FDA Wants Doctors To Better Inform Patients Of Possible LASIK Complications, Including “Psychological Harm”

The FDA wants doctors to use a decision checklist and better inform patients of potential risks and complications, as well as what to expect before, during, and after LASIK.

After undergoing LASIK in February 2021, Alexis Mencos began experiencing complications, including excruciating eye pain, dry eyes, and infections that occurred throughout the year.

Mencos, 28, had no idea that she might have lingering issues from the procedure, a common eye surgery in which a laser is used to shape the inner cornea to correct vision problems. The procedure costs about $1,500 to $2,500 per eye and typically takes around 30 minutes or less.

“If all the risks were written on a checklist, I promise you I would not have gotten LASIK,” Mencos told BuzzFeed News. “The only things on my consent form were temporary side effects.”

People like Mencos are the reason why the FDA is trying to increase awareness of potential risks and complications of LASIK. Although the surgery may allow some people to see clearly without glasses or contact lenses, the FDA issued a draft guidance in July detailing what information should be given to patients.

The draft guidelines recommend patients be given a decision checklist that clarifies the pros and cons of LASIK, including which people are good candidates for the procedure, based on testing and other health conditions, and what the long-term risks might be, including possible “long-term psychological harm.”

There have been some reports of “severe depression and suicidality” following LASIK, according to the federal agency.

Although a causal link between LASIK and psychological harm has not been established, the FDA said a study on suicide and laser refractive surgery suggested that psychiatric complications such as psychosis, depression, and suicidal ideation can occur, although very rare (less than 1%).

LASIK side effects can include: an irreversible loss of vision; debilitating visual symptoms, like glares, halos, and difficulty with night driving; severe dry eye syndrome; and results that diminish with age. Some people will still need glasses or contact lenses to correct their vision. For example, the procedure can’t correct age-related loss of near vision, so reading glasses may still be necessary. Others may not be good candidates for LASIK in the first place — for example, those with severe dry eyes, a thin cornea, an active infection or inflammation, or uncontrolled blood sugar due to diabetes.

However, some people love their results and their ability to see without glasses or contact lenses (or at least wear them less often than before surgery). The American Academy of Ophthalmology said LASIK recovery can be “relatively quick” and that 9 out of 10 people achieve vision between 20/20 and 20/40 without glasses or contact lenses.

To date, the FDA has received 693 comments on the document, ranging from calling LASIK “a miraculous surgery” to saying “Lasik ruins lives.” After the comment period, which ended Nov. 25, the FDA plans to implement the rules, although it declined to say exactly when that might happen.

”The FDA is in process of reviewing and considering these submitted comments while preparing the final documents,” press officer Carly Kempler told BuzzFeed News. “We do not have a definitive timeline to share on when the final guidance will be issued.”

Mencos, who was diagnosed with stage 4 cancer before LASIK, making her immunocompromised and chronically ill, might not be considered a candidate according to the FDA’s proposed recommendations.

“I wish that patients were informed properly. I should have been told, as a cancer survivor, that I’m at higher risk for permanent nerve damage, and if that was a risk I was willing to take,” Mencos said. “They didn’t inform me of that.”

The guide was created to “enhance, not replace, the physician-patient discussion,” according to the FDA.

It’s been more than 25 years since the FDA declared LASIK a safe option to reduce, or eliminate, the need for glasses or contact lenses. An estimated 10 to 15 million people have undergone LASIK since it was first approved in 1995, making it the most common ophthalmologic surgical procedure in the US.

The technique replaced earlier procedures like radial keratotomy, and there are currently other non-LASIK options and alternative laser procedures for vision correction, including photorefractive keratectomy, small incision lenticule extraction, and conductive keratoplasty.

July’s guidance draft isn’t the first time the FDA has weighed in on the procedure. The FDA issued a letter in 2009 to provide doctors with information about LASIK advertisements and promotions. It issued a second letter in 2011 to address the lack of information about the risks and complications of eye surgeries. Additionally, the agency has sent warning letters to 17 LASIK centers after inspections.

One ophthalmologist said he believes that the FDA draft may not be beneficial for patients. Dr. Jerry Tsong, a retina eye doctor at Greenwich Ophthalmology, said the FDA draft guidance is unnecessary given improvements in LASIK procedures.

“This draft also left out the fact that laser technology has improved dramatically since LASIK was first approved in1999. So the risk of certain visual symptoms such as glare, halos, or difficulty with night driving is much lower than in the past,” Tsong said. He also said the FDA should have used more recent data and medical research.

“I think this is a missed opportunity to provide updated information to patients,” Tsong added.

Mencos said support groups, such as LASIK Complications, offer a space for individuals to share their experiences and find more information about post-surgery symptoms.

“When my complications first started, and before I found a support group, I honestly didn’t know if I was going to be able to live,” Mencos said. “I was like, There’s no way I could live my life like this. I was in pain, I couldn’t work, and it wasn’t until I found my current doctor who validated my experience that I had a little bit of hope.”

If you’re considering LASIK, make sure to:

Do some research: The FDA provides a LASIK surgery checklist, including what makes someone a poor candidate for the surgery, the risks and procedure limitations, the best ways to find the right doctor, and what to expect. The FDA YouTube page published a video describing LASIK risks. Other videos provide a step-by-step visual of the procedure to ensure patients understand the surgery.

Additionally, since LASIK can be considered a cosmetic procedure, some insurance companies will not cover the costs. Before considering LASIK, compare costs from different providers.

Know your health history and get tested: When considering LASIK, your healthcare provider will likely conduct visual testing and full eye examinations. They may also perform other tests, such as a fundoscopic exam, which doctors use to assess the retina and optic nerve.

Since LASIK surgery can cause or worsen dry eyes, patients should also have a dry eye exam, the FDA said.

Another recommended exam checks the pressure inside the eye. High intraocular pressure can be a sign of glaucoma, another contraindication for LASIK.

Additionally, certain conditions, such as uncontrolled autoimmune diseases or immunodeficiencies, or specific medications, including acne drugs like isotretinoin and immune-system suppressing steroids, can slow down the healing process and make someone unsuitable for LASIK.

Ask your doctor about your own personal risks and benefits: Tsong said that it’s important for a doctor to address both potential benefits and risks for each individual patient.

“Every patient is different. For patients that are very worried about surgery, I recommend that they get consultations with at least two different LASIK surgeons,” Tsong said. “That way, if the patient passes both doctors' screening tests and is considered a ‘good candidate’ by both surgeons, this provides added reassurance to move forward with surgery.” ●

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