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

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

After undergoing LASIK in February 2021, Alexis Mencos began experiencing complications, including excruciating eye pain, dry eyes, and infections that continued for a year.

Mencos, 28, had no idea she might have long-term 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 approx $1,500 to $2,500 per eye and usually takes about 30 minutes or less.

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

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

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

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

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

Side effects of LASIK may include: irreversible vision loss; debilitating visual symptoms, such as glare, halos, and difficulty driving at night; severe dry eye syndrome; and scores 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 necessary. Others may not be good candidates for LASIK at all—for example, those with extremely dry eyes, a thin cornea, active infection or inflammation, or uncontrolled blood 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, in the range of the name LASIK “miraculous operation“say”Lasik destroys lives.” After a comment period that ended Nov. 25, the FDA plans to implement the rules, though they declined to say exactly when that might happen.

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

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

“I would like patients to be well informed. “I should have been told, as a cancer survivor, that I was at greater risk of permanent nerve damage, and if that was a risk I was willing to take,” Mencos said. “They didn’t inform me about it.”

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

It has been more than 25 years since the FDA declared LASIK a safe option to reduce or eliminate the need for glasses or contact lenses. Estimated 10 to 15 million people have undergone LASIK since it was first approved in 1995, making it the most usual ophthalmic surgery in the USA.

The technique has replaced earlier procedures such as radial keratotomyand currently there are other options other than LASIK and alternative laser procedures for vision correction, including photorefractive keratectomy, small-incision lens extraction, and conductive keratoplasty.

July’s draft guidance isn’t the first time the FDA has gotten involved in the process. FDA issued letter in 2009 to provide physicians with information about LASIK advertisements and promotions. She issued a second letter 2011 to address the lack of information about the risks and complications of eye surgery. In addition, the agency sent warning letters 17 LASIK centers after inspections.

One ophthalmologist said he believes the FDA’s draft may not benefit patients. dr. Jerry Tsong, a retinal eye doctor at Greenwich Ophthalmology, said the FDA’s draft guidance is unnecessary given the improvements in LASIK procedures.

“This draft also left out the fact that laser technology has improved dramatically since LASIK was first approved in 1999. So the risk of certain visual symptoms such as glare, halos or difficulty driving at night is much less than in the past,” said Tsong. 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 Complications of LASIKoffer 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 live,” Mencos said. “I was, like, There’s no way I could live like this. I was in pain, I couldn’t work, and it wasn’t until I found my current doctor who confirmed my experience that I had some hope.”

If you are considering LASIK, make sure you:

Do some research: FDA provides a LASIK surgery checklist, 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 YouTube page posted a video describing LASIK risks. the rest videos provide a step-by-step visual representation of the procedure so that patients understand the operation.

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

Find out your health history and get tested: When considering LASIK, your doctor will likely perform visual examination and complete eye examination. They may also perform other tests, such as fundoscopy, which doctors use to evaluate the retina and optic nerve.

Because LASIK surgery can cause or worsen dry eyes, patients should also have dry eye examinationthe FDA said.

Another recommended exam checks the pressure in the eye. High intraocular pressure can be a sign glaucomaanother contraindication for LASIK.

Additionally, under certain conditionssuch as uncontrolled autoimmune diseases or immunodeficiencies, or specific medications, including acne medications like isotretinoin and steroids that suppress the immune system, can slow the healing process and make someone unsuitable for LASIK.

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

“Every patient is different. For patients who are very concerned about surgery, I recommend consulting with at least two different LASIK surgeons,” Tsong said. “That way, if the patient passes both doctors’ tests and is considered a ‘good candidate’ by both surgeons, it gives extra confidence to proceed with surgery.” ●

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