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LASIK has “potential risk of psychological harm” according to FDA

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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 he might have lingering problems 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 about 30 minutes or less.

“If all the risks were written 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 of the risks and potential complications of LASIK. While the surgery may allow some people to see clearly without glasses or contact lenses, the FDA issued draft guidance in July detailing what information patients should be provided.

Preliminary guidelines recommend that patients receive 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 risks might be. long term, including possible “long term psychological damage”.

There have been some reports of “severe depression and suicidal tendencies” after LASIK, according to the federal agency.

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

LASIK side effects can include: irreversible vision loss; debilitating visual symptoms such as glare, halos, and difficulty driving at night; severe dry eye syndrome; and results that decrease with age. Some people will still need glasses or contact lenses to correct their vision. For example, the procedure cannot correct age-related near vision loss, so reading glasses may still be needed. Others 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 blood sugar due to diabetes.

However, some people love their results and their ability to see without glasses or contact lenses (or at least they 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 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 miracle surgery” to saying “Lasik ruins lives.” After the comment period, which ended Nov. 25, the FDA plans to implement the rules, though it declined to say exactly when that might happen.

“The FDA is reviewing and considering the comments submitted as it prepares the final documents,” publicist Carly Kempler told BuzzFeed News. “We do not have a definitive timeline to share when final guidance will be issued.”

Mencos, who was diagnosed with stage 4 cancer before LASIK, making her immunocompromised and with a chronic illness, may not be considered a candidate under proposed FDA recommendations.

“I would like patients to be properly informed. I should have been told, as a cancer survivor, that I am at increased risk of permanent nerve damage, and if that was a risk, I was willing to take it,” 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 for reducing or eliminating the need for glasses or contact lenses. An estimated 10 to 15 million people have had LASIK since it was first approved in 1995, making it the most common eye surgery procedure in the US.

The technique replaced previous procedures such as radial keratotomy, and there are now other non-LASIK options and alternative laser procedures for vision correction, including photorefractive keratectomy, small-incision lens extraction, and conductive keratoplasty.

The July draft guidance is not the first time the FDA has evaluated the procedure. The FDA issued a letter in 2009 to provide physicians 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 surgery. In addition, the agency sent warning letters to 17 LASIK centers after inspections.

One ophthalmologist said he believed the FDA’s draft might not be beneficial to patients. The Doctor. Jerry Tsong, an ophthalmologist with Greenwich Ophthalmology, said the FDA’s draft guidance is unnecessary because of improvements in LASIK procedures.

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

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

Mencos said that support groups such as LASIK Complications provide 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 could 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 a little bit of hope.”

If you are considering LASIK, make sure you:

Search: The FDA provides a LASIK surgery checklist, including what makes someone a poor 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, because LASIK can be considered a cosmetic procedure, some insurance companies do not cover the costs. Before considering LASIK, compare the costs of different providers.

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

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

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

Also, certain conditions, such as uncontrolled autoimmune diseases or immunodeficiencies, or specific medications, including acne medications like isotretinoin and immune-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 it’s important for a physician to address the potential benefits and risks for each individual patient.

“Each patient is different. For patients who are very concerned about the surgery, I recommend that they consult with at least two different LASIK surgeons,” Tsong said. “That way, if the patient passes both physicians’ screening tests and is considered a ‘good candidate’ by both surgeons, it provides more confidence to proceed with the surgery.” ●