LASIK Eye Surgery
What is LASIK Eye Surgery?
LASIK (Laser-Assisted In Situ Keratomileusis) is a surgical procedure that can reduce a person's dependency on glasses or contact lenses. The procedure permanently changes the shape of the cornea, which is the delicate clear covering on the front of the eye. In order to have clear vision, the eye's cornea and lens must bend (refract) light rays properly, so that images are focused on the retina. If light rays are not clearly focused, blurry vision can result.
LASIK eye surgery is performed most often on people who have nearsightedness (myopia). LASIK is an outpatient surgical procedure that normally takes 10 to 15 minutes for each eye.
How the FDA Regulates LASIK
In the United States, the U.S. Food and Drug Administration (FDA) regulates the sale of medical devices, including lasers used for LASIK. A person or company must seek FDA approval before legally selling a medical device in the U.S. In order to gain approval, the applicant must present evidence that the device is reasonably safe and effective for a particular use (the "indication"). Afterward, a doctor may decide to use an approved medical device for other indications if in the best interest of the patient. However, the FDA does not regulate such use ("off-label use") or the practice of medicine.
Therefore, the FDA does not have the authority to:
- Regulate a doctor's practice - the FDA does not tell doctors what to do when running their business or what they can or cannot tell their patients.
- Set the amount a doctor can charge for LASIK eye surgery.
- "Insist" that the patient information booklet from the laser manufacturer be provided to the potential patient.
- Make recommendations for individual doctors, clinics, or eye centers - the FDA neither maintains nor has access to a list of doctors performing LASIK eye surgery.
- Conduct or provide a rating system on any medical device it regulates.
Who Should Not Use LASIK?
You are probably not a good candidate for LASIK eye surgery if:
- You are not a risk taker - certain complications are unavoidable, and there is no long-term data available for current procedures.
- It will jeopardize your career - some jobs prohibit certain refractive procedures. Be sure to check with your employer before undergoing any procedures.
- Cost is an issue - most medical insurance will not pay for refractive surgery. Although the costs have been decreasing, they are still significant.
- You required a change in your contact lens or glass prescription in the past year (refractive instability). Patients who are more likely to have refractive instability include patients:
- In their early 20s or younger
- Whose hormones are fluctuating due to disease such as diabetes
- Who are pregnant or breastfeeding
- Who are taking medications that may cause fluctuations in vision.
- You have a disease or are on medications that may affect wound healing. Autoimmune diseases (e.g., lupus, rheumatoid arthritis), immunodeficiency states (e.g., HIV), and diabetes, as well as some medications (e.g., retinoic acid and steroid) may prevent proper healing after LASIK eye surgery
- You actively participate in contact sports in which blows to the face and eyes are a normal occurrence (e.g., boxing, wrestling, martial arts).
- You are not an adult - no lasers are approved for LASIK on persons under the age of 18.
Your healthcare professional should screen for the following conditions or indicators of risk before undergoing LASIK eye surgery:
- Blepharitis (inflammation of the eyelids with crusting of the eyelashes)
- Large pupils
- Thin corneas
- Previous refractive surgery, such as LASIK, RK, or PRK
- Dry eyes
What Should I Tell My Healthcare Professional?
Before undergoing LASIK eye surgery, tell your healthcare professional if you have a history of any of the following:
- Herpes simplex or herpes zoster (shingles) involving the eye area
- Glaucoma, glaucoma suspect, or ocular hypertension
- Eye diseases, such as uveits/iritis (inflammations of the eye)
- Eye injuries or previous eye surgeries
LASIK Health Risks
While most patients are pleased with the results of LASIK or other refractive surgery, there are risks involved. The following are some of the risks that should be carefully weighed against the benefits of undergoing LASIK:
- Some patients lose lines of vision.
- Some patients develop debilitating visual symptoms such as glare, haloes, and/or double vision that can seriously affect nighttime vision.
- You may be under-treated or over-treated - you may still need glasses or contact lenses after surgery
- Some patients may develop severe dry eye syndrome - when the eye is not able to produce enough tears to keep the eye moist, it may cause discomfort and reduce visual quality.
- Results are generally not as good in patients with very large refractive errors of any type.
- For some farsighted patients, results may diminish with age.
- Long-term data is not available, since LASIK is a relatively new technology - the long-term safety and effectiveness of LASIK surgery is still unknown.
LASIK - Getting Legal Help
While the use of instruments for surgical procedures have certain anticipated risks, a manufacturer has a duty to make its products and instruments as reasonably safe as possible, and to inform the medical community and the public of known risks associated with its products. If a manufacturer fails to do so, it can be held legally responsible if patients are injured as the result of inadequate warnings or the unreasonably dangerous nature of the product, under a legal theory called "product liability."
If you or a loved one have experienced any dangerous health effects or unusual medical conditions after undergoing LASIK or other refractive surgery, you should first contact your doctor or other healthcare professional. You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by a LASIK procedure.