Recently Dr. Steinsapir was asked to comment on the safety of the brightocular eye color implant. For many of you who follow these issues you know what he has to say on the subject of the NewIrisColor implant:
Recently, he was asked if the brightocular implant was a safer alternative to the newiriscolor implant. Here is his response:
You ask: “I wanted to ask you if you heard about any case that the brightocular surgery went bad? The answer is yes I have.
Almost all published reports regarding these implants relate to the NewIrisColor implant. The Brightocular website claims that the brightocular implant is unrelated to other implants including the NewIrisColor Implant. You should read my article and the New York Times article carefully for yourself to see if you feel this statement is accurate or not. I will tell you that a lack of reports on the brightocular device does not in anyway imply safety.
The safety of a medical device is established by clinical trials published in peer reviewed scientific journals. I cannot recommend a device that has the potential to blind a healthy eye without significant published data on the safety of the device. The owners of the brightocular device have published no data regarding the safety of this device in the peer reviewed literature. There are no clinical studies establishing its safety.
Is the lack of published complications on the relatively new brightocular device the result of it being safe or is it just that it takes a while for complications of these type of devices to get reported? Time will tell. Non-medical factors can also slow the report of complications. For example, if patients are required to sign a non-disclosure agreement in order to have surgery, they might be reluctant to have their complications reported by their treating ophthalmologist for fear of being sued. The lack of reports regarding the brightocular device should not give one a sense of security regarding the safety of this procedure.
I continue to warn the public not to have this surgery. Is risking one’s vision worth the benefit of changing eye color? The answer is categorically no. If this surgery is safe, where are the published clinical studies establishing this safety? Don’t let internet trolls talk you into putting your vision at risk even if you very much want to change your eye color.
Thank you for your inquiry.
About Dr. Steinsapir
Dr. Steinsapir is a board certified eye surgeon and fellowship-trained in oculoplastic surgery and cosmetic surgery in Los Angeles where he specializes in balanced facial cosmetic surgery for natural results, with an emphasis on minimally invasive techniques, fast recovery time, and leadership in medical technology. Dr. Steinsapir has a private practice and also serves as an Associate Clinical Professor of Ophthalmology at the Jules Stein Eye Institute, at the David Geffen School of Medicine at UCLA. Contact us today to learn how Dr. Steinsapir’s experience and training make him an expert in cosmetic surgery, which can be a vital part of your evidence-based treatment plan.
Services described may be “off-label” and lack FDA approval. This article is informational and does not constitute an advertisement for off-label treatment. No services should be provided without a good faith examination by a licensed physician or surgeon and an informed consent with a discussion of risks, benefits, alternatives, and the likelihood of treatment success. Only you and your treating physician or surgeon can determine if a treatment is right for you.