September 5th, 2008
Dear Editor,
Recently LASIK Newswire reported that a citizen petition was filed with the FDA to ban LASIK. The petition is based on substantial deception in the labeling and an unreasonable and substantial risk of injury. The FDA's own data from LASIK clinical trials is cited. The petition states, "A meta-analysis of Summaries of Safety and Effectiveness for the twelve lasers approved from 1998 through 2004 (exhibit B) found that six months after LASIK, 17.5% of patients report halos, 19.7% report glare, 19.3% report night-driving problems and 21% report dry eyes." The analysis included newer custom LASIK technology.
The petition is published on the Regulations.gov website where comments are being accepted (http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2008-P-0319). As expected, LASIK providers and others who profit from LASIK are submitting comments to stop the ban. The first to comment was Glenn Hagele of the patient harassment organization Council for Refractive Surgery Quality Assurance (CRSQA), a fake LASIK patient advocate, LASIK marketing scam (see http://www.theglennhagelereport.com/ for more information).
LASIK surgeons commenting on the petition argue that complications such as chronic dry eyes and night vision difficulties should not be considered adverse events, calling them "side effects" or "symptoms". LASIK surgeons quote complication rates of 1% or less, even though clinical trials and peer-reviewed medical studies prove otherwise.
So who decides what counts as an adverse event?
"We encourage as much information as possible here, because FDA does look at every voluntary report that comes in. If it's a decrease in vision, if it's a halo, if it's a starburst, if it's a problem with night vision, these types of things would be considered adverse events to FDA, and we would want those reported because it has affected your vision," says Mary Weick-Brady of the FDA's Center for Devices and Radiological Health.
Source: http://www.npr.org/templates/story/story.php?storyId=90070220
This presents a conundrum for the FDA. The FDA guidance document for LASIK clinical trials, which is an exhibit of the citizen petition, states "Adverse events to occur in less than 1.0 % of population". Clearly, lasers failed to meet the guidance for approval.
The FDA's MedWatch program, which tracks adverse events from medical devices, contains hundreds of reports by LASIK patients suffering with post-LASIK dry eyes and night-time starbursts and halos. But most LASIK patients aren't aware that such a program exists. The reports are public record, however personal indentification information is redacted to protect patient privacy. The reports can be viewed at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm (type LZS in the product code field, change the date range, and click search).
The FDA database contains hundreds of reports of debilitating complications of LASIK, such as intractable dry eyes and incapacitating night vision impairment. Here's a sample:
I am in constant discomfort and pain due to severe dry eye. I am not eligible to receive medicare for another two years which means I have no health insurance. I have lost two homes and can no longer work at my regular job due to this problem. I have halos, starbursts, sensitivity to light, can't tolerate wind or air from fans, can't go to shopping malls or stores without extreme discomfort which has lead to depression and anxiety.
--------------------
It ruined my vision, and gave me permanent eye pain and dryness. I now see severe halos, ghosts, multiple images, streaks, starbursts, and my vision fluctuates terribly. My contrast sensitivity and depth perception are ruined. It affects my work, my hobbies, every aspect of my life is pain and difficulty. I wake up in the middle of the night from the painful dry eye. I never knew depression until lasik.
--------------------
I had lasik eye surgery, which resulted in a litany of problems: dry eyes, ghosting, starbursts and halos at night; an inability to see in low-light situations, and a regression of my vision in my left eye that necessitates the wearing of glasses at all times. I am unable to drive at night very well. I also have recurring infections. I suffered from depression after my eyesight was negatively affected. I was a high myope with large pupils and probably had a pre-existing dry-eye condition that the doctor did not screen me for. I was a terrible candidate for this surgery, but it was done anyway, to my everlasting despair.
LASIK patients with chronic dry eyes, night vision difficulties, or other complications can file a voluntary MedWatch report at this link: MedWatch
At the FDA hearing in April, LASIK surgeons in attendance heard stories of loss of quality of life, clinical depression, and suicides related to unbearable LASIK complications (click here for FDA hearing videos). In each case, post-LASIK dry eyes, night vision difficulties or both were reported. But LASIK surgeons continue to deny the problems, and don't consider these so-called "symptoms" significant enough to be counted.
It will be interesting to see how the FDA responds to this petition.
