Posted 5/26/2009
Petitioner calls for inspection of LASIK clinics, sanctions for clinics that fail to report complications.

May 25, 2009
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Dr. Margaret A. Hamburg
Commissioner of U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dr. Joshua M. Sharfstein
Principal Deputy Commissioner
Acting Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Daniel Schultz, M.D.
Director, Center for Devices and Radiologic Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

CITIZEN PETITION

The undersigned submits this petition under section 519 of the Federal Food Drug & Cosmetic Act (21 USC 360i), or any other statutory provision for which authority has been delegated to the Commissioner of Food and Drugs to request the Commissioner enforce compliance with medical device reporting (MDR) regulations by LASIK device user facilities and ASFs – Ambulatory Surgical Facilities (hereinafter referred to as “LASIK clinics”).

ACTION REQUESTED

The petitioner requests the Commissioner of Food and Drugs inspect LASIK clinics to ensure compliance with 21 CFR 803, Subpart C User Facility Reporting Requirements. Part 803 requires medical device user facilities to (1) establish written MDR procedures, (2) report adverse events to the manufacturer or to the FDA, and (3) submit annual reports to the FDA.

Further, the petitioner requests the Commissioner of Food and Drugs impose sanctions on non-compliant LASIK clinics as authorized under 21 USC 331 – 337. The regulation authorizes sanctions ranging from warning letters to injunction proceedings, civil penalties, and criminal penalties.

STATEMENT OF GROUNDS

In 1998, the FDA approved the first excimer laser for LASIK. Since then, approximately 8 million United States citizens have undergone the surgery.

It is now well-documented that problems after LASIK, such as night vision difficulties and dry eyes, occur frequently after LASIK.1 A meta-analysis of Summaries of Safety and Effectiveness for the twelve lasers approved for LASIK from 1998 through 2004 found that six months after LASIK, 17.5% of patients report halos, 19.7% report glare, 19.3% report night-driving problems and 21% report dry eyes which are worse than before surgery, much worse than before surgery, moderately severe or severe.2

Other complications of LASIK, such as irregular-thickness flaps, partial or incomplete flaps, buttonholed flaps, free caps (the flap is cut completely off), flap striae (wrinkles), decentered flaps, flap dislocation, infection, inflammation, haze, epithelial ingrowth, vitreoretinal complications, optic neuropathy, induced cataract, and corneal ectasia occur infrequently but may lead to irreversible vision loss. Complications may emerge weeks, months, or years after seemingly successful LASIK, which contributes to underreporting.

Long-term consequences of LASIK include problems with future cataract surgery, risk of undiagnosed glaucoma due to inaccurate intraocular pressure measurements, permanent biomechanical weakening of the cornea with associated risk of late-onset keratectasia (corneal failure), life-long increased risk of corneal infection due to a permanent portal in the corneal periphery for microorganisms to penetrate, persistent loss of keratocytes (corneal cells), reduced corneal nerve density, reduced visual quality, and non-healing of the LASIK flap (exhibit 1) with associated risk of late flap dislocation. These issues affect virtually 100% of LASIK patients.

The FDA requires that all prospective LASIK patients receive the Patient Information Booklet (device labeling) from their surgeon prior to surgery. Device labeling is intended to inform patients of contraindications and risks. LASIK surgeons commonly fail to provide the device labeling to patients, which denies patients access to information that could affect their decision to have the surgery.

Microkeratome blades which are used to cut the LASIK flap are cleared by the FDA for single-use, although surgeons routinely reuse the blade on the 2nd eye of the same patient. Reuse of blades on multiple patients has also been reported, which may expose patients to infectious contaminants. It is reported in the medical literature that quality of the flap-cut is reduced with reuse of blades. This exposes patients to an increased risk of complications in the second eye. Furthermore, tissue remnants left on the blade from the first eye may be dragged into the interface of the second eye, leaving debris trapped in the interface.

Over the past several years, patients who suffered serious complications, visual impairment, or chronic dry eyes after LASIK petitioned the FDA to ban LASIK or otherwise restrict the devices to provide greater protection to the public from improper use of LASIK devices. The most recent petition (located at http://www.regulations.gov, Docket ID FDA-2008-P-0319) was received by the FDA in May, 2008. No response has been issued as required by law, and no action has been taken by the FDA to provide better protection for the public.

In 2007, reports of LASIK-related suicides began circulating in the mass media.3 In February 2008, preliminary findings of an Emory Eye Center study of suicides among organ donors were reported in the media. These findings suggested a four-fold increased suicide rate among cornea donors who had had LASIK compared to cornea donors who had not had LASIK.4 These media reports were vigorously disputed by LASIK surgeons and LASIK industry consultants who openly denied any connection between a bad outcome from LASIK and diminished quality of life, depression, and suicide.5

On April 7, 2008, the American Society of Cataract and Refractive Surgery (ASCRS), a LASIK professional group, issued a press release6 announcing collaboration with the Agency to study post-LASIK quality of life and stated that only “140 comments relating to LASIK dissatisfaction” had been reported to the FDA in the past decade. This number, in contrast to the reported incidence of complications in FDA clinical trials, is a clear indication that LASIK clinics are not reporting LASIK adverse events as required by law. ASCRS speaks on behalf of the FDA in the press release stating, “The FDA reaffirms that LASIK is both safe and effective.” Injured LASIK patients would like to know the name of the FDA source for that statement. Earlier statements by Dr. Daniel Schultz, Director of the Center for Devices and Radiological Health (CDRH) reported in Reuters7 on March 17, 2008, seem to contradict ASCRS.

In March 2008, the FDA announced a special hearing of the Ophthalmic Devices Panel to be held on April 25, 2008 to address patient experiences with LASIK. Injured LASIK patients who spoke during the open public hearing had harsh criticism of the FDA’s unprecedented partnership with LASIK professional groups to study LASIK dissatisfaction.8 Injured LASIK patients believe that LASIK surgeons are biased and lack objectivity, and that the proposed study amounts to the FDA putting the fox in charge of guarding the hen house.

At the hearing, injured LASIK patients and family members of LASIK patients testified to the devastating psychological impact of post-LASIK dry eyes and night vision disturbances, including depression, suicidal thoughts, and actual suicides.9 Several speakers called for a moratorium on LASIK.10

An FDA Patient Representative brought several serious concerns surrounding LASIK to the attention of the FDA at the April 25, 2008 advisory panel meeting. Her testimony is published on the FDA website at http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4353t1-04.pdf beginning on page 315.

As media reports of the FDA hearing circulated, self-reporting of LASIK adverse events by patients to the FDA surged to over 500 in one year. Undoubtedly, patients were previously unaware of the FDA’s voluntary MedWatch program for reporting problems after LASIK. A disturbing trend can be seen in the patient reports – poor night vision, halos, starbursts, debilitating dry eyes, diminished quality of life, and denial by the LASIK surgeon.

In September 2008, the FDA updated its LASIK webpage to clearly define halos, glare, night vision problems and dry eye as adverse events which should be reported to the FDA.

In April 2009, LASIK surgeons led by Kerry Solomon, M.D. published results of a “world literature review” on LASIK satisfaction,11 which combined data from 19 peer-reviewed studies of 2,199 patients. The articles report that 95.4% of LASIK patients are satisfied with their surgical outcome. The authors state, “Although this database also includes information on visual outcomes, night vision symptoms, and dry eyes, for the purpose of this paper, the analysis of the database focuses specifically on patient satisfaction and quality of life”. Incidence of night vision disturbances and dry eyes reported by patients in the 19 studies was known by Solomon’s group, but not published. Injured LASIK patients who believe the literature review was a deceptive marketing ploy located several of the 19 studies and found the incidence of dry eyes and night vision disturbances in the 20 – 30 percent range.

Injured LASIK patients allege that the LASIK industry has engaged in a cover-up of the frequency and life-altering nature of LASIK complications, such as night vision disturbances and chronic dry eyes, and have consistently ignored MDR reporting requirements. Based on the number of LASIK MedWatch reports which are self-reported by patients, there is compelling reason to believe that most LASIK device user facilities have never filed a single MedWatch report.

The petitioner has no knowledge of data or information which are unfavorable to the petition.

ENVIRONMENTAL IMPACT STATEMENT

This petition qualifies for categorical exclusion under 21 CFR 25.30(a) from the requirement of an environmental impact assessment.

CERTIFICATION

The undersigned certifies that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.
___________________________
(Signature)

Scott A. Tolchin
[Address, phone redacted]

1. Sugar A, Rapuano CJ, Culbertson WW, Huang D, Varley GA, Agapitos PJ, de Luise VP, Koch DD. Laser in situ keratomileusis for myopia and astigmatism: safety and efficacy: a report by the American Academy of Ophthalmology. Ophthalmology. 2002 Jan;109(1):175-87.
2. Bailey MD, Zadnik K. Outcomes of LASIK for myopia with FDA-approved lasers. Cornea. 2007 Apr;26(3):246-54.
3. Puglionesi, L (2007, July 6). “Haverford man found dead at old hospital site.” Accessed 5/21/2009 from Delaware County Daily Times online at http://www.delcotimes.com/articles/2007/07/06/past%20stories/19986762.txt; “Suicide Series Part 1: Mid-Life Suicides” (2008, March). Accessed 5/22/2009 from WXOW ABC 19 online at http://www.wxow.com/Global/story.asp?s=8571827; “Brentwood Officer Found Dead In Apparent Suicide”. (2008, March 17). Accessed 5/22/2009 from NewsChannel5.com online at http://www.newschannel5.com/Global/story.asp?S=8029702 (LASIK blamed in suicide note presented at April 25, 2008 FDA panel meeting located at http://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4353oph1-07%20TODD%20KROUNER.pdf, slides 6 – 8)
4. Vollmer, S. (2008, February 3) Some link depression, failed LASIK. Retrieved 5/21/2009 from http://www.newsobserver.com/150/story/920341.html
5. Lindstrom, Richard. (2008, March 12) Letter to the News & Observer: http://www.newsobserver.com/opinion/letters/story/996053.html; Morse M.D., Jennifer (2008, April 25) FDA Special Hearing on Post-LASIK Quality of Life: http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4353t1-02.pdf; Schallhorn, Steven C. (2008, February 3) Some link depression, failed LASIK: http://www.newsobserver.com/150/story/920341.html
6. “ASCRS to participate in and co-fund study on post-lasik quality of life with US Food and Drug Administration” (2008, April 7). Accessed 5/22/2009 at http://www.ascrs.org/press_releases/ASCRS-TO-PARTICIPATE-IN-AND-CO-D-STUDY-ON-POST-LASIK-QUALITY-OF-LIFE-WITH-US-FOOD-AND-DRUG-ADMINISTRATION.cfm
7. Heavey, S. “FDA panel to review laser eye surgery” (2008, March 17). Reuters. Accessed 5/22/2009 at http://www.reuters.com/article/hotStocksNews/idUSN1761471320080317?sp=true
8. See 4/25/2008 testimony of Matt Kotsovolos, Dr. Lauranell Burch, Dom Morgan, Dr. Michael Patterson, David Shell, and Dr. Michael Mullery on the FDA website at http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4353t1-01.pdf, and http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4353t1-02.pdf
9. See 4/25/2008 testimony of Beth Kotsovolos, Gerard Dorrian, Dr. Michael Mullery, Dr. Roger Davis, Dr. Edward Boshnick, and Todd Krouner on the FDA website at http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4353t1-01.pdf, and http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4353t1-02.pdf
10. See 4/25/2008 testimony of Dr. Michael Patterson, Matt Kotsovolos, Dr. Lauranell Burch, Dr. Michael Mullery, and Dr. Roger Davis on the FDA website at http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4353t1-01.pdf, and http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4353t1-02.pdf
11. 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.
Exhibit 1

“Your corneal flap will never adhere to the surface of the eye with quite the same strength it did prior to the surgery, so there is a rare but possible risk of the flap becoming displaced with sufficient force.” Source: October, 2008 publication of the American Academy of Ophthalmology (AAO), International Society of Refractive Surgery (ISRS), and Opthalmic Mutual Insurance Company (OMIC) titled “Is LASIK For Me? A Patient’s Guide to Refractive Surgery” located online at http://www.geteyesmart.org/correction/upload/LASIK_guide.pdf

“The corneal flap can be easily displaced following trauma many months after LASIK.” Source: Ramírez M, Quiroz-Mercado H, Hernandez-Quintela E, Naranjo-Tackman R. Traumatic flap dislocation 4 years after LASIK due to air bag injury. J Refract Surg. 2007 Sep;23(7):729-30.

“The LASIK flap once cut may contribute little to the mechanical stability of the cornea and probably never completely adheres to the underlying stromal bed, with late traumatic flap displacement being reported as an infrequent complication.” Source: O’Brart DP, Mellington F, Jones S, Marshall J. Laser epithelial keratomileusis for the correction of hyperopia using a 7.0-mm optical zone with the Schwind ESIRIS laser. J Refract Surg. 2007 Apr;23(4):343-54.

“Our report, as well as the related literature, indicates that the healing of the flap is incomplete even 6 years after LASIK surgery.” Source: Landau D, Levy J, Solomon A, Lifshitz T, Orucov F, Strassman E, Frucht-Pery J. Traumatic corneal flap dislocation one to six years after LASIK in nine eyes with a favorable outcome. J Refract Surg. 2006 Nov;22(9):884-9.

“Although ocular trauma with corneal laceration can occur, we report that the lamellar flap is still susceptible to ocular trauma 7 years after LASIK. Informed consent should include discussion of long-term flap complications and patients should be advised to protect their eyes after LASIK, especially during high risk activities.” Source: Jin GJ, Merkley KH. Laceration and partial dislocation of LASIK flaps 7 and 4 years postoperatively with 20/20 visual acuity after repair. J Refract Surg. 2006 Nov;22(9):904-5.

“The fact that this potential plane can be disrupted many years after LASIK (7 years after the initial surgery in patient 1) indicates that corneal integrity is compromised by the surgical procedure and takes a long time, if ever, to restore.” Source: Cheng AC, Rao SK, Leung GY, Young AL, Lam DS. Late Traumatic Flap Dislocations After LASIK. J Refract Surg Vol 22, May 2006

“Another aspect of LASIK surgery is that during this procedure, a corneal flap is made, which will create lifelong lamellar corneal potential space.” Source: Galal A, Artola A, Belda J, Rodriguez-Prats J, Claramonte P, Sánchez A, Ruiz-Moreno O, Merayo J, Alió J. Interface corneal edema secondary to steroid-induced elevation of intraocular pressure simulating diffuse lamellar keratitis. J Refract Surg. 2006 May;22(5):441-7.

“However, one aspect still in discussion is the wound-healing process in the created interface that leads to an easily removable flap even years after treatment.” Source: Priglinger SG, May CA, Alge CS, Wolf A, Neubauer AS, Haritoglou C, Kampik A, Welge-Lussen U. Immunohistochemical Findings After LASIK Confirm In Vitro LASIK Model. Cornea, Volume 25(3), April 2006, pp 331-335

“Corneal stromal LASIK wounds were found to heal weaker than normal because these structures were not regenerated during the healing response. Moreover, the central and paracentral stromal LASIK wounds were found to heal by producing a hypocellular primitive stromal scar that is very weak in tensile strength, averaging 2.4% of normal, and displays no evidence of remodeling over time in specimens out to 6.5 years after surgery.” Source: Schmack I, Dawson DG, McCarey BE, Waring GO 3rd, Grossniklaus HE, Edelhauser HF. Cohesive tensile strength of human LASIK wounds with histologic, ultrastructural, and clinical correlations.
J Refract Surg. 2005 Sep-Oct;21(5):433-45.

“However, this case illustrates that even 4 years following the procedure, the lamellar flap remains an inherently weakened area of the eye, susceptible to traumatic disruption.” Source: Nilforoushan MR, Speaker MG, Latkany R. Traumatic flap dislocation 4 years after laser in situ keratomileusis. J Cataract Refract Surg. 2005 Aug;31(8):1664-5.

Reprinted with permission from fdaweb.com
5/26/2009

Days after FDA principal deputy commissioner Joshua Sharfstein launched an investigation into mounting complaints by injured LASIK vision-correction patients, one of them 5/25 filed a citizen’s petition asking for sanctions against LASIK clinics that have not reported adverse events as required under the medical device reporting (MDR) regulation. The petitioner, former Long Island (NY) restauranteur and LASIK patient advocate Scott A. Tolchin, also asked the agency to inspect clinics and to “ensure” their compliance with FDA’s user facility reporting regulation. Tolchin told FDA Webview he has been on disability for a year due in part to his LASIK-related problems which worsened since his 1997 surgery.

“Injured LASIK patients allege that the LASIK industry has engaged in a cover-up of the frequency and life-altering nature of LASIK complications, such as night vision disturbances and chronic dry eyes, and have consistently ignored MDR reporting requirements,” Tolchin’s liberally documented petition says. “Based on the number of LASIK MedWatch reports which are self-reported by patients, there is compelling reason to believe that most LASIK device user facilities have never filed a single MedWatch report.”

The petition criticizes FDA’s “collaboration” last year with the American Society of Cataract and Refractive Surgery to study post-LASIK quality of life. At the time, the society said there had been only 140 dissatisfied comments from patients in the preceding decade. “This number, in contrast to the reported incidence of complications in FDA clinical trials, is a clear indication that LASIK clinics are not reporting LASIK adverse events as required by law,” the petition says.

Tolchin says injured patients expressed “harsh criticism” of the “unprecedented partnership with LASIK professional groups” when they testified at a 4/25/08 Ophthalmic Devices Panel meeting where a moratorium on the surgical procedure was requested. “Injured patients believe that LASIK surgeons are biased and lack objectivity,” his petition says, “and that the proposed study amounts to the FDA putting the fox in charge of guarding the hen house.”

Other issues raised in the petition include alleged multiple reuse by surgeons of single-use microkeratome blades that cut a flap in the cornea prior to the LASIK procedure, a reported four-fold increase in post-LASIK suicides, and a surge in adverse reports from patients and family members after publicity about the 4/25/08 panel meeting, to 500 in a single year. The petition alleges that despite an FDA requirement that all prospective LASIK patients receive a Patient Information Booklet, LASIK surgeons commonly fail to do this.

“A meta-analysis of Summaries of Safety and Effectiveness for the 12 lasers approved for LASIK from 1998 through 2004 found that six months after LASIK, 17.5% of patients report halos, 19.7% report glare, 19.3% report night-driving problems and 21% report dry eye which are worse than before surgery, much worse than before surgery, moderately severe or severe,” the petition says. Since the first LASIK device approval in 1998, about 8 million American have undergone the surgery, it says.

On 5/22, CDRH director of compliance Timothy A. Ulatowski sent a letter to eye care professionals cautioning them against deceptive or misleading claims and providing sources of additional information about intended uses and adverse effects.

Reprinted with permission from fdaweb.com
Sharfstein Investigates LASIK Patients’ Complaints
05/21/2009

FDA acting commissioner Joshua Sharfstein told FDA Webview 5/21 that he is looking into complaints of many LASIK (laser-assisted in situ keratomileusis) eye vision enhancement surgery patients that the agency has failed to honor its commitments to investigate their complaints since 2006 that the technique has unacceptable risks.

The primary issue in their complaints is that, with an adverse-reaction risk factor in excess of 5% (patient dissatisfaction) rate at six months, nobody is doing research on the procedure’s long-term quality-of-life. It involves either blade- or laser-cutting of flaps in the corneal surface layer that patients complain never heal. A post-operative trauma to the patient’s head at any time can forever open the flap and allow the entry of viruses and bacteria to the stromal layer beneath, with commensurate vision impairment and even blindness.

According to the injured patients, despite the procedure’s 95% success rate, the extent of failures exceeds FDA’s allowable 1% limit and the agency has failed for three years to address petitions submitted since 2006 that sought enforcement of mandatory adverse event reporting (MDR) requirements on facilities performing LASIK procedures. They allege an effective FDA conspiracy with for-profit LASIK surgery surgeons in concealing true adverse event rates.

In drug and device regulation, FDA is constantly monitoring long-term risk-benefit issues and addressing them through labeling revisions. Since LASIK surgery is primarily a practice-of-medicine technology regulated at state, not federal, level, who is doing the same thing for these lasers which routinely enter the market without clinical studies justifying their safety and effectiveness?

FDA’s reliance on its collaboration with the main eye surgeons’ organizations, which have a members’ income conflict-of-interest in objectively measuring and voluntarily reporting failure rates (only their physical facilities and the device manufacturers must report to FDA), is analogous to the outright operational dependency on plastics and chemical lobbyists that FDA’s Center for Food Safety and Applied Nutrition developed over many years in regulating the mutagenic and neurological toxic effects of bisphenol A in food containers, including baby bottles.

FDA commenters on our Web site are already asserting from this that industry’s infiltration and takeover of government agencies (not just FDA) has been an ongoing fact of life for many years, so we better get used to it.

Sharfstein’s investigation challenges this assumption.

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

 

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.”

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.

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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.

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

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.