Medical Research Scientist Calls For Moratorium on LASIK at FDA Hearing

July 2nd, 2008



Gaithersburg, MD
April 25, 2008 

FDA HEARING PRESENTATION OF LAURANELL H. BURCH

I appreciate the opportunity to speak at this FDA hearing on post-market LASIK issues. My name is Lauranell Burch. I have a Ph.D. in Molecular Biology and Genetics and have been a medical researcher for over 20 years. I am trained to design, conduct, and review medical research studies.

We are all aware of recent media attempts by the LASIK industry to reframe the discussion of these hearings around post-LASIK satisfaction and quality of life issues. The public should be made aware that the proposed task force to examine post-LASIK quality of life issues is dominated by individuals who have conflicts of interest. One of these individuals, Dr. Kerry Solomon, was quoted this week by ABC news regarding this meeting saying: “This is not about safety and effectiveness of LASIK surgery at all,”… If there were no serious concerns about the safety and effectiveness of LASIK - we wouldn’t be here today. What is most important for us all to consider now is the growing body of evidence accumulating in peer-reviewed Ophthalmology journals that indicate that LASIK is a harmful procedure.

Despite claims made by surgeons and the industry about ‘patient satisfaction’, today’s happy 20/20 LASIK patients are often today’s dangerous drivers on our highways at night due to LASIK-induced loss of contrast sensitivity, and may ultimately experience debilitating late-onset complications of LASIK.

Patients who report that they are currently happy with the LASIK procedure likely have no idea of the nature and extent of damage they incurred during the LASIK procedure and the consequences of this damage for their future ocular health and vision. I believe that no patient would want this surgery if they fully understood its consequences.

Here is a short list of permanent adverse effects of LASIK eye surgery:

1. The flap never heals – it just seals a bit around the edges like a Tupperware lid leaving patients who have had LASIK susceptible to traumatic flap injury for life.
2. LASIK separates the stronger anterior cornea, leaving only the weaker posterior cornea to support the intraocular pressure of the eye. This can lead to corneal ectasia and corneal failure months or years after surgery.
3. LASIK causes permanent pathological changes in all corneas. According to an Emory University study that examined post-mortem LASIK corneas, “A spectrum of abnormal histopathologic and ultrastructural findings was present in all corneas.” Some examples include deranged and disorded collagen fibers, granules under the flap, and epithelial ingrowth under the flap.
4. There is no evidence that corneal nerves ever fully regenerate to their normal patterns and density after LASIK.
5. LASIK complicates future cataract surgery.
6. LASIK invalidates intraocular pressure measurement, which is critical in the diagnosis of glaucoma.
7. Perhaps the gravest of all adverse effects of LASIK was reported recently by Mayo clinic researchers in a study which indicates that patients undergoing laser corneal refractive surgeries lose keratocyte (or corneal stromal cell) density at higher rates even years after surgery. Apparently, excimer laser ablation of corneal stroma results in progressive cell loss in the cornea.

In the peer discussion following this study, LASIK surgeon Dr. Roger F. Steinert commented, and I quote him: “One can speculate that this loss might lead to corneal ectasia.”

Clearly, patient satisfaction surveys are no substitute for objective quantitative testing, particularly when the technology for performing objective tests is widely available.

I ask that the FDA abandon the proposed quality of life study in favor of a study which objectively and quantitatively measures aspects of post-LASIK dry eye disease and post-LASIK visual quality. These studies can be performed on existing patient populations with unoperated eyes as controls. Withdrawal of FDA approval for the LASIK procedure should take place immediately pending the outcome of these studies. Only then will the FDA be able to achieve evidence-based policy about corneal refractive surgery devices, and only then will the public receive the benefits of evidence-based medicine.

Entry Filed under: Latest News