About the Book – The Unsightly Truth of Laser Vision Correction

by Dr Morris Waxler PhD (Author) Morris Waxler is a vision scientist, neuropsychologist, and former science manager (Branch Chief) of the PRK/LASIK team at the Food and Drug Administration. He retired from the FDA in 2000. Then he was an FDA regulatory specialist at Hogan & Hartson, LLP (now Hogan Lovells), in Washington, DC and at Godfrey & Kahn, LLP, in Madison, WI. He then formed Waxler Regulatory Consultancy, LLC, which helped medical device companies navigate FDA regulations.

Contributors
Paula Cofer
Dr Edward Boshnick OD
Dr Cynthia J MacKay MD
Paperback‏: ‎ 155 pages
ISBN-13 : ‎ 979-8893793604

LASIK is unnecessary surgery performed on healthy eyes to eliminate the need for distance glasses or contact lenses. It does not prevent or treat eye disease. Eyes are essential. Those undergoing the surgery see perfectly well with glasses, so customers would not want LASIK surgery if it had a high risk of causing serious eye disorders. In fact, the risk of severe chronic complications from LASIK is at least 30% = Donnenfeld^ⁱ, Hovanesian^ⁱⁱ, Albietz^ⁱⁱⁱ, DePaiva^{^iv}, Shoja^{^v},Tuisku^{^vi}, Denoyer^{^vii}.

LASIK surgery is performed in every developed country in the world. Since 40 million people in the world have had LASIK, at least 12 million people are suffering today from these life-destroying complications. This is a huge public health problem.

LASIK-related disorders are multiple, disastrous, permanent, and untreatable. They include blindness, life-long pain, and disability, which, in a few dozen cases, have led to suicide.

This book will recount the efforts by many LASIK surgeons and the FDA to convince customers into having LASIK surgery by not warning them about the known serious chronic eye disorders.

The rise of LASIK did not happen overnight. We show how LASIK rose to prominence, and how the FDA went along with the industry.

The FDA website is very positive on LASIK. This, to put it mildly, is an unusual partnership between the agency and industry. We will provide evidence, and then you, the readers, will decide if FDA and the LASIK industry are fully transparent and honest about the risks of LASIK surgery.^{^viii}

Not all LASIK complications occur immediately after surgery. Moreover, the word “complications” does not adequately describe the unremitting decreased vision, eye weakness and chronic pain that occur far too often after LASIK surgery. Patients who are suffering from “complications” once had healthy eyes. They are now trying to live life with a chronic, untreatable disability. Often, seemingly innocuous post-LASIK symptoms – a slight eye itch that persists or a bit of blurriness, are signs of impending chronic eye disorders.

This book will tell the stories of LASIK-damaged patients who had no idea of the risk they were running before they had surgery. They describe their chronic eye disorders within these pages, while the FDA refuses to act. Also, it is the history of heroes – Paula Cofer, Dr. Cynthia MacKay, Dr. Edward Boshnick, and others – who have helped, and are helping, victims of LASIK rebuild their eyes and their lives.

Unfortunately, many LASIK surgeons and FDA do not adequately warn customers about these life-long eye disorders. Instead, they sell the short-term benefit of improved distance vision.

The LASIK surgeons’ criterion of success is patients being able to read the 20/40 line on the eye chart in their offices. However, a high percentage of these “successes” are suffering from pain, distorted vision, halos and glare at night, and many other problems described in this book.

The truth is that LASIK causes permanent eye disorders. That is why 5% are dissatisfied with the surgery a year post-surgery, and, 7 years after having LASIK, 55% say they wish they had never had the procedure. In this book, LASIK-damaged patients will tell you about their lived experiences with the unremitting eye disorders of LASIK.

i Donnenfeld ED, Solomon K, Perry HD, Doshi SJ, Ehrenhaus M, Solomon R, et al. The effect of hinge position on corneal sensation and dry eye after LASIK. Ophthalmology. 2003;110(5):1023–9. discussion 9–30. doi:10.1016/ S0161-6420(03)00100-3. {33 articles cite}
ii Hovanesian JA, Shah SS, Maloney RK. Symptoms of dry eye and recurrent erosion syndrome after refractive surgery. J Cataract Refract Surg. 2001;27(4):577–84. [6 cited]
iii Albietz JM, Lenton LM, McLennan SG. Effect of laser in situ keratomileusis for hyperopia on tear film and ocular surface. J Refract Surg 2002;18:113-23 [19 cited]
iv De Paiva CS, Chen Z, Koch DD, Hamill MB, Manuel FK, Hassan SS, et al. The incidence and risk factors for developing dry eye after myopic LASIK. Am J Ophthalmol. 2006;141(3):438–45. doi:10.1016/j.ajo.2005.10.006. [43 cites]
v Shoja MR, Besharati MR. Dry eye after LASIK for myopia: Incidence and risk factors. Eur J Ophthalmol. 2007;17(1):1–6 [20 cites]
vi Tuisku IS, Lindbohm N, Wilson SE, Tervo TM. Dry eye and corneal sensitivity after high myopic LASIK. J Refract Surg. 2007;23(4):338–42. [ 17 cited]
vii Denoyer A, Landman E, Trinh L, Faure JF, Auclin F, Baudouin C. Dry Eye Disease after Refractive Surgery: Comparative Outcomes of Small Incision Lenticule Extraction versus LASIK. Ophthalmology. 2014. doi:10.1016/ j.ophtha.2014.10.004. [41 cite]
viii Sissela Bok, Lying: Moral Choice in Public and Private Life (Pantheon Books, 1978; Vintage paperback editions, 1979, 1989, 1999), Kindle; Sissela Bok, Secrets: on the Ethics of Concealment and Revelation (Pantheon Books, 1982; Vintage paperback editions, 1984, 1989), Kindle.