Sunday, June 26, 2016
Surgeon: Patients need to be educated on dangers of cosmetic iris implants
NEW ORLEANS — Patients who are interested in receiving cosmetic iris implants to change the color of their eyes need to be educated on the ocular complications associated with the implants, according to a speaker here.
“[The implants] are heavily marketed, these are very savvy presented on the Internet, and there’s a lot of misleading information about FDA-approved material and U.S. patent studies. Of course there are no studies,” Tal Raviv, MD, said at Cornea Day preceding the American Society of Cataract and Refractive Surgery meeting. “And the reality is this causes such horrific damage.”
The two major brands of iris implants are New Color Iris and BrightOcular.
There were more than 700 patients implanted with the New Color Iris implants in Panama from 2006 to 2010.
In a study Raviv and colleagues conducted in 2012, more than 50% of patients who received the New Color Iris implants needed secondary surgery and sometimes multiple surgeries.
“There are severe and irreversible complications. This is not a reversible procedure. It’s just a removable implant,” he said. “The problem with these implants is that we cannot size them, and they are anterior chamber lenses that basically touch the angle 360° and cause severe damage.”
If the patient is showing early signs of iritis, high IOP, pupil ovalization under the implant, corneal decomposition or cataract, Raviv recommended that the surgeon should immediately explant the iris implant.
“Do not delay and do not hesitate to tell the patient that this is extremely dangerous,” he said.
Primary explanation should be performed without other secondary procedures. After explantation, patients should be evaluated to decide if phacoemulsification, Descemet’s stripping endothelial keratoplasty, glaucoma surgery or iris repair is needed, Raviv said.
For explantation, Raviv recommended surgeons use a one-cut removal technique, which consists of placing Miochol (Bausch + Lomb) in the eye, using 23-gauge graspers and scissors to make one radial cut into the implant close to the corneal entry, and removing the implant using an ophthalmic viscosurgical device.
“These are unapproved, unstudied cosmetic iris implants, and they are truly a public safety hazard,” Raviv said. “I believe that ophthalmic societies need to officially condemn these implants.