LASIK Eye Surgery Defined

Laser-Assisted in Situ Keratomileusis or LASIK is a surgical method that can lower the dependence of an individual to eye glasses or contact lenses. The method will permanently alter the form of the cornea, the fragile part of the eyes that cover the front of the eyes. The cornea and lens of the eyes must bend or refract properly to have the images focused on the retina and have a clear vision. If the light rays are not properly and clearly focused, it can cause blurry or hazy eyesight.

The LASIK eye procedure is usually done on individuals who are nearsighted, an eye condition called as myopia. LASIK is an outpatient surgical method that takes for about 10 to 15 minutes for every eye.

How FDA Regulates LASIK

The US Food and Drug Administration control the sale of the medical equipment and devices such as the lasers being used for the LASIK eye surgery. The individual or company must obtain the approval of the US FDA before they can legally sell a medical equipment or device in the US. The applicant must submit evidence that the device is safe and effective for a specific use or the “indication.” Then, the surgeon may decide to apply medical equipment or device which is granted approval by the US FDA for other indications for the best interest of the patient. But the FDA cannot regular the use of “off-label use” or the practice of medicine. Hence, US FDA cannot

• Control a doctor’s practice, which means that the US FDA cannot tell the doctors on what to do when operating their business or what they can or cannot inform their patients
• Demand that the patient information brochure from the laser manufacturer should be given to the potential patient
• Regulate the price that a surgeon can charge the patient for the LASIK eye surgery
• Perform or give a rating system on any medical device that it regulates
• Recommend for specific doctors, clinics, or eye centers since the US FDA does not maintain nor have access to lists of doctors doing the LASIK eye surgery

Who Must Not Use LASIK Eye Surgery?

You may not be a good patient for the LASIK procedure if:

• You are scared of taking risks because there are some complications that cannot be avoided and there is no long-term information and data that are available for the existing procedure.
• The cost of the procedure is of major concern because most of the medical insurance excludes some refractive procedures, so be sure that you check with your employer before undergoing any procedure.
• It will compromise your work or career because there are some jobs that do not support some refractive methods, so be sure to check this with your employer before undergoing any method.
• You needed a change in your contact lenses or glass prescription over the previous year due to refractive instability.
• The patients who are inclined to have refractive instability including patients who:
  • Have hormones that fluctuate due to some illnesses like diabetes
  • Are pregnant or breastfeeding their babies
  • Are in their early 20’s or below
  • Are taking some medications that may result to fluctuations in eyesight
• Have an illness or are on medications that may affect the healing of the wounds:
  • Autoimmune illnesses such as rheumatoid, arthritis, and lupus
  • Immunodeficiency conditions such as HIV
  • Diabetes
  • Other medications such as steroid and retinoic acid
• Are engaged in contact sports where blows to the face and eyes are inevitable occurrence such as wrestling, martial arts, and boxing.
• Are below 18 years old; FDA has not approved of any laser for LASIK procedure.

Your healthcare provider should examine the following conditions or indicators of the potential risks before the LASIK procedure:

• Inflammation of the eyelids with crusting of the eyelashes or an eye condition known as blepharitis
• Thin corneas
• Big pupils
• Dry eyes
• History of refractive surgery including LASIK, RK, or PRK

What should I tell my healthcare provider?

Before undergoing LASIK procedure, inform your healthcare provider if you have some history of any of the following conditions:

• Glaucoma, glaucoma suspect, ocular hypertension
• Herpes simplex, herpes zoster or shingles around the areas of the eyes
• Eye illnesses like uveits/iritis or inflammation of the eyes
• Keratoconus

Health Risks from LASIK

Most of the patients are satisfied with the results of the LASIK and other refractive surgery, but there are still health risks that are involved. The following are some of the risks that should be thoroughly considered against the benefits of the LASIK eye surgery:

• Some patients have developed symptoms of incapacitating vision such as haloes, double vision, and/or glare that can severely affective the vision at nighttime.
• Some patients experienced loss of vision lines.
• Some patients developed serious dry eye syndrome where the eyes are unable to produce adequate tears to make the eyes moist, and this condition may cause discomfort and lower visual quality.
• May be under-treated or over-treated which means that you may still need to use eye glasses or contact lenses after the procedure.
• Some patients who are farsighted who underwent the procedure, the results may disappear with age.
• Desired results are usually not as good as with the patients with big refractive mistakes of any kind.
• The long-term data and information is not yet available because the technology is still new, which means that the safety and effectiveness of the LASIK method is still not known.

Obtaining Legal Assistance

Since the application and use of equipment and devices for the surgical methods have their particular potential risks, it is the obligation of the manufacturer to produce products that are safe and inform the medical community and the general public of its known risks related to their products. If the manufacturer was unable to do these, then they will be held liable if the patients who are injured of inadequate warning or the hazardous nature of the products, under the legal theory which is called as “product liability.”

If you or any of your family members have suffered any health effects or rare medical conditions after undergoing the LASIK or other refractive procedures, you should contact first your doctor or healthcare provider. Then, you may look for an experienced lawyer to discuss with you options and safeguard your legal rights for treatment of any injury caused by the LASIK eye surgery.