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Laser-Assisted In Situ Keratomileusis, or LASIK, one of the most widely sought-after vision correction procedures, is now under scrutiny due to the potential for lasting side effects. Therefore, the U.S. Food and Drug Administration (FDA) recently announced that it is pushing for stronger warnings on LASIK procedures so patients can make more informed decisions on whether they want the surgery.
Consequently, this news has brought to light some of the dangers of the surgery, leaving many brokers and providers wondering what this FDA warning for LASIK might mean for their businesses. Here is a closer look at some of those warnings and recommendations, how providers can prepare for these new FDA changes, and how brokers can adapt to these changes as well.
Understanding the FDA’s Push for Stronger Warnings
Recently, the FDA has identified multiple potential risks associated with LASIK procedures. Therefore, they may be issuing new LASIK warning requirements.
As per an article on Healthline, some of these cautionary statements would encompass details regarding the potential hazards of experiencing double vision, dry eyes, persistent pain, and other complications arising from the surgery. Furthermore, patients would be informed that they might still require glasses following the procedure.
Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, says that patients being provided with comprehensive labeling, clearly describing the risks involved is essential. He believes these risks should encompass possible adverse outcomes like discomfort, dry eyes, and vision-related issues.
The FDA is exploring a new policy requiring doctors to disclose potential risks to patients. The draft guidance suggests what information should be given to patients about LASIK devices. This includes basic details about the surgery, its purpose, benefits, alternatives, contraindications, risks, warnings, precautions, and what to expect before, during, and after the procedure, as well as clinical study data and the manufacturer’s contact information.
Furthermore, an FDA representative stated that to guarantee that both physicians and patients possess the necessary information to make well-informed decisions, the FDA suggests that manufacturers supply doctors and patients with a “patient decision checklist” before undergoing a LASIK procedure.
The checklist aims to detail a list of conditions that could put a patient at risk for surgery-related problems, including a weakened immune system, both controlled and uncontrolled diabetes, and dry eyes.
What changes could be caused by the FDA Warning on LASIK?
As a broker, you may be asking, “What could this mean for healthcare providers?”
To start, if these new warnings go into effect, many people are likely to be shocked when they learn about some of these concerns. Research suggests that since the Food and Drug Administration approved the technology in 1998, 10 – 15 million people have had laser vision correction surgery.
So, LASIK has been considered an overall safe (albeit somewhat expensive) alternative to corrective lenses for quite some time. But, aside from patient reactions, healthcare providers may also be affected by having to provide additional patient education, such as why they may still need corrective lenses after their surgery or why their pre-existing dry eye condition could be made worse as a direct result of having the LASIK surgery.
To better prepare for these potential FDA changes, providers should familiarize themselves with the new guidelines and ensure they properly inform their patients of all the potential risks.
Vision Care Direct
At Vision Care Direct, we recognize the importance of these FDA LASIK warnings, their recommendations, and their checklists. In full support of increasing patient education in this area, we recommend that you review the new FDA guidelines and stay up-to-date on the current changes. By doing so, you can be prepared for any questions your clients may have.
If you have any questions or would like more information on the FDA’s push for stronger LASIK warnings, contact us today!