Archive for November, 2007

This information only pertains to doctors in the United States. Other countries have their own regulations and laws. In the US, some oversight of LASIK eye surgery falls under the jurisdiction of the Food and Drug Administration. Some aspects are overseen by each state’s medical licensing board.

The FDA does not control what doctors do in their practice, nor what they tell their patients. They don’t set fair prices, nor do they require that the doctors fully inform their patients of all the aspects or possible outcomes of LASIK eye surgery. They don’t recommend doctors, nor do they maintain a list of doctors who are qualified to do LASIK.

What the FDA does, in regards to LASIK eye surgery, is to regulate the sale of lasers used for LASIK, as well as regulate the sale of all other medical devices. Approval must be applied for, and granted before a medical device can be sold in the US. Evidence must be provided demonstrating “that the device is reasonably safe and effective for a particular use.” (From the FDA’s website at www.fda.gov/cdrh/lasik)

Now, even though a device has only been approved for one particular use by the FDA, once it has that approval, and it is in the hands of the doctor, that doctor can use that equipment for other purposes. All the doctor has to do is deem that it is in the best interests of the patient to do so.

This is called “off-label” use and is not regulated by the FDA. You can check the FDA’s website to see which lasers are approved for which indications and treatment ranges. If you don’t see your LASIK doctor’s brand and model of laser on that site, please ask why.

The United States Medical Licensing Examination (USMLE) is one of the exams required for licensing by a state medical board. You can see more information at www.usmle.org

Some states may have regulations regarding LASIK surgery and ethical practices. To learn more, check with the governer’s office or your state medical examining board. You can find a link to your state’s medical board at www.fsmb.org.

The medical profession polices itself, as well. Certifications to practice a particular specialty is issued, usually after testing, by one of these organizations. They can also withdraw that certification if your physician does not adhere to policies or keep up to date on new practices. Peer pressure at its finest. For ophthalmology (and therefore LASIK surgeons), turn to the American Board of
Ophthalmology atwww.abop.org.

Physicians take the Hippocratic Oath. A part of that oath reads: “I will prescribe regimen for the good of my patients according to my ability and my judgment and never do harm to anyone.” Your surgeon should test you thoroughly to make sure you are a qualified candidate for LASIK and fully inform you of any possible outcomes, either good or bad.

There may not be much direct oversight of your LASIK surgeon. However, they have graduated from a strenuous medical school, passed state licensing examinations and achieved certifications from professional organizations. You can also check with the county courthouse in the county where your surgeon practices to see if he or she has been sued for malpractice.