For more than 20 years, LASIK eye surgery has been a big business. Now, the U.S. Food and Drug Administration (FDA) wants consumers to know more about the risks and benefits before they undergo the operation.
The FDA has issued draft guidance to help improve the flow of information to both patients and health care professionals so that everyone knows what to expect with a successful procedure and what could go wrong.
"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," said Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health. "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."
Shuren said the draft guidance is designed to support discussions that patients should have with their eye care providers to help them make an informed decision before proceeding with the surgery.
LASIK is performed using lasers on an outpatient basis. It’s a procedure that permanently reshapes the cornea to change the way the eye focuses light rays onto the retina at the back of the eye.
Corrects common vision problems
Doctors who perform LASIK surgery use it to correct common vision problems such as nearsightedness, farsightedness, and astigmatism. It can also reduce a patient’s need to wear glasses and contact lenses.
According to the Mayo Clinic, there can be complications that result in a loss of vision, but they are very rare. Clinic doctors say other side effects of LASIK eye surgery -- particularly, dry eyes and temporary visual problems such as glare -- are fairly common.
A prominent Russian eye surgeon, Dr. Svyatoslav Fydorov, discovered the LASIK procedure in 1974 by accident when he was treating a young boy’s eye injury. The FDA approved the procedure in 1999. Since then, an estimated 10 million Americans have had the operation.
New FDA guidance
The FDA’s draft guidance includes the agency’s recommendations for both the content and format of patient labeling for LASIK devices. It includes:
General information about the surgical procedure
Indications for use, benefits, procedure alternatives, contraindications, warnings, and precautions
What to expect before, during, and after surgery
Clinical study information
Manufacturer contact information
The draft guidance also proposes the inclusion of a decision checklist as part of the labeling information that physicians provide to their patients prior to the procedure.
To help patients fully understand the decision checklist, the FDA said it will provide information about who is a good candidate for LASIK and a summary of the long-term risks.