Letter to Congress Seeking Moratorium on LASIK Devices

Posted 5/21/2009
The following letter was sent to members of the U.S. House of Representatives Committee on Energy and Commerce and Subcommittee on Oversight and Investigations and others members of Congress.

May 8, 2009

The Honorable Henry Waxman
Chairman
Committee on Energy and Commerce
2125 Rayburn House Office Building
Washington, DC 20515-6115

 

Dear Chairman Waxman:

My name is Scott Tolchin and I am the founder of the LASIK Surgery Watch Cause (LSWC) on Facebook.  LSWC is a community of individuals that include patients damaged by LASIK surgery.  The mission of the LASIK Surgery Watch Cause is to advocate on behalf of patients who have suffered adverse effects of LASIK surgery so that they can be counted, heard, and understood.

I am seeking an immediate moratorium on the use of excimer lasers for LASIK surgery as there has never been a clinical trial to support the safety guideline of less than 1.0% occurrence of adverse events required by the Food and Drug Administration (FDA) for approval.

Approximately 20% of patients in FDA clinical trials for LASIK reported complications (glare, halos, night driving problems, and dry eyes) at six months after surgery which were worse than before surgery, much worse than before surgery, moderately severe or severe.  These complications were deceptively reported in clinical trials as “symptoms” rather than “adverse events” in order to satisfy safety guidelines.  In 2008, the FDA reclassified these complications as reportable adverse events; however the agency allowed these devices to remain on the market for use in LASIK surgery.

Additional bases for a moratorium on LASIK devices include:

  • The FDA has been negligent in its oversight of LASIK ambulatory surgical facilities (ASF).  Part 803 of 21 CFR establishes reporting requirements for users of medical devices.  Specifically, all LASIK device user facilities must submit FDA MedWatch reports of individual adverse events; establish and maintain medical device reporting (MDR) event files; develop, maintain, and implement written MDR procedures; and submit annual reports to the FDA.  It is clear that users of LASIK devices have systemically failed to comply with MDR reporting requirements, which contributed to the FDA’s failure to monitor safety of LASIK devices post-market. This situation must be immediately rectified in order for the FDA to fulfill its post-market surveillance obligation.
  • In May, 2008 a citizen petition was filed with the FDA to ban LASIK due to substantial deception in the labeling and an unreasonable and substantial risk of injury.  The CDRH has failed to respond to the petitioner within the 180 deadline established by 21CFR Sec. 10.30.The petition references data from FDA LASIK clinical trials, which establish the failure of LASIK lasers to meet the FDA’s safety requirements for approval. It appears that the FDA was derelict in its approval of LASIK devices, putting the interests of the ophthalmic industry ahead of its duty to protect the public health. The petition can be viewed at www.Regulations.gov, Docket ID FDA-2008-P-0319.
  • Transcripts of Ophthalmic Devices Advisory Panel meetings indicate that the FDA knew, or should have known, of serious problems with the LASIK procedure.Warning letters dating back to at least 1999 were issued by the FDA to LASIK clinical trial sponsors indicating deviations and deficiencies in the sponsors’ responsibilities to ensure that the studies were conducted in accordance with applicable FDA regulations.
  • FDA clinical trial study design for LASIK lacked sufficient duration of follow-up to detect late onset complications, such as corneal ectasia, a serious sight-threatening complication of LASIK that may occur years after the procedure.The small patient population and short-term follow-up did not allow for thorough examination of adverse events and long-term consequences of LASIK.
  • According to the American Academy of Ophthalmology (AAO), dry eye is the most frequent complication of LASIK; however, assessment for dry eye in LASIK clinical trials were purely subjective – there was no objective dry eye testing.Corneal nerve damage resulting from LASIK surgery leads to loss of corneal sensation, which invalidates subjective patient questionnaires in detection of post-LASIK dry eyes.  Microscopic examination of post-LASIK corneas reveal reduced nerve density three years after surgery.  The true rate of clinical dry eye after LASIK is likely much greater than reported in clinical trials.
  • The importance of pupil size in LASIK screening and surgical planning has been systemically ignored by LASIK clinical trial sponsors and investigators and dismissed by the FDA.Objective tests demonstrate that visual aberrations increase with increasing pupil size after LASIK.  Failure of the FDA to place pupil-size restrictions in the device labeling led to improper treatment resulting in visual impairment of many patients.
  • The latest technology in LASIK surgery flap creation, femtosecond ophthalmic lasers, received FDA approval under a 510(K) application, bypassing the rigors and scrutiny of clinical trials.Numerous reports of complications associated with this device are found in peer-reviewed literature and in the FDA MedWatch database.
  • Since the media coverage of the April 25, 2008 FDA hearing on LASIK, adverse effect reports have surged!According to the FDA there were only 140 reports of adverse effects due to LASIK filed between 1998 and 2006.  In 2008 alone, over 500 LASIK adverse event reports were filed.  As most LASIK patients are unaware that the MedWatch reporting system even exists, and since the filing process is a visual process that may be inaccessible to many injured LASIK patients, it stands to reason that only a small fraction of adverse events are actually being reported.
  • In response to LASIK complaints and allegations of corruption surrounding the approval of LASIK devices, the FDA held a public meeting in April, 2008 to consider patients’ experiences with LASIK.The FDA announced that further study of LASIK dissatisfaction was needed and reported that it had formed an unprecedented partnership with LASIK professional groups to conduct a prospective LASIK study to begin in 2009. The proposed study amounts to putting the fox in charge of the hen house. Surgeons selected to lead the study include those with direct ties to LASIK device manufactures – a clear conflict of interest.

Congress and the American people should be made aware that there are universal adverse effects of LASIK, even in the absence of any immediate clinically relevant complications:

  • LASIK weakens the cornea, which may lead to late onset corneal failure.
  • The LASIK flap never completely heals and may be accidentally dislodged indefinitely.
  • LASIK patients are at life-long increased risk of corneal infections.
  • LASIK causes dry eye, which may be permanent.
  • LASIK complicates future cataract surgery.
  • LASIK invalidates intraocular pressure measurement, which is critical in the diagnosis of glaucoma.
  • Excimer laser ablation causes persistent keratocyte (corneal cell) death.
  • LASIK can lead to significantly reduced quality of vision, sometimes occurring years after the procedure.

At the present time, there is no technology that will restore a patient’s post-LASIK vision to the same quality experienced before undergoing LASIK surgery.  Post-LASIK patients who are no longer able to work leads to additional costs to the US Treasury in the form of disability payments and a loss of revenues from formerly tax-paying individuals.

I believe the FDA Center for Devices and Radiologic Health (CDRH) and Office of Device Evaluation (ODE) has not maintained the distance from the LASIK devices industry required for impartiality. This has resulted in the FDA’s failure to uncover problems, apparent to others, with LASIK surgery.

The FDA should never have approved the use of excimer lasers for an elective eye surgery that was known to be harmful to patients. Congress must correct this error by instructing the FDA to fulfill its regulatory obligation to protect the American public from unsafe medical devices by withdrawing the approval of excimer lasers for LASIK.

Source material for the information discussed above can be provided upon request.

I look forward to a reply at your earliest convenience.

Sincerely,

Scott A. Tolchin
Founder, LASIK Surgery Watch Cause on Facebook

 

Bladeless LASIK device cleared by FDA without clinical trials

FDA Webview (reprinted with permission)
5/15/2009

510(k) Route to Market Under New Attack

Two new pointers to the inadequacy of Sec. 510(k) to protect public health and safety emerged last week in a New York Times exposé of vaginal sling toxicity and new medical literature reporting elevated safety issues with new ophthalmic lasers. Both devices, substantially different from the “predicate” devices they referenced in their “substantially equivalent” 510(k) submissions to FDA, are now the subjects of liability or malpractice lawsuits. They add to a growing list of earlier examples of problems with 510(k) reviews in CDRH that cited other devices and are currently under Congressional scrutiny. One, ReGen Biologics’ Menaflex, is the focus of an internal FDA re-examination ordered by acting commissioner Joshua Sharfstein.

FDA’s current advice on what makes a device “substantially equivalent” relies on whether, “in comparison to a predicate, it:

    • has the same intended use as the predicate; and
    • has the same technological characteristics as the predicate;
      or
    • has the same intended use as the predicate; and
    • has different technological characteristics and the information submitted to FDA;
      • does not raise new questions of safety and effectiveness; and
      • demonstrates that the device is at least as safe and effective as the legally marketed device.”

In practice, a predicate can be a device that has been marketed for so short a period of time it has not established a meaningful safety record, and it can be a part of a string of such predicates.

The New York Times exposé cited adverse reactions leading to repeated surgeries for women using Mentor Corp.’s ObTape internally to control urinary leaks. The device was approved under a 510(k) that asserted it was “substantially equivalent” to older products, Johnson & Johnson’s Tension Free Vaginal Tape System and American Medical Systems’ Sparc Sling System which were themselves, in turn, 510(k)’d as “substantially equivalent” to J&J’s Protegen sling, recalled in 1999 and described by FDA then as “adulterated and misbranded.”

The newspaper recounted life-altering miseries characterized by persistent, painful and often bloody vaginal discharges, fear of cancer and a feeling that “I’m stuck with this for the rest of my life.”

According to the Times report, FDA declined requests for an interview and in an email answered that “Any legally marketed device can serve as a predicate for a premarket submission,” even if it has been recalled and called “adulterated and misbranded.” A subsequent 5/10 editorial said FDA “needs to take a hard look at whether it has been too lenient in clearing medical devices that may not be safe.”

In the ophthalmic lasers example, injured LASIK patients circulated on the Internet a Journal of Cataract & Refractive Surgery editorial by William J. Dupps, Jr. that commented on a University of Toronto clinical study of 149 eyes treated with a 15kHz Intralase femtosecond laser in which 56% were associated with an adverse event called opaque bubble layer (OBL). New-generation lasers with higher pulse frequencies may be less likely to cause OBL, Dupps said. All these devices entered the market through 510(k) clearances. Although OBL only rarely impacts visual acuity at three months post-procedure, it is part of a growing number of “a new array of complications” with femtosecond lasers, which are used to bladelessly create corneal flaps preparatory to LASIK reshaping. According to injured patients, these include corrugated corneal stromal bed, extreme light sensitivity, partial flaps, rainbow glare, torn flap, vertical gas breakthrough, epithelial ingrowth, flap necrosis, diffuse lamellar keratitis (DLK), corneal perforation, incomplete flap, decentered flaps, small flaps, slipped flaps, flap folds, traumatic flap dislocation, gas bubbles in the anterior chamber, optic nerve damage, flap tears, haze, macular hemorrhage, infection, stromal cell necrosis, inflammation, keratocyte cell death, corneal nerve damage, goblet cell reduction, and interface particles.

The Intralase devices were cleared on the basis of their “substantial equivalence” to a string of six other Intralase 510(k)’d predicates going back to 1999.

The study Dupps cited concluded that OBL was associated with thicker corneas and smaller corneal flaps and “did not seem to have detrimental long-term sequelae, although a small harmful effect could not be ruled out.”

Unlike the ObTape victims, the far more numerous injured LASIK patients support numerous Web sites and have formed networks in which they complain of permanent vision loss and a wide array of sight defects, inadequate or false advice from surgeons before undergoing the procedure, and FDA failure to investigate ambulatory surgical facilities for failure to report adverse events to FDA.

Responding to an FDA Webview request for comment on the vaginal sling and LASIK examples, FDA press officer Siobhan DeLancey said the majority of patients in both “report a positive outcome. However, we are aware that a small percentage of patients do experience serious adverse events. We released a Public Health Notification last fall about these surgical meshes used for stress urinary incontinence and pelvic organ prolapse (the indications mentioned in the NYT article), and that PHN can be found at http://www.fda.gov/cdrh/consumer/surgicalmesh-popsui.html. We are also in the process of a consumer education initiative on LASIK and held a public meeting last year to encourage the reporting of adverse outcomes. That information can be found at our advisory committee site (http://www.fda.gov/ohrms/dockets/ac/cdrh08.html#Ophthalmic, please see the information for the April 25, 2008 meeting).

“It’s important to note,” she continued, “that the report of an adverse event is not proof that a device caused the event. If the data reviewed by the FDA suggests a possible link between an adverse event and a device or use of a device, we may require further study before issuing a PHN or other health advisory.

“Adverse event data is not necessarily useful in making a direct correlation between a device and the event. The FDA uses this data to look for trends and safety signals of potential problems that most likely require further study and more intensive follow-up.”

On the LASIK issues, DeLancey said the agency had allowed a follow-up interview 5/14 by Consumer Reports with CDRH director of ophthalmic and ENT devices Malvina B. Eydelman. In that, Eydelman apparently provided a long list of FDA accomplishments since the 4/08 advisory committee meeting on patient injuries, including development of an FDA LASIK Web site; updating LASIK-related information in the SightNet program for health professionals to emphasize that halos, glare, night vision and dry eye problems from LASIK should be reported to FDA; developing a patient information card with the American Academy of Ophthalmology to help LASIK doctors calculate the lens implant power should they need to have future cataract surgery; recognizing the new LASIK standard from the American National Standards Institute; and opening a public docket for LASIK so that any interested person can pose comments, or concerns. This docket is web based and all comments submitted are able to be viewed by the public. All comments on the docket are examined and assessed by FDA staff on a regular basis.

“We are also working on collaborative agreements with organizations that have expertise in evaluating quality of life after LASIK,” DeLancey said. “We are currently collaborating with the National Eye Institute (NEI) on a pilot study to validate the web-based administration of previously validated paper versions of ophthalmic health-related questionnaires. Web-based administration of such questionnaires will help facilitate the pivotal study of patient-reported outcomes after LASIK.

“The pilot study is the first of its kind in the area of ophthalmology. Subjects with ocular surface disease and subjects with a normal ocular surface are being enrolled. People interested in participating in the pilot study at the NEI of the National Institutes of Health (NIH) in Bethesda, MD, and getting a free screening for dry eye and other ocular surface diseases, can learn more about the study by going to http://clinicaltrials.gov/ct2/show/NCT00678860?term=NCT00678860&rank=1.”

FDA Update on LASIK

4/30/2009

Question: What has the FDA accomplished in the past year to protect the public from being harmed by LASIK? Answer: Not much.

March 27, 2009 (Gaithersburg, Maryland). Good morning. I’m Kwame Ulmer, Chief of the Diagnostic and Surgical Devices Branch, and this morning I’ll be giving an update on activities in our branch. On April 25, 2008, FDA convened a Public Advisory Panel of outside experts to listen to patient experiences with LASIK and consider how to improve information for patients and physicians about LASIK. In response to the feedback, from public and LASIK experts, we’ve been working on several improvements in our communications with the public regarding LASIK-related safety issues.

Our accomplishments to date include FDA LASIK website. We’ve made it easier for LASIK patients to report problems within two clicks from the FDA LASIK website. On the FDA LASIK home page, select report a problem at the bottom left column, and then select report a LASIK problem to MedWatch. We’ve updated the other resources section of the website to provide a wider range of information about LASIK to patients and physicians. We’ve clarified the contact us section on how to submit a question about LASIK to FDA and how to submit a comment or concern about LASIK to the public record.

SightNet, we’ve updated related information in SightNet, a program used by healthcare professionals at participating facilities to share concerns about potential safety issues with ophthalmic medical devices and report problems to FDA. The updated information includes an emphasis that halos, glare, night vision problems, and dry eye from LASIK should be reported to FDA.

Patient information card, we’ve worked with the American Academy of Ophthalmology to develop a card that physicians can fill out with the patient’s eye measurements before LASIK surgery. Patients can keep this card to help the doctor calculate the lens implant power should they need to have future cataract surgery.

FDA recognition of ANSI laser systems for corneal reshaping. In March of 2009, FDA officially recognized the new LASIK standard from the American National Standards Institute, ANSI, entitled Laser Systems for Corneal Reshaping. FDA, as a member of ANSI, works closely with this and other national and international standards organizations. This group meets to develop and come to a consensus on appropriate national and international standards for device testing and performance.

LASIK docket. We’ve opened a public docket for LASIK so that any interested person can post questions, comments, or concerns regarding LASIK. This docket is web-based, and all comments submitted are able to be viewed by the public. All comments on the document are examined in excess by FDA staff on a regular basis. The LASIK docket can be found at www.regulations.gov and can be accessed with the keyword, LASIK, or typing in the LASIK docket number FDA-2008-N-0488.

These are just a few of the ways FDA is working to ensure that patients and physicians have current, accurate information to help them with their decisions about LASIK and to facilitate their reporting problems. As we continue to monitor the safety and effectiveness of LASIK, we’ll 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. Thank you.

###

Source: Transcript of the 3/27/2009 FDA Ophthalmic Devices Panel. Available at: http://www.fda.gov/ohrms/dockets/ac/09/transcripts/2009-4423t1-001.pdf. Accessed April 30, 2009.

Lt. Col. Scott Barnes, M.D. Does ‘About Face’ on LASIK

9/26/2008

In response to widespread reports of problems with LASIK eye surgery, the Food and Drug Administration (FDA) called a Special Hearing of the Ophthalmic Devices Panel on April 25, 2008 to address post-LASIK issues such as poor visual outcomes, debilitating post-LASIK dry eye, loss of quality of life, depression, suicidal thoughts, and a number of LASIK-related suicides.

Thirty-one presentations were given during the open public hearing, many from patients suffering from long-term complications of LASIK. Among the proponents of LASIK was Lt. Col. Scott Barnes, MD, an Army eye surgeon who made an impassioned plea on behalf of soldiers at Fort Bragg in North Carolina, “Please don’t take [LASIK] away from us.”

While Dr. Barnes spoke about “refractive surgery”, his testimony in the context of a special hearing on LASIK implied that his arguments were in support of the LASIK procedure.

Indeed, the Summary Minutes of the FDA hearing state that, “Dr. Barnes of the Warfighter Refractive Eye Surgery Program emphasized the importance of LASIK to the military.”

The FDA hearing testimony of Lt. Col. Scott Barnes is inconsistent with his recent publications. William Trattler, MD and Scott Barnes, MD published an article in the July, 2008 issue of Current Opinion in Ophthalmology,1 which states:

“At Fort Bragg, North Carolina, the Army surgeons have moved to 100% surface ablation in the past 2 years; the five known traumatic flap dislocations (out of 2500 procedures) due to ‘typical’ soldier activities contributed to this change but not as much as an analysis of the visual outcomes. A review of the 28,000 procedures has shown that soldiers with PRK or LASEK have a 20% greater chance of achieving an uncorrected visual acuity of 20/15 or better than soldiers with a similar level of refractive error undergoing LASIK.”

Since manuscripts typically require months in preparation and the editorial process before they appear in print, we can assume that Lt. Col. Scott Barnes was already aware of serious problems with LASIK eye surgery when he testified at the April 25th special hearing. Why, then, did Barnes fail to raise concerns about safety and efficacy of LASIK at the April 25th hearing? Did Army eye surgeon Scott Barnes intentionally mislead the FDA and the public during his testimony to the FDA?

Watch video of Lt. Col. Scott Barnes testifying before the FDA panel on April 25, 2008.

Reference:

1. Trattler WB, Barnes SD. Current trends in advanced surface ablation. Curr Opin Ophthalmol.
2008 Jul;19(4):330-4.

Ophthalmologist Warns the FDA, LASIK is Russian Roulette

8/9/2008

This letter addresses my concern about the safety of LASIK surgery. I have practiced ophthalmology for thirty-three years. After taking all the courses on LASIK, I decided not to do the surgery. I believe LASIK surgery is not consistent with the ophthalmologist’s hypocritic oath of “first do no harm. ” Statistics on complications could easily be manipulated by surgeons and I don’t think their reporting of complications can be relied upon.

I think a few points are more valid: it was reported in the last year in the literature that LASIK surgeons have an income creating the setting for significant bias. A highly significant fact that seems to be passed over without much comment is that the LASIK flap can be easily lifted for up to at least ten years exposing the pt to the risk of dislocating and/or losing the flap when subjected to injury. A recent article told of four such cases after ten yrs. When I have explained this fact to hundreds of patients who were considering LASIK, everyone stated that it is enough reason not to do the surgery. I explained to them that it’s as if you had a circular patch of skin incised and replaced and it could be easily lifted up ten years later. Everyone is overwhelmed with this fact and say they are convinced that they won’t do the surgery. When I have seen patients that have had LASIK surgery with other doctors, none of them were aware of this fact. We are playing Russian roulette with these patients, hoping statistically that they won’t be hit in the eye. We are also playing this Roulette game hoping beyond all hope that they don’t get infection, but we all know infections happen.

I went to a meeting at the last conference in 2007 which was concerned with how commonly senior citizens eyes become irritated from dryness and the use of multiple preservatives over the years. I asked the panel at the meeting, many of whom are LASIK surgeons, why aren’t we more concerned about the damaging effects of LASIK which causes dry eye and damaged corneal nerves. They elected not to answer the question.

I think we have a panel already in this country that is ideal to give you the answer to the problems with LASIK. The panel consists of the thousands of ophthalmologists who chose not to do this procedure knowing they could make a half million dollars more per year. I think you should send a questionnaire out to all the ophthalmologists, especially those who don’t do this surgery and ask them why they don’t do it.

I have seen other examples of where the FDA allows higher risk manipulations of the eyes when it clearly is against the patients’ interest. Two of these examples are allowing all-in-one chemical solutions for contact lenses without advising the patient to rinse off the detergent and disinfectant with saline. These patients are soaking their eye all day in these two irritating chemicals. The three most commonly used solutions do not recommend rinsing. Another pandering to patients is the following of no-stitch cataract surgery, even though Medicare has shown the doubling of the incidence of infection in the eyes in the last ten years since no-stitch surgery has been initiated. This is not likely a coincidence.

The three examples cited in the letter, i. e. , LASIK surgery, all -in-one contact lens solutions, and no-stitch cataract surgery are all examples of pandering to patients vulnerable instincts in an effort to promote a “wow” factor, rather than a healthier outcome. I have seen over the last thirty-five years in ophthalmology a steady trend within the profit side of medicine taking precedence over “first do not harm”.

Source: FDA Maude Database Report

Did the FDA and ASCRS knowingly misrepresent the numbers of bad LASIK outcomes?

6/16/2008

Reports of LASIK complications to the FDA’s MedWatch program (MAUDE Database) for medical device adverse events have nearly doubled since the public announcement of the the April 25th, 2008 Special Hearing of the Ophthalmic Devices Panel, held to discuss post-LASIK quality of life, depression, and suicide. At the hearing, two medical doctors, two optometrists, three psychologists, and a number of injured patients presented compelling information establishing a causal link between bad LASIK, depression, and suicide. Excerpts from two suicide notes were presented, including that of a medical student (video: http://www.youtube.com/watch?v=UX855jmViaM) and that of a police officer who was well respected in his community (video: http://www.youtube.com/watch?v=PBAqnVfJ5GU).

Over the past decade since LASIK was FDA-approved, the Agency has failed to enforce physician reporting of adverse events. In March and April, 2008, patients were made aware of the voluntary reporting option by media reports of an upcoming FDA Special Hearing on LASIK problems.

The recent, rapid growth of complaints in the MAUDE database is, presumably, particularly embarassing for the American Society of Cataract and Refractive Surgery (ASCRS). In its April 7th, 2008 press release, ASCRS attempted to spin public perception of the Special Hearing by stating that “Between 1998 and 2006, the FDA received a total of 140 comments relating to LASIK dissatisfaction, representing less than 1 in 10,000 U.S. LASIK patients.” Unfortunately for ASCRS, nearly twice as many complaints have been received in the last six months as in the last ten years since LASIK’s approval.

The growth of complaints is also embarassing for the FDA, since some patients at the meeting charged that they are victims of an ongoing medical coverup, perpetrated by collusion between ASCRS and the FDA. Indeed, in its April 7th, 2008 press release, ASCRS stated that “The FDA reaffirms that LASIK is both safe and effective.” LASIK critics have responded to this assertion by asking publicly “When exactly was ASCRS authorized to make public announcements for the Food and Drug Administration?”

Three other sources of information suggest collusion between ASCRS and FDA. First, prior to the Special Hearing, patients who came to the FDA’s website were encouraged to use a comment form to report their vision issues and dry eye complaints to the FDA. Unknown to patients, these complaints were held by FDA Center for Devices and Radiological Health (CDRH), but were never registered in the MAUDE reporting system. Neither were they reported in the April 7th ASCRS press release. Why did the FDA CDRH choose to suppress these complaints? Was it to make LASIK look safer than it really is? Even though LASIK surgeons are required to report adverse events from LASIK to the FDA, most surgeons have apparently never filed a single MedWatch report, despite the fact that ASCRS admits that up to 5% of patients are dissatisfied with their results.

Second, compare the ASCRS press release with a 2006 document issued by the FDA CDRH at http://www.fda.gov/cdrh/postmarket/mdpi-report-1106.html. In this document, CDRH states frankly that “The data that are submitted via MDR rely upon a generation-old software platform (MAUDE) to organize, store and allow management of the data. This software, due to its age and limitations, does not allow MDR to serve its customers well. FDA staff and stakeholders report that MDR…does not provide timely and usable data to staff or other system users…[and]…has a large backlog of reports which hampers the ability to detect signals or identify problems.” Obviously, this document establishes that the FDA has long been aware of deficiencies in the MAUDE reporting system. Why, then, did the FDA allow ASCRS to speak for the agency? Why was ASCRS allowed to publicize deficient and inaccurate information in order spin public perception about the safety of LASIK? If the MAUDE system was known to be broken, why were complaints issued to the agency through its LASIK comment form never counted?

Third, according to an article in the June 2008 issue of Cataract & Refractive Surgery Today, in November 2006, the same month the FDA released criticism of its MAUDE reporting system, the FDA approached ASCRS and American Academy of Ophthalmology (AAO) to form a Joint LASIK Study Task Force in response to complaints sent to the FDA and Congress by damaged LASIK patients. Apparently, ASCRS surgeons had over 1.5 years notice of FDA’s intention to call a Special Hearing for LASIK post-market issues. In contrast, medical doctors, optometrists, psychologists, and injured patients who spoke on behalf of thousands of LASIK victims were not aware of the planned hearing until it was publicly announced in the Federal Register at the end of March, 2008. These individuals had just one month to prepare. Why did the FDA give the LASIK industry 1.5 years notice of the Special Hearing while patient groups and the public had only a one month notice?

Patient advocates want answers to these questions. So do thousands of damaged LASIK patients.

LASIK Industry Deceives the Public with Smoke and Mirrors

5/31/2008

Amid bad publicity for the LASIK industry, a group of LASIK surgeons announced ‘preliminary’ findings from an ‘unpublished’ review of medical studies showing a “95.4% global LASIK satisfaction rate”.

Press releases issued by LASIK industry insiders appeared to link this literature review to the FDA with misleading statements such as, “The FDA reaffirms that LASIK is both safe and effective.” When asked for clarification about the link between the study and the FDA, LASIK surgeon Kerry Solomon admitted that the study was performed independently from the FDA.

Clearly, this literature review was the LASIK industry’s attempt to reframe the discussion of last month’s FDA hearing concerning problems with LASIK. The review has not been published, but surgeons involved in the study report that 19 studies (2,199 patients) were selected from the thousands of LASIK studies in the body of peer-reviewed literature for the meta-analysis. This represents only .013% of patients who have had LASIK world-wide.

Interestingly, many more published medical studies show large percentages of patients experience complications after LASIK, even when the visual outcome is considered satisfactory.

Similarly, a published review of data for the twelve lasers approved by the FDA for LASIK between 1998 and 2004, including current technology, shows that six months after LASIK, 17.5 percent of patients report halos, 19.7 percent report glare (starbursts), 19.3 percent have night-driving problems and 21 percent complain of eye dryness. Based on these data, the lasers failed to meet the FDA’s safety requirements for approval.

Not only did the FDA approve unsafe devices for LASIK, the Agency also failed to enforce reporting of adverse events. When a patient experiences a bad outcome from LASIK, the physician should notify the manufacturer or the FDA by filing a MedWatch report. The medical literature contains hundreds of case reports of serious complications after LASIK, and thousands of medical studies of LASIK showing frequently occurring complications, yet the FDA recently announced that only 140 reports of adverse events after LASIK have been reported through MedWatch in the past decade. Apparently, most LASIK surgeons have never filed a single MedWatch report, even though all LASIK surgeons have patients with complications. And patients are not informed that they may voluntarily file their own MedWatch report. Clearly, adverse events from LASIK have been grossly underreported, and LASIK surgeons are not held accountable. In response to complaints from patient advocates, the FDA added a link to file a MedWatch report on its LASIK website in late May, 2008.

Patients feel FDA is disingenuous about interest in LASIK complications

5/4/2008

LASIK is a 2.5 billion dollar per year industry.  LASIK is considered by some as the “gravy train” of ophthalmology.  Recently many questions have been raised about the frequency and severity of complications, and now many are wondering if LASIK really lives up to the hype.

In the past decade, several lasers have received FDA approval for use in LASIK surgery.  A report of data from FDA clinical trials for LASIK, including current technology, reveals that approximately 20% of patients report complications.1  The report shows that six months after LASIK, 17.5 percent of patients reported halos, 19.7 percent reported glare, 19.3 percent had night-driving problems and 21 percent complained of dry eyes.  It appears that if FDA had properly classified these “symptoms” as adverse events or complications, the devices would have failed to meet safety requirements for approval.

The FDA’s MedWatch program allows healthcare professionals and consumers to report adverse events associated with medical devices, such as those used to perform LASIK.  However, patients are not informed about the MedWatch program and there is no enforcement of reporting by physicians.  The inconsistency between the reported complication rates from LASIK clinical trials and the number of adverse events reported to the FDA through the MedWatch program clearly shows that complications from LASIK are grossly underreported.

Reports of widespread, serious problems with LASIK prompted FDA to hold a post-market meeting on April 25, 2008 to hear patient complaints and to accept recommendations from a panel of experts.  The panel was chaired by LASIK surgeon, Dr. Jane Weiss.  In her closing remarks, Dr. Weiss blamed the problems on “some surgeons who should be doing a better job”, rather the surgery itself.  Patients felt the hearing was a sham.

Two weeks before the FDA hearing, the American Society of Cataract and Refractive Surgery (ASCRS), a 10,000 member strong organization of ophthalmic surgeons, issued a press release stating the organization had formed a joint task force with FDA, National Eye Institute (NEI), and the American Academy of Ophthalmology (AAO) to conduct a prospective post-LASIK quality of life study.  The timing of the press release seems to indicate that the LASIK industry had inside information that the FDA had no plans to act swiftly on recommendations from the public at the hearing.  The unprecedented partnership between the LASIK industry and the FDA has raised eyebrows in the patient community.

These events followed on the heels of media reports of patients who experienced depression, and a report of suicide, due to complications from LASIK.  ASCRS fired back (see below) at the North Carolina newspaper that broke the story in February.  A flurry of bad press for the LASIK industry followed.  By early March, the LASIK industry had launched its damage control campaign by releasing preliminary findings from a meta-analysis of LASIK studies, which showed a 95% satisfaction rate.   Patients consider this meta-analysis a smokescreen to conceal the high rate of complications, such as dry eyes and night vision impairment.  Four suicides and numerous cases of depression related to LASIK were reported at the FDA hearing.

LASIK industry leadership subsequently announced the names of doctors who were hand-picked to design and conduct the post-LASIK quality of life study with the task force.  One of the doctors selected for the study is a well-known defense expert witness who testifies against LASIK patients who file medical malpractice lawsuits, has financial ties to the LASIK industry, and has made public statements that LASIK complications do not lead to depression.  Patients believe that all of the doctors chosen for the study are biased and lack objectivity, and that the study as proposed amounts to “the fox guarding the hen house”.

In a National Public Radio interview this week, , an FDA spokesperson, encouraged patients to report LASIK complications to the Agency using the MedWatch program.  Weick-Brady stated that halos, starbursts, and problems with night vision are considered adverse events.

The question that many damaged LASIK patients now want the FDA to answer is, how did a medical device with a 20% rate of adverse events receive FDA approval in the first place?

###

“There is simply no scientific basis to support a direct connection between a sub-optimal outcome from eye surgery and suicide.”
Lindstrom, Richard. (2008, March 12) Letter to the News & Observer
Originally published at http://www.newsobserver.com/opinion/letters/story/996053.html

——————–

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