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 laser is used to shape the inner cornea to correct vision problems. The procedure costs around $1,500 to $2,500 per eye and usually takes around 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 tries to educate the public about the 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.
Draft guidelines recommend patients receive a decision 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 a study of suicide and refractive laser surgery suggested that psychiatric complications such as psychosis, depression and suicidal thoughts could 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. 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 levels 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 in 10 people achieving between 20/20 and 20/40 vision 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, 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. “They didn’t inform me of that.”
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. 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 United States.
The technique has replaced earlier procedures such as 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.
The July draft guidance isn’t the first time the FDA has looked at the procedure. The FDA issued a letter in 2009 to provide physicians with information about LASIK advertisements and promotions. He published a second letter in 2011 to address the lack of information about the risks and complications of eye surgeries. Additionally, the agency sent warning letters to 17 LASIK centers after the inspections.
An ophthalmologist said he thinks the FDA project may not benefit patients. Dr. Jerry Tsong, a retinal ophthalmologist at Greenwich Ophthalmology, said the FDA’s draft guidelines were unnecessary given improvements in LASIK procedures.
“This project 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 to drive 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 LASIK Complications, provide a space for individuals to share their experiences and find more information about post-surgery 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 research: The FDA provides a LASIK surgery checklist, including what makes a person a bad candidate for surgery, the risks and limitations of the procedure, the best ways to find the right doctor, and what to expect. ‘expect. The FDA’s YouTube page posted a video outlining 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 tested: When you are considering LASIK, your health care 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.
Because LASIK surgery can cause or worsen dry eye disease, 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 to LASIK.
Also, certain conditions, such 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 unsuitable 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.” ●