out of me I had to tell them the truth. Many did not believe it since the right side showed no indication of injection or bruising. I finally call the office and spoke to the RN since the MD was in a procedure. She stated bruising was a side effect and that each side of the body was different and that is why one side bruised and the other did not. Her solution was to put makeup one. I tried the makeup but due to the deep-deep purple the bruise was still very noticiable. On day Friday I called again since the bruise traveled further, and stated my concern that noone had checked back with me. I then e-mail about 10 pictures to the MD showing the prognosis of the bruising from day 1-5. It is now day 9 and the bruising is starting to subside. I truely believe the radiese is safe but the MD’s techinque was not up to par. I paid $855 for botox and the radiesse. After 7 days the botox does not seem to be working since I can still frown and the crease in my forhead is still there. I am not sure if I should ask my credit card company to hold the payment. Is it MD technique or not??? I’m pretty upset about the whole situation. –

Paula
I had PSL deep line filler put in around my mouth and between my eyebrows on 18/02/10. About three weeks (couple of days before I went on holiday) I noticed that I had a small hard lump on one side of my face (where I had the filler). During the holiday the lump got bigger and I got them on the other side of my mouth as well. by the time I got back I looked like I had had a stroke one side of my mouth is dropping (with the weight of the hard lumps) I have a lump in the middle of my forhead and the bridge of my nose into one of my eye sockets is swollen. I can not see the person that carried out the procedure until tomorrow (as she only works for the company once every two weeks). I am absolutely beside myself I look dreadful and am worried sick. I cannot understand what has happened. Has anyone else exeprienced these problems.

karen
I had two injections of sculpta in my cheeks about 3 weeks apart.I had fat injections in 2007 when I had some plastic surgery. But my family has thin fac es and Ijust wanted a little more volume in my cheeks. I thought of juvedern,but my dr. recommened scuptra since it last longer. I did research and took arnica, bromelaine and the dr. gave me vit. k (prescription) prior to the proceure. I was bruised and swollen at the first injection, It healed. After the second one(not as much bruising) I developed a lump on the top of my cheek.the dr. said it was a pimple and not to worry. Well it got bigger and redder. I went back. He said it was a hemamatoma and drained it. It was painful., I had to apply an antibiotic and wear a small bandaid for a week.When I returned a week later, it looked better. Now its’ over a month and a have a red lump. I went back and the dr. said it would eventually heal. I apply a hot water bottle and ironically enough, it reduces them swelling In fact, when I wake up in the morning it looks flat. but as the day progresses it gets larger(nothing like before) but after spending all this money,I am beyond my wits end trying to disguise something that should never have happened at all. If anyone ever had this or has a suggestion, please let me know.I went to a cosmetic md who said that it would go away, but he wouldn’t do a laser treatment because there is no guaranatee and he couldn’t see taking my money, I am disgusted.

Erika
Restylane seems to be dangerous. Q-med must take more responsibility for this product. This gel dont break down so fast as they say, just say it is up to your body.SCARY!!!

leni
I’m wondering if CA June 30, 2009 ever found out what was wrong with her son and if not would suggest a muscle biopsy. A friend was getting Restylane and after several treatments developed dermatologic problems, then muscle problems; she was diagnosed with dermatomyositis and eventually needed a heart transplant. Coincidence? She was fine before the Restylane

Ruby
I had Restylane injections in the lines in the naso labial folds 5 years ago. At the time of the injections the doctor told me that I didn’t need an allergy test because it was safe and something that is already in the body. The doctor is a well respected dermatologist in my area. I trusted him. But when he injected me I could tell that he was putting more in one side than the other and that it was going into the cheek area of my face and not just the lines around my nose. It was very upsetting, but I thought he knew what he was doing. Right after the injections I looked at the results when I got to my car. I had horrible bruising and had to cover it with makeup every day for over 2 years (I still have some discoloration-darkening of the pigment where I was injected and still have to use makeup on it!) . I also had an allergic response to the injections and had to call the doctor the next day. He gave me a prescription for an antibiotic and an allergy pill for the swelling. I took pictures of the mess on my face at the time of the injections, it’s bad! I used to really like my cheekbones and they still don’t look the same. I am now having another problem even though it has been 5 years since this happened. It has become itchy again and swollen in my cheek area. I have one cheek bigger than the other. I also have discoloration just above the injection site and it does not cover up with makeup. My skin is without color in that area and looks really bad. I have had people make fun of me and ask “what happened?” I have discoloration across my nose as well that does not cover with makeup. I would tell anyone who is considering these injections not to have them. You just don’t know how you will react to Restylane or any filler for that matter. I would also say that the FDA should take it off the market. It’s not a temporary filler if I’m still having problems with it after 5 years and shouldn’t be marketed as such. And it’s not “safe” for everyone.

Brenda
I had radiesse injected into my smile lines it’s been two weeks my face is swollen like a chiipmunk I have a smile scary smile. I don’t look anything like lit use to be can somebody do something about it why they are getting away with that and ruined people faces.

.cathy p
I had radiessa injected in to my cheeks.It’s been two weeks and i still have swelling.I look like Grace the mule face woman from the book of freeks.this stuff does migrate.what looks good in the doctor’s office,does not mean your going to wake up to.people need to be warn of the side affects.my heart goes out to everyone.for I know your pain.

pertrail
i been takeing serquel for 3 years now and it still have not help me out with my sleeping disorder or my depression i still have sucide taughts i cant sleep my bones hurt real bad since i been on the serquel my weight gose up and down and my apitie been way off and nothing change since i been subscribe the medication

D
I had restylane injected into my smile lines this afternoon and the injections were terribly painful. My eyes were drenched with tears and I cringed liked a wounded animal trying not to move and endure the pain to enhance my beauty–yuk. Now, eight hours later, the area around the injection site is swollen like a chipmunk, I can’t hold a smile, I feel numb and sore in my face and I am really terrified that this will not go away. Prior to the injections, my doctor offered to see me tomorrow to treat the bruising w/ a laser. I wonder whether I should ask her to start removing the swelling with the neutralizing agent that the person suggested above. Best of luck to everybody.

heather
I had juvederm injection inbetween eyes for deep crease yesterday and it was performed by the best company in the country…..or so they say. It has swelled right up and i now have a large lump in place of the deep crease. It is only day two but it just doesnt look right and although it is swollen it feels very solid. Im sure its not meant to look like this. I look really wierd with a big lump shaped like a diamond inbetween my eyes.

Danielle
I had Restylane injected in my inner cheek area to fill in where I had lost volume. Instead of plumping up my cheeks, I looked like I had large bug bites on my cheeks. It was put in 3 1/2 years ago and small amounts of it still remain. I have tried everything to break it down–heat , red lights, massage. It has been a complete nightmare. This product should not be advertised as breaking down in 4-6 months.

Mandi
Please help! I am totally panicked. I just Radiesse in naso labial fold. I asked the physician for restylane and instead he talked me into using radiesse. My face is swollen and bruised around the mouth on one side. I am not so concerned about the bruising. I am really concerned about my smile – it has changed and the place between my nose and upper lip is longer like a chipmunk. Is it only temporary. I has been about 18 hours since I did the treatment. I am going on a cruise in the next 2 days ( I told the physician about this) and this was such a bad choice. It gives me so much pain.

ventaris
I had juvederm in upper left lip only …three injections about 4 mths apart…long story short. It has left me paralyzed …no smile on left side of face. confirmed thru emg and mri tests…

joy
I had juverderm injected under the hollows of my eyes 22 months ago. 18 mos prior, I had had restylane done to the same area under my eyes and was not too pleased with those results. I was pleased, however, with the juverderm more so than the restylane and felt confident about continuing with the juverderm. But, as the months passed by I’m now left with puffiness and bruising which I never experienced with the restylane. I asked my doctor about these bruises and he said laser would be an option to get rid of most of the discoloration. But, I am quite concerned that it may do more harm. Has anyone ever had the bruising under their eyes treated with laser and if so, has it helped? Also, what can be used to minimize the discoloration other than make up. Is there a cream that some one can reccomend to help conceal or heal these bruise marks?

Leigh
I had juverderm 1 week ago under my eyes and the bruising is almost gone; however, he injected my lips which my lower one looks fine but the upper appears to keep getting fuller – go figure. I too had an injection between my eyebrows to smooth our a deep wrinkle and it looks like someone hit me. This DR has done for me in the past, not sure what happened this time. In the past I’ve had Restylane…maybe that’s the way to go.

Jennifer
I had juvaderm injected between my eyebrows to smooth out a deep wrinkle. WELL……..I’m now left with a LARGE LUMP and it looks horrible. The problem from my research is THIS…it is NOT the product, but the DR. lacking the skills to INJECT…..Research your PS before you get this done. I’m NOT against JD, but you best know your PS.

Bridget
Annika, and others, you can get rid of hyaluronic acid fillers like Juvederm, Restylane and I think the new Prevelle by injecting hyaluronidase, an enzyme that breaks down the hyaluronic acid in the filler. Not all doctors using the injectables stock the enzyme to break it down, but there are doctors who do. It is virtually painless and will result in a very quick reduction in volume as it breaks down the filler. Sometimes you actually have to pay for this from the same doctor who injected you, which I think is wrong, but if you can’t stand it you might as well get rid of it. I don’t agree with having to pay for something that disfigures you, but it’s rare that a doctor or nurse will refund your money. If they don’t get it all dissolved in one go, you may have to go back, but worth it if you really need to get rid of it. The enzyme will not work with collagen fillers, or Radiesse, which is made of calcium hydroxyapatite, and that is not dissolvable. Under eye injecting is difficult as you really have to judge how much to put in, to account for the additional volume you will get after injection because hyaluronic acid attracts water from the body. If injected properly, you will get more volume for your $$. Technique by the injector is paramount, it is art and science. Too many people are doing this who don’t know what they’re doing, but even experienced injectors can misjudge, so their service after treatment is really important. Juvederm *can* migrate, that is documented according to my doctor. HTH

Annika
I have a question about restylane. Because have used this stuff in my cheeks. I didnt like the results and now I wondering if every body can break this down and then I mean the protein who binds it. Its BDDE and they use it in restylane. If restylane isnt permanent the BDDE should break down to. Can anybody with experience answer this question?

Krystal
I went to a board-certified plastic surgeon who said I would “love the results” and his office workers said “everybody loves the results!” of juvederm under the eyes. Well, i sat on the table, and he came after my face with that needle and my gut told me to get out fast, but i did not listen. He took one tube of juvederm and plugged half under each eye. It was WAY TOO MUCH! i did not have any reactions to the juvederm,no bruising (i took arnica montana before I went in), but for 5 months I was horrified at what I paid someone $750 to make me look sick and older with eye bags I did not have before I went it. I was wearing sunglasses when I did not have to just to cover my eyes. Finally about six months later, i went to dermatologist who put in too much vitrase, then caused deep indentations that were not there before. Then i was horrified so i went to another BCPS who injected juve back in, which was still a little too much, but not as bad as what the first guy did. I do not think I am nearly as beautiful as i used to be, i have unevennes under my eyes and on the left eye i have bulge that has been there for 1.5 years now, and the right eye the juve migrated downwards so now i have indentation, then a long bump snaking down my face, then another indentation under it. The key is to get someone competent in the first place! demand before and after pictures. Anyone who refuses to show you , walk out the door. Remember, this is your face YOU have to wake up with every day of your life. They take your money and forget about you as soon as you walk out the door and have to deal with what they did to you.

Sherri
Had restylane injections done in the nasal bifolds and around my mouth 1 week ago. During the process my left side swelled up immediately during the injection, and very little on the right side. During the injections it felt as if the nurse was not injecting this in the right spots. This is day five after and it is definately apparent that it was not. She did not inject it in the bifold creases but about a 1/4 inch or so below them. Now I have product that is in the side of my upper lip instead of the creases which looks like I have big bumps on the sides of my lips and made the creases look even deeper because their is no product in them. I called her to let her know as she works out of her own office backed by a cosmetic surgeon. She seemed very upset and said that was impossible…….she would have to see it……….I have gone to her for almost 6 years for botox and did the same restylane treatment 4 yeats ago and it all has turned out great till now. The restylane treatment 4 years ago lasted almost 2 years. I also have an area of swelling that does not want to leave. I am scheduled to go back in 2 days……I do not understand how she could have injected it in the wrong area. At this point she refused to admit it. In the 6 years of never complaining about anything it is clear that this is a real problem. I pray there is some way to correct this………I don’t want to be like this for 2 years…..I also don’t feel I should have to pay more money to correct this problem if it is correctable.

Priti
I had juvederm under my eyes. It had left me severely bruised, and perhaps even with a hematoma (my doctors are unsure), and inflammation. I had it partially removed. I decided to to this after a consultation, at which time I was told about the risk of bruising, but that a laser could be used in order to take away the bruising if needed. 2 months later, after several consultations, I decided to go back and have the juvederm with this particular doctor. He did inject me, I did sign a consent, which again discussed some side effects -none along the lines of what I have experienced. Approximately one week later, I returned because of the extreme discoloration. At that time, he did not mention that it looks like I have bled excessively. In fact, he stated that it’s likely I have tyndall effect or hemosiderin staining -although each of these imply improper injection technique. He also discussed that he could not use the laser on me at this time because my skin color was too dark -this was the complete opposite of what was said at my consultation. And after 4 weeks, I still have severe discoloration underneath the eyes that is a yellowishish-brown. I have been to other doctors for 2nd and 3rd opinions, who have all suggested that a vein or several blood vessels were hit, though no one seems sure of what this is. I am also in pain around the nasal-jugal groove. I look tired, feel tired, and cannot sleep because of the worry I constantly feel about the side effects that I have experienced and continually exprience. I think that doctors have not been performing this technique long enough, particularly in the tear trough to really know it’s side effects (short-term and especially long-term) to be able to tell /advise their patients and unfortunately there are few ethical doctors out there to be that honest with their patients in light of it’s being lucrative and filling a need in society. I hope that this brings greater enforcement or training requirements like needing to have done a certain amount of injections, trained a certain number of years in terms of filling a particular area (on or off lable) and full disclosure of all possible (known) side effects within that time period.

Angela
On September 2009 I had Teosyal Deep injected into the nasio fold lines and the fine lines around my mouth, even though I had been using Arnica products the bruising and swelling around my mouth was absolutely horrendous, I was told you would have slight bruising for a couple of days, my bruising was instant.. I had to cancel a job interview because no amount of makeup would cover up the brusing, I went on a pre-booked holiday 6 days after the filler and the bruising remained for the 2 weeks I was away, albeit slightly lighter. What concerns me most though is the lumpiness around my mouth, on one side more than the other, making it look swollen and people have noticed, and, whether this is a coincidence or not, whilst I was on holiday I had a cough/cold and the cough won’t go, I am suffering constant headaches and I’m worried that the filler has impaired my immune system.

angi
I had juvederm 1.5 years ago under the eye area. Its been terrible. I went into the day spa for a scheduled facial and in the consultation room they asked about my concerns. I mentioned the hollowness under the eye. They just happened to have the ENT who does the procedures there that day and somehow talked me into juvederm injections. The tear trough areas both bruised and did not give a natural fullness. Instead you could feel bumps and the whole area was bruised for 4-5 days. After that it just looked puffy. The bags and bumps were MUCH worse than the hollowness. I called to ask him about it and he was very defensive. I ended up getting hyluralonic injections (reverses and spreads out the lumps as much as is possible) by a leading derm in my area who is willing to try to correct other mistakes with juvederm. It helped some. I still have a puffy ridge right at the eye socket bone that I think is permanent and not a natural puffiness or natural aging process. MY ADVICE..DO NOT GET JUVEDERM IN THE TEAR TROUGHS. I had it in cheek and nasolabial, and lips and was pleased with all those areas.

Kathleen
Last August I had my first injection of Restylane. I thought the doctor was an experienced injector. He immediately bruised my left eye. Before I left the office you could see the beginnings of my hugh black eye. I had people asking me if my X punched me in the face. The next eye he damaged was my right eye. I now have a big gash under my right eye which is hollow because there is a bubble of skin above it. This gash extends down into my cheek. His injection technique was to go down below the muscle because it supposedly yielded better results. When he was injecting into my right eye you could immediately see the mark that was never there prior to the injection. His comment “oh that is just a skin fold, it will go away once the Restylane settles in.” It never settled in an now I am scared for life until I trust someone enough to operate on my eyes. That is the only way the damage can be undone. Too make matters worse I had a severe allergic reaction to the Restylane that they do not tell you about. I was in severe respiratory distress. I was unable to breathe normally and talk. I have been on Advair Disc for the past year along with a rescue inhaler. Restylane is DANGEROUS and the FDA should do something to protect us. Restylane should be taken off the market. I looked at the adverse events on the package insert and found out there are others who have had severe respiratory problems. I reported everything to the company and they created a medical file on me but to date I still have not received any reimbursement for this toxic biohazardous material that was injected into my body. I was lied to and told that it was safe and natural. Same ingredients found in the human body. Yea Right.

lynn
I had juvedrem injected into a deep frown line between my eyes. It looked great at first and then began to migrate downward!!! I am now left with a LARGE bump at the top of my nose and above it the same deep frown line I was trying to erase. There should be money-back guarantees on this stuff – it’s so expensive. I don’t even know where to start to have this fixed and can’t afford more treatments anyway.

Vickie
Restylane injections done on August 13, 2009 (almost 3 weeks ago). I had restylane injections into my tear troughs at the suggestion of the RN at my Plastic Surgeons office, which I later decided to try, and immediately my PS stated, oh no I bruised you. So right away I knew that I would have a bruise under my right eye. He had injected into the vein at the very bottom of the tear trough. He applied heavy pressure to the area for a few minutes and then continued to inject the restylane in both tear troughs. The left eye did not bruise or swell up like my right eye did, but by the very next morning it was already apparent that the left eye was lumpy and it didn’t even completely fill in the tear trough area and the fat pocket that is just beneath the bottom eyelid was still more raised than the area that had been filled, so in my opinion it was not good. The left eye has also developed a blue shaded area that is not a bruise, it is just a blue coloration of some type. The right eye was so swollen and bruised that I called in sick at work the next day and continued to put ice packs on it, which ultimately caused skin burn as I was not warned that this could happen to a tender swollen area. The skin burn is fading thank goodness. There is still a blue bruise like spot with a lump under the right eye 3 weeks later. I also expected that the outer corners would be treated with the restylane at the same time, but later found out that my PS has never injected the outer corners of the eye (crows feet area) which still looks loose, puffy and wrinkled and it is not a smooth transition from the inner corner to the outer corner, especially with the lumps that are visable. I went back to my PS about 10 days after the procedure and he said that I was just one of those people that did not have a good response to the restylane and that he wouldn’t recommend that I do it again (here’s your sign!), and he did apologize that it didn’t work well for me. I mentioned to him that I was concerned that the restylane was injected into the vein and he responded by saying, “I don’t think so”, paused a minute and then said, “I know I didn’t”, but there is a blue raised vein like streak from the inner corner down the tear trough to the middle area just beneath the eye. I believe that that restylane did get into the vein. There has been only tiny tiny improvement in the size of the lump and the darkness of the bruise, but the blue vein like area is still raised and blue. I look 10 years older than I did when I went in to have the injections, it is my fault ultimately for make such a poor decision to go through with it, I hope I don’t have to kick myself forever for that poor decision! I have read so many other stories about this stuff lasting more than 12 months that I am extremely worried. Oh yes, he used the left over restylane, with my permission of course, to fill in the lines around my outer mouth area, and now I have several acne breakouts in those areas now, so I am a hidious mess right now. My advice to anyone reading this DON”T USE ANY INJECTABLE FILLERS AS YOU NEVER KNOW WHEN YOU WILL BE THE PERSON WRITING THIS LETTER.

Cheryl
The day before I had Perlane injections in my nasal folds, eyebrows, and smile lines. I left the office fine, woke up the next day fine, tiny bruise (I took arnica for days before–that helps) This morning I woke up and felt the swelling on two of the injection sites on one side of my face. I’ve a call into the doctor. crossing my fingers, but must say after reading the above am now quite scared. I hope tomorrow I wake with no swelling.

Gayle
I had restylane injected under eyes, nasofolds, lips. I made it very clear i only wanted small amounts. Every day i look different. THis was 3 weeks ago. I have under eye bags i did not have,my eyes swell and get really red, my cheeks feel tight and look chipmunk like when i smile, and my lips also swell. I also had botox and also look horrid from that. My brows dropped and i look years older. I am having tension headaches and my forehead feels in spams. This has been a total nightmare. The only thing i am worried about being permanent is the under eye bags. I suggest everyone report their bad reactions to the FDA and restylane company. This is the only way the info is going to get out there!! Under eye injections are not an FDA approved procedure (they call it off label use).

Margaret
I had Juvederm injected into the nasal folds and the sides and below my mouth last August. Shortly thereafter, I developed some sort of pneumonia and wound up in an ambulance on my way to the emergency room. After doing a Cat Scan it was determined that I had some node type things growing in both my lungs (never before did I have respitory problems), of course I was put on a course of strong antibiotics. The pulmonary specialist suggested I wait 3 months and go in for another Cat Scan. When I went back they couldn’t find anything. Strange? I believe wholeheartedly that it was a result of the Juvederm. In addition, I have cronic acne on that part of my face (I am in my fifties). Stay away from any of this stuff! I reported the incident to the FDA, but who knows if they do anything about these dangerous products.

CA
My son had restylane injected in his left upper lip area to fill in a permanent scar. On the same day, 3 mos. ago the L.A. Ca. Dr. also injected the filler below his eyes. He had to be flown home to Wa. state where we live 7 wks. ago to undergo tests because he feels like he has some kind of disease that has attacked his nervous system. He has symptoms such as leg and arm weakness, blurred vision, hardness/stiffness in his upper arms, plus leg and arm “heavy” feelings. He has had 2 MRIs, an EEG, an upper extremity ultra sound, has had his eyes and heart checked, seen an allergist, a Physical Therapist and a Naturopath, plus trips to the ER. The Endocrinologist is tomorrow. He is trying to rule everything out and so far we have nothing….anxiety is setting in, but anxiety did not cause these unbelievable symptoms. He is 30 yrs. old and is at home, being cared for by his parents, and is unable to work out or drive at this time. Could this all be due to the Restylane injections? He was healthy and busy working on his career when these possible side effects began. Should he be part of the FDA Panel investigation?? Ca

Loom
I had Resty done yesterday at 7.30pm. I woke up at 2.30am this morning just with that ‘something is wrong’ feeling. Went to the bathroom mirror, my whole top lip had swollen up and was almost touchng my nose. Needless to say I properly freaked out. I called the doctor who did the injecting, he told me to take 2 Piriton tablets. That seems to be working a bit. He’s also on his way round to see me so I’m happy that I have a decent doctor who cares enough to pay me a home visit. Wish I’d known about this side effect though. It’s a very frightening thing to see your face like that!!!!

Gloria
I had Restylane injections around my eyes 6 months ago and had a terrible reaction. I took tons of photos and my eyes were red, swollen and my upper lids sagged. I was 60 and looked 45, now I look 60! I can’t use any eyes creams or moisturizers with swelling and puffiness and I have deep creases that I did not have before the injections. They promised me instant gratification and I got instant nightmares. The follow up treatment to the injections was even worse and administered without anesthetic! I paid a lot of money to see a doctor I thought was one of the best in San Francisco because she’s famous for creating the Proactiv line! My results are depressing and I suspect permanent.

Michelle
Having terrible swelling and brusing from Radiesse injections around mouth, but only on one side! Other side is fine.. After 2 1/2 weeks, I am sore on inside and outside and still have a slight bruise where injected (which I bled alittle after injection). Why am I so swollen and why so painful so long? My Dr. keeps saying wait wait… it will heal. and go down. I am iceing at the moment and it hasn’t gone down. And I take ibuprofen also. Any help and what could he have done wrong on ONE SIDE!!!

Mary
I had restylane done from the nose down (around the mouth) and around the jaw area…..I use to have 20/20 vision and now can barely see out of one eye….I have seen every Dr. and had every test to rule out anything else……This happened shortly after the injections. I wish I had NEVER done this nightmere….and have since read that although this is rare it can happen…….I wish I had been told that.

Karen
I regret every day for almost two years now, the day, on a whim, I walked through the door of this board certificated plastic surgeon’s office for a cosmetic consultation and got a hardcore sales pitch on these injections called Sculptra “Not Risky Like Surgery, Just Some Injections”. Brain surgery is less risky. I live with chronic pain. The surgeon injected in all the thin skinned places, I have huge rock hard painful lumps on the injection sites to prove it. This injectable is to unpredictable for anyone to use on a patient nevermind injected by someone who injects it like Botox. I have lumps in the rims of my eyelids, they migrated. The skin that was almost wrinkle free under my eyes has sunken in and is also raised on the surface like a range of mountains with valleys. Lumps in he interior of my mouth and deep in my jaw, with time they have gotten larger and are on the nerve endings. I have flair ups of inflammation when my face, out of the blue, looks like a balloon about to burst. Nerve medication just cuts this pain a bit. Of course I paid several thousands of dollars to this man and didn’t even get the promised “new colligan”. To add insult to injury he turned around and stated he informed me of risks no one in their right mind would agree to subjecting themselves. There is too much deception at play. It’s ugly and so unethical. The only word to describe Sculptra is a nightmare I can’t wake up from. Of course the surgeon than said he fully advised me of these risks that no one would never take. Actually this surgeon knew better than to inject. This is all so unethical. I though I walked into a medical doctor’s office, not, in my case I walked into a someone’s office who looked at me as dollar signs not a patient. Going on two year my under eye area is so disfigured, deep lines like ‘x’ marks, discoloration and under the skin is an intense bacterial infection, no antibiotic can fight off with intense inflammation that flares up. Just two months ago, my face blew up like a balloon. I have clumps of this garbage in my eye lid, it migrated. There are rock hard large lumps in my mouth and deep in my jaw on all the nerves endings. I am in chronic pain and always aware of these lumps “called a foreign body sensation”. I have been to easily ten doctors and was charged of course for these consultations – paying again in hopes they can correct this wackos mess. Amazing I paid him to wreck my face, healthy and sanity, than I pay to see reputable surgeons will not attempt removal, I am not saying they should give me their time for free, the problem removal will cause additional scarring and they are concerned about an inflammatory reaction. You can probably find one to take your money, say an under eye bag lift would do it, my head probably would have blown off on the operating table but they would have a sign consent form. This injectable was a bomb in Europe. Why didn’t the drug company just wait and develop a product that didn’t harm? Everyday now they change their story, yes they have trainers, no they don’t. If you give them all your personal information, they will review and of course give you nothing. You are a trail study. When you read the website, the Iinjector is actually a fault, my consent form did not look like their sample, oh course the surgeon knew the brochures were so misleading, he sure didn’t use that Depot method. So actually the surgeon overlooks his reponsiblity for the quick bucks and he should be held accountable if the surgeon you went to has zero ethics like “my guy”, than the best, He Blames The Patient. I wish tomorrow morning I would wake up and suddenly I never went in for that consultation, I didn’t waste several thousand dollars and didn’t even have a bit of that “new collegan” that never happen. That I didn’t have to live on nerve medication for the pain. That there were standards and this md would have to do something else for a living.

Dawn
I had Radiesse injected under my eyes 6 weeks ago. It has been a nightmare. Under one eye I have a large bubble and uner the other eye its lumpy. Underneath both eyes the whiteness of the Radiesse shows through. I have been to a few doctors and they keep telling me to wait but I have seen litttle if any improvement over the last few weeks.

Susan
I had juvederm used as a filler for my lip area in oct. 2008 which caused facial paralysis. It has been over 7 months and have the paralysis.

Julie
I had juvederm injected in September of 2007. I still have huge eye bags and loss of vision. This product has caused me two be miserable for amost two years. It was supposed to go away in 9 months or so. It didn’t.

Sondra
I had juvederm plus yesterday in the nasel fold area an now I have hugh red distorted looking face. I could not sleep it hurt so bad. I did keep ice on my face and that felt better. I had to go to my allergist today and she said what happened to you. I hope these hugh red blobs go away soon I had reaience that cost a fortune and did nothing a thousand dollars down the drain.

donna
Eleanor & others I have a friend who has the same SCULPTRA nightmare. She went for a MRI and was told the product wasn’t injected correctly and should not be used under her eye and the big lump is not able to be removed. Please contact me and let me know what you did and where you went to get it fixed. My friend needs help. sculptraproblems@yahoo.com Thanks.

eleanor
sculptra was injected under my eyes to decrease hollowness. It was a nightmare I had bumps that were a mess and had to be removed surgically. My ps cannot remove all of them because I might get holes and scarrring because the sculptra is placed under the skin quite deeply. It has taken two years to remove God knows how many lumps.I did nothing but cry for years because I looked distorted.There is now much improvement but I can still feel the lumps. I was never informed this might happen If I had been told I would not have done it. I am very angry that I had to go through this. I feel as if four years of my life was ruined.The two years I waited for the lumps to so call disolve and the removal,another two yearsI hope no one goes near this awful product.It should be taken off the market

noreen
I had injections for nasal folds and lines above the lip. My lips were swollen after this and now my face has black and blue bruising in the area and I have bruised lips. We paid a lot of money for this, my husband had some areas done too. We did not see any noticeable improvements. Although, I feel the surgeon was competent, the product leaves a lot to be desired.

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