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FDA issues new laser eye surgery guidance: The profession reacts

LASIK eye surgery may mean no more corrective lenses. Should it be subject to tighter regulation? A leading surgeon says ‘no’.

Side-view of the human eye, viewed approximately 90° temporal. Image by Paul Savage. CC BY 2.0
Side-view of the human eye, viewed approximately 90° temporal. Image by Paul Savage. CC BY 2.0

The U.S. FDA has issued a new LASIK Patient Labeling Guidance Ruling. The ruling was first intended to come out late November/ early December. The ruling has apparently caused a level of confusion among consumers, and it has upset a number of ophthalmologists.

LASIK (laser-assisted in situ keratomileusis), commonly referred to as laser eye, is a type of refractive surgery for the correction of myopia, hyperopia, and an actual cure for astigmatism, since it is in the cornea.

The FDA has been concerned about the effectiveness of certain laser treatments. For example, the FDA’s director of the Division of Ophthalmic Devices, said about a LASIK review: “Given the large number of patients undergoing LASIK annually, dissatisfaction and disabling symptoms may occur in a significant number of patients”

This has brought the FDA into dispute with many eye-surgery professionals. Explaining why the ruling has caused a level of concern is Dr. James Kelly. Dr. Kelly is a renowned LASIK/ refractive surgeon specialist and comprehensive ophthalmologist in NYC.

According to Kelly, the FDA has not (yet) changed the non-binding status of its LASIK guidance issued in December 2022. This means: “The late December 2022 anti-LASIK news cycle has fortunately abated and perhaps it is best not to stir the hornet’s nest.”

By deciding to publish a “Device Labeling” (a patient guidance manual/checklist regarding the risks of LASIK surgery), Kelly says the FDA should not attempt to regulate the practice of medicine and he sees any attempt to do so in an intrusion.

Kelly opines: “What the FDA strategy may be is an overreach into the patient doctor relationship by cloaking their intentions in issuing this Device Labeling to laser manufacturers, in essence, using them as a proxy to regulate LASIK surgeons indirectly.”

Kelly continues, hoping that campaigning will lead to the ruling being dropped: “As ophthalmologists (and physicians in general) many of us are hopeful the FDA does not interfere in the practice of medicine by mandating enforcement of its LASIK Draft Guidance.”

To aid patients, Kelly explains that: “Much LASIK misinformation exists, especially online. Patients and prospective patients often find it difficult navigating the vast amount of information they encounter. This is precisely why it is important for patients to undergo a thorough in person consultation to discuss the risks, benefits and alternatives of surgery with their physician. At that time the unique circumstances of any individual patient can be assessed.”

Kelly is concerned about the power of the lobbyists, noting: “An emerging trend we are witnessing is for certain influencers to be paid to vilify LASIK (among other procedures). It is apparent that negativity garners greater engagement than positivity. Human nature at work.”

Kelly is not sure who is funding this movement. He states there are some possible groups he has identified:

1) The glasses and contact lens industry

2) A significant percentage of optometrists

3) A small minority of ophthalmologists

4) Medical malpractice attorneys

5) Professional activists

6) Angry post LASIK patients (a very small but very vocal group).

With the patients, Kelly observes: “Interestingly, many in this last cohort refuse help to improve their situation even when offered by experts at no charge. In the early days of LASIK 25 years ago patient selection and treatments were sub optimal. Now with improved diagnostics and laser technology and superior medications we can help with side effects and complications.”

Kelly maintains that the focus should be on patients: “As a profession we are always willing to help patients. As a profession we will call out meritless attacks. Interestingly, the FDA has quietly extended the comment period for the Draft Guidance in violation of its own policies. It almost seems that the anti-lasik activists and the FDA are in a sort of collusion to “game” the system. On my soapbox it seems there is a creeping bureaucracy into the practice of medicine by politicians and unelected officials alike. It must feel good to wield power over people without the requisite knowledge of medicine.”

Kelly continues with his warning: “Within a 2023 omnibus appropriations bill is a section paving the way for how medicine is practiced. There is legislation that may ban the off-label use of medications and medical devices, which is commonly used. This is a direct intrusion of government into the practice of medicine and between a doctor and her/his patient. The government can do a back door entry into the medical care by banning devices/medications for particular uses.”

Many people have some form of vision impairment and over 19 million people in the U.S. have had LASIK surgery, so a new proposed ruling is set to influence a large number of people.

Kelly goes further, in stating: “The proposed FDA guidance is biased (and inaccurate in places) and concentrates very disproportionately on risks over benefits.”

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Written By

Dr. Tim Sandle is Digital Journal's Editor-at-Large for science news. Tim specializes in science, technology, environmental, business, and health journalism. He is additionally a practising microbiologist; and an author. He is also interested in history, politics and current affairs.

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