Skin Deep: Questions Surround Iris Implant Procedure – Skin Deep

January 3rd, 2013

ANITA ADAMS was born with one green eye and one brown eye. While differently colored irises, a condition otherwise known as heterochromia, may look exotic on David Bowie and Kate Bosworth, Ms. Adams did not like them on herself.

“I wanted my irises to match,” said Ms. Adams, 41, who works as a caretaker for at-risk adolescents in Grand Junction, Colo.

In mid-2008, she began looking online to see if there was any solution other than colored contact lenses (which comprised about 20 percent of the $ 7.8 billion global contact lens market in 2011, according to a January 2012 report published by BCC Market Research). She found a company, New Color Iris, marketing a device invented by a Panamanian ophthalmologist, Dr. Alberto Delray Kahn, that could apparently implant an artificial or prosthetic iris over her natural one.

The device was not approved by the Food and Drug Administration, nor were there any clinical studies or peer-reviewed publications about it. But Ms. Adams found Facebook posts and YouTube testimonials from patients whose eyes had gone from drab brown to an icy blue and were thrilled with the results. On his Web site, Kahnmedical.com, Dr. Kahn wrote that he supported “programs for the prevention of blindness in the Kuma and Embera Indians of Panama,” who have high rates of ocular albinism, which makes them sensitive to light. 

Ms. Adams was impressed. At the company’s request, she went for routine tests to her ophthalmologist, who told her he had never heard of the procedure and advised against it. She didn’t listen. “I went, ‘Oh, whatever,’ ” she said. “I don’t think anything was going to convince me not to do it. At that point my mind was made up.”

Ms. Adams is not alone in her quest for symmetry, whatever the risk.

Dr. Gregory J. Pamel, a corneal and refractive surgeon in Manhattan and a clinical assistant professor of ophthalmology at New York University, said that for the last two years he has received about three inquiries a month from patients who have learned from his Web site that he implants artificial irises for medical reasons. “They’d want to enroll in the clinical trial, and I would say, ‘There’s nothing available in the U.S.,’ ” he said. “There are no approved devices in the U.S. to change the eye color cosmetically. There are no clinical trials to date that are looking into this. There’s nothing on the horizon.”

There are, however, iris implants for patients with serious conditions like aniridia, a rare hereditary absence or partial absence of the iris, that are available under a special “compassionate use” F.D.A. provision. The provision allows patients with serious or life-threatening medical conditions to be treated with devices that have not been approved by the F.D.A., but “we can only use it for people with trauma,” Dr. Pamel said. “I would be very hesitant and skeptical about any technology that purports to change the iris color for cosmetic reasons.” 

Dr. Kenneth Steinsapir, an oculofacial surgeon and ophthalmologist in Los Angeles, also received calls from patients wanting their eye color changed, so he began investigating New Color Iris. He found no positive reports, but he did find a number of studies reporting serious complications. In July 2010, he blogged about it on his Web site, “The colored disk that is put in the eye has been shown to cause harm,” he wrote.  “If you are not albino and missing iris pigment or have part of the iris missing either from a birth defect or from trauma, then there is no compelling medical reason for this surgery.” 

But Ms. Adams was determined to fix her perceived imperfection. In September 2008, she wired nearly $ 2,000 to New Color Iris, and a month later flew with her mother (paying their airfare) to Panama. She was told the surgery would present no complications other than a slight risk of glaucoma. She signed a consent form, paid an additional $ 5,000 and underwent the 15-minute procedure.

For two days, Ms. Adams’s vision was blurry, which she was told was normal. By the third day, she could see well enough to tour around the city. “I was happy with the experience at the time,” she said.

She appeared on “Inside Edition” to talk about how delighted she was, for which she said New Color Iris paid her $ 500, promising an additional $ 500 for every future media appearance she did. She also allowed the company to use her likeness on its Web site and on YouTube.

Ms. Adams was pleased with her matching irises for about two years. But in fall 2010, she said, her vision grew “spotty,” and she was “scared to death I was going blind.” She 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.

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.

Ms. Adams said she contacted it using a fake name and was told that the procedure was being offered in Istanbul and soon “in all of Europe” and that the company was not affiliated with New Color Iris. Convinced this was untrue, she contacted Dr. Steinsapir in February 2011, and he began blogging about a possible relationship between the two companies. On Aug. 16, 2011, Dr. Steinsapir received a certified letter from Kevin J. Abruzzese, a lawyer in Mineola, N.Y., representing Stellar Devices, which owns the trademark for Brightocular, that denied that any association existed between the two companies. The letter also asserted that Stellar Devices was working with Minnesota Eye Consultants, in Minneapolis, to obtain “F.D.A. compassionate approval for a patient with aniridia,” and ordered  the doctor to remove “any and all defamatory content” about Brightocular.

Still skeptical, Dr. Steinsapir found a registered trademark for Brightocular, originally filed March 18, 2010 and granted registration on April 19, 2011.

But the company to which the trademark was registered was not Stellar Devices, but New Color Iris. What’s more, New Color Iris and Stellar Devices shared the same Midtown Manhattan address. Dr. Steinsapir later published his findings. He said he also arranged surgery for people who had iris color surgery and needed urgent help.

Alain Delaquérière contributed research.

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