November 25, 2022
NCHR does not support nonbinding FDA LASIK guidance saying it is not enforceable and does not protect patients
We are pleased to have the opportunity to express our views to the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) on the proposed Guidance for Labeling Recommendations for Patients considering Laser-Assisted In Situ Keratomileusis (LASIK).
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
Our president testified at the FDA’s Advisory Committee meeting on LASIK in 2008 and expressed our strong concerns that patients were not adequately warned about the risks of LASIK in ways that patients could easily understand. We stated, “The FDA website information for patients and professionals is difficult to navigate and the information is not useful to patients. Even the patient booklets are clearly not designed to help patients: they are much too long, the vocabulary is much too sophisticated — using terms such as ‘visual acuity’ and ‘N=350’ — and the booklets look like a grad school homework assignment. They are clearly not designed to be read – if they were, they would not start with a biology lesson about parts of the eye. To be blunt: the patient booklets are apparently designed to satisfy someone at the FDA who does not care if any patients read or understand the patient booklets.”
We again expressed our concerns to the FDA in response to their request for written comments in 2009, quoting a published article based on FDA Summaries of Safety and Effectiveness for the 12 LASIK lasers approved by the FDA from 1998 through 2004. We noted that “six months after LASIK, 8% of patients reported halos, 20% reported glare, 19% reported night driving problems, and 21% reported dry eyes that were worse, or much worse, than before surgery.”[1]
We are very disappointed that it has taken FDA more than 13 years to develop guidance, and that guidance consists of nonbinding recommendations that companies can ignore. Even if some companies comply with these recommendations, their compliance may come too late for millions of patients. We agree that clinical and scientific knowledge has increased in the last decade about the risks of LASIK, including dry eye, pain and discomfort, and visual symptoms. However, the data that had already been published in 2007 and the comments provided by patients, public health experts, and consumer advocates made it clear in 2008 and 2009 that FDA had failed to ensure that patients received information in a format that the FDA now says is important — “that allows them to make a well-informed decision about whether to have LASIK.”
The FDA guidance itself is very long and includes details that would not be helpful for most patients. For example, patients need to know that “loss of vision” is a possible risk, but they don’t need to know the details of the different ways that LASIK can cause permanent damage to the cornea, as described on page 15 of the guidance. It is also worth noting that the pain and discomfort of dry eyes is minimized on page 16 of the guidance, with statements such as, “the sensation of dryness can vary from mild to severe, but in most cases, the feelings are a minor annoyance. Eye drops such as artificial tears, or other treatments, such as plugs in the tear drainage system of the eye, may reduce these symptoms, but may not completely resolve them.” The reader must keep reading to learn that, “A small number of patients experience extreme discomfort that interferes with their ability to do daily tasks,” and even that does not convey the terrible pain that some LASIK patients have described to the FDA.
Our research center has worked with many patients, and most appreciate simple information in a patient checklist, rather than a typical lengthy patient booklet or device labeling. We, therefore, appreciate that the FDA’s LASIK patient checklist example is short and easy-to read, and includes illustrations of visual problems that LASIK can cause. However, we know from experience with other devices that companies and physicians tend to add information to checklists that protects them from liability, provides information that the patients already know about surgical risks, remind the patient about benefits that patients are already aware of, and makes the checklist so lengthy that few patients will read all the information about risks, contraindications, and warnings.
Moreover, there are several shortcomings of the FDA LASIK checklist example. Here are just two examples of statements that patients are asked to sign that are not adequately balanced to warn patients:
- “I am prepared to regularly use lubricating eyedrops to manage dry eye symptoms,” should also add, “but I understand that some patients experience extreme discomfort that eyedrops may not alleviate.”
- “About 41% of patients may experience visual symptoms such as glare, halos, starbursts, and double images, as illustrated in Figure 1” should be followed by an explanation that “These can make driving very difficult, especially at night, and are unlikely to be corrected with glasses or contact lenses.”
We are especially concerned that FDA guidance is nonbinding. We strongly urge the FDA to require patients to be provided with short, easy-to-understand labeling prior to scheduling surgery, and that the FDA improve their example of a LASIK Patient Checklist to provide more balanced information about risks. This is necessary to give patients the information many have told the FDA that they wish they had known before their LASIK procedure.
Thank you for considering our recommendations. If you have any questions, we can be reached at info@center4research.org.
Reference
- Bailey MD, Zadnik K. “Outcomes of LASIK for myopia with FDA-approved lasers.” Cornea. 2007 Apr; 26(3): 246-54.