Bioethics of Artifical Retinal Implant Surgery

Mrs. Adelman, a woman in her late fifties suffered from a visual disorder called age-related macular degeneration, also commonly known as AMD. AMD occurs when the macula, a small spot near the center of the retina and the part of the eye needed for sharp vision, deteriorates overtime due to age [1]. Once Mrs. Adelman was diagnosed with the disorder, her and her husband, immediately began to do extensive research, trying to see if there was any cure. After months of researching, they came across an article, which talked about the latest innovation of an artificial retinal device. It said the perfect candidates for the implantation surgery were those suffering from Retinis Pigmentosa and AMD. Because they resided in Pittsburgh, Mrs. Adelman and her husband, went to the University Of Pittsburgh Medical Center (UPMC), to see if they offered the surgery. They asked the head surgeon Dr. Stein, and he said they did. He first wanted to run some tests to see whether Mrs. Adelman was a strong candidate. When he found that she would be a good match, Dr. Stein ensured the couple that the surgery would be successful, and convinced them with promising statistics and the hope that she could possibly have normal, if not better than normal vision. He then went on to describe the procedure of the surgery, where he and his team would implant a photovoltaic chip in her eye [2].He explained that image data received from an overhead video-camera would be transmitted to the chip, enabling some sort of pixelated vision. As I was walking by his office, I overheard Dr. Stein explain the process of the surgery that was not yet approved by the FDA. I would know this because for the past 20 years, I have been working at UPMC in their bioengineering department developing and testing the latest artificial retinal device. As of now, we have been improving on the Second Sight’s model of the artificial retinal device. Second Sight is an American medical products company, which developed the first FDA approved artificial retinal device [1]. Unlike Second Sight’s model, our model uses a photovoltaic chip and contains more electrodes in the artificial retina. Thus far, it has only been tested on rats, but not on human subjects. Therefore, when I overheard Dr. Stein talking about the latest retinal surgery, we offered, I was faced with a pressing ethical dilemma. This woman was putting her trust in a doctor, who was not being completely honest with her. However, Dr. Stein is my superior at UPMC and if I spoke against him, I could possibly lose my job and 20 years of hard work would go down the drain. On one hand, if the surgery was successful, then there was a chance it would work on other human subjects as well. Moreover, the device is not much different than the Second Sight’s FDA approved model, it just contained a greater number of electrodes, so the surgery is not too risky. However, if the surgery was very successful and gave her better than normal vision, the ethical debate of enhancement vs. nature would arise. Some people would support the significant improvement in human vision, while others would say it was unethical to further enhance what nature has given. Nevertheless, the slight chance the surgery failed, the woman’s health and well-being would be at stake. Also, blindness is not a life-threatening condition, but rather an inconvenient disability, so is it necessary to take that risk of implanting a chip that may potentially cause her a life threatening condition? Most importantly, the FDA did not approve the device yet. However, Dr. Stein is my boss and I don’t know if it’s in my place to question his authority. Plus, I do not want to lose my job. What do I do?