Authors of a retrospective study into complications associated with iris implants advise that the procedure should be considered as malpractice.
Reviewed by Dr Jorge L. Alio.
Cosmetic iris implants pose serious risks and are strongly discouraged, according to Dr Jorge Alio and Dr Francesco D’Oria, both from Vissum Alicante Miranza Group and the Miguel Hernández University of Elche in Alicante, Spain. However, despite the potential risks, the surgeries are still performed.
The currently available models are the NewColorIris (Kahn Medical Devices) and BrightOcular (Stellar Devices). The NewColorIris, a silicone iris diaphragm with six rounded flaps in the periphery to hold the device in place, has a diameter that ranges from 11 to 13 mm and a pupillary aperture of 3.5 mm and thickness of 0.16 mm. The BrightOcular, which is held in the eye by five triangular flaps in the periphery, comes with diameters ranging from 11.5 to 13.5 mm and thicknesses of 0.16 and 0.18 mm; the authors reported that the posterior face has grooves to facilitate aqueous flow.
Dr Alio and Dr D’Oria conducted a retrospective study of the medical records of five patients (10 eyes; age range, 27–46 years) who had received one of the devices (two with NewColorIris and eight with BrightOcular). The patients had been referred to the Vissum Instituto Oftalmológico de Alicante for complications associated with the latest models of the implants, which had been available for 6 years.
The authors reported that all the devices had been explanted 1–60 months after the surgeries (Figures 1 and 2). The mean endothelial cells density was 848 ± 227.5 cells/mm2. Corneal transplantations had to be performed in 30% of eyes; in other words, two eyes had a Descemet membrane endothelial keratoplasty and one eye had a penetrating keratoplasty.
Three other patients were advised that they would need a corneal transplant. Nine of the 10 eyes developed ocular hypertension and a filtrating surgery was needed in two cases. Early development of cataract was a common complication, with 40% of the patients—who were a mean age of 36 years—requiring cataract surgery.
A representative case was that of a 37-year-old woman who had a cosmetic iris implanted in both eyes and returned 2 years later with problems in her left eye. This patient had a dramatic endothelial cell loss of 1,163 cells/mm2.
Following referral, iris atrophy was seen superiorly. The investigators said that the endothelial cell density was relatively conserved after explantation, at 1,054 cells/mm2. The cosmetic implant of the other eye also had to be removed for similar reasons.
Neither of these commercial devices had been approved by the United States Food and Drug Administration or received a CE mark, but they continued to be implanted. Newer models have not been improved and cause the same complications to develop as the previous models.
“Patients with cosmetic iris implants have a high risk of definitive loss of vision and other serious complications that should be described to patients before implantation,” Dr Alio concluded. “Implantation of cosmetic [iris] implants should be considered today as malpractice in the light of available evidence.”