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:
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.