Cosmetic iris implants - double edge sword

Abstract

Iris implants were originally described as an option to treat photophobia and glare associated with aniridia, coloboma, corectopia or any other causes of acquired or congenital iris defects. They are not designed to be used in healthy phakic eyes and not approved by regulatory bodies anywhere in the world for cosmesis. However, widespread publicity and the compulsive need for beautification has popularised the use of these implants illicitly. Implantation into phakic eyes causes mechanical irritation of angle structures leading to chronic inflammation, pigment dispersion, prolonged endothelial cell loss and compression of the trabecular meshwork. The consequences are dire, leading to presentation of such patients with serious complications involving the cornea, angle, and lens. Here we give an extensive review of available literature on cosmetic iris implants and also describe a case with bilateral cosmetic iris implants (New-ColorIris). The patient presented with corneal decompensation, glaucoma, and cataract in both eyes, seven years after the implantation and was successfully managed with explantation of the device followed by a DMEK Triple procedure.

Glaucoma secondary to cosmetic iris implants in congenital iris coloboma

“…NewColorIris implants are known to cause severe ocular morbidity often requiring implant explantation and secondary procedures to control complications. [4][5][6]8 BrightOcular implants have limited data as compared with NewColorIris implant. Our case is the first to report a patient with iris colobomas who required both glaucoma drainage implants and corneal transplant surgeries to manage complications secondary to BrightOcular device implantation for cosmesis.…”

“…Previously, the most widely used, the NewColorIris (Kahn Medical Devices Corp.), artificial iris implant has a well-documented list of complications throughout the postoperative period. [4][5][6] In 2012, the BrightOcular (Stellar Devices) implant came to market claiming to have a greater safety profile, purportedly due to posterior grooves and ribs to limit persistent intraocular pressure (IOP) elevations from improved aqueous flow and minimized iris contact. 7 Cosmetic implants are not approved by the U.S. Food and Drugs Administration (FDA) in the United States nor the Conformite Europeenne in Europe, leaving patients to travel to other countries for cosmetic surgery.…”

“…The 2 major types of prosthetic iris devices are iris–diaphragm implants, which lie anterior to the iris, and iris–lens implants, which lie posterior to the iris, placed in the capsular bag, ciliary sulcus, or fixed to the sclera. 4 Iris–lens implants are generally viewed as safe, especially for treating true ocular pathology resulting from iris deformities. By contrast, cosmetic iris–diaphragm implants used to externally change iris color or mask congenital defects are significantly less benign because of placement in front of the natural iris in the anterior chamber.…”

Iris Reconstruction: A Surgeon’s Guide

“…One of the major disadvantages of the Morcher 67 implant is that there are only plain black artificial iris options, so it offers no chance of cosmetic symmetry [40]. More recently, Morcher have developed models that do come in 45 different colours [41]. However, this device is no longer available due to failing to meet the latest Medical Devices Regulation (MDR) Standards.…”