New Orleans—Cosmetic iris implants were first developed in Panama, where more than 700 people received bilateral implants between 2006 and 2010, said Tal Raviv, MD, speaking at Cornea Day at ASCRS 2016.

At the time, the implant was called the New Color Iris; it has now been replaced with the BrightOcular.

A medical iris implant, such as the HumanOptics, has ironically has been used in cases after the New Color Iris was explanted, he said.

These cosmetic iris implants serve no other purpose other than to change people’s iris color.

Functional implants, however, are designed to be placed in the capsular bag or ciliary sulcus. Cosmetic implants are placed in the anterior chamber over a healthy iris and in direct apposition to the angle structures.

The BrightOcular, however, is being heavily marketed on the Internet, with what Dr. Raviv called misleading information. He showed an Internet “commercial” where an African American male raved about his new baby blue eyes, and how “everyone” was complimenting them, and how there was no pain and how quick the procedure was.

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The problem, Dr. Raviv said, is that people are buying into the hype. He cited a well-known rapper’s wife who went overseas to have the implants and how her actions is now creating a “status symbol” of sorts, with the local news only labeling the implants “controversial.”

“These implants can cause horrific damage,” he said. “Frequently, even after these implants have been removed there is permanent, irreversible vision loss.”

No safety studies, approvals

At issue for corneal surgeons is that the BrightOcular has no safety studies or approvals of the implant, even though the product’s website notes there is a U.S. patent and the implant is made with FDA-approved materials which the company claims “makes it safer.” It is currently being implanted in 10 countries outside the United States and Europe.

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“Studies show severe complications, including corneal decompensation, uveitis, uncontrolled glaucoma, and cataracts,” Dr. Raviv said.

More than 50% of the patients need secondary surgeries once the implant is removed—including Descemet’s stripping endothelial keratoplasty, penetrating keratoplasty, tube shunts or trabeculectomy, and cataract extraction.

“Most disheartening, however, is that a small percentage of implant patients refuse explantation despite uncontrolled IOP, iritis, and diminishing vision,” he said.

In another case series of 12 patients with the BrightOcular implanted, four of 12 refused removal, even though they had uncontrolled uveitis or IOP in the 40s.

“When they show up in your office, their chief complaint is that they’ve run out of drops,” he said. “Do not hesitate to tell your patients how dangerous these are.”

Explanting the devices

There are different reported techniques to describe how to explant these silicone prostheses, Dr. Raviv said.

Most techniques involve cutting the implant into three pieces, but Dr. Raviv prefers a one-cut removal technique using a 23-gauge micro-grasper and micro-scissors to make a single radiant cut into the implant close to the corneal entry.

Then, Dr. Raviv advised removing the implant with “copious amounts of ophthalmic viscosurgical device and a really gentle I/A. Be in the eye as little as possible.”

“These unapproved, unstudied cosmetic iris implants are a public safety hazard,” he said, yet they continue to be promoted and implanted unabated in less-regulated countries.

“Our national implant societies need to publish a joint, unambiguous, public health warning about these implants,” Dr. Stein said. “The lay press needs to be corrected about the dangers these implants pose rather than continuing to label them ‘controversial.’ We need to officially condemn them.”

Originally Published on Ophthalmology Times