Topside Change at CDRH Continues its Corruption

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

09/25/2024

[Analysis by Jim Dickinson] Physician-attorney Jeff Shuren is gone from CDRH but his hand-picked interim successor, deputy director Michelle Tarver, continues his cozy-with-industry corruption of FDA’s patient safety mission at the Center. A troubling part of their legacy is the broken lives of patients devastated by medical devices that entered the market through slipshod scrutiny of their safety, as seen in such cases as LASIK (laser-assisted in situ keratomileusis), mercury-laced dental amalgam, cancer-linked breast implants and power morcellators.

That is exactly what former CDRH advisory panel member Paula Cofer sees in Tarver’s current appointment as interim CDRH director. Center media officer Kristina Wieghmink told FDA Webview Tarver “has and continues to adhere to the FDA’s stringent ethics requirements”. Shuren’s 15-year leadership of CDRH was characterized by repeated ethical questions about his relationships with medical device companies, especially those associated with his wife Allison’s lobbying activities at the powerful Arnold & Porter law firm, the focus of a hard-hitting New York Times exposé last month. Similar concerns have been leveled at Tarver, an ophthalmologist with strong connections to the Bowie, MD-based LASIK-promoting eye surgery firm of Solomon Eye Physicians and Surgeons, whose Web site advertises her availability for consultations. As physicians, Shuren and Tarver are permitted to see private patients when not on duty at FDA provided that this doesn’t create a perception of a conflict of interest. In Tarver’s case such a perception might be created when she is simultaneously working on medical device company regulatory issues at CDRH.

CDRH media officer Kristina Wieghmink told FDA Webview Tarver “has and continues to adhere to the FDA’s stringent ethics requirements. She recuses herself as required under the applicable provisions of the conflict of interest law or where there may be an appearance of a conflict.”

A Tampa, FL victim of LASIK surgery, Cofer says she has spent “considerable time” researching refractive surgery, vision disorders, eye disease, and post-refractive surgery visual rehabilitation. She served as the patient representative on an FDA advisory panel on LASIK issues in 2008. In 2014, Cofer started the LASIK Complications Support Group on Facebook. In 2018, she and four of her colleagues gave presentations on LASIK problems to several FDA officials at FDA headquarters. She started the patient education and support organization, Vision Advocacy, Inc., in 2021. Cofer appears in the 2024 LASIK documentary, Broken Eyes, which is showing at film festivals around the country. She volunteers much of her time to helping patients with refractive surgery complications, and she has given numerous media interviews for reports on LASIK.

In 2008 FDA commissioned the Patient Reported Outcomes with Lasik (PROWL) study by the U.S. Navy and NIH which Cofer says was ”set up to make LASIK look good.” Tarver collaborated with CDRH director of ophthalmology devices Malvina Eydelman in a 11/23/2016 JAMA Ophthalmology article on PROWL’s assessment of patient satisfaction with LASIK. The visual “complications” from the LASIK procedure that PROWL focused on were double images, glare, halos, and starbursts.

In a statement to FDA Webview, Cofer wrote:

“When I think of PROWL, I think of ‘lies, damned lies, and statistics.’

“FDA officials have worked hand-in-glove with representatives of the LASIK industry from the beginning. They prioritize the LASIK industry’s financial interests over protecting the public from harmful LASIK devices. Moreover, biased LASIK surgeons on the PROWL steering committee had too much influence.

“The authors did not control for pre-op dry eye symptoms due to contact lens wear, which is reversible with discontinuation of lens wear, and they did not control for visual symptoms due to pre-op refractive error, which resolves with glasses. These flaws in the design of the PROWL questionnaire led to under-reporting of LASIK-induced dry eye symptoms and visual symptoms.

“Also, because the PROWL authors reported ‘overall’ symptoms post-operatively, they gave the LASIK industry a misleading marketing soundbite to hide the percentage of subjects with new symptoms after surgery. (If 49% of subjects said that they were worse after surgery, but 51% said that they were better, you can technically say that ‘overall patients were better after surgery,’ which sells more surgery than citing the actual percentages).

“Quote from the manuscript: ‘Overall, the prevalence of visual symptoms and dry eye symptoms decreased…’ LASIK surgeons don’t include the rest of that sentence in the soundbite, which states: ’although a substantial percentage of participants reported new visual symptoms after surgery’ (up to 46% at three months). LASIK advertisers also fail to mention that 28% of subjects without dry eyes before LASIK developed dry eye symptoms at three months post-op. And remember, both of those stats are based on their false positive data due to manipulation of the questionnaire. The true percentage of new symptoms is likely much higher.

“According to PROWL, patients with the least problems before LASIK have the greatest risk of new problems after LASIK. I think prospective LASIK patients would like to know that.

“Lastly, the word ‘pain’ (or ‘painful’) is nowhere to be found in the manuscript, although the questionnaire asks how often the subject has painful or sore eyes. I absolutely do not believe that no subject reported pain after LASIK, and that’s one reason why further analysis of the raw data is important. A recent peer-reviewed study by academic researchers reported that eye pain increased after laser eye surgery (LASIK or PRK) from 7% pre-op to 23% at three months and 24% at six months. Did the PROWL authors simply choose to leave the pain data out of the manuscript? I don’t know.”

After he retired from FDA, former CDRH branch chief for ophthalmic devices Morris Waxler re-examined safety data that had encouraged him to approve femtosecond and excimer lasers for LASIK procedures. He found that instead of the LASIK industry’s vaunted “less than 1%” complication rate from the procedure, the actual rate was 10-30%, depending on the laser used. Waxler petitioned FDA in 2011 to withdraw the LASIK approvals. The agency took three years under Shuren’s influence to deny his petition.

Cofer’s group continued their pressure and in July 2022 the agency proposed to issue a LASIK labeling draft guidance containing several of the group’s stronger warning recommendations This was vigorously opposed by the LASIK industry as “inaccurate, factually incorrect, not supported in the literature and a misrepresentation of current factual credible data and information concerning the modern LASIK procedure.”

In the face of this, the draft guidance has since remained in limbo.

LASIK Complaint on Violative Ads Seeks Woodcock Action

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

03/31/2021

The leader of a Facebook group involving patients injured by LASIK eye correction procedures is urging FDA acting commissioner Janet Woodcock to crack down on false and misleading advertising by LASIK providers. Paula Cofer, who founded the 7,400-member LASIK Complications Facebook Group in 2014 to give a voice to people who have been allegedly harmed by corneal refractive surgeries, emailed Woodcock 3/30 asking for her to help rid the marketplace of the violative LASIK ads that she says have been rampant for 20 years.

The clearly frustrated Cofer notes in her email to Woodcock that over the years she has reported to FDA several violative LASIK ads, “but to my knowledge, no enforcement action has ever been taken. I basically gave up on the agency doing anything about false, deceptive LASIK ads. However, today when I saw an ad (masquerading as a press release) claiming ‘zero complications,’ I could not ignore it.” She also characterized LASIK in general as a “scandal,” which has caused at least 30 suicides and “left hundreds of thousands of unsuspecting citizens with chronic dry eyes, persistent corneal neuropathic pain, and debilitating visual symptoms, including blindness and loss of eyes.”

The recent “advertisement” that prompted Cofer to try again to get someone at FDA’s top to address her concerns is a press release posted on EIN Presswire for Park Avenue LASEK, which is described as “the only laser vision correction center in the U.S. that specializes exclusively in Advanced Surface Ablations (in other words we don’t cut, which means no LASIK and no flaps). We have the only glass operating room in the United States since we have zero complications.”

Cofer’s email urged Woodcock to use “whatever enforcement action necessary to remove this ad from the Internet and prevent future false claims… Please, also look at other LASIK ads and Web pages operated by LASIK surgeons. You’ll see that virtually none of them are in compliance with the statutes.”

The email, which was also copied to numerous other FDA officials, apparently garnered immediate agency attention because Woodcock 3/31 emailed Cofer to request that the original email be resent to her. Shortly thereafter, CDRH ombudsman Abiy Desta emailed Cofer that her complaint about the LASEK advertisement has been forwarded to the device center’s Allegations of Regulatory Misconduct Team. According to FDA’s Web site, an allegation of regulatory misconduct is a claim that a medical device manufacturer or individuals marketing medical devices may be doing so in a manner that violates the law.

Cofer’s email to Woodcock also pleaded for her to look at MedWatch reports filed by patients who have been harmed by LASIK procedures, adding: “When is the FDA going to do something about this needless epidemic of harm?” Additionally, she pointed out that CDRH director Jeffrey Shuren’s wife, Allison Shuren, is an attorney (Arnold & Porter) who defends LASIK surgeons and attends LASIK surgeon conventions. “How is this not a serious conflict of interest for Dr. Shuren?” Cofer asked. FDA Webview requested comments on the potential conflict-of-interest, and FDA and both Shurens did not respond at press time.

Modern laser in situ keratomileusis outcomes – A review.

The LASIK industry has a long history of manipulating data and publishing junk science to protect the public perception of LASIK.

In 2009, leading LASIK surgeons published a literature review titled LASIK world literature review: quality of life and patient satisfaction1 which concluded that “95.4% of patients were satisfied with their outcome after LASIK surgery“. Nineteen articles were cited in the references as being the source of the data. What the manuscript fails to disclose is that a large percentage of these so-called “satisfied” patients reported complications such as bad night vision, night-time visual distortions, and dry eyes. The blog article at this link exposes the deception behind the 2009 literature review and reveals why you can’t believe anything these biased surgeons say.

The authors are well aware of the blog article which exposes the deception behind the 2009 literature review. So, in 2016 they tried again and published Modern laser in situ keratomileusis outcomes.2 Four of the co-authors on the 2009 review also co-authored the 2016 review — three of which are past presidents of the American Society of Cataract and Refractive Surgery (ASCRS), the largest U.S. professional society for surgeons who practice LASIK and other forms of unnecessary vision correction surgery. In the 2016 review, the authors withheld most of their sources, apparently to frustrate attempts by their critics to expose them again for publishing junk science. The authors state that they located 97 relevant articles in the literature search; however, the references contain only 17 citations, and it doesn’t appear that most of the 17 articles were part of the 97 articles retained for the analysis. In other words, they did not disclose their sources.

However, the authors made reference to the largest data-set (48% of total) in the review, which was a non-peer-reviewed article3 of one-month LASIK outcomes in low to moderate myopia at Optical Express, a large LASIK provider in the United Kingdom, by Steven Schallhorn, MD. The article was published in an Optical Express sponsored supplement to the Journal of Refractive Surgery. The source of the remaining 52% of the data is still a mystery. This begs two questions: what are they hiding, and how did this pass peer review?

Schallhorn is well-known for being a paid medical malpractice defense expert witness (testifying against injured LASIK patients), industry consultant, and medical director of Optical Express, making public statements and publishing literature denying connection between a poor LASIK outcome and diminished quality of life, and having financial interests in companies that manufacture LASIK devices.

Schallhorn’s article is not credible. For example, it cites an incidence of dry eyes at one month after LASIK of .18%. The paper doesn’t provide details as to how dry eyes were assessed. It says only that “common LASIK complications were observed“. LASIK surgeons know that this dry eye statistic is utter nonsense. In the ASCRS 2017 Clinical Survey, respondents said that LASIK significantly increased the level of dry eye at 6 months post-op in 22% of their patients.

In December 2016, a Dutch television program, Zembla, aired a documentary on LASIK. Zembla journalists interviewed Dr. Ton Rouwen, a LASIK surgeon and Secretary of the Dutch Society of Refractive Surgeons. Rouwen cited the 2016 review as evidence of the supposed success and safety of LASIK. Zembla filmmakers — aware of the controversy surrounding the review — contacted the authors of the review to question them about their sources, but their questions were not answered. Zembla then sent the paper to an expert at the Cochrane Institute who opined that it gave the impression of cherry-picking.

The 2016 review states, “Industry bias was not evident [in the sources]”. This statement is impossible to verify, as sources of 52% of the data were not disclosed. (It has already been established that Schallhorn — the source of 48% of the data — is heavily biased). However, industry bias is clearly evident in the review itself. One author, Richard Lindstrom, MD, was reported to have received nearly a million dollars in industry payments in 2016, the year of publication, by a U.S. federal government website. Eric Donnenfeld, MD, was reported to have received over $400K. Richard Potvin, OD, was reported to have received close to $200K. Kerry Solomon, MD, was reported to have received close to $100K. These figures don’t include profits from performing LASIK or other LASIK-related services. Five of the seven authors reported conflicts of interest in the very lengthy financial disclosures at the end of the manuscript.

The 2016 review also discloses support by the American Society of Cataract and Refractive Surgery and the American Refractive Surgery Council. These organizations are devoted to promoting LASIK and protecting the interests of LASIK surgeons.

The 2016 review further states, “An FDA panel meeting was held in 2008 in response to 140 dissatisfied LASIK patients to reevaluate the procedure.” At the time of publication in 2016, several thousand LASIK injuries had been reported to the FDA, not 140 — a fact that the authors conveniently fail to disclose.

Another excerpt from the review states, “In October 2009, the FDA instituted the LASIK Quality of Life Collaboration Project [which included a clinical study known as PROWL]… Industry and organized ophthalmology were not involved in the study design or the evaluation of data.” The latter statement is not true. The 2017 PROWL manuscript names three LASIK surgeons with conflicts of interest who served on the steering committee of the FDA LASIK study. Moreover, clinical investigators in PROWL also had conflicts of interest.

In summary, LASIK surgeons attempt to divert attention from the long-term consequences and widespread problems with LASIK by citing short-term patient satisfaction statistics from biased junk science. Forty-eight percent of the data in Modern laser in situ keratomileusis outcomes was taken from an article that was not peer-reviewed and is therefore unreliable. The remaining 52% of the data is from hidden sources. This is junk science published solely to promote LASIK. The authors and the peer-reviewers are not credible. The media should verify the veracity of the sources that representatives of the LASIK industry cite.
~~~

Side bar: A closer look at LASIK patient satisfaction.

One reason for the initial high rate of LASIK satisfaction is that patients are told that “side effects” (dry eyes, starbursts, halos, and double vision/ghost images) are temporary. So, although patients may be experiencing problems — such as dry eyes and night vision difficulties — they claim to be happy with the initial visual outcome while believing that so-called temporary side effects will resolve.

Cognitive dissonance is another reason for the initial high rate of satisfaction after LASIK. Patients who experience a less than optimal outcome have an internal conflict to resolve. Denying the problems is their way of coping. It’s easier psychologically than admitting to having made a bad, irreversible decision.

Another reason for reported satisfaction with LASIK is known as the Hawthorne effect, which states that patients may rate their level of satisfaction highly to please the surgeon.

An additional reason for the initial high rate of satisfaction with LASIK is this: When patients are contemplating undergoing LASIK, they may be due for an eye exam and new eyeglasses or contact lenses (virtually no one decides to get LASIK shortly after paying for a new pair of glasses). Because of this, they may not be seeing as clearly with their old eyeglasses or contact lenses prescription. So, when they have LASIK, it’s as if they updated their glasses and are suddenly seeing better than before. The difference is, with eyeglasses you can always get a new pair when your vision changes; but after LASIK, the outdated prescription is permanently lasered onto your corneas.

Dr. Edward Boshnick, a Florida optometrist who specializes in treating vision problems after laser eye surgery, estimates that roughly 80 percent of the failed LASIK cases that he treats were initially satisfied with their surgery but developed vision problems over time. He has treated hundreds of LASIK patients with post-LASIK corneal ectasia, a serious complication which may present many years after seemingly successful LASIK.

References:

  1. Solomon KD, Fernández de Castro LE, Sandoval HP, Biber JM, Groat B, Neff KD, Ying MS, French JW, Donnenfeld ED, Lindstrom RL; Joint LASIK Study Task Force. LASIK world literature review: quality of life and patient satisfaction. Ophthalmology. 2009 Apr;116(4):691-701.
  2. Sandoval HP, Donnenfeld ED, Kohnen T, Lindstrom RL, Potvin R, Tremblay DM, Solomon KD. Modern laser in situ keratomileusis outcomes. J Cataract Refract Surg. 2016 Aug;42(8):1224-34.
  3. Schallhorn SC, Venter JA. One-month outcomes of wavefront-guided LASIK for low to moderate myopia with the VISX STAR S4 laser in 32,569 eyes. J Refract Surg. 2009 Jul;25(7 Suppl):S634-41.

FDA Lifts, Then Dashes LASIK Patients’ Hopes

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

After a decade of stonewalling injured patients’ complaints about adverse reactions to LASIK vision-therapy laser surgeries, CDRH last week lifted their hopes for a change of heart at a one-hour meeting — then dashed them five days later in a 9/18 statement that doubled down on the agency’s existing position: LASIK is safe and effective for nearly everyone. At issue in the long-simmering controversy is the level of adverse effects that should be tolerated — FDA accepts industry claim of less than 2% while the patient group cites PMA data showing rates as high as 20%, pointing out that for a medically unnecessary, elective cosmetic procedure it should be close to 0%. LASIK marketers promote it as an alternative to wearing glasses.

Morris Waxler, the retired CDRH branch chief who approved the LASIK indication for the devices and led the patient group that met with CDRH 9/13, said the devices produce “2% catastrophic problems and 20% chronic daily pain and vision distortions.” FDA is “trapped by the facts and owned by industry,” he told FDA Webview in an email after the meeting. His presentation recited data in AMO Manufacturing, Nidek and Alcon PMAs showing that 2% of patients have worse than 20/40 vision without glasses 12 to 24 months after surgery, 2%-20% had vision distortions 6-12 months or longer after surgery and a similar number suffer dry and painful eyes 3-12 months after surgery.

Among other issues raised by the 6,000-member patient group was their characterization of an FDA-produced video on the agency’s Web site, LASIK Surgery and its Risks, as so “promotional” for the procedure that it could have been written by the LASIK industry. In a critique of the video, group member and former CDRH advisory committee consumer representative Paula Cofer cited the following excerpts:

Video: “Leaps and bounds have been made in advancements to LASIK in the last decade.”

Cofer: In terms of harm caused by the surgery, technological advancements in LASIK devices have made little differences in LASIK outcomes.

Video: “As in any surgery, there are risks involved.”

Cofer: A certain degree of risk is acceptable when the surgery is medically necessary. Because LASIK is unnecessary and performed on a healthy eye the acceptable complication rate should be virtually zero.

Video: “Most people are satisfied with the outcome of their surgery.”

Cofer: Short-term “satisfaction” is neither scientific nor a reliable indicator of LASIK safety or efficacy. Moreover, LASIK complications may present months or years after the surgery.

Video: “You may require additional surgery to get the desired outcome.”

Cofer: This statement recklessly minimizes risk of multiple surgeries for which the FDA has no data establishing safety and effectiveness. Retreatments are riskier than primary LASIK.

Cofer was especially critical of a government-funded post-LASIK quality of life study known as Patient Reported Outcomes with LASIK, also known as PROWL, published in the 1/2017 issue of JAMA Ophthalmology. She said LASIK surgeons with conflicts of interest “were involved in the study design and as investigators in the clinical arm of PROWL … key conclusions of PROWL are bogus, or falsely positive for LASIK.”

She told FDA Webview the group had hopes of a breakthrough with FDA after the agency agreed to meet with them, and based on informal interactions after the meeting, which was convened as an outgrowth of commissioner Scott Gottlieb’s patient outreach effort. Then came FDA’s 9/18 statement in an email from press officer Alison Hunt, who attended the meeting:

“We recognize the need to engage the wider stakeholder community and we value patient input. We are committed to ensuring that patients considering LASIK can make informed decisions based on objective information concerning the benefits and risks of the surgery. The FDA, in collaboration with the National Eye Institute and the Department of Defense, launched the LASIK Quality of Life Collaboration Project. The results of the studies conducted as part of this collaboration have demonstrated that more than 95 percent of participants were satisfied with their vision following LASIK surgery. However, importantly, of those participants with no visual symptoms before surgery, almost half reported at least one visual symptom at 3 months after surgery (most often halos). No more than 2 percent of all participants reported difficulty performing daily activities without corrective lenses due to visual symptoms (starburst, ghosting, halos, glare) after LASIK surgery.

“This is precisely the type of information that patients and providers need to make informed decisions about whether LASIK is appropriate for individual patients.

“As part of the Quality of Life Collaboration Project, Patient-Reported Outcomes with LASIK, or PROWL, studies were designed to fill a void that was not being addressed by any researchers in the ophthalmologic community. Their purpose was to evaluate questionnaire scales (including some newly created scales) to measure symptoms, patient satisfaction, and expectations before and following LASIK surgery. The studies did this and we have published the results in peer-reviewed publications (here and here). In the more than 500 patients studied, the development of debilitating symptoms after LASIK was uncommon. Over the last decade, via regular website updates, presentations at professional meetings and other public communications, the FDA and its partners have kept the public informed throughout the study process to reflect agency activities, progress and plans for the study. As with any area of study, more research will help further our understanding of the benefits and risks of this procedure.

“The development of a scientifically rigorous and validated questionnaire was a resource-intensive and complicated task. The questionnaire can now be used to consistently assess the prevalence of visual symptoms in LASIK patients. Multiple studies and clinical sites are already utilizing the questionnaire to assess clinical outcomes in patients undergoing LASIK and we anticipate that most future studies submitted to support marketing approval of LASIK devices will utilize the PROWL questionnaire (in whole or in part) to ensure that the public continues to have access to objective, useful information concerning the symptoms associated with LASIK.

“The FDA reminds patients considering the LASIK procedure to thoroughly discuss the benefits and risks of the procedure with their health care professional. The FDA has made a significant amount of consumer-focused information available on its website about the benefits, risks and expected outcomes associated with LASIK.

“Our work with LASIK is ongoing. In addition to transparently communicating the results of the PROWL studies as described above, we have incorporated the studies’ findings into our device review program. In addition, we are in the process of developing a LASIK patient labeling guidance that will provide recommendations to industry about how to clearly communicate risks of LASIK to patients. As we continue to monitor the safety and effectiveness of LASIK we will also explore additional ways that we can improve the quality of information available to the public about LASIK and ways to ensure that FDA receives better information about problems with LASIK.

“For more information, please see: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/default.htm”

Cofer commented: “I am extremely disappointed in FDA’s statement. I actually thought that the FDA listened to us, and I left the meeting hopeful for the first time in 10 years. Today those hopes were dashed because the FDA continues to parrot the LASIK industry’s misleading claims of high patient and stands behind its faulty analysis of PROWL.”

Waxler commented: “Notice FDA did NOT provide even one complication rate! They make vague references to risk/benefit with absolutely no numbers. The PROWL study was conducted under the best conditions and they found 2% had persistent difficulties with daily vision tasks. They continue to promote LASIK. Pathetic response from a public health agency.”

FDA Meets with Patients Advocating LASIK Ban

NEWS RELEASE

September 7, 2018

Contact: Morris Waxler, PhD, 608-219-7947, morriswaxler@gmail.com

Mark your calendar for a news conference with a group advocating a ban on LASIK eye surgery. The news conference will take place on September 13, 2018 from 1:00 to 2:00 PM, in the Maple Room at the Sheraton Hotel, 8777 Georgia Ave., Silver Spring, Md. Prior to the news conference, the group will meet with FDA officials at the FDA’s White Oak facility in Silver Spring, Md.

A lover of golden retrievers, Eminem and red sports cars, Max Cronin, 27, of College Station, Texas, had only begun to check off his life’s goals. After serving in the Iraq War, he was studying for a degree in engineering. Before he left the Army, though, in 2011, he had LASIK eye surgery.

Cronin’s ophthalmologist convinced him that LASIK (laser in situ keratomileusis) was a low-risk way to correct his near-sightedness and ditch his glasses. The surgery triggered a four-year deterioration of his vision. In 2015, a second surgeon gave him an “enhancement” surgery to improve his vision. It left him visually-impaired and gave him excruciating, constant pain. Six months later, he committed suicide.

Now, Cronin’s mother, Dr. Nancy Burleson, will be one of five members of the LASIK Complications Facebook Group who will meet with representatives from the FDA’s (U.S. Food & Drug Administration) Division of Ophthalmic and Ear, Nose and Throat Devices on September 13 in Silver Spring, Md. The Division regulates devices for corneal refractive surgeries including LASIK, photorefractive keratectomy (PRK) and small incision lenticule extraction (SMILE).

Burleson is an obstetrician/gynecologist in Gonzales, Texas.

“This is the first time the FDA has agreed to meet with us,” said Paula Cofer of Tampa, Fla., who founded the 6,100-member LASIK Complications Facebook Group in 2014 to give voice to people who have been harmed, she said, by corneal refractive surgeries. “Our membership grows daily because doctors convince patients these are safe surgeries. In fact, they can cause intractable, severe pain; corneal ectasia [deformity], chronic dry eyes, night vision problems and vision loss.”

Cofer’s LASIK in 2000 resulted in painful dry eye, astigmatism and impaired night vision.

The group also includes people who have had their LASIK-damaged eyes removed and people like Burleson whose family members committed suicide after being unable to live with LASIK-induced pain and vision loss.

About 300,000 Americans have corneal refractive surgeries each year, according to Market Scope. In total, about 10 million Americans have had these surgeries to date. About 14,000 complaints about these surgeries have been filed since 2013 with the FDA’s online MedWatch. “Unfortunately, most people aren’t aware that bad outcomes from LASIK should be reported to the FDA, so most LASIK-injuries are never counted. But the larger problem is, the FDA ignores the thousands of reports that have been filed,” said Cofer.

In addition to Burleson and Cofer, those representing the LASIK Complications Facebook Group will include Dr. Cynthia MacKay, a New York, N.Y., ophthalmologist; Morris Waxler, PhD, a Madison, Wis., neuroscientist, and a patient who will tell her post-op story but wants her name withheld.

The patient agreed to be part of an FDA study to approve SMILE in 2013. She chose to have SMILE in one eye and LASIK in the other. The surgeon assured her that complications are rare. Immediately after surgery, she had pain, but the surgeon shrugged it off. “I was suicidal within weeks because I couldn’t get relief,” she said. “I finally found a medication that gives me partial pain relief, but my vision is poor and it can’t be corrected with glasses. I can no longer work and I’ve lost my independence.”

Waxler was the FDA official who approved the original LASIK device in the 1990s. “When I retired, I was shocked to see the widespread harm that LASIK had done,” he said. “I re-analyzed the FDA’s data and, in 2011, petitioned the FDA to issue public warnings about LASIK and rescind its approval of LASIK devices.” The FDA rejected his petition. Waxler now advocates for LASIK-impaired people.

MacKay is one of only a few ophthalmologists in the U.S. who speak to the media about the perils of LASIK, though they discuss it among their peers, according to her website. Before she retired this year, she treated post-LASIK patients and learned of 11 LASIK-related suicides.

“After years of inaction,” said Cofer, “we’re demanding the FDA move the focus from the interests of powerful ophthalmologists to real people’s suffering.”

Cofer and her colleagues will propose an Action Plan that includes these deadlines:

  1. Within 30 days, the FDA and doctors must quit deceiving potential patients with promises of zero side effects and, instead, warn the public about the true severity and prevalence of side effects, which is about 20 percent.
  2. Within six months, the FDA must convene a panel on care and compensation of LASIK-injured patients, many of whom have lost their jobs and can no longer pay their medical bills.
  3. Within six months, the FDA must ban these surgeries, before any more lives are destroyed.

The group will also ask the FDA to quiet the equipment manufacturers’ and doctors’ touting of the “new technology” as “better,” when the SMILE patient who will attend this summit is evidence that new isn’t necessarily better.

In 2008, the FDA heard a panel of corneal surgery patients tell their post-op stories and plead for the banning of these surgeries. But nothing happened.

“Look at all the people whose lives were destroyed since 2008,” said Cofer. “This time, we have to succeed. If only the FDA could meet with LASIK-injured patients at least as often as it meets with the doctors who profit from these procedures.”

Most important, Cofer plans to tell her FDA audience: “LASIK is inherently harmful. Before LASIK, our eyes are healthy. Yet, the Hippocratic oath says, ‘First, do no harm.’ This doesn’t make sense. The FDA can begin by acknowledging this.”

FDA will be represented by the following officials: Dr. Malvina Eydelman, CDRH/ODE Director, Division of Ophthalmic and Ear, Nose, and Throat Devices; Dr. William Maisel, CDRH Acting Director, Office Of Compliance, Director, Office of Device Evaluation and Chief Medical Officer; Dr. Jose Delgado Donayre, CDRH/OSB Associate Director for Post Market Surveillance and Ken Skodacek, CDRH Deputy Ombudsman.

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THE TRUTH ABOUT LASIK

by CYNTHIA J. MACKAY, M.D., OPHTHALMOLOGIST

Few ophthalmologists are willing to have LASIK done on their own eyes, but almost none will discourage his or her patients from having it done on their eyes. I am one of the very few ophthalmologists who is willing to speak out publicly against LASIK.

Like most doctors, I am reluctant to criticize my fellow doctors. I know how challenging it is to give good care, and I always want to give others the benefit of the doubt. This may be why other eye doctors will not criticize LASIK publicly, although when I talk to them in private they readily admit how dangerous this procedure is.

I was one of the first people in the world to hear about LASIK. I was in the Eye Clinic at Presbyterian Hospital in the early 1980s, examining a patient, when Dr. Steve Trokel burst into my room. He shoved a piece of paper into my hands, plopped himself into a chair, and began to talk. I had never seen him so excited.

I realized at once Steve’s paper showed an electron microscope photograph of a cornea. (The cornea is the clear, curved window in the front of the eye.) A perfect rectangle, sides straight as a ruler, had been sliced into this cornea. Steve told me this rectangle was created using an ultraviolet excimer laser. I was impressed. I realized this excimer laser could shave the cornea with unbelievable preciseness, molecule by molecule.

I liked and respected Steve. His restless mind was always churning out new ideas. He had made a name for himself pioneering the use of the MRI to diagnose and treat diseases of the bony structure around the eye, which is called the orbit. His work greatly improved the ability of ophthalmologists to treat orbital diseases.

I listened with fascination as Steve explained his new cornea-shaping technique. The thought crossed my mind I might have this procedure myself someday, to eliminate my nearsightedness.

After Steve ran into the next room to show his picture to another ophthalmologist, I began to have reservations. What he said was far too simple. The more I thought about what he was planning to do, the more doubtful I was it was a good idea.

One of the major flaws, in my view, was that this technique would make the cornea thinner. Thin corneas are weak corneas – more likely to be injured and/or develop other serious problems. It would also create a huge wound in the cornea. A wounded cornea repairs itself by forming scar tissue. A cornea covered with scar tissue will not see well. Also, I knew the cornea has no blood supply, and therefore it would be notoriously slow to heal.

The worst flaw was how much pain this procedure would cause. Any injury to the cornea – for example, a corneal abrasion – is excruciating, because the cornea has more nerve endings than any other part of the body. Anybody who has accidentally scratched a cornea knows about this problem.

I decided Steve’s idea was great in theory, but it would never catch on because the side effects would be too horrific. I was wrong. I had vastly underestimated the desire of the public to get rid of their glasses. There is a huge market for cosmetic surgery, and that is what LASIK is — cosmetic surgery.

What exactly is LASIK, and why has it become so popular? LASIK is a cosmetic procedure that changes the curve of the cornea in order to “cure” refractive errors of the eye, such as nearsightedness, farsightedness, and astigmatism, and thereby eliminate the need for distance glasses.

During LASIK, the corned is carved into a new, different shape with an ultraviolet laser called the excimer laser. There is so much confusion about lasers and LASIK a brief explanation is in order.

Lasers have been used to treat the eye since the 1950s. Here is a description of the different kinds of lasers used by me and my fellow eye surgeons. Some of these lasers are designed for use in the front part of the eye, or anterior chamber. Others are used in the back part, or posterior chamber. The excimer laser – the laser used in LASIK – treats the cornea, which covers the anterior, or front, part of the eye.

The first laser used in the human eye was a ruby laser, not an excimer laser. The argon laser soon supplanted the ruby laser. The argon laser treats the retina, in the back chamber of the eye.

The argon laser puts minute spots of heat – typically one half to one quarter the size of the head of a pin – into the retina with exquisite precision. This technique is called “photocoagulation”, i.e. curdling tissue using light energy. These tiny spots of heat destroy abnormal and leaking blood vessels with stunning precision, and thereby restore and save sight.

The argon laser is a genuine miracle. It has revolutionized the treatment of a major cause of blindness across the world: diabetic eye disease. An estimated 4.1 million Americans have diabetic retinopathy, and a million of these have vision-threatening retinopathy. Among US adults who are 20–74 years old, diabetic retinopathy is the number one cause of blindness, according to the CDC. Since these years are the peak ages for working, untreated diabetic retinopathy has major economic consequences.

The results of the first randomized trial of the argon laser to treat diabetic retinopathy were reported in 1976 – two years before I began my eye residency. The researchers stopped the trial early because it was obvious patients who had been treated with the argon laser were doing much better than untreated ones.

Before the argon laser, all diabetics who developed retinopathy eventually went blind. Since the argon laser came into use, they almost all keep their vision – if their retinopathy is diagnosed and treated early. An estimated 50% of patients with diabetic retinopathy are not getting yearly eye exams. These people are often diagnosed too late for treatment to be effective.

The argon laser is also used to treat other blinding retinal diseases, such as retinal tears and detachments, vein occlusions and sickle cell eye disease. We once used this laser to destroy the abnormal blood vessels of wet macular degeneration, but now we inject a drug into the eye that inhibits these abnormal vessels. This drug is more effective, and less risky, and it has fewer side effects.

This laser has saved the sight of millions of people. There is an argon laser in every major eye hospital in the world today.

Another laser, the Nd:YAG laser (which stands for Neodymium-doped Yttrium Aluminum Garnet), works via photo-disruption, not photocoagulation. Instead of heating tissue, the YAG laser sends extremely short (10 to 25 nanosecond) pulses of infrared light into the anterior chamber. (A nanosecond is one billionth of a second – this technology is so advanced it makes the head spin.) These pulses create miniscule explosions that cut through anything in their path.

The YAG laser revolutionized the treatment of angle closure glaucoma. In this disease, pressure builds up inside the eye because the iris – the colored part of the eye – covers the drain and blocks it. Angle closure is treated by cutting a hole in the iris, which unblocks the drain.

When I was in my first year of residency, all surgeons treated angle closure glaucoma by putting the patient under general anesthesia, slicing the eye open, cutting out a chunk of iris, and then sewing the eye up again. This procedure produced a lot of bleeding, and a cataract would inevitably form within a few years. Of course, this operation made the eye vulnerable to infection.

When I was in my second year of residency, eye surgeons began to use the YAG laser to punch a hole in the iris and unblock the drain. What an improvement – minimal bleeding, no anesthesia except for one numbing drop, zero chance of infection, quick (five to ten minutes) surgery, and almost no pain.

We also use the YAG laser to clear away the cloudy membrane that inevitably forms after modern day cataract surgery. After a period of time – the range is as early as a few weeks, to as long as many years, but is usually three to five years – the capsule of the old lens, which holds the new clear plastic lens in place, clouds up. The patient no longer sees clearly. A procedure called a YAG capsulotomy opens a hole in the membrane so the eye can see clearly again. A YAG capsulotomy is quick – three to five minutes – and painless.

Yet another eye laser is the selective laser. This laser treats open angle glaucoma, a disease where the drain of the eye clogs, causing the eye pressure to go up. The selective laser puts tiny spots of light into the drain of the eye. These spots open the drain and increase outflow, and the eye pressure goes down again.

All three of these widely-used lasers – argon, YAG and selective – are designed to be used in eyes with a serious disease that threatens to destroy vision. They are not used in normal eyes, and they are not used for cosmetic reasons. I use at least one of these lasers, at least twice a month, and they have allowed me to save tens of thousands of eyes that would otherwise be blind.

The excimer laser used during LASIK has a completely different purpose. Unlike the other three lasers, it is not designed to fix eyes that have a serious problem. It is used for purely cosmetic reasons: to eliminate the need for distance glasses. LASIK is the eye equivalent of breast augmentation, a tummy tuck, a face lift, or a nose job.

There is nothing wrong with eyes that have LASIK, except for the fact that they need glasses for distance. They see well before the procedure. They ought to see equally well after the procedure, but LASIK does not make eyes see any better. Although LASIK patients often do not realize their vision is worse, if they are carefully tested all eyes see less clearly after LASIK (see “Night Vision Disturbances after Successful LASIK Surgery”, British Journal of Ophthalmology, August 2007.) Patients are not told this nasty little fact.

LASIK is a cosmetic procedure, so it is not covered by most insurance. Medicare.com says “LASIK is not considered medically necessary; therefore, it is not covered.” LASIK.com states “Most insurance companies don’t cover LASIK…it is nearly always considered an elective or cosmetic surgery”. This means LASIK surgery is not subject to the price limits set by insurance companies.

Surgeons begin a LASIK operation by flattening the eye with a suction ring. This temporarily increases the pressure inside the eye to four times normal. Then they cut a flap off the flattened surface of the cornea, as if they were cutting a slice off a loaf of bread. Then the surgeons use the excimer laser to shave off part of the cornea underneath the flap, thereby changing its curvature. Finally, they place the flap back on the eye, and trust it will seal itself back onto the cornea again.

A similar procedure, photorefractive keratectomy, or PRK, also uses the excimer laser to reshape the cornea, but instead of making a flap the surgeons scrape off the top layer of the cornea. They then often put a toxic chemotherapy agent, Mitomycin C, on the cornea, to prevent haze. This drug is usually not mentioned in the consent form patient sign.

PRK was the first procedure approved to re-shape the cornea with the excimer laser. It is more painful than LASIK short term. Patients who have had PRK run the risk of all the other LASIK complications, although they do not suffer flap complications. Like LASIK, PRK is a purely cosmetic procedure.

My negative opinion of LASIK grew slowly, patient by patient, scientific article by scientific article, over many years. I saw many happy LASIK patients, but I saw more and more whose lives had been ruined.

I began warning the public about the dangers of LASIK surgery in the late 1980s. I was largely ignored. Then Dan Dorfman telephoned me out of the blue, and asked my opinion about LASIK. Dorfman was an infamous “stock picker” for CNBC. Stock market traders followed his comments closely. His opinion about a stock always caused its value to move sharply up or down.

I told Dorfman how terrible LASIK was, he reported my comments, and the next day the stock value of the excimer laser companies lost millions of dollars. Many LASIK surgeons retaliated by claiming I was “naïve” and did not know what I was talking about.

On May 18, 2008, I was interviewed by Dr. Jon LaPook, the CBS medical correspondent, for a piece about LASIK. I told him it was a horrible procedure and nobody should have it. On November 24, 2013, I discussed the many disastrous complications of LASIK on the Oz show. Both programs are on YouTube. Even that failed to discourage people from having it.

The problems of LASIK have been known for close to thirty years. Nothing has been done to curb this dangerous cosmetic surgery, and the public remains clueless about the dangers. Exhibit A: David Brooks, the New York Times columnist, wrote a column on January 13, 2017 that said: “LASIK eye surgery produces more patient satisfaction than any other surgery.” (He was using LASIK as an example of how free markets work to lower the price of surgery.) He could not be more wrong. I – and other LASIK activists – feel as if we have been talking into a vacuum.

Many of the 17 million people in the US who have had LASIK surgery are happy – at least for the moment– but many have suffered devastating side effects, including dramatically decreased vision, inability to see at night because of glare and halos around lights, excruciating eye pain that never goes away, and a weakened eye that can go blind after minor trauma.

All of the problems I foresaw when Steve first told me about LASIK have come true, and more have arisen that I did not anticipate. Today when I go to Google and type in “LASIK complications”, hundreds of pages come up.

I can personally testify LASIK has destroyed many careers. It has ended marriages. It has driven at least eleven victims to suicide. I know the names of seven of these victims. The names of four others have not been disclosed, at the request of the families. I also know the name of a woman who has had the contents of her eye removed to get rid of her unbearable pain.

A study published in 2016 in JAMA Ophthalmology confirmed a significant percentage of people who undergo LASIK develop new side effects. “To our knowledge, our study is one of the few that have reported the development of new visual symptoms” after LASIK, the researchers said.

In this study, the researchers followed two groups of people before, and up to six months after, they had LASIK. The patients filled out a web-based survey about their vision before they had LASIK, and several times afterward.

There was a major flaw in this study. One of the pre-op questions was: “Do you have glare and starbursts WITHOUT your glasses?” Almost all patients who are nearsighted – especially if they also have astigmatism – will see at least some glare, double vision, and starbursts WITHOUT their glasses. These symptoms disappear when they put their glasses on.

About two thirds of the patients reported some visual symptoms before surgery, so these patients were excluded from the tally of those who developed “new symptoms” after surgery. Result: the study statistics are –artificially – lower than they should be. It makes me wonder if the researchers had a bias in favor of making LASIK appear safer than it is.

Overall, people’s ability to see small letters on the eye chart without glasses did improve after LASIK. However, in the subset of subjects – roughly one third – who reported no visual symptoms without their glasses prior to surgery, about 45% percent reported new symptoms three months after their surgery. These symptoms included double images, glare, halos and starbursts. Remember, this statistic is artificially low.

LASIK surgeons advertise heavily. An ad from the “LASIK Vision Institute” states: “Wouldn’t it be nice if you didn’t have to struggle to see the alarm clock in the morning? Wouldn’t it be better if you didn’t have to take out your contacts at night to go to bed? Wouldn’t it be easier if you could participate in fitness activities without worrying about breaking your glasses? It’s just a better way to live your life. “. The ads frequently guarantee patients will have perfect vision after LASIK. They often claim all patients will be able to throw away their glasses. Neither of these statements is true.

Most LASIK patients continue to use glasses after their surgery. In a 2009 Consumer Reports survey of 793 LASIK patients, almost two thirds of them still had to wear glasses or contact lenses, either some or all of the time, for either distance, or reading, or both. The FDA website on LASIK correctly states: “Only a certain percent of patients will achieve 20/20 vision without glasses or contacts”.

Vision is far from perfect after LASIK, even in the lucky patients who see 20/20 without glasses. The FDA website states: “Some patients lose lines of vision that cannot be corrected with glasses or contact lenses.” It would be more accurate if it said: “All patients lose some vision after LASIK.” All LASIK patients lose – permanently – the ability to distinguish between subtle shades of grey, which is called “contrast sensitivity”, and all have night vision disturbances.

The reason LASIK patients inevitably lose contrast sensitivity is that when the flap is replaced back on the cornea after LASIK, it heals into place by creating multiple tiny scars. This means that LASIK patients look at life through scar tissue. Now they are looking through frosted glass instead of clear glass. One LASIK patient said: “I feel as if I am looking through Vaseline.”

LASIK surgeons measure visual acuity in dim light using high contrast black letters on a white background. That isn’t the way we see in the real world. Objects are not all pitch black with straight crisp sides standing out against a clear white background. Our eyes have to distinguish between multiple subtle gradations of color and form in the real world.

LASIK surgeons take a cornea that has a smooth curve – a perfect dome – and convert into a plateau. After LASIK, all corneas have two curves: a flatter curve in the center, and a steeper curve in the periphery. The new, reshaped, central part of the cornea focuses incoming light directly on the retina. The peripheral part focuses light either in front of the retina, or behind it.

As a result, all LASIK patients have at least some double images, ghost images, halos, or starbursts around lights, even if some of them do not recognize these changes.

This distortion is especially marked in dim light, when the pupil dilates and the peripheral cornea comes into play. All LASIK patients take some risk when they drive a car, or pilot a plane, at night. I believe all LASIK patients should have drivers and pilot licenses that restrict them to day driving and piloting. They are a danger to themselves and others at night. The irony is airline pilots must have uncorrected vision of 20/20 to qualify for their job. If they do not, they often have LASIK. After LASIK, they may be able to see 20/20 with high contrast letters, but their actual vision is worse than before LASIK. I would not want to fly in a plane that is piloted by  somebody who has had LASIK. Nobody would.

LASIK surgeons define “success” as being able to see 20/40 in their office without glasses. By that definition, many miserable patients are “successes”. The unhappy patients I have seen would not agree with this definition of “success”.

One LASIK patient I know of had to quit her job as a theatre critic after she had LASIK, because she could no longer see the actors on the stage after the lights went down. An anesthesiologist I know had to retire because he could no longer see a chart in a dim operating room. LASIK destroyed their ability to do their job.

LASIK surgeons almost always do both eyes at the same time – a practice frowned on in other eye surgeries. Why do they do that? The patients who are most aware of the visual distortions caused by LASIK are the ones who have had LASIK in only one eye. They can compare their LASIK eye to their other eye, so they are aware how poorly they see out of their operated eye. Although they may not need glasses to see the eye chart, they know their vision is not good.

One of these one-eye-LASIK patients came into my office, saying: “I cannot see out of my LASIK eye. You have to give me glasses.” When I tested her eye in the usual way, using high contrast letters, her LASIK eye saw 20/20 without any correction. She was one of the lucky 33% of LASIK patients who do not need distance glasses.

The LASIK surgeons would call her a complete success, but she did not think her operation was a success. Like all LASIK patients, she had visual distortions, ghost images, and decreased contrast sensitivity, which do not show up in the usual office eye test.

“Glasses will not help you.” I told her. She stormed out of my office, saying she would get her glasses somewhere else.

Another problem created by LASIK is when the flap is replaced back on the cornea, it does not hold on as strongly as it did before (see J Refract Surg. Sept-Oct 2005). Even mild trauma – rubbing the eyes, being hit by a wave, contact sports – can dislocate the flap. The sight will instantly become blurred once that flap comes off. The dislocated flap must be replaced surgically as soon as possible.

LASIK consent forms rarely mention this, and LASIK patients who develop this problem swear their doctor never told them about it. I tell all my LASIK patients they must wear eye protection during contact sports, and goggles while swimming. I am not the one who should be warning them about this. This is the responsibility of the surgeons.

Because the flap never heals down completely, bacteria can easily creep inside the cornea – even many years after the surgery. (See Vieira et al, 2008.) All LASIK patients face a life-long increased risk of cornea infection.

Another disturbing problem is that the cornea is not an inert sheet of plastic. It is a living structure that continues to grow and remodel throughout life. Result: vision after LASIK is often not stable.

In many cases, LASIK eyes go right back to being nearsighted again within a few months or years. Other eyes go in the opposite direction, and become far sighted. I have several LASIK patients who are more far sighted every year they come to my office, and their eyes show no evidence of stopping. Again, many LASIK consent forms do not warn patients about this.

One of the major problems I foresaw when Steve Trokel first told me about LASIK was that LASIK makes corneas thinner. Some patients have corneas that are unusually thin to begin with. Their corneas will relentlessly bulge outwards in the trimmed area after LASIK (see Clin. Ophthalmol. 2012, 6:1801-1813). This problem is called “ectasia”. (In rare instances, ectasia is caused by a hereditary eye disease, keratoconus.)

As ectasia gets more and more pronounced, the eye becomes more and more nearsighted, and it develops marked irregular astigmatism. Glasses and soft contact lenses cannot correct vision destroyed by ectasia.

The world got an accurate picture of the incidence of ectasia when a company called Avedro, Inc. went public in 2016. Avedro is a medical device and pharmaceutical company that sells a drug-device combination treatment that performs cornea collagen cross-linking, using riboflavin and ultraviolet light. Avedro claims this treatment stiffens the cornea and – supposedly – halts the progression of ectasia. In a press release in July of 2016, Avedro stated that 160,000 patients in the U.S. are affected with “corneal ectasia following refractive surgery” [i.e. LASIK and PRK].

In February 2015 only 100 cases of ectasia had been reported in the literature. Where did Avedro get the number 160,000? There is only one possible source: the LASIK surgeons. One LASIK surgeon said recently at a cornea research meeting that surgeons don’t report ectasia to the FDA because of the risk of lawsuit.

Another major problem I foresaw after LASIK was pain, but I had no idea how bad this pain would be. LASIK cuts the many tiny nerves that run through the cornea and keep it healthy. Once these nerves are cut, they never grow back normally. (See Am. J. Ophthalmol, Dec 2005; Optom. Vis. Sci Sept 2015). They fire constantly, causing what is called “neuropathic pain”. This same phenomenon occurs when a patient loses a limb. In this case it is called: “phantom pain”.

All patients will develop at least some neuropathic pain after LASIK. Neuropathic pain causes a foreign body sensation, burning, and dryness. Some LASIK patients must put wetting drops in their eyes several times every hour. Yes, I mean every hour. Walk into any drug store and you will see shelves full of artificial tears labelled “For LASIK dryness”.

LASIK patients are frustrating to treat because there isn’t anything an eye doctor can do for a LASIK damaged cornea. LASIK patients are angry, and I would be angry too if I were in their position, but instead of blaming their LASIK surgeon, or getting upset at themselves for not doing the proper research, they often get angry at me. They assume I am being perverse when I tell them I cannot help them. The only thing I can do is listen and sympathize. Actually, that sometimes does help some of them.

A chilling story was told at the FDA committee hearing on LASIK in April, 2008. Larry Campbell, a police officer, killed himself because he could no longer live with the constant pain and blurred vision he suffered since he had LASIK. His suicide note states: “The pain, distorted vision, chronic dry eye is not bearable … Do not have LASIK surgery! Tell the media!”

A mother, who is a doctor herself, sent me the following letter about her son:

“My son, Max Cronin, age 27 years old, committed suicide 1-14-16, as a direct result of complications he experienced from Lasik. He left suicide letters stating this. He kept details of his complications… vision loss, constant eye pain, dry eyes, haze, and loss of quality of life resulting in depression and his suicide. He was unable to work or continue his life goals due to his eye complications.

As a medical physician, I can definitely state that Lasik complications can lead to suicide. I can also say that no one should have elective Lasik on their eyes.

For an elective procedure, the risks and long term complications are understated. The resultant complications and negative quality of life issues increase the risks of depression, attempted suicide, and suicide.”

Nancy L. Burleson MD FACOG, Gonzales, Texas

I do not understand why so few of my fellow ophthalmologists will inform patients about the complications of LASIK. Surely, they must have some empathy for all the suffering people who have been damaged by this procedure. Most seem to accept without question the right of LASIK surgeons to operate on patients who have no idea of the risks they run when they sign up for LASIK.

I can only speculate this elective surgery is so financially beneficial their judgement is affected.

The most accurate statistics about LASIK complications I am aware of come from a citizen’s petition filed by Morris Waxler with the FDA in January of 2011. Morris formally asked the FDA to revoke its approval of LASIK. Ironically, Morris knew all about the process by which LASIK had been approved, because he was the chairman of the FDA committee that approved it in 1998.

Morris was the FDA’s chief scientist in charge of all clinical research trials. When he retired from the FDA, more and more miserable LASIK patients began to contact him. He knew something was not right. He re-examined the original documents filed with the FDA by the LASIK surgeons and LASIK manufacturers – the ones presented at the time LASIK won approval – and he became convinced that the FDA had been, in his words, “hoodwinked”.

Morris discovered what the LASIK industry had called “temporary side effects” were permanent and devastating injuries. The actual data the LASIK surgeons presented to the FDA showed that twelve months after LASIK almost 60% of patients had fluctuating vision in dim light, 50% suffered from gritty eyes, and 20% had problems driving at night.

Morris heard I was one of a handful of ophthalmologists willing to speak out about the dangers of LASIK. He asked me to go with him to Washington, D. C. on September 22nd, 2010 to testify before the FDA about LASIK complications. I cancelled all my appointments, and went.

Morris told the FDA committee about the misleading statistics that tricked him into recommending LASIK be approved, and why he had changed his mind. I told them how the cornea behaves when it is wounded, and why the side effects are unavoidable and disastrous. I also told them about my many patients whose lives had been ruined by this procedure. ABC News ran a special about Morris’ testimony that evening.

Today there are thousands of MedWatch complaints on file with the FDA about LASIK injuries. Three quarters of them involve dry eyes, poor vision at night, and decreased visual acuity. There are over 1,200 signatures on a petition to stop LASIK. Many of the patients make heart-breaking comments. (See Petition to Stop LASIK). Despite all the evidence, the FDA has not revoked its approval of LASIK.

LASIK is an extremely dangerous procedure. Patients have no idea of the risks they are running, because the consent forms they sign before they have LASIK is deceptive and inadequate. The risks are not explained in clear English, with the percentages of each risk.

If I designed a consent form for prospective LASIK patients, I would say this:

LASIK IS AN ELECTIVE COSMETIC PROCEDURE.

  • If you have LASIK, there is less than a 50-50 chance you will be able to throw away your glasses, according to a 2009 Consumer Reports survey.
  • Even if you see better at distance, you will have other problems you did not have before LASIK. For example, people over forty years old will almost always have to wear reading glasses.
  • There is a 100% chance you will no longer be able to distinguish between subtle shades of grey.
  • There is roughly a 50% chance you will develop a painful dry eye. This means your eyes will constantly feel as if sand is pasted inside your lids, and they will burn as if you have hot pepper sauce in them. The chance this pain will be with you for the rest of your life is close to 100%.
  • There is a significant chance you will no longer be able to function in dim light. You may have to give up driving at night and going to the movies. If your job requires functioning in dim light, you may become permanently disabled.
  • LASIK permanently bends, thins and weakens the cornea, which can lead to ectasia. Ectasia is a progressive steeping, or bulging, of the cornea – rather like a hernia, or a tire that has a weak spot. As the weakened cornea is progressively pushed further and further out, the eye develops irregular astigmatism that cannot be corrected by glasses or soft contact lenses. Ectasia can develop twenty-five years after apparently successful LASIK.
  • To cap it off, your eye is likely to go right back to being nearsighted, or it may even become farsighted. Some eyes continue to fluctuate in vision for as long as twenty-five years.

The LASIK consent forms today are nowhere near this detailed and specific. These problems are sometimes mentioned, but the forms do not give percentages, and they are not written in plain language so the patients do not understand them.

If the risks were explained to each patient like this, in plain language, with the percentages of each risk included, nobody in their right mind would have this procedure.

I will close with a recent letter from a LASIK-damaged patient. She had PRK, i.e. LASIK without the flap:

“You have renewed my faith in the medical industry. After meeting with many ophthalmologists (private and at teaching hospitals) to try to find some relief from my PRK complications, you are the first M.D. I have been exposed to that has questioned the PRK/Lasik outcomes. I have had some that said they would not have it themselves, but they still recommend the procedure to others.

My purpose in writing is to bring to your attention another documented complication (and longer term, so it is never talked about.) This is the fact that LASIK/PRK patients as a group develop cataracts much sooner than the general public.

I had bilateral retinal detachment after my PRK. At the age of 57, seven years after my PRK, I was diagnosed with a steroid induced cataract by my retina specialist. (The only steroids I have ever used were after my PRK and the enhancements.)

Before my surgery I could find no one unhappy with the surgery, and after my surgery they seemed to be everywhere. But people will not hear what they do not want to.

I tell everyone I know who is contemplating the procedure to at least record (not secretly) the conversations with their surgeons. I believe the discussion will follow much more the list that you have described and that I recently saw on my Facebook support group. (Even WebMD and MAYO Clinic websites, where I started my research, portray a surgery where all side effects are short lived and, as you know, there really are no long-term studies.) I do feel like this is a public health debacle with young people risking their life-long eye health to problems that will sometimes not show up for years.

Thank you for helping to inform the public. You are a light shining in darkness!”

A study in the February 2015 edition of the Journal of Cataract & Refractive Surgery found that LASIK patients undergo cataract surgery up to 15 years sooner than people who have not had LASIK.

I get nothing from telling the truth about LASIK except the criticism of my peers, but I could not live with myself if I did not do it. I went into ophthalmology to heal sick eyes. LASIK takes healthy eyes, and turns a hefty percentage of them – in some studies, 100% – into sick eyes.

I remember how incredulous I was at my medical school graduation in 1977 when Dr. Lowell Bellin, New York City’s chief health officer and self-described “medical cop”, told my class that some doctors do not put their patients first. Now I have proof that LASIK surgeons do not care about their patients. Instead of doing good, they do harm. They destroy eyes instead of healing them. I am turning into a medical cop myself.

Bottom line: the less eye surgery, the better. No eye surgery should be done unless there is a pressing need. If surgery is done to save sight – retinal detachment surgery, for example – we accept the risk. Getting rid of glasses is not a pressing need.

The increasing number of malpractice suits against LASIK surgeons shows LASIK is giving ophthalmology a bad name. Ophthalmologists should save sight, not destroy it. Speak up, my fellow ophthalmologists, and share your reservations. The world is watching.

I have watched damaged LASIK patients cry uncontrollably in my office. They howl they trusted their doctor, and their doctor betrayed them, never warned them this could happen to them. I want to drag every LASIK surgeon into my office, one by one, chain them to the furniture, and force them to listen to this suffering human being until they vow they will never perform LASIK again.

The best way to stop LASIK, in my opinion, would be to require all LASIK surgeons to have the procedure before they are allowed to perform it on others.

 

Violative Medical Device Ads: Why FDA Doesn’t Act

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.
01/04/2017

(Report by Jim Dickinson) FDA has statutory authority to regulate the advertising and promotion of “restricted” medical devices, but even in the face of injured patient complaints, it’s an authority it rarely uses. That’s probably because in the broad sweep of device safety issues and recalls that grab headlines and congressional attention, complaints about ads from injured patients directly to the agency’s Center for Devices and Radiological Health are few and far between. And that’s probably because injured patients don’t know that CDRH is supposed to be regulating violative device ads.

One injured patient, however, does know and in November she complained to CDRH about a violative ad by LASIK (laser-assisted in-situ keratomileusis ) eye surgeon T. Hunter Newsom, in Tampa, FL. A former FDA advisory committee consumer member, injured Tampa LASIK patient Paula Cofer complained that Newsom’s Web site omitted all risk information in extolling the benefits of his new Wavelight laser by Alcon Laboratories. CDRH regulatory counsel Deborah Wolf responded that she’d referred the complaint to the Allegations of Regulatory Misconduct Branch, with the suggestion that Cofer communicate directly with them.

When Cofer did so, she got an email form letter saying “FDA does not provide information on ongoing investigations. Such information can be obtained pursuant to a Freedom of Information Act (FOIA) request once an investigation is closed … Please note that on average, investigations take a minimum of six (6) months to complete.” There was no information on how Cofer could learn of the investigation’s completion, other than the unsaid implication that she could begin inquiring on her own schedule after the minimum six months.

For the FDA-savvy Cofer, this was “Unbelievable!” For injured patients without FDA familiarity it would likely be plain impossible, given (a) their unawareness that FDA even has a role in false or misleading medical device promotional claims enforcement, and (b) their inability to discover who at FDA might handle such complaints.

There was a time when CDRH took this issue a little more seriously than it does now. In September 2011, hard on the heels of an acrimonious campaign by injured LASIK patients against LASIK surgeons’ violative promotions, then-CDRH compliance director Steven Silverman issued a Dear Eye Care Professional letter politely urging them to be mindful of the law. In it, he reminded them that this was the second time in two years that FDA had taken this direct approach to their promotional practices. He gave them 90 days to comply with the law.

“After that time,” Silverman wrote, “the FDA may take regulatory action against eye care professional whose advertisements or promotional materials violate the FD&C Act. Agency actions may include Warning Letters, product seizures, injunctions and civil money penalty proceedings.”

Actually, this was CDRH’s third attempt to bring the LASIK practitioner community into compliance. The Center sent a similar letter separately to the community’s national body, the American Society of Cataract and Refractive Surgery.

Cofer and the earlier prolific complainers among the LASIK injured patient community say these efforts had no effect on the number of deceptive promotions and advertising by practitioners. Indeed, since Cofer complained about Newsom, she says she has found three additional active violative Web sites belonging to the 37-state, 68-center LASIK Vision Institute, California-based Saroudi Advanced Lasik and Eye Centers, and surgeon Manoj Motwani.

For ongoing and proliferating violations dating back more than seven years, why doesn’t FDA do more than say it can’t confirm or deny the existence of its investigations and invite FOIA requests after an investigation is complete? Probable explanations include ꟷ if the agency allowed itself to publicly discuss the matter: (1) Lack of resources to prosecute so many cases which have comparatively few reports of actual harm; (2) the agency’s dismal track record in court cases involving First Amendment issues (which LASIK surgeons would surely invoke if prosecuted); (3) the need to defend its failure to aggressively address the related issue of permanent eye injuries in a small minority of LASIK patients who were deceived; and (4) lack of congressional and media interest.

While LASIK may be dismissed as an isolated case because of its elective nature, other areas of violative promotional activity among users of restricted devices may be encouraged by its example. That’s a bet FDA appears to be confident in making.

Shuren Promises Action on Suicidal LASIK Patient

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.
6/10/2016

Although CDRH has repeatedly refused in the face of mounting adverse reaction/injury reports to remove the LASIK indication from lasers labeled for that vision-enhancement indication, Center director Jeffrey Shuren 6/10 took less than 40 minutes to tell a LASIK activist CDRH would “look into” a patient’s report that he/she was considering suicide because of LASIK injuries. The call on Shuren came in an email from LASIK injured patient/activist and former CDRH advisory committee consumer representative Paula Cofer, who in two months ago launched a nationwide Internet petition for Congress to fire Shuren over the LASIK issue and his purported “capture” by industry. Continue reading →

Hundreds Petition Congress to Fire CDRH’s Shuren

04-14-2016
Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.

An Internet petition to Congress authored by LASIK injured patient/activist and former CDRH advisory committee consumer representative Paula Cofer has drawn more than 270 signatures from across the country in its first 24 hours, demanding the removal of CDRH director Jeffrey Shuren from office. Last October, Cofer and some of the current signatories were involved in a 1,500-message email blitz of Shuren’s government in-box calling on him to resign. Shuren and FDA shrugged off that campaign. Now Cofer and her supporters want Shuren fired by Congress. Their petition charges that his leadership has seen the Center “become mission-corrupted, placing industry interests over public health.

“Failures of the CDRH,” it continues, “have harmed countless people and led to many preventable deaths. CDRH is ‘captured’ by industry. Division managers at the CDRH have close working relationships with representatives of medical device manufacturers. Fraud and data tampering occurs regularly in FDA clinical trials of medical devices. The CDRH’s oversight of device trials is weak and ineffective, leading to approval or clearance of unsafe devices.

“Post-market surveillance by CDRH is lax,” the petition goes on. “Problems with medical devices go undetected, which leads to injuries to unsuspecting American citizens. Patient advocacy groups and whistle-blowers who reach out to the CDRH to raise a red flag about problems with a medical device have been shut out or ignored. MedWatch reports of device-related injuries fall into a black hole at the agency.

“We call on the United States Congress to remove CDRH director Jeffrey Shuren from the FDA so that a new leader can take his place. A new CDRH leader must honor the agency’s mission to protect and promote the public health.”

Among numerous comments signatories have posted to the petition are some Cofer characterizes as “brutal” about Shuren. They include this from a Tara Howie in New Jersey:

“In 2011 Shuren, when asked about the 510(k) process, Shuren said he doesn’t know where precisely it is going, but it certainly won’t be scrapped. He believes the system works well, although he knows there are those in the industry with ‘angst’ about the program — and he has seen this concern increasing. But the largest challenges pertain only to a small minority.

“This is my biggest problem with Shuren,” Howie’s comment continues, “the 510(k) process is a legal loophole for untested devices to go straight to market without any pre-market testing, simply based on the fact the device resembles a predicate device. Having had a device implanted that was based on a predicate device that was pulled from the market, yet the devices in me were not shows exactly where a huge problem exists.

“Is Shuren that shortsighted? I think not. In his time at the CDRH he has lied (kinda) under oath, he has pushed his agenda, one that benefits him, yet leaves the consumer, frankly, screwed. The ‘small minority’ Shuren speaks of is not too small actually. Perhaps in his limited view of everything that doesn’t pertain to him, or the lobbyists he’s been making extremely happy, it is small, but if you ask thousands and thousands of consumers what they think of the way Shuren has decided to run the CDRH, they will undoubtably tell you there are many, many problems. Not only ‘minor’ ones.

“How can anyone within the FDA, or specifically the CDRH, be trusted when they work so closely with representatives from medical device manufacturers? The writing is on the wall so to speak. And it’s well past time to make the changes necessary to protect the consumers, and not the wallets of the medical device industry. Greed in this country is putting dollars before clear, rational thinking. And it’s time to change this, along with the leadership at the CDRH, beginning with Shuren, and all of his cronies. Let’s put people back into the conversation, the consumers, the patients…But, don’t ask the thousands of already deceased ones, just ask their families.”

Cofer says her petition is being followed by Pennsylvania Republican congressman Mike Fitzpatrick, and she hopes he will bring it to the attention of his colleagues. Fitzpatrick has strongly supported injured patients’ criticisms of Shuren and CDRH safety management in the power morcellator and Essure birth control controversies.

FDA spokesman Eric Pahon would say only that the agency “is aware of the petition.”

Despite Protests, FDA Hangs Tough on LASIK

9/9/2015

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

Despite continued agitation on the part of patient activists claiming injuries from LASIK vision correction procedures, FDA said 9/9 it has “not found any new safety concerns associated with LASIK devices to lead it to believe that there is no longer a reasonable assurance that these devices are safe and effective under the conditions of use in the labeling of the device.” The statement came after FDA Webview asked why the agency had not responded to a 5/8 letter from LASIK activist Paula Cofer to acting commissioner Stephen Ostroffthat attached 1,073 electronic signatures supporting reconsideration of FDA’s denial of a LASIK ban petition from former CDRH ophthalmic devices chief Morris Waxler.

Cofer herself chided Ostroff for his non-response in a second letter attaching an investigative report in the September issue of Consumers Digest and advising him that two more ex-FDA officials are now speaking out against LASIK: Former CDER ophthalmic division deputy director Everett Beers, quoted in Consumers Digest as supporting Waxler’s assertion that LASIK should not have been approved, and former medical device compliance director Larry Pilot, quoted in the same article as saying, “When it comes to LASIK, it isn’t that the agency has dropped the ball, it’s that they never even moved it.”

Cofer’s second letter to Ostroff told him: “For years we’ve been complaining to the FDA about this issue. In 2008 your agency said you would reevaluate the safety of LASIK. It’s been seven and one-half years, and nothing has changed except for the growing number of injured LASIK patients. Now it’s your watch, Dr. Ostroff. Are we to expect more of the same treatment ─ injured citizens shut out of the regulatory process? Or will you do what’s right and respond to our grievances and concerns?”

FDA’s response to FDA Webview said the agency entered Cofer’s 5/8 letter to Ostroff as a public comment to the docket to Waxler’s 7/22/14 petition for reconsideration, and the agency’s failure to notify her of this was an “oversight.” As for Cofer’s latest letter, “it is currently under review. The FDA will respond directly to Ms. Cofer if necessary.”