Miracle or Nightmare?
LASIK surgery has become a common choice for people who are experiencing vision problems. We have become a world that is focused on instant gratification. LASIK surgery offers an instant improvement for some types of eye problems.
It’s estimated that almost one million people a year undergo LASIK surgery.
Is the surgery really as safe as it seems? Is this another case where more testing should have been done before release?
Every day we see examples on the television of a drug that has been recalled because it proved to be more dangerous than it appeared to be. We see advertisements for new drugs with a long list of possible side affects. We hear the horror stories of people who have experienced complications after LASIK and their eyesight is now more damaged. Make sure that you know the risks and possible side affects of LASIK surgery before you have the surgery.
Is LASIK surgery another case where it should be recalled for the protection of the general public?
Even the FDA regulators who were responsible for approving the procedure appear to be having doubts about the safety of the procedure.
The former head of the branch of the FDA responsible for checking the information about LASIK, Morris Waxler, told ABC News in an interview that he had suspicions that the side effects were not taken seriously enough.
“It’s right there in the record. The agencies and the refractive surgeons, people know these problems occur, and there doesn’t seem to be a plan to handle some of the more difficult problems that are created.”
ABC News reports that some patients who had the LASIK procedure say they are suffering from side effects including halos, starbursts, double vision, glare, and night blindness.
Some of the patients they spoke with reported that they could no longer drive or do their job because of these problems.
Some of the medical problems reported after LASIK surgery are:
- a persistent decrease in keratocytes (corneal cells): it is unknown how this decrease affects long-term viability of the cornea
- severing and destruction of the corneal nerves which stimulate tear production, potentially leading to permanent Dry Eye Syndrome
- permanent weakening of the cornea, which may lead to ectasia (corneal thinning and bulging) weeks, months, or years later, leading to vision loss
- future problems when undergoing routine glaucoma screening and cataract surgery, prompting the FDA to recommend that LASIK patients obtain a copy of their LASIK medical record
- star bursts around objects when they try to focus on them
- double vision has also been reported
There is some controversy over whether it is the procedure or the surgeon who is at fault for the problems patients have reported. In either case the problems have been severe enough to have negatively impacted the lifestyles of many people. Some have reported no longer being able to drive because of the blurred vision (star bursts) or impaired night vision.
It would not be the first time that inadequate record keeping and error reporting was connected to medical procedures. The FDA issued warnings to at least 17 surgical centers for not having adverse event-reporting systems in place and functioning.
In other words, the problems that occurred during the LASIK surgeries were not being reported or documented properly. To try and get an accurate picture of the amounts and types of problems the FDA has set up a website so that patients who have had an adverse reaction to the surgery may report them.
Waxler said that he feels the FDA should force LASIK surgeons and manufacturers to explain more fully to patients the possible side effects of the procedure.
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How large a problem is it?
Since LASIK surgery was approved in 1998, over 17 million people world wide have had this surgery. It is estimated that approximately 700,000 people will have the surgery each year.
It is becoming clear that for some people LASIK is truly a nightmare. Further research needs to be done to determine if there is a way to single out people who could have a bad reaction to the surgery. When the process was released there was no data to support who should and shouldn’t have the surgery.
Just as some people are not good candidates for skin grafts because of their skin type or race, there may be some people who just are not good candidates for LASIK surgery. However, the process, like many others was rushed into production without taking the time to establish guide lines on who might have serious side affects from it.
What steps are being taken?
The FDA (Food and Drug Administration) is joining with the National Eye Institute and the US Department of Defense to study patients who have had LASIK surgery and to determine the changes in their quality of life after the surgery. They hope that the study will help to establish predictors of risks for side affects from the surgery. The hope is that the study will improve the understanding of LASIK surgery risks and reduce the number of people who have bad side affects from it.
While this is a good plan it may not help those people who have already undergone the surgery and found that the risks were greater than represented at the time.
Even those people who have had no side affects from the surgery, may find themselves feeling a bit cheated. While they may now be able to see at a distance there is a good chance that they will need corrective lenses for close up work. So no miracle cure after all.
Our recommendation is that, if you are considering the LASIK procedure, you be sure to get all the facts about the risks you may be facing. For some people this procedure may still be worth the risk, but you should make an informed decision.