Rhinoplasty
UPDATE on Hydrelle Allergies and Complications
I am speaking today to the CEO of Coapt. I am hoping she will decide to voluntarily remove Hydrelle from the U.S. market. I have had doctors and patients contact me from all over the country about serious Hydrelle complications and as I suspected, the number is growing.
The only thing that doctors can do right now is report the issues to Coapt and Anika. Unfortunately the doctors all tell me that the Coapt representatives act as if their case is the first case.
Any complaints with a medical device such as a filler should be reported to the FDA by filling out the online 3500 form:
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
I will keep you posted after my conversation with the Coapt CEO today. I appreciate all the phone calls and emails and online posts from doctors and patients throughout the U.S., sharing their frustrations and problems with Hydrelle.
Coapt has been a major company and a good company in the cosmetic surgery industry with some fantastic products on the market. Also, there are plenty of patients who have been injected with Hydrelle with no complications or problems. But the ratio and incidence of complications is very alarming and disturbing compared to other FDA approved fillers in the U.S.
I just spoke with the CEO of Coapt, the company that distributes Hydrelle (Hydrelle is produced by Anika).
The Coapt CEO admitted that there have been lots of complaints and issues by doctors from all over the country. But she said the overall ratio of problems and complaints to syringes of Hydrelle sold is low. But still, she admitted that its high enough to warrant a closer look at the product (Hydrelle) by Anika.
She said the problems have been needles popping off syringes as well as allergic reactions and sterile abscesses reported by doctors.
She was confident that the vast majority of patients getting Hydrelle are safe and are not having any problems at all.
I was not entirely satisfied with the outcome of the phone call but it is what it is at this point and we have to await further data, research and modifications of Hydrelle by Anika.
Comment by Dr. Naderi — January 19, 2010 @ 1:53 pm
Any more news about hydrelle?
Comment by Susan — February 10, 2010 @ 1:53 pm
Hi Susan,
I still get phone calls and emails once or twice a week from doctors, nurses and patients through out the United States telling me their complications and issues with Hydrelle. Just this morning I received an email from a Plastic Surgeon in North Carolina who is doing the admirable thing and taking care of another doctor’s patient who is having Hydrelle complications. Reports keep coming in. Fortunately my patients are out of the woods by enlarge but I suspect the problems throughout the country wont die down. I have also received some “nasty” emails from random doctors or injectors who think I am out trying to smear Hydrelle’s name or that I am trying to take away a source of their income!?!? That could not be farther from the truth. The fact is that I was one of the first doctors who wrote an article showing my excitement for an FDA approved HA filler with Lidocaine and I felt obligated to write about the subsequent high rate of Hydrelle complications and since then my blog and website has become a source of useful information and hope for other patients and doctors dealing with Hydrelle issues and complications. I have stopped using it and have gone back to the relative safety of Juvederm and Restylane.
Comment by Dr. Naderi — February 12, 2010 @ 1:54 pm
I end up with bumps in my face that appear and disappear if I massage them after being injected with hydrelle. Please can you tell me how long will my body take to get rid of the filler before I can have my face back? Does this fillers disappear suddenly or gradually? Is it true that the body will absorb the filler? please help.
Comment by maria — March 10, 2010 @ 12:09 am
Maria, the filler will get absorbed gradually over many months but you should see your doctor to see if you need additional therapy such as injection of Hyaluronidase to melt the Hydrelle faster, etc
Comment by drnaderi — April 6, 2010 @ 5:37 pm
3 1/2 weeks a go I had Hydrelle injected into my lips. Immediately my lips began to swell and I had difficulty sleeping due to the extreme swelling. After the swelling went down, I received mixed comments about my lips. Now they are developing painful lumps and swelling on the upper left lip. At times they feel numb and tingle. It’s an odd sensation and I plan on making an appointment this week to see if I should get Hyaluronidase. I’ve had injections in my face without reactions in the past. I appreciate your efforts to get this off the market. If only I had read this before I had the injections. Now I just pray that this will be the last of my bad experience.
Comment by Connie — May 16, 2010 @ 7:44 pm