LASIK eye surgery patient warning to FDA: More warning of ‘side effects’ needed.

Patients who had LASIK, or laser-assisted in situ keratomileusis, vision-correcting surgery have been weighing in on recent draft guidelines from the Food and Drug Administration (FDA) related to the surgery.

The FDA’s draft has been causing controversy among eye experts, and it’s also creating mixed reactions from patients.

The draft is a 25-page report detailing how patients should be better informed, before surgery, of the risks of potential side effects of the LASIK procedure.

FDA WARNS LASIK SURGERY PATIENTS NEED TO BE BETTER INFORMED OF RISKS BEFORE EYE PROCEDURE

FDA guidance states that patients considering LASIK surgery should be given a “decision checklist” that describes the procedure.

Patients should also be given a list of possible side effects that may result from the surgery. These side effects can include dry eyes, difficulty driving at night, double vision, seeing halos around objects, having persistent eye pain in some cases and needing glasses, the FDA said in the same document.

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FDA guidance states that patients considering LASIK eye surgery they should receive a “decision checklist” outlining the procedure.
(iStock)

Boris A. of Los Angeles, California, told Fox News Digital this week that after his LASIK procedure, “his eyes were burning for a whole month and [he] had to use eye drops daily and couldn’t stand sunlight or anything [of] White color “

The California resident said if he could go back in time, he would never have had the procedure.

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At first, he said, the surgery seemed to work.

“In that moment [after the surgery]yes… I could see it clearly for those 15 years.”

He said that eventually, however, he “lost my 20/20 [vision]. I’m back to wearing prescription glasses.”

A California resident told Fox News Digital that if he could go back in time, he would never have had the LASIK procedure.

A California resident told Fox News Digital that if he could go back in time, he would never have had the LASIK procedure.
(iStock)

A typical day for him, he said, involves putting several eye drops in his eye twice a day, because of the dry eye. (Her last name is omitted for patient privacy.)

When asked by Fox News Digital if she felt she was fully informed of the potential side effects before the surgery, she simply replied, “No.”

“Benefits and Risks of Surgery”

The FDA released draft guidelines in July, which suggested what content should be included in patient labeling information for LASIK devices.

“It is important that people considering LASIK have clear and understandable information about the benefits and risks of the surgery to help inform their decision about whether to have LASIK,” the FDA said in the draft guidance. .

FDA also accepted comments from the public, individuals and groups associated with eye care, including professionals in the field.

“These recommendations, when finalized, are intended to help ensure that physicians can share and patients can understand information about the benefits and risks of LASIK devices,” the agency said.

“Additionally,” the agency noted, “this information is intended to enhance, but not replace, physician-patient discussion about the benefits and risks of LASIK devices that may pertain solely to individual patients.”

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FDA also accepted comments from the public, individuals and groups associated with eye care, including professionals in the field.

More than 600 comments, some positive and some negative, on the draft guidelines were accepted until November 2022.

Patients shared their experiences in the FDA’s comments section, and many of the comments posted there seemed to strike the same notes that Alegria de Los Angeles shared.

"It is important that people considering LASIK have clear and understandable information about the benefits and risks of the surgery to help inform their decision about whether to have LASIK," the FDA said in its draft guidance.

“It is important that people considering LASIK have clear and understandable information about the benefits and risks of the surgery to help inform their decision about whether to have LASIK,” the FDA said in its draft guidance
(iStock)

One person posted this comment: “LASIK ruined my life. Please do something about it. Our society needs to know the truth.”

The person added: “My eyes can’t see well at night after LASIK. I have massive ghosts, halos and starbursts. I had perfectly clear, undistorted vision with contacts and glasses before I had it LASIK. I was only 26 at the time of LASIK. How sad!”

This same individual also felt that there was a lack of information given at the time of the procedure.

“My eyes can’t see well at night after LASIK. I have massive ghosts, halos, and starbursts.”

“He assured me that worst case scenario…I would need glasses after LASIK. They didn’t tell me that LASIK [would] create vision problems that glasses and contact lenses could not correct.”

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This same person added: “I have a lot more floaters in my eyes and sensitivity to light. I have spent thousands of dollars on my eyes after LASIK to try to get my old vision back. I wear scleral contact lenses, which only help to some”.

Other patients, however, touted the benefits of the procedure.

“I have not regretted my choice”

The purpose of the procedure is to reduce a person’s dependence on glasses and contact lenses by using a type of laser to change the shape of the cornea (the covering at the front of the eye that refracts light), according to the FDA. web site

“My eye surgeon was very comforting during my procedure, letting me know exactly what was going on and explaining it to me,” said one patient in the report’s comments section.

One person wrote in the comments section of the FDA's draft guidance, "My only regret is not having it [the surgery] rather"

One person wrote in the comments section of the FDA’s draft guidance: “My only regret is not having [the surgery] before.”
(iStock)

This person also wrote: “I have no regrets about my choice to have LASIK. My only regret is not doing it sooner. I woke up the next morning and immediately turned on the TV to see if I could see what was on TV..”

She also wrote: “I went to lunch and kept asking my fiance to ask me what someone’s license plate or traffic sign said. I couldn’t believe I could see without glasses or contacts on. Everything seemed to I was in. HD. I’d do LASIK a million times over if I could—it’s seriously changed my life.”

The procedure takes about 30 minutes and is usually not covered by insurance.

The procedure takes about 30 minutes and is usually not covered by insurance, health experts told Fox News Digital.

Concerns about informing patients about the risks of LASIK in advance were raised more than a decade ago, according to the FDA’s website.

The federal agency said it issued a letter to eye care professionals in May 2009, providing information about the promotion and advertising of FDA-approved lasers used during LASIK surgery.

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The FDA said it has since received additional complaints that eye care professionals failed to inform patients of the indications and risks and limitations associated with LASIK procedures.

“The topics discussed in the guidance document are important to the informed consent process, but they are not presented in sufficient depth and nuance,” said Dr. Stephen McLeod, CEO of the San Francisco-based American Academy of Ophthalmology, said in a statement to Fox News Digital.

"Effective informed consent" before surgery "is a process of shared information and decision-making that takes place between the doctor and the patient," said Dr.  Stephen McLeod, CEO of the American Academy of Ophthalmology, in a statement to Fox News Digital.

“Effective informed consent ‘before surgery’ is a process of shared information and decision-making that occurs between the physician and the patient,” said Dr. Stephen McLeod, CEO of the American Academy of Ophthalmology, in a statement to Fox News Digital.

“The academy believes that effective informed consent is a process of shared information and decision-making that occurs between the physician and the patient,” McLeod also said.

“A discussion of risks and benefits can sometimes seem abstract, and for it to be meaningful to an individual, [the details] they should be interpreted and discussed specifically for that person, taking into account their unique characteristics and needs,” continued McLeod.

“They take the money without telling us the risk in the future,” said one patient in Los Angeles.

“We are also concerned that there are several statements that are not well supported by the latest evidence, and some that have actually been refuted,” McLeod added.

Patients like the Los Angeles man, however, told Fox News Digital that the guidelines are necessary.

“Yes, to protect us as they take the money without telling us the risk in the future,” he said.

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The FDA published its draft guidance in July 2022.

It accepted more than 640 comments on the suggested draft guidelines from professionals, associations and individuals through November. 25, 2022.

The FDA told Fox News Digital that it “will consider the comments submitted as it prepares the final documents.”

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No set timetable has been given for when the final guidance will be issued.

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