FDA Lasik Hearing: Lauranell Burch, PhD

After I hear her presentation, I'm firm that I'm not going to undergo the LASIK procedure. Thanks you Lauranell Burch.

I appreciate the opportunity to speak at this FDA hearing on post market LASIK issues. My name is Lauranell Burch. I have a PhD in molecular biology and genetics and have been -- Am I not speaking in the microphone? Sorry. -- and have been a medical researcher for over 20 years. I am trained to design, conduct and review medical research studies. I come here today as a private citizen with no financial interests to report. 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 with conflicts in interests. 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 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 all of us 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 in 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 the 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.

Number one, the flap never heals. It just seals it better on the edges like a Tupperware lid, leading patients who have had LASIK susceptible to traumatic flap injury for life.

Number two: LASIK separates the stronger anterior corner, 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 the surgery.

Number three: LASIK causes permanent pathologic 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 of these findings include: Deranged and disordered collagen fibers, granules under the flap, and epithelial ingrowth under the flap.

Number four: There is no evidence that corneal nerves ever fully regenerate to their normal patterns and density after LASIK.

Number five: LASIK complicates future cataract surgery.

Number six: LASIK invalidates intraocular pressure motion which is critical in the diagnosis of glaucoma.

Number seven: Perhaps gravest of all, Mayo Clinic researchers recently found that all patients undergoing laser corneal refractive surgeries lose coracite or corneal stromal cell density at higher rates even years after surgery. Apparently, excimer laser ablation to corneal stroma results in progressive cell loss in the cornea. In a peer discussion following this study, LASIK surgeon Dr. Roger S. Steiner 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 serving 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 evidenced based policy about corneal or refractive surgery devices, and only then will the public receive the benefits of evidence based medicine. Thank you.

Above report from: http://www.lasikfda.com/index.php?option=com_content&view=article&id=51&Itemid=60