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High rate of severe, potentially blinding complications reported with cosmetic iris implants

Issue: March 2016

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ATHENS, Greece — Cosmetic iris implants are a non-approved, high-risk procedure that can lead to severe, potentially blinding complications in the majority of cases, a speaker said at the European Society of Cataract and Refractive Surgeons winter meeting.

Wajiha Kheir, MD, told the audience that 700 procedures were performed with the NewIris implant (Kahn Medical Devices) since 2010 and that many complications have been reported, including increased IOP, iritis with keratic precipitates, corneal edema and hyphema. Use of the implant was discontinued because of irreversible ocular damage.

Wajiha Kheir

“Complications were due to intraocular positioning but also to the surface of the implant, which has a lot of irregularities and sharp edges that contribute to abrasion of the corneal endothelium and iris. The frequent rubbing on the iris results in pigment dispersion, glaucoma and iritis. The hinges press on the iris root, causing secondary sectoral atrophy and melt. Impingement on trabecular meshwork causes synechiae, IOP increase and angle closure glaucoma. Pupillary block may occur when the artificial iris is implanted without iridotomies and because it is often oversized or undersized,” Kheir said.

The newer BrightOcular implant (Stellar Devices) was launched in 2012 with an improved design, but severe complications continued to occur.

“We collected a series of 12 cases. The majority developed uveitis and glaucoma, half developed corneal decompensation, and half had their vision significantly affected. Vision improved after explantation, but quite a few refused to have the device explanted,” Kheir said.

Béatrice Cochener, MD, PhD, moderator of the session, said that an international alert should be launched to warn against the implantation of these devices.

“Most patients are very young patients who want a cosmetic procedure and may not be fully aware that it can result in blindness,” she said. – by Michela Cimberle

Disclosure: Kheir reports no relevant financial disclosures.