Rhinoplasty
Warning about Hydrelle
Warning About Hydrelle
The introduction of an FDA approved, safe, Hyaluronic Acid filler, with premixed Lidocaine, for patient comfort, was long awaited and exciting news. Up to that point the Hyaluronic Acid fillers had proved to be the most versatile and safest of all the available fillers. But unlike Cosmoderm Collagen or Artefill which both had premixed Lidocaine, or Radiesse which could be readily mixed with Lidocaine, the Hyaluronic Acid fillers (Juvederm, Restylane, Perlane) were not mixed with any numbing fluid for increased patient comfort.
Over the last 10 years, after thousands of injections with all sorts of FDA approved fillers, prior to Hydrelle, and having not ran into a single problem whatsoever, I have unfortunately noticed 2 recent issues with Hydrelle. One patient developed a diffuse allergic reaction to Hydrelle about 35 days after the injection with diffuse symmetric facial swelling. The allergic reaction was treated with medication and the swelling resolved, but then a granulomatous reaction followed just a few days later. This is being treated with Hyaluronidase and steroid injections to dissolve the Hydrelle particles and the scar tissue. She has improved significantly and she should have no long term effects from this. The second patient had Hydrelle to her lips and she developed a localized infection on one side. This was treated with antibiotics and drained and she is back to normal again.
My recommendation to other Plastic Surgeons and Dermatologists is that just because something is FDA approved, it does not guarantee its safety. I have prided myself in always waiting for more data before offering a product or service to my patients. In the case with Hydrelle, my patients were so excited about a Hyaluronic Acid filler with Lidocaine that I started offering this product when it entered the U.S. market as an FDA approved filler.
I would say, for now, Juvederm and Restylane remain the two most versatile fillers with the highest relative safety index. Could the two incidences with Hydrelle have been pure coincidence? Perhaps. But I find it odd that after 10 years and thousands of injections, these two incidences occurred back to back in the same week with Hydrelle.
When and were did these occur? We have a patient that sounds identical to the 1st patient. Her’s occured 5 days post injection. And another incidence on a smaller more localized scale. I’ve injected 1000’s of clients and never had issues with Restylane, Perlane, Juvederm or Radiesse. If it’s a preservative because of lidocaine or the HA? I inject Prevelle Silk and that has lidocaine and no problems??? Don’t think I want to continue risking injections with Hydrelle even though it goes such a long ways if doing lips & NLF (vs. juvederm). Do you know whom I can talk to regarding outcomes of these patients? Thanks.
Comment by Florida Injector — December 16, 2009 @ 1:34 pm
Thanks for your input. I find it outrageous that the company does not act to remove this product from the market and equally disturbing is how the FDA cleared this filler!? I have had thousands of patients will all sorts of FDA approved fillers without a single problem and now after only injecting 5 patients with Hydrelle, 3 have had granulomas that have required Hyaluronidase and kenalog injections as well as some needing oral antibiotics and steroids and benadryl. One patient is back to normal, one is 95% improved and should be fine soon and the other is 80% improved and should be fine in a few weeks. Please feel free to keep in touch as I have complained to the company about Hydrelle on a constant basis but have had no useful response from Coapt or Anika.
Comment by Dr. Naderi — December 16, 2009 @ 3:52 pm
As of this morning yet another experienced physician from Ohio has experienced 2 such complications with 2 patients receiving Hydrelle. Per a conversation with her, she apparently had done everything properly and by the book, and despite never having a problem with Juvederm or Restylane, now she has 2 patients experiencing complications from Hydrelle which almost certainly have nothing to do with her injection technique and most certainly everything to do with the Hydrelle product.
I have been in frequent contact with Coapt and Anika (makers and distributors of Hydrelle) but I have not received any real solutions or satisfactory explanations other than excuses.
HYDRELLE SHOULD BE PULLED OFF THE SHELVES BY COAPT OR THE FDA!
Comment by Dr. Naderi — December 21, 2009 @ 3:01 pm
FDA approved filler, Hydrelle, is causing serious granuloma complications all over the country from DC to Ohio to Florida to Colorado. Doctors are calling me to report delayed onset granulomatous complications. The FDA has been notified by us and we urge all physicians to report Hydrelle problems and complications to the FDA by filling out online form 3500 on the FDA website. The company (Coapt/Anika) is not accepting responsibility. Patients are considering a Class Action Lawsuit against the company.
Comment by Dr. Naderi — December 28, 2009 @ 3:20 pm
I find these comments ridiculous. I have been using this poduct since it was launched in the United States. These are both possible complications that can happen with any filler. My customers have been very happy both with the product and the results. If you have a moment I believe that doing your research and giving proper information to your audience would be a much better approach.
Please refer back to the initial launch of Restylane. That product was reformulated because of the amount of complications. Secondly, the outcomes of the 2 patients above is possible with any patient using a filler. I would love to know the amount injected (this filler is supposed to be injected at half the amount of the others).and if this was taken into account when injections were performed.
Having a higher concentration of HA is important in the administration of this product.
Lastly, my patients love this filler and also love that the cost is almost half. This keeps my patients coming back.
Comment by Kendall — January 23, 2010 @ 3:46 pm
Dear Kendall,
Thanks for telling us your personal experience with Hydrelle.
It sounds like you have had a good experience and like Hydrelle but please don’t call the experiences and frustrations and SERIOUS COMPLICATIONS of many experienced doctors “ridiculous!”
The Plastic Surgeons, Facial Plastic Surgeons, Oculoplastic Surgeons, Cosmetic Surgeons, Dermatologists, in Ohio, NY, California, DC, Baltimore, Florida, Colorado, and their many patients who have had SERIOUS COMPLICATIONS such as excessive redness and swelling, walnut sized nodules and pus filled abscesses, Emergency Room admissions and week long hospitalization, etc, would all take offense with your blanket statement and complete disregard of their experience. They have all had to deal with these issues and none of their grievances are “ridiculous!”
If you would like to post your name and number and email address on here, I am sure these doctors and their patients who have suffered would love to tell you about their “ridiculous” experience!
As far as research and knowledge: Yes, these are indeed possible complications and side effects but such issues occur in 1 in 3000 to 1 in 10000 with Restylane and Juvederm while with Hydrelle, the esteemed doctors who have had problems are seeing these complications 10-60% of the time! Furthermore, none of these highly experienced doctors need your “basic lesson” in use of Hydrelle. These doctors have all injected THOUSANDS of patients with many many difference types of FDA fillers and none are novice injectors.
Again, nothing “ridiculous” about these comments other than the experience of the doctors and patients who have had to endure Hydrelle. I am glad you have not had such experiences.
Comment by Dr. Naderi — January 23, 2010 @ 4:50 pm
I had Hydrelle injections on December 2 and 9. Although I had some bumps up to about three weeks ago, now I feel and look like I never had any filler. I am scheduled to have a pearle fraxel on Tuesday, Feb. 9. Do you foresee any complications due to the Hydrelle? Thanks for your imput.
Comment by R. Thomas — February 4, 2010 @ 10:40 pm
Hi,
Its important to note that the large portion of patients injected with Hydrelle have not had any issues at all. The same goes for most fillers. The issue with Hydrelle has been that the portion of patients who have had actual complications is much higher than Juvederm or Restylane which are very closely related. Interestingly, both Restylane and Juvederm now come with Lidocaine mixed in for comfort – which was the initial attractive aspect of Hydrelle.
If you have not had any problems with Hydrelle after 2 months then the chances of developing any issues from it at this point are extremely rare to none.
Comment by Dr. Naderi — February 9, 2010 @ 9:25 am
On December 28, 2009 I had one syringe of Hydrelle (1/2 each side). It was about 3 weeks later that I began noticing problems. By February 5, when I went to my Dr. I had an abscess on each side of my face. He prescribed an oral antibiotic for the weekend, and gave me a steroid injection. I felt immediate relief on my left side. On February 8 I went back to begin the process of dissolving the Hydrelle particles, and now have developed facial swelling on my left side. Although the abscess on my right side is still there, it has improved to some degree. I have another appointment on February 12 for more injections.
I understand each patient is different but would like to know about how long this whole process takes before I’ll have my face back?
Lastly, after two weeks. I’ve decided to take off the baseball cap I’ve been hiding under and share my nightmare with anyone who stares long enough. Hydrelle needs to be removed from the market immediately!
Best,
From Sugar Land, TX
Comment by kk — February 11, 2010 @ 6:26 am
It’s been 4 months since my injections and 2 months since I was released from my 8 day stay in the hospital. Last night I notice a nodule on the other side of my face. I am afraid to even go to the doctor for fear of what he might san and want to do next. The right side of my face which landed me in the hospital is better but certainly not 100%. The doctor is fearful I will not regain the elasticity in that side of my face and if the redness and swelling all go away I could be left with a crater on that side. This is a nightmare that does not stop giving.
I am scared. The first episode was horrible. The three blisters at three different times were unbelievable. If you dodge that reaction consider yourself very, very lucky.
Good luck!!
Comment by Shelley in Los Angeles — March 1, 2010 @ 12:12 pm
I am so glad I found this site. I have had Restylyne 2x with no complications and since I moved states my new doctor suggested Hydrelle b/c of the lessened pain. I will say that the injections were virtually pain free but I did get afraid because I noticed immediately it was unnaturally big. (I found out later you are not supposed to use as much product with this and I wonder if my Dr knew this?) A week and a half later the bruising and swelling finally was going down (I never had bruising or swelling last more than 24 hrs previously) But the product never spread or absorbed evenly like my Restalyne had in the past. I was too self concious to smile b/c I had huge pearls of product under my skin. VERY noticable. Even after massaging the product didn’t spread or budge. then about 2 weeks into it I work up each morning with a HUGE swollen lip. So big I could barely talk or eat, and could not smile at all without feeling like my lip would tear open. I’m a month into it now and the swelling is at it’s worse. It’s obviously not from the injections but from the actual product. I went back to see my doctor today and actually broke into tears because I had been toughing it out for a month but it just got to me that I have been avoiding being in public and smiling for a month now. This is a nightmare! Not to mention the constant pain, if I barely brush something against my lips it hurts sooo bad. He told me to take ibuprofen and benadrylle and in 2 days he said if there was no improvement we would start steroids. I just hope that I’m at the worst of it. From reading some previous responses talking about hospital stays who knows though. I should also mention that my unique job depends on me looking great everyday and I have had to stay at home out of work for the last month losing all income.
Any suggestions advice are appreciated. Mostly though, I’m just glad that I have found that others are having problems and it’s not that something is just wrong with ME.
I did notice that the product site mentions not to use on patients allergic to tannens in red wine and dried fruits. Very odd.. but yes I do get major headaches from red wine.
Comment by Jennifer R — March 30, 2010 @ 8:25 pm
KK, you need to continue seeing you doctor weekly. It takes several weeks of proper treatment to stabilize.
Shelley, I hope you continue to improve. Don’t worry about elasticity and divots. Those can be dealth with later.
Jennifer R, head aches from red wine doesnt mean you are allergic to it but it is something to consider. You need possible treatment to melt the Hydrelle and deal with any granulomas or abscesses. See your doctor and have him read the blogs on sites like this so he knows what to do. I get emails from doctors all over the country on a weekly basis at times. Its a tough problem that many are dealing with. Good luck.
check this out:
http://www.virginiafacialplasticsurgery.com/blog/04-05-2010/protocol-for-treating-hydrelle-complications.html
Comment by drnaderi — April 6, 2010 @ 5:46 pm
I received injections in my cheeks 2 months ago. 1 day following the injections, my face became beet red and swollen. My face was warm to the touch and i applied ice to it which seemed to help a bit. This lasted several days. then one month later, my face got beet red and hot again for about 5 days. i applied ice when it happened and it helped. now, i have periodic redness, though much better but my face feels a little sore. the redness seems worse after drinking wine. it seems that i am having reactions to face cream of most kinds which i’ve never had before. I do not seem to have any nodules that i can feel under my skin. could i have them if i don’t feel them? am i over the worst of it?
Comment by Beth Hughes — April 16, 2010 @ 8:05 am
Hi Beth,
You may want to check to see if you are allergic to Sulfites. Wine and some skin care creams have Sulfites and patients with allergies to these should not be injected with Hydrelle. I am just guessing, but it may be that you have NOW developed an allergy to the sulfites. Its just a guess obviously but worth considering. Hydrelle is supposed to last for man months so you may want to consider having your doctor melt the molecules of Hydrelle with Hyaluronidase injections and then go back to Restylane, Juvederm or Perlane. See your doctor and make sure you are followed up until your symptoms resolve. What you are experiencing may also be totally unrelated to the Hydrelle. Again a guess but worth considering.
Good luck
Comment by drnaderi — April 16, 2010 @ 5:02 pm
I had a horrible experience with this Product. Be Careful.
In January 2010, my doctor injected Hydrelle a form of Hyalronic acid into the frown lines around my mouth to plump up these areas. She also injected Hydrelle into the sides of my chin area to plump up my skin. For three days, these areas were swollen. At the doctor’s instruction, I iced these areas constantly to try to reduce the swelling.
After two or three week, the left side of my face where the Hydrelle had been injected remained swollen and slightly larger than the other area; therefore, I went back to my doctor. She explained that this was not a problem and prescribed a steroid pack for me. I took the steroids for the prescribed time period.
During the third week of February, I noticed I was having pain around my middle (stomach area) and sides. Touching these areas caused more pain. There was no noticeable swelling or discoloration in these areas. I also noticed that the areas where I was injected with the Hydrell (particularly on my right side) were swelling and becoming very lumpy. I immediately notified my doctor.
On Monday, February 22, 2010, I visited with my family doctor. She told me that I had Shingles. She prescribed pain medication and Famciclovir, 500 mg tablets. She also examined the swelling in my face and told me to make an appointment to see my plastic surgeon.
I went to work on February 23, 2010, but had to leave early because of the pain around my middle and sides. By Saturday, March 27, I was experiencing more pain and swelling in my face. I contacted my doctor and saw her in the office to see what was going on with my face. She noticed me immediately that the right side of my face was swollen badly and that I was in great deal of pain. She kept saying that she has never had this happen to a patient before. She decided to use the ultra sound machine to try and determine the problem. The ultra sound showed that I had large pockets of fluid in my face around the areas where she had injected the Hydrell. She immediately determined that she had to drain these pockets of fluid. For the next two hours, I endured sticking large needles into my face to make tracks in the skin to try and drain the product Hydrelle. By the time she finished, my lips were the size of oranges and the right side of my face had doubled in size.
During my visit the doctor informed me that she was able to locate a doctor in Florida who experienced the same problem with the product when he used it on several of his patients. According to the Florida doctor, these patient’s faces and lips became swollen and sore. The product which was supposed to become firm after injection had liquefied four weeks later. The doctor’s patients endured weeks of had swelling and pain in the areas he had injected. He also had to extract the product from the areas he injected.
The doctor prescribed an antibiotic for me because she was not sure if the areas were infected. She had her assistant take a culture of the fluid coming from the open tracks in my face. I left the office in a great deal of pain, went home took more pain medicine and iced the infected area.
On Tuesday, March 2, 2010, I went back to my doctor. She had to open the tracks in my face to press out more of the Hydrelle product. Again, this was a very painful process. She said the product had to come out of my face.
Comment by Deborah Love — April 20, 2010 @ 3:53 pm
Hello All,
So glad I found this site! I recieved my first injection of Hydrelle on Friday, May 14 at approx. 12:00 pm and has the normal post-injection swelling. I had to have a MRI on my left shoulder imm. following my injection (one syringe on my NLF folds, both sides). By the time I got out of the MRI machine ( approx. 1:30)my lips and NLF were 2 times their normal size. So I went home took two Benedryl and applied ice for 2 hours and laid down because I was not feeling well. I took a nap for approx. 30 minutes. When I awoke at 4:00, my ENTIRE face was swollen to the point it looked like my lips were going to explode and I could not open my eyes. I rushed to the ER because I was HORRIFIED. They quickly rushed me to the ER and gave me all kind of IV drugs and Epinepherine and Benadryl and Pepcid and Morphine and everything you can imagine. They were so worried that I was going to swell in my tounge and throat they admitted me into ICU until 2:00 the next day. I just hope and pray after reading all these horrible reactions that people are having to this medication that a class action lawsuit is filed!! I know that my medical bills will be in the upwards of $10-15,000.00 dollars for one STUPID syringe of this evil filler! There should be MORE warnings given to physicians about the possible if not inevetiable side effects. I contacted the Coapt rep. for my derms. office and HE KNEW about all the side effects, yet his company did not put out a WARNING. Someone please contact me if they are willing to take legal action against this company! Like I said, the rep. for Hydrelle told me personally that is the reason that they are no longer sampling this medication and “that there will be a lawsuit”! Im just so glad that I have somewehere to vent and know that I am not the only one that this has happened to! I just pray that I eventually look normal again! Please contact me at the below number if anyone is willing to start a class action with me! Thanks for your time!
Kristina S.
Cedar Park, Tx
(512)___ – ____
Comment by Kristina — May 17, 2010 @ 1:28 pm
Its a nightmare! Every day is different. I can have nice calm days where my face is not killing me…then the next day my face is hot, red, swollen and killing me. Its a never ending situation and no one knows what to do. I’m at the doctors office twice a week getting needles injected into my face to extract this crap and yet seconds later the lumps fill right back up…right in front of our eyes!!! Its horrible. I’ve contacted my attorney and he’s looking into it for me. I am so afraid that this will never end and that if it ever does…I’m going to be scarred for life! I already have such dark spots on the sides of my mouth and chin and I noticed that I have a black eye today…probably from the constant pressing to get the crap out of my face. Its no use though…its back in seconds and its never going to end. If the advertising says that this crap lasts up to a year then imagine how much more pain and suffering we’re all going to have to endure! I should have never said yes when my doctor suggested we try this product. I should have stuck w/my restalyne and I would be fine right now. This is unbearable and I know you are all going through the same thing as I am. No one knows what it is and what can fix it so all of us including the doctors are just using trial and error. Winging it without a plan…hoping something will work eventually. If anyone finds or hears any good suggestions…please be sure to post them here so that we might be able to benefit as well.
Comment by TT — May 18, 2010 @ 1:38 pm
I too ended up with bilateral abscesses from Elevess. Anika is shameful and deserves a class action law suit. Why would you change the name of a known and successful product? The company knows it has problems and acts with no integrity. It has been seven months and I am guessing that this stuff lasts for a year, I have indentations where the product drained out, a little scaring and granulomas. The first month post Elevess produced strange swelling and burning from the injection site (Nasolabial folds) to my eye sockets. The second month was worse – each day a new and frightening swelling or growth. Nothing works, I tried everything… steroids, antibiotics, antihistamine, anti-inflammatory. Until the abscesses drain there is nothing to be done but hide. It took three months before my face was relatively normal.
I called Anika six times over two days, I didn’t want to sue them or even yell at them I just needed advice on what to do next. They told me they would call back and never did – six times.
Comment by Jane — June 14, 2010 @ 10:55 pm
I am a personal injury attorney who is investigating a claim for injuries on behalf of a client who had a severe adverse reaction to Hydrelle. She had used other dermal fillers in the past and never had any problems. I am curious whether anyone has made a claim against the manufacturer and/or distributor of Hydrelle and what have been the results. If anyone has hired an attorney, I would be very interested in speaking with them and sharing information.
Comment by Stanley Buky — July 22, 2010 @ 3:38 pm
Hi! I too have developed a large rubbery mass in my upper-lip (left side) after being injected with Hydrelle. I had never even heard of this product until I saw it on my bill. For many of us, we will not get the opportunity to research Hydrelle before it is injected. I was injected on June 21st and started to notice the mass just a few days ago. I immediately went back to the dr. who injected me and am now on a course of oral steroids. My lip is large, distorted, and sore. I am hoping that the steroids work. From the sound of it, this is going to take a very long time to resolve. Please DO NOT allow yourself to be injected with this product, there are many other safe ones out there.
Comment by k.l. — July 28, 2010 @ 10:29 am
For those of you that have been injured by Hydrelle lawsuits are being filed on a case by case basis.
The evaluation is free. Just fill out the Free Case Evaluation form here:
http://www.attorneyone.com/Hydrelle-Lawsuits/Lawyer-Attorney.cfm
Comment by AttorneyOne.com — August 9, 2010 @ 7:52 pm