Health knowledge made personal
21 Comments
|
|
Hi Quincy,
I'm so sorry you are experiencing this. What a nightmare! I spoke to a Coapt sales rep and she said the complications people are experiencing with Hydrelle has mostly been infections and this is probably because the nurse or the physician is not cleaning the skin properly! This company does not want to take responsibility for anything!
Okay two links for you. First, this link is to a physician's website. He started a blog about Hydrelle. (22 posts as of today)
Below is a link to the FDA website for reporting adverse outcomes. Your physician may have (and should have) reported it to the company, Coapt Systems, and they legally have to notify the FDA. I would still voice my complaint on the FDA website. It becomes a public document while remaining anonymous.
http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm
Again, I am so sorry you are going through this. Please stay in touch and let me know how you are doing.
I've hired an attorney highly experienced in medical device cases and represents patients that were injected with Novielle. You may not want to pursue a lawsuit because you are protecting your physician, but he or she is also a victim. Doctors were not told about Carbopol 974P, which is acrylic and a material found in Novielle Gel and Novielle Gel Plus. Your doctor will be protected. If you are still experiencing side effects from Novielle, Novielle Gel, Novielle Gel Plus, Novielle Voice and Coapt Gel, please write me at NovielleVictim@hotmail.com.
This is not a class action, my attorney will represent each of you indivdually. You will not be required to pay up front. His law firm collects 30% when the case settles. Also, you do not need to live in the same state. My attorney is currently representing California, New York, Florida and Texas.
I have received several comments about Hydrelle.
"Hydrelle" was marketed as Elevess a couple of years ago by a company call Artes Medical. The company filed Chapter 7 December 08. The product is manufactured by a US company, Anika, and for a brief time, Elevess was taken off the US market. In 2009, Anika re-introduced it to the US as Hydrelle using Coapt as the distributors. Anika did not have to get FDA approval again because it was already FDA approved as Elevess.
Below is a quote from another physician on www.realself.com.
By Charles K. Lee, MD - San Francisco Plastic SurgeonI encourage all of my health professional colleagues to stay away from Hydrelle. I did not think an HA filler could have such extreme reactions, but I have a patient now who is suffering from injections into her nasolabial folds. I have injected 5 patients total and have obviously stopped using this product since this reaction started. 1/5 is a 20% complication rate. I know another surgeon in the area who had 4/6 patients have a reaction (67%).
I am not talking about a small reaction. I am talking about severe swelling, pain, abssess requiring surgical drainage. Had I known about this, I would have never touched the product. This product should be taken off the market. I have contacted the company and they have responded lethargically. I have filed my complaint with the FDA and will not rest until this product is deleted.
This is the link to the FDA website for Elevess complaints: (there are 251 complaints to date)
Please contact me if you are interested in filing a suit for your Hydrelle reaction.
I`m a lawyer in Argentina and I have a client who was injected with Novielle and suffered several damages
I'd like to receive more information about the case and also to know if there's a class action or any legal action against COAPT
Thanks
I can't believe I have run across this site - I got injected with Coapt Gel over 19 months ago and everyday is the same nightmare.... the stuff does not break down although I hope everyday. And recently it festered up into a big cyst that had to be drained - didn't diminish the size of the big rubber-like glob of "poison" under the skin as I had hoped. I am wondering how to get rid of it.... short of surgery to cut it out... any suggestions....
They continued to inject this stuff "after" they knew what it was doing to people. I am in touch with three women who had this done six months before me, all with terrible reactions (to this day!!!).
Something needs to be done!
Sherry Lane
I fully agree with you Sherry, something needs to be done!!! In my case, I'm representing an argentine women who was injected 14 months ago (only 3 women were injected in our country).
You must talk to a lawyer and sue them?
Where are you from?
Good luck
In response to your question about treatment for Novielle Gel and Novielle Gel Plus:
The following is information from physicians:
For inflammation, my physician has injected steroids. For discoloration, nothing seem to help. My physician has drained cysts that appear every now and then, and prescribed antibiotics. Additionally, he cultured the fluid which came back negative for bacteria. It has been suggested by some of the most creditable physicians in the country, the use of 5FU,or Fluorouracil injected into the effected area, may help reduce the granulomas. I have not done this yet, however I am scheduled for a test dose in July. One physician offered his laser treatment which is done surgically under the skin. It is suggested by several physicians, surgical intervention would be the last option, if ever. Surgery may cause a more severe and permanent disfigurement and/or permanent nerve damage.
The bottom line, I don't think anyone really knows what to do to remove the product 100%.
COAPT SYSTEMS - IF YOU REVIEW THIS BLOG, ANY SUGGESTIONS?
FJR - thank you for your response! I live in Pismo Beach California
nhayes Thank you!! I will see my derm today and show him your post... it almost seems the more we do to our face, the worse it gets...I wonder if it will ever go away or if those lumps are now scare tissue..
Can you tell me more? Email me at slane111@charter.net.
Sherry
ah ha it works! i had fillers put in 9 years ago (vanity vanity) 4 yrs ago i eveloped a non painfull nodule over my upper lipwhich was surgically removed. over 4 yrs it grew back and bigger so at the end of may it was injected with steriods. far from improving the situation the thing has taken off and run riot. i have a large granuloma over my upper lip and my whole face feels on fire. i have been to several specialists all of whom have given me a very gloomy prognosis....wait for absess formation and then have it drained...a female max fax surgeon even told me about a patient of hers who has a permenant drain in her face....i nearly fell off my chair with shock. i dont know whether im doing the right thing but tommorow im having "minor" surgery to remove the main granuloma. im very scared not only about tommorow and the possibility of the situation being made worse but also what the future holds. im not a model or film star but my looks have always been an asset to me ,an asset which it looks as if i might loose in the most hideous of ways. i have friends and family wo are currently sympathetic,...but has anyone read kafka "metamorphosis" concerning a familly member who slowly transforms into a cockroach? it describes how as the person gets less human looking, he begins to be treated as something less than human.....at the moment i look different but ok but can someone tell me how bad it gets and how one deals with it? could anyone email me or telephone me? reverse the charges etc ambrocklebank@gmail.com
wish me luck for tommorow!
Write a comment:
|
Although many dermal fillers are safe and have minimal complications, there was a filler that was introduced to the facial aesthetic market that resulted in a high percentage of patient complaints. This product was FDA approved for vocal folds but was not given FDA approval for any other indication. In January 2009, the manufacturer Coapt Systems, instructed their sales team to market Novielle Gel and Novielle Gel Plus to medical spas, dermatologists and cosmetic surgeons for the correction of wrinkles and lipoatrophy of the face. The reps were told to compare these products to other dermal fillers that currently have FDA approval for facial cosmetic enhancement. Within weeks, Coapt Systems requested all unused syringes be returned. During this trial period, several patients were injected with Novielle Gel and Novielle Gel Plus. As of the date of this writing, one year after the product was removed from cosmetic offices, patients continue to experience adverse effects, some noted with obvious disfigurement, scarring, granulomas and such severe inflammatory response, ongoing steroid injections are required.
If you had Novielle Gel or Novielle Gel Plus injected into your face and are experiencing complications, I would appreciate your feedback.