FDA Statement in Response to 'GMA's' Story on LASIK Eye Surgery

In its consideration of LASIK applications, the FDA followed the October 10, 1996 guidance entitled "Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers."

Prior to publication of the guidance document, preliminary drafts were discussed extensively at two public meetings of the Ophthalmic Devices Advisory Panel (7/20/1995 and 4/1/1996). Information from these meetings and input from the Eye Care Technology Forum (ECTF) working group, manufacturers, health care professionals, and consumers, was incorporated into FDA's final guidance. (Oct 10, 1996). After publication, proposed expansions of the guidance were discussed at two additional public meetings of the Ophthalmic Devices Panel (10/21/97 and 10/22/1998). These discussions resulted in a broad consensus regarding the definition and acceptable levels of occurrence of adverse events in IDE clinical trials for refractive surgery laser systems. These were utilized in the subsequent reviews of LASIK pre-market submissions.

In addition to an extensive pre-clinical and clinical data review by FDA, for each first-of-a-kind indication for LASIK devices, input was sought from an Ophthalmic Panel.

How satisfied are you that doctors give patients a clear pictures of not just the benefits, but the risks of the surgery?
The FDA firmly believes in patient education.

Each LASIK laser has a patient information booklet that describes the risks associated with that particular laser. In addition, we have strengthened information on our Web site that outlines risks and benefits of LASIK as well as a "checklist" for patients thinking of undergoing the procedures.

However, it is important to remember that the FDA does not regulate the practice of medicine. We regulate the lasers used in the procedure. Thus, while each manufacturer has a patient information booklet, we can not enforce physician distribution of the booklets to all patients.

During the April 2008 panel meeting, we heard concerns from patients regarding the lack of balanced information about LASIK from their eye care providers.

This was one reason we issued a letter to eye care professionals, providing them with important information about the promotion and advertising of FDA-approved lasers used during LASIK. This letter was widely disseminated with the help of the professional organizations.

There's a chart on your website which indicates that "after surgery" many of the side effects disappear in a short time. Data shows that is not true for everyone. Is this chart misleading?
The chart on our Web site that you are referring to is found in the section titled "What should I expect before, during, and after surgery?"

This chart along with the accompanying text is meant to provide patients with a general understanding of what symptoms may be expected postoperatively and when those symptoms are generally expected to wane.

It is not meant to represent the experience of each individual patient, or to replace a discussion between the patient and his or her eye doctor on what symptoms that particular patient should expect and how long those symptoms are expected to last.

We discuss symptoms in the context of risks of surgery in the section of the Web site titled "What are the risks and how can I find the right doctor for me?"

Again, the Web site is meant to help spur dialogue between the patient and his or her doctor.

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