Concerns Over LASIK Prompt FDA to Consider Action

Are you thinking of throwing away the glasses and having LASIK eye surgery? In the future, the FDA may require more up-to-date or revamped materials than are offered currently to those considering the surgery. This comes as a result of several complaints from recipients of LASIK (laser-assisted in situ keratomileusis) surgery, and the FDA's decision to review the current situation.

LASIK eye surgery devices were first approved over a decade ago and LASIK surgery has become one of the most performed voluntary surgeries. The Society of Eye Surgeons feels that 95 percent of patients are satisfied with the results of the surgery. They have also stated that side effects are rare. Due to more than 140 complaints since 1998 being reported to the FDA, they are now reviewing the procedure and the information regarding the procedure that is provided to potential patients.

LASIK surgery is usually chosen as a surgical alternative to wearing eyeglasses or contact lenses. The procedure is performed by an ophthalmologist with costs an average of $2,000 per eye. LASIK is virtually painless and requires a short recovery time. It is a type of refractive laser eye surgery that involves creating a thin flap on the eye and folding it up to allow for the restructuring of the eye tissue underneath with the laser. The flap is then repositioned and the eye is left to heal.

Dr. Kerry Solomon of the Medical University of South Carolina, who led a review of LASIK's safety, stated that one in every four patients is not a good candidate for LASIK surgery. There have been a few LASIK surgery recipients whose results were not as they expected and were life changing, but Soloman states that less than 1 percent had severe side effects such as poor vision, severe dry eyes, poor night vision, and glare problems.

The Federal Food and Drug Administration believes there are 5 percent of LASIK surgery patients that are unsatisfied. Due to the complaints of some of those patients, the FDA is now reviewing the warnings in regards to the risks of the surgery and considering if they are descriptive enough. The FDA is working with a group of surgeons, in a study of hundreds of LASIK patients, to find those that had negative outcomes and exactly what those were.

Members of the FDA met with its advisors recently to discuss LASIK surgery and the warnings associated with the surgery and side effects. A panel of mostly eye doctors, still wearing glasses, recommended that the FDA update the current warnings provided to potential LASIK surgery recipients and make them clearer.

Some of the panel's recommendations to the FDA are listed below:

• Add photographs to the side effect warnings helping to illustrate what sufferers from the side effects actually see.
• Give more specific percentages in regards to those who suffer from dry eyes after the surgery.
• Doctors and warnings should be more descriptive when identifying those patients that are not potential LASIK patients and why, such as, those suffering from severe nearsightedness or have large pupils.
• Surgeons should explain more clearly, to potential patients if they are nearsighted, that after surgery they will need glasses for reading when reaching middle age. They may not require reading glasses without the surgery.

It seems that no one is considering restricting LASIK surgery, but the FDA and doctors are taking a closer look at those that were dissatisfied with their results to determine the side effects and possible causes. There have been many advances made in the LASIK procedure over the past several years and millions of patients have benefited from the surgery. The FDA seems to be taking further measures to better define parameters around the surgery as well as make advances to the warning now offered in regards to LASIK surgery.