Your patients may have seen wife of rapper T.I. and reality star Tameka “Tiny” Harris appear on Good Morning America this week to reveal she had undergone surgery to permanently change her brown eyes to “ice gray,” sparking a national conversation about the safety of such a procedure.
Atlanta-Your patients may have seen wife of rapper T.I. and reality star Tameka “Tiny” Harris appear on Good Morning America this week to reveal she had undergone surgery to permanently change her brown eyes to “ice gray,” sparking a national conversation about the safety of such a procedure.
The implant, which is made by BrightOcular, is not FDA approved in the United States, so Harris became a medical tourist and traveled to Africa for the surgery. BrightOcular markets itself as a “United States-developed artificial iris implant made of a thin, flexible, biocompatible, colored medical-grade silicone which has been developed to alter iris appearance for medical and cosmetic purposes.”
A quick procedure for a permanent eye color change may appeal to some patients-so what should you tell a patient who may inquire about such a technique?
“I would tell the patient that it is not FDA approved, it’s new technology, and I’m not familiar with the consequences for short or long term. I would hold off until it’s a viable option,” says Optometry Times Editorial Advisory Board member Walt Whitley, OD, MBA, FAAO, in Norfolk, VA. “And if you want to change your eye color, there are great options with cosmetic contact lenses.”
Dr. Bowling: Snake oil scam claims to restore vision
“It’s unfortunate that medical tourism is inadvertently being promoted by Good Morning America without checking more deeply on why it’s not approved in the U.S. and discussing the risks involved,” says Scott Hauswirth, OD, FAAO, in Minneapolis.
The BrightOcular website describes the implant as a United States patent-approved-not to be confused with FDA approval-although it claims the implant materials are FDA approved. The implant can treat or alleviate heterochromia and ocular albinism and cover up iris defects like coloboma, aniridia, severe iris atrophies, and iridoschisis. But BrightOcular states the implant can be used for purely cosmetic reasons, as was the case with Harris.
The implant is available in a variety of colors-sea green, ice gray, baby blue, amber, smokey gray, olive green, and turquoise, according to the company’s website.
Harris debuted her new eye color on her Instagram and even offered her fans a promo code for the procedure. She says she has not suffered any significant side effects two weeks after the procedure, but many practitioners warn of the potentially serious consequences.
“I’m not sure what her experience was with cosmetic contact lenses. That seems like it would be a much safer option,” says Dr. Whitely. “This surgery is unproven technology that comes with risk.”
4 ways non-Rx costume contact lenses can ruin your patients' vision
Dr. Whitley says patients may develop an infection,1 some of which can be devastating. Other risks include:
• Decreased visual acuity1-4
• Corneal edema1,4
• Inflammation in the anterior chamber and potentially in the macula, leading to macular edema2
• Elevated IOP1-4
The company is clear via an FAQ on its site that is not associated with another device invented by Panamanian ophthalmologist Dr. Alberto Delray Kahn, which was featured in this New York Times article last year. The implant was marketed under the company New Color Iris. According to the article, a Colorado woman named Anita Adams who received the implant began experiencing complications two years after the surgery.
“(Adams) repeatedly tried to contact Dr. Kahn as well as the company in New York, but said she received no response. She started a Facebook page (now dismantled) highlighting her negative experience, noticing that other people had shared similar stories,” author Abby Ellin writes. “And when she returned to the New Color Iris Web site, she was redirected to another site, Brightocular.com, which was marketing another implant to cosmetically change eye color and offering more glowing testimonials.”
Florida ophthamologist charged with Medicare fraud
According to the article, the now-defunct New Color Iris and BrightOcular have some commonalities-for example, the BrightOcular trademark was originally registered to New Color Iris.
BrightOcular doesn’t have a published list of where the procedure is available-you have to contact the company through its website to find out.
“I don’t think BrightOcular is on track to be approved in the U.S.,” says Dr. Hauswirth. “For the past 12 years, we’ve been involved in the human optics artificial iris implants trials. There have been complications, such as aniridia, trauma, and loss of the function and structure of the iris. However, these implants have a good track record, while the cosmetic ones do not.”
Despite the risks, some practitioners say more and more patients will be looking for permanent cosmetic fixes.
“People want a permanent fix. They don’t want to deal with contact lenses. The reality is that we live in a very vain society,” says Optometry Times Editorial Advisory Board member Marc Bloomenstein, OD, FAAO, in Scottsdale, AZ. “We think it’s outlandish because it’s so superficial. It’s just a cosmetic change. We look at it and think, ‘Do you really need to do that?’ But why not?”
Dr. Bloomenstein compares this procedure to other ocular procedures that seemed unusual in the past but are now accepted practices.
Sagging lids and conjunctiva are an OD's responsibility
“I remember 15 years ago when we were talking about lens replacement in hyperopes,” he says. “The establishment wondered why would you take a viable healthy piece of tissue and replace with an implant. Now lens replacement is much more acceptable. This is no different. If someone wants a permanent change to the color of the iris, here’s how to do it.”
In commenting on cosmetic ocular procedures, Dr. Bloomenstein also mentioned stromal whitening, like the I-Brite eye whitening procedure offered by the Boxer Wachler Vision Institute.
“Changing the iris color is one thing, but making them permanently white is something else,” Dr. Bloomenstein says. “The doctor strips the episcleral tissue. You remove a lot of that vasculature on the sclera, which incudes a permanent whitening of the eyes. The procedure takes about 20 minutes. Nothing is without risk. I’ve seen patients with huge chemotic inflammation where the procedure was.”
“We as a society look at things for the now, we don’t look at the tomorrows,” he says.
1. Hoguet A, Ritterband D, Koplin R, et al. Serious ocular complications of cosmetic iris implants in 14 eyes. J Cataract Refract Surg. 2012 Mar;38(3):387-93.
2. George MKL, Tsai JC, Loewen NA. Bilateral irreversible severe vision loss from cosmetic iris implants. Am J Ophthamol. 2011 May;151(5):872-5.
3. Hull S, Jayaram H, Mearza AA. Complications and management of cosmetic anterior chamber iris implants. Cont Lens Anterior Eye 2010 Oct;33(5):235-8.
4. Garcia-Pous M, Udaondo P, Garcia-Delpech S, et al. Acute endothelial failure after cosmetic iris implants (NewIris). Clin Ophthamol. 2011;5:721-3.