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LASIK poses 'potential risk of psychological harm', FDA says

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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 she might have lingering problems from the procedure, a common eye surgery in which a The laser is used to shape the inner cornea to correct vision problems. The procedure costs approximately $1,500 to $2,500 per eye and usually takes about 30 minutes or less.

“If all the risks were written down on a checklist, I promise you I wouldn’t have had LASIK,” Mencos told BuzzFeed News. “The only things on my consent form were temporary side effects.”

People like Mencos are the reason the FDA is trying to raise awareness potential risks and complications of LASIK. Although surgery may allow some people to see clearly without glasses or contact lenses, the FDA released draft guidelines in July detailing what information to provide to patients.

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

According to the federal agency, there have been reports of “severe depression and suicidality” after LASIK.

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

Side effects of LASIK can include: irreversible vision loss; debilitating visual symptoms, such as glare, halos and difficulty driving at night; 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 cannot correct age-related loss of near vision, so reading glasses may still be needed. Other blood may not be good candidates for LASIK in the first place – for example, those with severe dry eyes, a thin cornea, active infection or inflammation, or uncontrolled sugar due to diabetes.

However, some people like 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 recovery from LASIK can be “relatively quick”, with 9 out of 10 people achieving it. 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 the call to LASIK”a miraculous operation“say”Lasik ruins lives.” After the comment period, which ended in November. On Jan. 25, the FDA plans to implement the rules, though it declined to say exactly when that might happen.

“FDA is reviewing and considering these submitted comments as it prepares final documents,” press secretary Carly Kempler told BuzzFeed News. “We don’t have a definitive timeline to share on when the final guidelines will be released.”

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

“I want patients to be properly informed. I should have been told, as a cancer survivor, that I was at a higher risk of permanent nerve damage, and if it was a risk, I was willing to take it,” Mencos said. ‘have not informed of this.”

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

It’s been over 25 years since the FDA declared LASIK a safe option to reduce or eliminate the need for glasses or contact lenses. Around 10 to 15 million people have had LASIK Since its first approval in 1995, making it the most commmon eye surgery in the United States.

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

The July draft guidance isn’t the first time the FDA has looked at the procedure. The FDA Published a letter in 2009 to provide physicians with information about LASIK advertisements and promotions. He issued a second letter in 2011 to compensate for the lack of information on the risks and complications of eye surgery. In addition, the agency sent warning letters to 17 LASIK centers after control.

An ophthalmologist said he thinks the FDA project may not benefit patients. Dr. Jerry Tsong, retinal ophthalmologist at Greenwich Ophthalmology, said the FDA’s draft guidelines are an unnecessary improvement to LASIK procedures.

This draft also omitted the fact that laser technology has improved dramatically since LASIK was first approved in 1999. Thus, the risk of certain visual symptoms such as glare, halos or difficulty in driving at night is much lower than in the past,” Tsong said. He also said the FDA should have used more recent medical data and research.

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

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

“When my complications 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 can 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 some hope.

If you are considering LASIK, be sure to:

do some researchThe FDA provides a Checklist for LASIK surgery, including what makes someone a bad candidate for surgery, the risks and limitations of the procedure, the best ways to find the right doctor, and what to expect. The FDA’s YouTube page posted a video describing the risks of LASIK. Other videos Provide a step-by-step visual of the procedure to ensure patients understand the surgery.

Also, since LASIK can be considered a cosmetic procedure, some insurance companies won’t cover the costs. Before considering LASIK, compare the costs of different providers.

Know your medical history and get testedWhen you are considering LASIK, your healthcare provider will likely perform vision tests and comprehensive eye exams. They may also perform other tests, such as a fundus exam, which doctors use to assess the retina and optic nerve.

Since LASIK surgery can cause or worsen dry eye disease, patients should also have a dry eye examthe FDA said.

Another recommended exam checks the pressure inside the eye. High intraocular pressure can be a sign of glaucomaanother contraindication to LASIK.

In addition, certain conditionssuch as autoimmune diseases or uncontrolled immunodeficiencies, or specific medications, including acne medications like isotretinoin and immune-suppressing steroids, can slow the healing process and render a person unfit for LASIK.

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

Every patient is different. For patients who are very worried about surgery, I recommend that they see at least two different LASIK surgeons,” Tsong said. “That way, if the patient passes the screening tests from both doctors and is considered a ‘good candidate’ by both surgeons, that provides more reassurance to go ahead with the surgery.” ●

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