FDA Warns of Potential Side Effects Associated With LASIK Surgery
A recent FDA draft recommends that patients be better warned of potential complications ahead of undergoing LASIK surgery.
LASIK is an elective procedure that corrects people’s vision, allowing them to have better sight without the use of corrective lenses.
Experts explain what the surgery is and what patients should know before undergoing the procedure.
Even the surgeries with the highest success rates come with risk—and you should always know what you’re getting into before agreeing to any medical or surgical procedure. Now some patients who have suffered long-term complications from LASIK surgery are bringing these potential side effects to light.
Due to patients calling for a clear explanation of complications before undergoing the procedure, a recent FDA draft is recommending that patients be better warned of potential side effects and long-term complications that result from LASIK surgery. These warnings, suggested by the FDA, would include information on the risks of double vision, dry eyes, ongoing pain, and other issues that may result from the procedure. Patients would also be advised that they may still need glasses even after the surgery.
If you’re tired of using eyeglasses or contact lenses and are considering getting LASIK, here is everything you need to know.
What is LASIK surgery?
LASIK is a surgery that is used to correct refractive errors, such as far-sightedness, near-sightedness, and astigmatism, so that people can be less dependent on glasses and contact lenses to get the best vision, says Benjamin Bert, M.D., ophthalmologist and LASIK surgeon at MemorialCare Orange Coast Medical Center in Fountain Valley, CA.
“The actual surgery itself uses two separate lasers,” he explains. “The first laser cuts a flap in the cornea at the front of the eye, that flap is then lifted and the second laser is used to treat the cornea underneath the flap in order to actually change the shape of the lens.” He adds that the flap is then, “positioned back and the body heals around the edge of the flap, which gives you pretty fast recovery of vision after the surgery.”
What kind of patients typically decide to undergo LASIK surgery?
Most of the time, “The patients who are considering LASIK surgery are people who are either having difficulty using glasses or contact lenses or simply are tired of the hassle of using corrective lenses and want to have the best uncorrected visual acuity possible,” says Dr. Bert. He adds that usually, the people who are interested in the surgery are between the ages 20 and 40.
What are the potential complications of LASIK surgery?
Just like any surgery, it’s important to discuss both the benefits as well as the potential side effects or complications that can happen. While it’s a pretty straightforward surgery and it’s highly successful, there is still a small percentage of patients that have complications or long-term troubles after LASIK, says Dr. Bert. “These may include inflammatory conditions, infections, shifting of the flap… many which are treatable, some of which can have long-term consequences.”
A lot of what has progressed with this surgery over time is the way that patients are screened as candidates for LASIK, says Dr. Bert. “The key is trying to screen out anyone who has anything that could become a potential problem after the surgery, and our diagnostic equipment has become much more advanced in being able to rule out some of the most devastating complications from LASIK.”
In rare cases, some patients can develop chronic dry eye or neuropathic corneal pain. “When you create the flap, you are cutting nerves in the cornea, which has the highest density of nerve endings of any tissue in the body,” explains Dr. Bert. This type of injury to the nerves is why some patients may rarely develop neuropathic corneal pain. He says that although these complications are highly unusual, they still need to be discussed before surgery.
Are there comparable alternatives to LASIK for patients who might have concerns over the surgery?
Photorefractive keratectomy, or PRK, is an alternative to LASIK, says Dr. Bert. “[PRK] basically uses the second laser that is used in LASIK to reshape the cornea, but it’s done without creating a flap, so while there is some trauma to the cornea, it’s less overall trauma than what LASIK creates.”
Small incision lenticule extraction, or S.M.I.L.E., is another alternative laser procedure where a laser is used to cut a small amount of the corneal tissue deeper in the cornea, which is removed in a very small incision, says Dr. Bert. “So again, there’s less trauma overall to the corneal nerves, which reduces the possibility of dry eye or the extreme neuropathic corneal pain.”
Other, more invasive options carry their own set of risks. I.C.L. (implantable contact lens) is a surgery inside the eye where an additional lens is inserted into the eye itself in order to correct someone’s prescription, explains Dr. Bert, “But those are more limited to what prescriptions they can correct.”
The bottom line
“LASIK has been around now for multiple decades and it has a very good success rate but nothing is 100%,” says Dr. Bert. Therefore, it’s important to know and weigh the risks and benefits before proceeding with any surgical procedure.
The most important thing is for people to educate themselves on what they’re getting into, says Dr. Bert. “I usually have multiple pre-operative visits to take patients’ questions [before agreeing to perform the surgery].”
After all, LASIK is a completely elective procedure where we are operating on normal, healthy eyes that simply need either glasses or contact lenses to have the best vision, says Dr. Bert. “So people deserve to know exactly what they’re getting into.”
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