11/20/2019
Recently, CBS News has run stories regarding the safety of LASIK surgery, featuring a former FDA Investigator who now says he thinks the procedure should never have been approved. Here are some thoughts from Mark Mandel, M.D., the refractive surgeon we have used for all of our refractive surgeries since we started in 1996.
From Dr. Mark Mandel:
Over the last week, many of us ( and our patients) have been watching CBS news, social media, and other news outlets regarding the dangers of LASIK and how Morris Wexler a former FDA advisor recommends that LASIK be removed from the market.
His point is that he believes that the complication rate for LASIK is between 10 and 30%!
This is a ridiculously and outrageously misleading number.
I have been doing LASIK since it was approved in 1996 and PRK for a year longer. To date, I have performed approximately 70,000 cases. My complication rate is exceptionally low. Although it is difficult to calculate exactly because I have so few complications, my estimate is it is well below .5% in my hands.
How can there be such a discrepancy?
Wexler and others clearly have an ax to grind. In order to come up with the complication rate of 10 to 30%, they manipulate older data using the results from first generation, non-wavefront/outdated lasers used by doctors who had not yet developed experience. Additionally, they exaggerate and catastrophize the newer data from more recent studies. Naturally the complication rate will be higher in those cases.
However, there are some salient points in what they are saying. Most importantly, if patients choose the wrong surgeon, the complication rate absolutely will be higher. As an experienced LASIK surgeon and cornea consultant, I have been referred many cases of complications from inexperienced or unscrupulously aggressive surgeons. Unfortunately, there are surgeons in the community who do not have the experience, and/or the patient's best interest in mind.
For example, it is critically important that the surgeon and referring optometrist be fastidious about treating even a mild dry eye preoperatively and not operate on the eye until the dryness has resolved. This will help ensure that a post-operative dry eye will not ensue. Additionally, Pentacam scans, not just surface topography, must be performed and guidelines adhered to with respect to not performing LASIK on patients at risk for developing post-LASIK ectasia. Although nothing is 100% safe, femtosecond lasers are much safer than the use of microkeratomes and should be the preferred method for flap creation. Wavefront-optimized, wavefront-guided or topographic-guided LASIK should be performed... conventional LASIK should no longer be employed. This all but eliminates glare, halos and starburst effects. If corneas are too thin, PRK or ICLs rather than LASIK should be selected. Preoperative preparation of the eye including eyelid scrubs, antibiotics, and vigorous adherence to sterile technique should be observed.
As many of you know, I will postpone a LASIK if a patient has any staining on the laser day and may treat this dry eye for many months before proceeding. In some instances, for safety/accuracy, I will reject a patient for LASIK or redirect them to a procedure more appropriate for them such as PRK, ICL or CLE. Safety first!
If patients are selected and treated properly pre-operatively and during the operation ... post-operative complications are exceedingly low.
