Reviewed by Jorge L. Alio, MD, PhD
Cosmetic iris implants pose serious risks and are strongly discouraged, according to Jorge Alio, MD, and Francesco D’Oria, MD, both of Vissum Alicante Miranza Group and Miguel Hernández d’Elche University in Alicante, Spain. Spain.
However, despite the potential risks, surgeries are still performed. The models currently available are the NewColorIris (Kahn Medical Devices) and the BrightOcular (Stellar Devices).
The NewColorIris, a silicone iris diaphragm with 6 rounded flaps on the periphery to hold the device in place, has a diameter ranging from 11 to 13 mm and a pupillary opening of 3.5 mm and a thickness of 0.16 mm. The BrightOcular, which is held in the eye by 5 triangular flaps on the periphery, is available with diameters ranging from 11.5 to 13.5 mm and thicknesses of 0.16 and 0.18 mm; the posterior surface has grooves to facilitate aqueous outflow, the authors reported.
Alio and D’Oria conducted a retrospective review of the medical records of 5 patients (10 eyes; age range, 27-46 years) who had received 1 of the devices (2 with NewColorIris and 8 with BrightOcular). The patients had been referred to the Vissum Instituto Oftalmológico de Alicante for complications related to the latest models of implants, available for 6 years.
The authors reported that all devices were explanted 1 to 60 months after the surgeries. The average endothelial cell density was 848 ± 227.5 cells/mm2. Corneal grafts had to be performed in 30% of the eyes; that is, 2 eyes had Descemet membrane endothelial keratoplasty and 1 eye had penetrating keratoplasty. Three other patients were informed that they would need a corneal transplant. Nine of the 10 eyes developed ocular hypertension, and filtering surgery was required in 2 cases.
Early development of cataract was a common complication, with 40% of patients aged 36 years on average 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 loss of endothelial cells of 1163 cells/mm2. After referral, iris atrophy was seen upward. Endothelial cell density was relatively preserved after explantation at 1054 cells/mm2, the researchers said. The implant in the other eye also had to be removed.
None of these commercial devices had been approved by the FDA or had received the Conformité Européenne mark, but they continued to be implanted. Newer models have not been upgraded and result in the development of the same complications as earlier models.
“Patients with cosmetic iris implants are at high risk for permanent vision loss and other serious complications that should be described to patients prior to implantation,” Alio concluded. “Implementation of cosmetic products [iris] implants should be considered malpractice today in light of the available evidence.