Hydrelle Complications / Risks of Hydrelle
Ever since Hydrelle was introduced to the U.S. by Coapt (made by Anika and distributed by Coapt), there have been a significant series of complications that have resulted from the use of Hydrelle:
1) Allergic Reaction
2) Infections
3) Abscess formation
4) Necrotizing Granulomas
5) Scar tissue
6) Delayed onset problems
Most of these problems have been a delayed onset reaction with Hydrelle patients. Patients who had injections return about 4 weeks later presenting with infections from Hydrelle, Allergy to Hydrelle, Large scar tissue Granulomas from Hydrelle to name a few.
These issues were nearly non existent with other US FDA approved fillers until Hydrelle came along. Although the complications listed above can occur with any filler the reported numbers in literature are 1 in 3000 to 1 in 10000.
Personally, I have injected thousands of fillers from Restylane to Juvederm to Captique, to Hylaform, to Radiesse to Artefill, to Perlane, to Evolence, to Prevelle and never had even one single complication. With Hydrelle, I have only injected 5 patients and 3 developed some of the Hydrelle complications listed above!
More significantly, two doctors from Florida and one from Ohio have emailed me, called me, and written feedback on my website about their own identical problems with Hydrelle. These highly experienced doctors also have never had complications with any of the other fillers.
To make matters worse, Coapt and Anika have refused to remove Hydrelle from the market until further studies are done on Hydrelle. They have also recently refused to reply to our emails and phone calls. As such, these complications have been reported to the FDA for review. The online form that must be filled out by doctors can be found here:
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
The treatment of Hydrelle complications may include:
1) Oral abtibiotics for Hydrelle complication
2) Oral steroids for Hydrelle complication
3) Hyaluronidase (wydase or Hydase) injections to melt the Hydrelle molecules
4) steroid injections to dissolve the hydrelle granulomas
5) drainage of pus and abscess from Hydrelle complication
6) re injection with Restylane or Juvederm to re inflate the deflated areas after the Hydrelle complication is resolved.
This problem with Hydrelle complications is not over yet.
