Medhealth Review

Draft Guidance Issued by FDA to Improve Patient Communication on LASIK Benefits & Risks

LASIK, one of the most popular elective procedures, has long piqued the FDA’s interest. The FDA convened an advisory committee meeting in 2008 to discuss patient labelling. The cornea is permanently altered during the outpatient procedure known as LASIK to change how the eye focuses light onto the retina at the back of the eye. LASIK surgery aims to eliminate the need for eyeglasses and contact lenses by treating common vision problems such as near-sightedness, farsightedness, and astigmatism.

The FDA’s Center for Devices and Radiological Health is headed by Dr. Jeff Shuren says, “It is important to provide patients with comprehensive labeling that clearly describes the risks involved with LASIK surgery, including potential adverse effects such as dry eye, pain and discomfort, and visual symptoms.” Jeff added, “These proposed labeling recommendations, based on extensive consultation with stakeholders and patients, are intended to present information about LASIK in language that is easy to read and understand and include images that convey visual symptoms that could occur following LASIK. The draft guidance is designed to support discussions that patients should have with their eye care providers about the benefits and risks of LASIK to help them make informed decisions before proceeding with the surgery.”  

The FDA collaborated with outside experts on the research projects that shaped the advice in the draft guidance. As part of the LASIK Quality of Life Collaboration Project, the agency conducted research with the National Eye Institute and the Department of Defense to better understand the potential risk of issues that could arise after LASIK. The Patient-Reported Outcomes with LASIK PROWL Symptoms and Satisfaction (PROWL-SS) questionnaire was developed as a result of this project and is approved by the FDA’s Medical Device Development Tools (MDDT) program.

The FDA is encouraging feedback on proposed labelling recommendations from patients, health care providers, and stakeholders by issuing draught guidance for public comment. LASIK devices continue to be monitored by the FDA as new information becomes available, and it collaborates with professional medical societies and patient advocacy groups to ensure patients are informed about risks related to LASIK devices. Concerning risks, the FDA recommends that labels begin with the most severe and common complications, such as vision loss, and then progress to rarer, milder side effects.

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