LASIK Study Shows Significant Number of Problems

October 19, 2014
Preliminary results from FDA study of LASIK show significant number of patients experience problems.

Presenting preliminary results of the long-awaited LASIK Quality of Life Study during a keynote lecture at a meeting of the American Academy of Ophthalmology in Chicago on 10/17/2014, ophthalmologist Malvina B. Eydelman, MD, director of the FDA’s Division of Ophthalmic and ENT Devices, said that “dissatisfaction and disabling symptoms may occur in a significant number of patients”.

Plans for a study to consider how LASIK impacts patients’ quality of life were initially announced in 2008 around the time of a public meeting of the FDA’s ophthalmic devices advisory committee. The meeting was called in response to growing public criticism of the procedure and widespread reports of serious injuries. Testimony at the meeting from members of the public included reports of life-altering LASIK injuries and stories of LASIK-related suicides. Department of Defense LASIK surgeons and representatives of organized ophthalmology groups strongly defended the surgery.

Although LASIK critics were in favor of re-evaluating LASIK safety, many were incensed at the FDA’s plan to partner with organized ophthalmology groups for a prospective study, accusing the agency of placing the fox in charge of the hen house.

More than a year elapsed with no word on the proposed study. Then in October 2009, the FDA issued a press release announcing plans for a government-funded LASIK Quality of Life Study in collaboration with the National Eye Institute and the US Department of Defense. Mysteriously, military LASIK surgeons had replaced organized ophthalmology groups in the planned 2-part clinical study.

An article in the December, 2009 edition of the Journal of the American Medical Association (JAMA) reported that Steve Schallhorn, MD, Capt, US Navy (Retired) is “confident that once the quality-of-life issues are studied, LASIK will be shown to be even more safe and effective.” LASIK critics accused the agency of trading one embarrassing collaborator with conflicts of interest for another.

As a side note, in January 2011, former FDA branch chief for ophthalmic devices, Morris Waxler, PhD, petitioned the agency to withdraw FDA approval for all LASIK devices and issue a LASIK Public Health Advisory. Waxler had been conducting his own review of LASIK safety, and had concluded that the agency had made a mistake in granting the approval.

Five more years passed after the FDA’s 2009 update on the LASIK study. During the six year wait for the study results, the practice of LASIK continued status quo while LASIK injury reports stacked up at the agency. Currently, there are thousands of LASIK injuries on file with the FDA, although LASIK critics insist most injuries are never reported.

With the LASIK Quality of Life Study finally complete, LASIK critics wait for the manuscript to be published. Meanwhile, they point to data that were reported in Chicago to support their assertion that the procedure does not meet FDA safety requirements and therefore should not be performed.

  • Thirty percent of subjects with no symptoms of dry eyes before LASIK, reported dry eye symptoms at three months after their surgery.
  • Nearly half (45%) of subjects who had no visual symptoms prior to LASIK reported one or more visual symptoms 3 months after LASIK. These include halos at 35 percent, followed by starbursts at 28 percent, glare at 16 percent, and ghosting at 6 percent.
  • Visual symptoms were “very” or “extremely” bothersome in up to 4 percent of subjects.

LASIK critics assert that adverse outcomes are more common than the current study shows, as ‘real world’ outcomes are never as good as those reported in clinical trials. Visual symptoms, which are discounted by the FDA in evaluating LASIK safety, accounted for the majority of dissatisfaction with LASIK.

Ten percent of eyes did not achieve 20/20 vision, although subjects were presumably treated using the “latest technology.” Only 63.1% of subjects in study-1 and 53.5% of subjects in study-2 were “completely satisfied” with their vision at 3 months after LASIK.

The study included only 262 military subjects treated at the US Naval Medical Center San Diego with 6-month follow-up and 312 civilian subjects treated at five clinical sites across the US with 3-month follow-up. LASIK critics point to studies which suggest that LASIK results decline over time and published case reports of sight-threatening late onset complications which indicate that problems may present months or years after seemingly successful LASIK.

Moreover, average nearsightedness of subjects was just 2.5 diopters in study-1 and 3.6 diopters in study-2. Had the investigators included more patients with stronger prescriptions, the outcomes would have been even worse.

In her closing remarks, Eydelman is quoted as saying, “Further analyses are needed to explore other associations with dissatisfaction, and additional longitudinal studies are recommended to explore the factors associated with and predictors of poor outcomes.”

Remarkably, six years and many tax-payer dollars later, Eydelman is suggesting “further analyses” and additional studies. LASIK critics say Eydelman is a pawn of the LASIK industry and should be fired, and the FDA should take immediate action to protect the public by withdrawing its approval of LASIK. Although LASIK critics say they feel vindicated by the early reporting on the LASIK study, they doubt anything will change.
***
Sources for this article include:
(1) “FDA program tracks post-LASIK patient-reported outcomes.” Ocular Surgery News. Healio. Web. 17 Oct. 2014.
(2) Krader, Cheryl Guttman. “LASIK Quality of Life Collaboration Project characterizes benefit, burden.” Ophthalmology Times. Modern Medicine. Web. 17 Oct. 2014.
(3) Mike Mitka. “FDA Focuses on Quality-of-Life Issues for Patients Following LASIK Surgery.” JAMA.2009;302(22):2420-2422.
(4) Frederick Ferris, MD. PowerPoint presentation at AAO convention. 19 Oct. 2014.
(5) “LASIK Quality of Life Collaboration Project.” FDA. Web. 20 Oct. 2014.
(6) Larkin, Howard. “FDA Releases LASIK Patient Survey, Warns Of Large Numbers Of Dissatisfied Patients.” EuroTimes. Web. 20 Oct. 2014.
(7) Malvina Eydelman, MD. “LASIK Quality of Life Collaboration Project: Study Results Presented at the Refractive Surgery Subspecialty Day of the American Academy of Ophthalmology (AAO) on October 17, 2014” (PDF) FDA. Web. 21 Oct. 2014

Give FDA Authority over All Medical Device Ads?

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.
8/2/2014

Historically, U.S. law has given the Federal Trade Commission (FTC) primary authority to regulate the advertising and other promotion of prescription medical devices not otherwise “restricted” by FDA.

Restriction most commonly occurs in the conditions of approval stipulated in writing by FDA at the time of PMA approval, leaving the overwhelming majority of Class I and II devices unrestricted and therefore subject only to FTC, and thus scant, regulation of their advertising and promotion.

This is in stark distinction to other FDA-regulated prescription medical products, primarily drugs and biologics, which are unequivocally regulated in their promotional activities by FDA.

In practice, this has meant that the advertising and promotion of prescription drugs and biologics have been much more closely regulated than the marketing claims commonly made for most medical devices.

Lacking the in-house scientific backup that FDA has, FTC’s interest in medical devices has been minimal, a neglect that many Washington device lawyers justify by citing a fundamental difference between devices and drugs: the former’s characteristic ongoing and frequent design and materials change throughout the product life cycle, versus the latter’s static adherence to the formula, ingredients and indications as approved by FDA.

Arguments that there should be a public safety-based regulatory consistency for both categories of medical products frequently get short shrift from legal scholars.

But consider the case of hyper-advertised LASIK excimer lasers, which are “unrestricted” Class III devices and are therefore in FTC’s regulatory bailiwick, where they enjoy an unrestricted advertising world of bright-eyed people who’ve thrown away their glasses forever after what the ads portray as a quick and easy, painless procedure with a high-tech laser.

If you listen to CDRH former CDRH Diagnostic and Surgical Devices branch chief Morris Waxler, who approved the LASIK devices and Harvard assistant clinical ophthalmology professor Perry Rosenthal, who has studied their effects, you’ll glimpse the dark underbelly of FDA and FTC regulatory negligence. Here there’s an alleged LASIK adverse event rate that’s 20 times higher than FDA accepted when it approved the LASIK indication, and industry-dependent professional ophthalmology journals that reject papers trying to draw attention to it.

LASIK (laser in-situ keratomileusis) is a popular in-office procedure in which a U-shaped flap is cut by microkeratome blade in the surface of the cornea over the iris, the underlying stroma is contoured with an excimer laser, and the flap then folded back in place. However, untold to patients, the flap never heals, and is always prone to dislodgement and infection in such violent activities as contact sports and accidental trauma.

Waxler, who led the review team that approved the first of these lasers for LASIK in the late 1990s, was content with the decision until 2004, when a volatile and outraged Florida microjet salesman, Dean Kantis, tracked him down, now retired in Madison, Wisconsin.

Kantis operates a flamboyant Web site and belongs to country-wide networks of other injured LASIK patients. All allege they had received no FDA-required patient informed consent, namely the agency’s approved product-specific patient information brochure. LASIK surgeons do not answer to FDA because medical practice is regulated at the state level.

Kantis connected Waxler to other injured patients around the country. At first the retired FDA veteran was wary, but he gradually became sufficiently intrigued to begin personally researching the stories of the severely injured LASIK patients (including the mother of patient she said committed suicide due his LASIK injuries) and re-analyzing the industry-submitted PMA data on which he had relied to approve the devices. After five years in this effort, Waxler petitioned FDA in 2011 to withdraw the devices’ LASIK indication and issue a public health advisory.

Waxler’s conclusion: to get PMA approval, the laser makers had submitted fraudulent data to FDA attesting to a less-than-one-percent incidence of post-LASIK adverse events. Waxler’s re-examination of the PMA data revealed an incidence of more than 20 percent.

On this basis, the other 80 percent have no post-surgery problems, thus explaining, in part, the paucity of public complaints. Also the same devices have therapeutic, non-LASIK uses that are uncontroversial.

Meanwhile, Harvard Medical School assistant clinical professor of ophthalmology Perry Rosenthal had come to a parallel conclusion about the hidden LASIK adverse events.

Rosenthal identified and studied 21 patients who developed “unrelenting agonizing” eye pain following LASIK surgery, pain that had persisted for 2-15 years at the time of the study. He found that their pain was so “devastating and resistant to treatments that most of these patients admitted to thoughts of suicide.”

Rosenthal also discovered that the onset of this “neuropathic” eye pain was delayed in the majority of these patients, sometimes for many years after their eyes had healed and were comfortable. This type of pain had not been reported in the medical literature and because these eyes typically looked normal the sufferers had been accused of exaggerating or fabricating their suicide-provoking pain.

Nevertheless, his paper detailing these findings was rejected by two peer-reviewed ophthalmology journals and Rosenthal says he was forced to post it on his nonprofit Web site to avoid it being buried. He estimates there are 800,000 LASIK procedures every year worldwide and the available pool of surgical candidates is growing by 2 million eyes per year.

Rosenthal’s next step was to send his paper to FDA, despite being warned that the agency would not respond. FDA not only blew off Rosenthal’s study, it also blew off Waxler’s petition, just as it had previously blown off Kantis’ angry and insulting tirades (“Go to FTC,” it told him, but he found that agency to be just as disinterested as FDA).

After a 30-month wait, this past June Waxler received FDA’s formal denial of a petition he had filed seeking removal of the LASIK indication from all excimer lasers.

On July 22, he plunged onward, filing a petition for reconsideration in which he charged that FDA “grossly underestimates the risks of LASIK by conflating data used to legally support the PMAs with LASIK industry information used to promote sales.”

In doing so, he wrote, CDRH had sent two messages: that the LASIK industry could feel secure because “the agency has your back,” and that the public should beware because “FDA does not have your back.”

Waxler told the agency that it had “made deals” with the LASIK industry that “degraded the scientific quality of the collection and analysis of adverse event data of LASIK devices.”

He listed alleged deals with the following entities: Kremer Laser, American Society for Cataract and Refractive Surgery, CRS Inc., and more than 100 user facilities that he says received IDEs “to study LASIK in order to minimize their exposure to violating off-label rules.”

Would giving CDRH the authority to regulate all medical device advertising change its subservience to industry?

The only model we have is the more tightly regulated market environment for prescription drugs and biologics at CDRH’s sister Center for Drug Evaluation and Research (CDER), where historically promotional activities have been strenuously regulated. CDRH has a staff of three to review restricted device promotional activity, while CDER boasts a staff of 60 for this kind of work.

Medical device lawyers and proponents abhor the prescription drug regulatory template for the industry’s products, and the 1976 Medical Device Amendments and subsequent legislation have been careful to avoid such an imposition.

But when it comes to marketing and advertising at least, the LASIK experience gives us pause.

Patient Advocate Slams FDA Denial of LASIK Petition

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.

07/07/2014

LASIK patient advocate and former FDA LASIK advisory panel patient representative Paula Cofer has sharply criticized an eight-page FDA letter that denied a citizen petition submitted by former CDER branch chief Morris Waxler seeking the market withdrawal of approved LASIK excimer lasers and a public health advisory on their continued use.

Writing to FDA Webview, Cofer says the letter states that “risks associated with each LASIK device are described in the patient labeling” (patient information booklet), yet in 2006 FDA removed from laser approvals the requirement for patients to be given the patient labeling, stating, “[i]t is the responsibility of the practitioner, who is not regulated by the FDA, to provide the patient information booklet to their patients.”

Prior to 2006, Cofer writes, the conditions of approval for LASIK lasers contained the following or similar language, “[p]rospective patients, as soon as they express an interest in LASIK and prior to undergoing surgery, must receive from the treatment provider the Patient Information Booklet.” However, she says, LASIK patient advocates have repeatedly complained to the agency that LASIK practitioners withheld the booklets ─ “likely because the information contained in them would cause many patients to decline the surgery.”

Cofer says that in addition, FDA denied that it was ‘pressured’ by laser manufacturers to classify post-LASIK glare, halos, dry eyes, and night driving problems as ‘symptoms’ instead of adverse events; however, the agency acknowledged that these problems ‘may occur following LASIK surgery.’ They state that ‘[n]ot all of these visual symptoms are clinically significant enough to warrant classification as an adverse event’ and are often not persistent, according to published literature.

FDA, Cofer writes, “is aware of several LASIK-related suicides due to these types of so-called ‘symptoms,’ and the agency’s own database of medical device-related injuries contains thousands of reports of these very symptoms after LASIK, many of which describe these ‘symptoms’ as life-destroying. The agency states that ‘such visual symptoms are disclosed as potential risks in the patient labeling’ and that the ‘patient labeling for each LASIK device also includes a summary of the data on these visual symptoms observed in the clinical studies submitted in the PMA application.’

Cofer concedes that patient labeling for LASIK devices, “which most patients never see because the agency won’t enforce, discloses that approximately 20% of patients in LASIK clinical trials report halos, glare (starbursts), night driving problems and dryness persisting beyond the endpoint of the trials.

“Furthermore,” she continues, “the agency acknowledges the issue of problems with future cataract surgery raised by Dr. Waxler, but indicates that it has addressed this problem by partnering with the American Academy of Ophthalmology in the development of a patient k-card to record patients’ preoperative eye measurements. Again, the FDA has placed the fox in charge of the hen house. Virtually no LASIK practitioner provides the k-card to patients because doing so would alert patients to long-term consequences of LASIK, which were not disclosed prior to surgery.

Astonishingly, the agency refers to short-term patient satisfaction surveys in disputing points raised by Dr. Waxler in his petition. The scientists and officials at the FDA know full well that use of unvalidated surveys or questionnaires is neither scientific nor a reliable indicator of LASIK safety or efficacy.

“Indeed, the FDA repeatedly takes cover behind the patient labeling in its letter denying Dr. Waxler’s petition while simultaneously refusing to ensure that prospective LASIK patients actually receive the labeling. Dr. Waxler led the team at the FDA that reviewed the original pre-market application for LASIK. He knows what transpired. He was there. This is not simply a case of FDA failure to ensure the safety of a medical device; this is the FDA acting deliberately in the best interest of industry over public health. This is the FDA saying that patients do not have a right to know the hidden risks of LASIK before undergoing this irreversible, unnecessary surgery on their only pair of eyes. Clearly, as long as the current team is in charge at the CDRH and the Division of Ophthalmic Devices, they will continue protecting Big Ophthalmology.”

How FDA Dropped Patient Warning Rule from LASIK Approvals

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.
11/5/2013

FDA explains how a little-noticed change in its conditions of approval for LASIK lasers removed a patient-protection requirement two years before public complaints about eye injuries from the procedure erupted.

Two years before rising complaints erupted in public from LASIK patients with post-surgical vision problems, FDA’s Center for Devices and Radiological Health, on its own initiative, quietly removed a LASIK laser condition of approval that “[p]rospective patients, as soon as they express an interest in LASIK and prior to undergoing surgery, must receive from the treatment provider the Patient Information Booklet.” It took injured LASIK activists seven more years to notice the language change in CDRH laser PMA approval letters.

Last week, activist Paula Cofer questioned the approval letters’ language change in an email to FDA Webview editor Jim Dickinson, who in turn asked FDA for an explanation, and whether the change had been sought by the LASIK laser industry or by eye surgeons’ representatives. Both communities had been accused by activists for years of not passing on FDA-approved patient labeling to prospective patients prior to LASIK surgery. Although Cofer says their adequacy “is all over the place,” FDA-approved LASIK Patient Information Booklets often contain objective risk-benefit information, precautions and warnings.

In a response from FDA public information officer Synim Rivers, the agency acknowledged that it had used the missing language prior to 2006 as a condition of approval, and that it still requires final labeling (professional-use and patient labeling) from manufacturers during the review of marketing applications. “During this review,” Rivers’ response said, “we ensure that adequate safety/risk/procedural information is accurately conveyed in plain, understandable language. The manufacturer, in return, is required to provide this patient information booklet to the practitioner.

“In 2006,” the response continued, “we internally revisited the conditions of approval with respect to FDA’s regulations, and revised the conditions of approval for subsequent LASIK approvals. It is the responsibility of the practitioner, who is not regulated by the FDA, to provide the patient information booklet to their patients.”

As for whether the language change had been sought by industry or professional organizations, the response asserted that “the changes to our approval letter were not the result of external organizations or inquiries from external organizations. Instead, the changes were a direct result of internal discussions.”

Cofer told FDA Webview the agency’s explanation for dropping the Patient Information Booklet requirement “doesn’t hold up to the smell test,” especially since the change occurred shortly after the responsible CDRH review division was taken over by an ophthalmologist (Malvina Eydelman). “Malvina attends their conferences and rubs elbows with the leading refractive surgeons,” Cofer said.

“Why would FDA require patient labeling for LASIK devices, but not communicate the necessity of providing it to prospective patients? And how is this any different from a pharmacist negligently not providing patients with drug labeling? Why are patients’ rights more protected when they pop a pill than when they undergo an irreversible elective surgery on their eyes?

“Why not just clarify in the approval letter that the manufacturer is required to provide practitioners with patient labeling, and practitioners are required, in turn, to provide the patient labeling to ‘prospective patients as soon as they express an interest in LASIK and prior to undergoing surgery’, rather than simply eliminating the mandate from the approval letters altogether? This deliberate omission of the patient labeling mandate from the approval letters indicates that the agency is more concerned about protecting refractive surgeons than in ensuring that patients are fully informed of the known risks of LASIK.”

LASIK is safer than contact lenses MYTH

October 8, 2013

“LASIK is safer than contact lenses” is a myth that began with a letter from three biased LASIK surgeons, Mathers et al, to the editor of the journal Archives of Ophthalmology in 20061. In the letter, Mathers and colleagues draw some bizarre conclusions about the safety of contact lenses vs. the safety of LASIK, based upon a couple of published articles of eye infections from contact lenses and LASIK.

You’ve heard the phrase, “Lies, damned lies, and statistics”… The logic of Mathers and colleagues is so ridiculous that even other ophthalmologists have scoffed at it. But it does make a really good marketing soundbite, and so it has been widely adopted by LASIK surgeons seeking to scare patients into having LASIK. (Note: In 2009, Mathers co-authored a LASIK vs. contact lenses “decision analysis” based on a literature review2, which again failed to make the case that LASIK is safer than contact lenses.)

LASIK frequently leads to chronic dry eyes and night vision problems3,4. Some patients suffer lasting eye pain. The bottom line is this: If you follow proper lens hygiene and don’t sleep in your lenses, contacts may be worn safely for a lifetime. LASIK, on the other hand, is an unnecessary surgical procedure performed on a very necessary organ of your body, which leads to permanent consequences such as incomplete healing of the flap with associated lifelong risk of flap dislocation, reduced and disordered corneal nerves which may lead to persistent pain and dry eye disease, risk of corneal ectasia (bulging) with associated vision loss, problems with future cataract surgery and glaucoma screening, and increased risk of eye infections. Furthermore, if you wear contacts and your vision changes, you can simply get a new pair. If you’ve had LASIK and your vision changes, you’ll face increased risk with repeat surgeries.

Any LASIK surgeon who employs the scare tactic “LASIK is safer than contact lenses” is a menace to society!

Update August 2015: The U.S. Center for Disease Control (CDC) issued a press release concerning risk behaviors associated with contact lens-related eye infections. A survey of contact lens wearers found that more than 99 percent of respondents reported at least one risky behavior. Clearly, if contact lens wearers clean, disinfect, wear, and store their contact lenses as directed, the risk of infection is extremely low — much lower than the risk of complications from LASIK.

References:

1. Mathers WD, Fraunfelder FW, Rich LF. Risk of Lasik surgery vs contact lenses. Arch Ophthalmol. 2006 Oct;124(10):1510-1.

2. McGee HT, Mathers WD. Laser in situ keratomileusis versus long-term contact lens wear: decision analysis. J Cataract Refract Surg. 2009 Nov;35(11):1860-7.

3. Sugar A, Rapuano CJ, Culbertson WW, Huang D, Varley GA, Agapitos PJ, de Luise VP, Koch DD. Laser in situ keratomileusis for myopia and astigmatism: safety and efficacy: a report by the American Academy of Ophthalmology. Ophthalmology. 2002 Jan;109(1):175-87.

4. Bailey MD, Zadnik K. Outcomes of LASIK for myopia with FDA-approved lasers. Cornea. 2007 Apr;26(3):246-54.

Military Deployments Delay FDA Studies on LASIK

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.
9/9/2013

Post-operative quality-of-life studies on military personnel who have undergone LASIK eye surgeries have been delayed indefinitely due to personnel “deployments and the focus of all military staff on the war efforts,” an FDA spokeswoman tells FDA Webview. The study, known as Patient-Reported Outcomes with LASIK (PROWL-1) and commissioned by FDA under a Department of Defense contract to be conducted at the Naval Medical Center San Diego, was announced in 2009 but mysteriously kept under wraps for a year. In October 2010, FDA issued an update estimating that enrollment would begin with three months and completion by the end of 2012.

FDA Webview was told that enrollments for the final, non-military phase of the studies, known as PROWL-2, will be completed in December 2013.

Although activists for injured LASIK patients have shown skepticism about the objectivity of the studies, since Navy ophthalmology surgeons have publicly expressed enthusiasm for the controversial procedure, it is expected that they will shed light on complaints that it leads to a serious adverse reaction rate far higher than the maximum 1% on which FDA approval was based.

The Scandal of LASIK

Copyright Perry Rosenthal, M.D. at www.bostoneyepain.org. Republished by permission.

By Perry Rosenthal, M.D.

09-09-2013

Imagine a surgical procedure being performed for non-medical reasons on a healthy organ critical to our ability to function. Considering that this surgery neither treats nor prevents disease, what is its acceptable rate of serious and permanent complications? Shouldn’t it be zero? How can we even consider it being far greater than those of vaccinations that, while also given to healthy people, provide invaluable disease-prevention benefits? LASIK/PRK laser surgeries do not.

How has it been possible that the well-documented, disastrous, permanent complications of these procedures have been ignored by the FDA–never mind the eye care professions? I have a confession to make. Despite my having been aware of the many blinding consequences of this surgery having treated many of them when I worked at the Boston Foundation for Sight (which I founded but no longer am affiliated with), I too failed to act on my observations that these surgical procedures can destroy the quality of life of these victims.

I did nothing until I became aware of a complication that had not been previously reported; long lasting and in many cases, probably permanent suicide-provoking eye pain. This is not the pain that many patients experience after the surgery. Why hasn’t this devastating complication been previously reported? The answer, I had assumed, was that eye doctors had been misled because these eyes typically look normal and well healed. And since, we have been trained to believe that the cause of chronic eye pain can always be identified during traditional examinations and that if nothing is found to explain it, this devastating eye pain must be imaginary. Moreover, as I discovered, the onset of this type of pain can occur years after the surgery and its connection to the surgery easily dismissed. I hadn’t even considered that there could be a coordinated effort to suppress this information.

I did detailed examinations on 21 such patients (how rare can it be?) and wrote a paper detailing the characteristics of this pain disease which I call corneal neuropathic centralized pain. I explained why it differs from typical temporary post operative pain. In it I presented my theory about its mechanisms and included suggestions on how it might be possibly prevented. Shouldn’t it be of interest to eye doctors, the FDA and prospective patients? In fact, it was summarily rejected by a leading peer-reviewed journal in ophthalmology. I shrugged my shoulders and submitted it to one that specializes in corneal laser procedures, fully expecting it to be accepted. It too was rejected outright for reason, according to the reviewers, that were impossible to address. I could have explained that, because of the infrequency of this complication, it would take more than 15 years at an incredible cost to perform the studies they insisted would be needed by other journals. In other words their suggestions were beyond the pale. Nor was I allowed to respond. The decision was irreversible. I was confused. So I sent the paper to world-class pain researchers for their opinions. All supported its being published. (One called my work “transformative”.) It is interesting that both journals ignored my recommendation that at least one of the reviewers be an expert in pain. I began to wonder if they had a hidden agenda. Was I becoming paranoid?

As I began to read the history of LASIK and its complications I became aware of the central role of the FDA in continuing to sanction these procedures despite their history. So I sent my paper to the FDA to document this previously unreported complication despite being warned that they will not respond. I didn’t believe it. I was wrong. I sent the paper twice without it even being acknowledged. Of course they could always say that the paper has no standing because it had been rejected. However, a cursory look at the results of any search engines provides a day’s read. Where is the shame?

I would never have imagined that editors of scientific peer-reviewed journals, a vast, profitable manufacturing/marketing industry and even some practicing doctors would collaborate to hide these complications from the public and prospective patients. And what about the government agency whose primary responsibility is to protect the public?

As of 2011, it was estimated that more than 11 million of these procedures had been performed in the US. (http://bmctoday.net/crstodayeurope/2013/02/article.asp?f=ndyag-treatment-of-epithelial-ingrowth) and more than 28 million have been done world-wide (http://www.aao.org/publications/eyenet/200906/feature.cfm?) and it was predicted that at the current rate of 800,000 procedures per year, the available pool of surgical candidates is growing by 2 million eyes per year (http://bmctoday.net/crstoday/2011/08/article.asp?f=the-lasik-market-yesterdays-technology-or-poised-for-recovery). This is a huge industry with tentacles that appear to reach the bowels of the FDA. In the meantime, I think about what will be happening to the vast numbers of the people who will be undergoing these procedures ignorant of their possible life-destroying complications. Shouldn’t they at least be able to make an informed decision?

I have been accused as having an over-abundance of naivety. But, I can no longer be silent.

Study Finds 21% of Serious Eye Injuries Due to LASIK

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.
7/25/2013

Thirty-one months after it back-burnered a former CDRH [FDA’s Center for Devices and Radiological Health] branch chief’s petition seeking withdrawal of the LASIK indication for ophthalmic lasers based on unacceptably high permanent injury rates, CDRH has been sent a new retrospective study indicating that 21% of patients with serious corneal pain had received laser surgery on their eyes. The 6/14 study, from Harvard Medical School assistant clinical professor and Boston EyePain Foundation founder Perry Rosenthal, found 21 out of 100 consecutive patients diagnosed with centralized corneal pain had previously undergone laser keratorefractive surgery.

In his moribund petition, former CDRH branch chief for diagnostic and surgical devices Morris Waxler complained about a LASIK industry-promoted injury rate of less than 1% on which his review team had based its approval of the devices, compared with his subsequent assessment of an injury rate in excess of 20%. Waxler alleged that “Manufacturers and their collaborators withheld more than 10% of the adverse event data from 13 of the 25 studies, more than 20% from 12 studies, and more than 40% from seven studies.”

He said manufacturers pressured FDA to not include halos, glare, night vision problems, and dry eyes as adverse events in order for their lasers to meet FDA’s requirement of a less-than-1% adverse event rate. After approval, FDA decided these “symptoms” should be reportable events.

The new study by Rosenthal, which was rejected by two ophthalmic professional journals* heavily supported by the LASIK industry, carries the adverse event rate far beyond the six-month post-operative followup point in most of Waxler’s data, extending out as far as 15 years post-op. Rosenthal found eight patients who had experienced symptoms immediately after surgery, three whose symptoms were delayed between three and 28 days, two who experience symptoms between one and six weeks post-op, and eight whose symptoms began between one and 15 years post-op.

Rosenthal’s study describes the symptoms observed as chronic centralized neuropathic corneal pain. It says the recognition that this “can be a complication of laser keratorefractive surgery is the first step to developing mechanism-based treatments for this overlooked, crippling and currently intractable neurological complication.”

Rosenthal acknowledges in the study that the 21 subjects described differed from those who experienced “typical” post-LASIK dry eye-like pain in that they reported “higher intensity descriptors such as burning, aching, pressure, stabbing and in many of these patients, the presence of otherwise unexplainable photosensitivity (photoallodnia).”

He dismisses what he calls “anecdotal observations” that suggest centralized corneal neuropathic pain is rare. “This begs the question of why some people are susceptible to this complication,” he writes. “Vulnerability to neuropathic pain is believed to be influenced by certain genetic and epigenetic factors and efforts to develop useful predictive tests continue, including measurements of an individual’s endogenous sensitivity to pain.”

Rosenthal recommends screening of LASIK candidates for family history of autoimmune diseases which are known to be associated with a higher incidence of peripheral neuropathies. “Reports that delayed treatment of post-operative pain has a deleterious effect on pain outcomes suggest that [post LASIK] pain should be treated aggressively and perhaps even preemptively,” Rosenthal says in his study report. “In this context, early interventions that accelerate corneal epithelial and nerve healing and suppress inflammation may also be helpful in avoiding the transition to centralized corneal neuropathic pain. Because of the devastating nature of this complication the search for effective topical analgesics capable of being used safely prior to and for an extended period of time after surgery is, in my opinion, a high priority.”

* Elsevier’s [Ophthalmology:] Journal of the American Academy of Ophthalmology and The Journal of Cataract and Refractive Surgery

An Interview with Justice of Lasik Scandal

4/20/2013

A new website, LasikScandal.com, reveals risks and adverse effects of LASIK eye surgery, and exposes LASIK industry corruption. LasikNewswire’s editor interviewed the new site’s Director & Medical Researcher, Justice.

LNW: Good evening, Justice, and thanks for giving us this interview. Tell us about yourself. How did you become interested in LASIK?

Justice: I had a bad outcome from LASIK several years ago. I suffer from chronic dry eyes and distorted night vision — starbursts, halos, double vision… It turned my life upside down. I needed to understand why, what went wrong, and if it could be corrected. So that’s why I began my research.

LNW: And what did you find out? I mean, what went wrong?

Justice: Well, nothing went wrong according to my surgeon. But really, everything went wrong. When you do surgery on perfectly healthy, normal tissue… When you create a flap one-third the thickness of the cornea, and then vaporise more of the cornea with a laser, the cornea never recovers fully. Researchers have found permanent pathologic changes in all post-LASIK corneas studied.

LNW: You said you have night vision problems. Do you have large pupils?

Justice: Yes, and of course, that’s the problem.

LNW: Where did your research lead, as far as finding a solution for your vision problems?

Justice: Well, I consulted several leading surgeons. They proposed a retreatment. One surgeon actually suggested corneal transplant, bilateral. By that point I knew the risks associated with another surgery. Not only that, but also, the data seemed unconvincing that a retreatment would be effective. I decided to try rigid contact lenses, but my expectations were low because I had not been able to tolerate hard lenses before LASIK, and now, with my eyes much drier after LASIK, I knew they would be difficult to tolerate, and that was the case.

LNW: How has LASIK-induced dry eyes affected you?

Justice: I’m glad you asked that question because, unless you’ve experienced first-hand the pain and burning and all the rest that goes with it, people seem to think that dry eyes is just a minor issue that is easily managed with eye drops. But that’s definitely not the case. It has a huge impact on my life. I have to plan my activities around it. I always carry eye drops and goggles wherever I go. My eyelids stick to my eyes. It’s scary and painful. I instill eyedrops several times throughout the night. My optometrist once told me, “Your corneas are pretty beat up”. Beat up from the dryness and trying to wear lenses.

LNW: Let me get this straight. You need to wear hard lenses because your vision is impaired by LASIK, but LASIK caused you to have extremely dry eyes which makes it difficult, or impossible, to tolerate lenses?

Justice: (laughs) Yeah, crazy, right?

LNW: And tell our readers how LASIK causes dry eyes.

Justice: Mainly because corneal nerves are damaged. A normal cornea is highly innervated. It needs to be to protect your eyes, to let you know if your eyes are dry, to blink, or if you get sand in your eyes, to make tears to wash the sand out. But LASIK cuts the nerves and destroys nerves in the cornea. The feed-back loop is disrupted. The eyes are dry but there’s no information transmitted from the corneal surface telling the brain to send the message back to the lacrimal glands to produce tears.

LNW: What did your LASIK surgeon tell you, or warn you, about dry eyes before LASIK?

Justice: He never mentioned it. I still have a glossy brochure from his office which said that you’ll need to use eye drops for two weeks after LASIK.

LNW: Just two weeks?

Justice: That’s what it says. Two weeks.

LNW: The FDA website warns that dry eyes after LASIK can be permanent, so…

Justice: Right, I was not informed. You think you can trust doctors. It’s just not in our DNA to believe a doctor would hurt you.

LNW: I’m sorry. Is there anything else you would like to say about your experience?

Justice: Well, it’s not just the dry eyes and the bad night vision. It’s the betrayal of trust and the denial. It’s a bitter pill to swallow. It takes its toll. And then the cost. It’s crazy what you spend trying to manage LASIK complications. Thousands of dollars, year after year. And the ripple effect on all aspects of your life, and even your family’s lives. It’s devastating. And you feel as if you have no future. It’s not the life you expected. But you learn to keep going, you have to.

LNW: You’re wearing glasses. What is your vision like with glasses?

Justice: Yes, I started regressing right away, and my vision has been unstable ever since. In the daylight with glasses I see pretty well. I can function normally in bright light. But in dim light, or night-time, forget it. I dread the short days of winter. I don’t drive at night. I also have induced floaters, which bother me in bright light, I almost forgot. (laughs).

LNW: Floaters, dry eyes, bad night vision, regression? Anything else?

Justice: Induced astigmatism. And DLK.

LNW: Tell our readers. What is DLK?

Justice: Diffuse lamellar keratitis. Inflammation of the cornea. I had it in one eye and it left mild scarring.

LNW: Do you believe you were a bad candidate?

Justice: Yes, I do. I was becoming intolerant to my soft contact lenses, which indicates dry eyes, so that should be a contraindication. And I have large pupils, and that’s a definite contraindication, regardless what you might hear, it is a contraindication, period. But even if you’re a so-called ‘perfect candidate’, LASIK always leads to dry eyes, at least for a period of time, and virtually always reduces night vision. It’s a matter of severity. If your eyes are dry before, they’re going to be a lot drier. If you have large pupils, you’re going to have worse night vision than someone who has smaller pupils with the same refractive error. I see LASIK ads talking about newer technology and better night vision. No technology can treat a patient, appropriately, with very large pupils without taking off too much tissue. You only have so much cornea.

LNW: Yeah, if you remove too much corneal tissue, you place the patient at risk of corneal ectasia.

Justice: Right. That’s the complication that LASIK surgeons most want to keep quiet.

LNW: Justice, thanks for telling us your story. Before we wrap this up, let’s talk about LasikScandal.com. It’s a great looking site.

Justice: Thanks, but I’m not the web designer. Jeff and Bob deserve the credit.

LNW: You write content for the site?

Justice: I wrote some of the content, yes.

LNW: Well, it’s very compelling, well researched. I understand you’re building a patient registry.

Justice: Yes, now that we’ve got a site up, we’re going to be focusing on the patient registry and the forum.

LNW: Justice, thank you again. Best of luck with the new site.

Justice: Thank you.

20/20 Institute Indianapolis Lasik slapped with FDA warning letter

From a 12/18/2012 FDA press release:

The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information about associated risks, as well as warnings and possible adverse events.

The five providers that received FDA Warning Letters are:

  • 20/20 Institute Indianapolis LASIK, of Indianapolis
  • Scott Hyver Visioncare Inc., of Daly City, Calif.
  • Rand Eye Institute, of Deerfield Beach, Fla.
  • Eye Center of Texas, of Bellaire, Texas
  • Woolfson Eye Institute, of Atlanta

“Advertising by many eye care professionals who perform laser vision correction surgery provides patients with the risk information that they need to make informed decisions,” said Steve Silverman, compliance director at FDA’s Center for Devices and Radiological Health. “But providers whose advertising does not provide adequate risk information are finding out today that the FDA is serious about consumer protection.”

Continue reading press release

Read warning letter to 20/20 Institute Indianapolis LASIK addressed to Mark S. Danzo, O.D.