Patient Information Booklet (Patient Labeling)

What you should know about Patient Information Booklets for FDA-approved lasers for LASIK

February 22, 2014

The public generally understands LASIK as a painless, nearly risk-free procedure, one that is certified "safe" by the FDA. Unfortunately, the public knows LASIK mainly through industry marketing. Scrutiny of industry practices, clinical trials documents, and federal law, however, exposes a very different picture. The FDA and LASIK surgeons are engaged in a cover-up of the high incidence of adverse surgical effects reported in clinical trials. Prospective patients are being denied information required to give informed consent for LASIK surgery. 

Everyone who has taken medication, whether over-the-counter or prescription, is familiar with the package insert or medication guide that is supplied. This document contains important safety information, precautions, and instructions for use.    

FDA-approved medical devices, such as lasers used in LASIK eye surgery, also come with a guide, known as device labeling, which is mandated under federal law. Each excimer laser has unique FDA-approved labeling, which contains outcomes of the FDA-required clinical trials. 

The laser device labeling has two sections -- a section for physicians, known as Professional Use guide or Physician Instruction Booklet, and a section for patients, known as Patient Labeling or Patient Information Booklet. 

When the FDA approves an excimer laser, the agency issues an approval letter, which, until 2006, reminded the laser manufacturer of the patient labeling mandate.  Below are two examples. The first example is found in a 2003 FDA approval letter for the VISX laser, and the second is found in the VISX Physician Instruction Booklet.

"Prospective patients, as soon as they express an interest in wavefront-guided LASIK for myopic astigmatism and prior to undergoing surgery, must receive from the treatment provider the Patient Information Booklet..." Link to source (See page 2)

"All patients must be given the opportunity to read and understand the Patient Information Booklet and to have all their questions answered to their satisfaction before giving consent for Laser Assisted In Situ Keratomileusis (LASIK) or Photorefractive Keratectomy (PRK) surgery." Link to source (See pages 16 - 17)

Unfortunately, the FDA does not enforce this requirement upon physicians, leaving prospective patients with insufficient information to make an informed decision to consent for surgery. Considering that clinical trial data found in these booklets would likely lead most patients to decline LASIK surgery, it is not surprising that LASIK surgeons withhold this material. Post-operative complaints, such as halos, starbursts, difficulty driving at night, and persistent dry eyes are commonly reported by patients at the endpoint of clinical trials, typically six months or one year. View examples at this site, scroll down

A review published in 2007 of the twelve lasers approved from 1998 through 2004 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 which are worse than before surgery, much worse than before surgery, moderately severe or severe. Source: Bailey MD, Zadnik K. Outcomes of LASIK for myopia with FDA-approved lasers. Cornea 2007 Apr;26(3):246-54.  View chart

Eye surgeons who profit from LASIK are not compelled to inform prospective patients of these disturbing statistics. Moreover, surgeons generally dismiss these complaints as "temporary side effects.” To a LASIK surgeon who only follows a patient for six months to one year, adverse effects may be temporary, but to a patient who has to live with the consequences of LASIK for a life-time, they may be long-lasting or even permanent. 

U.S. federal statutes (21 CFR 803) contains mandatory requirements for users of medical devices to report adverse events to the device manufacturer or to the FDA through the FDA's MedWatch system. Injured consumers may file a voluntary MedWatch report. To an eye surgeon who does not regard chronic dry eyes, night driving difficulty, and visual disturbances as complications, there is nothing to report. However, the MedWatch database of LASIK-related injuries tells a different story. Although the public generally remains unaware of the MedWatch program, more than eight hundred reports have been filed by injured LASIK patients.  The overwhelming majority of patient-reported LASIK injuries pertain to chronic dry eyes and night vision problems. Moreover, there have been several documented cases of suicide and suicide attempts due to so-called "side effects" of LASIK. Clearly, there is a huge disconnect between eye surgeons who perform LASIK and the LASIK patient population regarding what constitutes a LASIK-related injury.

Lasik Surgery Watch, a LASIK patient advocacy group, conducted an analysis in 2012 and found that 73% of the injuries patients reported to Medwatch involved dry eyes, night vision problems, poor visual quality and corneal ectasia. By contrast, the group says just 16% of injuries reported by medical professional involved these complications.

Many LASIK patients report more than one adverse event, such as dry eyes and visual distortions, or corneal ectasia and depression, occurring concomitantly. Although more than 800 patients have filed LASIK injury reports as stated, these patients reported more than 1,600 adverse events.

So the question is, why doesn't the FDA enforce the Patient Information Booklet mandate? 

Unfortunately, the FDA has a long history of colluding with industry. Critics of LASIK have long accused the FDA of being captured by the LASIK industry and putting industry interests ahead of public health. They claim the LASIK industry continues to influence the FDA's oversight of LASIK devices.  

Industry pressure was key in FDA's original approval of LASIK, according to Morris Waxler, PhD, former FDA executive and chief scientist in charge of the early clinical trials review for LASIK. Several years later, Waxler began an independent review of LASIK safety based upon subsequent medical studies. Evidence of the injurious nature of the surgery was so compelling that Waxler filed a citizen petition with the FDA in 2011, calling for withdrawal of FDA approval for all LASIK devices and issuance of a Public Health Advisory. More than three years later the FDA has not acted on the petition. 

It's clear the FDA maintains a close relationship with eye surgeons. The director of the FDA's Division of Ophthalmic Devices is an ophthalmologist named Malvina Eydelman, M.D. who routinely attends LASIK surgeon conventions. After Eydelman took charge of the division, the Patient Information Booklet mandate was dropped from future LASIK device approval letters. In 2013, the FDA was questioned by Jim Dickinson, editor of the FDA-watchdog publication, Dickinson's FDA Webview, regarding the Patient Information Booklet mandate, and its mysterious disappearance from the laser approval letters in 2006 under Eydelman. The agency, through a public information officer, Synim Rivers, acknowledged that it had used the missing language prior to 2006 as a condition of approval, and stated that it had revised the conditions of approval after an 'internal review'. Rivers told Dickinson that it is the responsibility of the practitioner, who is not regulated by the FDA, to provide patients with the booklets. 

Does this make any sense -- the FDA requires laser manufacturers to produce LASIK Patient Information Booklets, but they can just sit on a shelf somewhere without patients ever seeing them? This is terribly wrong. 

Clearly the FDA has the power to right this wrong, but it is unwilling. In 2009, the FDA issued a press release, advising consumers not to use a certain cold medication that was associated with the loss of smell, which may be long-lasting or permanent, and emphasizing the seriousness of loss of smell and its effect on quality of life. The press release stated that the FDA had received "more than 130 reports of loss of sense of smell" associated with the use of the cold product. But for years, the FDA has ignored hundreds of reports filed by patients who suffered visual impairment and loss of quality of life from LASIK eye surgery devices. As stated, more than eight hundred such reports have been filed with the FDA.  How could the FDA place greater importance on sense of smell than on sense of sight? It's absurd. The only explanation is that the cold medication company did not have close ties with the agency.  

Eyesight is our most precious sense. LASIK is completely unnecessary -- it serves no medical need. Consumers have a right to be fully informed. If you are considering laser eye surgery, demand a copy of the Patient Information Booklet. If the surgeon refuses, download it from the FDA website. Once you have had a chance to see the clinical trial data, we think you'll decide to keep your glasses.