FDA Demands Better Transparency Concerning LASIK Risks
According to an online news report published on deseret.com, the U.S. Food and Drug Administration is asking manufacturers to present a special checklist that will better inform potential LASIK patients of potential risks before they signup for the eye-correcting surgery. The checklist was prompted after the U.S. Food and Drug Administration asked for patient comments concerning its proposed guidance for individuals who are considering LASIK eye surgery, and it received responses ranging from very happy to "the surgery destroyed my life."
The U.S. Food and Drug Administration thinks that LASIK eye surgery patients need more additional information about all possible complications and risks of LASIK surgery (laser-assisted in situ keratomileusis). LASIK surgery uses a laser to change the shape of the cornea, and the treatment corrects astigmatism, nearsightedness, farsightedness, and can eliminate the need for prescription glasses.
The Food and Drug Administration recommends that manufacturers supply patients and physicians with a "patient decision checklist" before the LASIK procedure is purchased. This will make sure that patients and doctors have all the information necessary to make an educated decision.
The patient decision checklist warns patients that certain medical conditions, such as dry eyes, diabetes, and a weak immune system, might put patients at higher risk of post-surgical complications. The possible complications are serious and include double vision, permanent loss of vision, dry eye, retinal detachment, and post-operative eye pain. The draft patient decision checklist will also advise patients that they may still need prescription eyeglasses after the LASIK surgery.
The Food and Drug Administration also states that some LASIK patients can experience severe depression and even thoughts of suicide which may be a complication related to LASIK operations. This causal link has not yet been scientifically proven.
The patient decision checklist would also be optional and not legally required.
Each year, about half a million people opt for LASIK surgery to correct their poor vision. Ophthalmologists call LASIK surgery safe and serious complications are highly unusual.
According to Dr. Vance Thompson, V.P. of the American Society of Cataract and Refractive Surgery, believes the patient decision checklist is sensible, but it emphasizes the risks and potential complications of LASIK without mentioning the advantages. He also stated that the tone of the patient decision checklist is negative and could scare patients. He reports that 90% of patients in the FDA study were very happy with their LASIK surgery results.
There are some optometrists who are saying patients do not receive enough pre-op information concerning all of the potential risks prior to opting for LASIK surgery. The draft patient decision checklist would include the following statement, "LASIK may cause or worsen visual symptoms, such as glare, halos, starbursts, and ghost images/double images, most commonly experienced in dim lighting conditions as well as blurred and fluctuating vision."
The patient decision checklist also states that six months after the LASIK surgery, about 25% of patients suffer dry-eye symptoms, and 40% develop some visual issues. Moreover, after six months, around 1 in 25 LASIK patients developed some "very" or "extremely" aggravating symptoms. And 2% reported that they found it difficult or impossible to perform certain activities without their glasses or contact lenses. Although side effects usually disappear within three to six months, some are permanent.
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