2/25/2010

In his first television interview on the subject, former CDRH branch chief for diagnostic and surgical devices Morris Waxler says that the agency didn't pay enough attention to negative side effects in some patients. Speaking in an exclusive on ABC's Good Morning America, Waxler said the staff didn't know what to do with data showing potential problems.

"I wouldn't say it was pooh-poohed, so much as it was just shoved aside as the kind of, we don't know what to do with that data," he said. "It's right there in the record. The agencies and the refractive surgeons, people knew these problems occur and there doesn't seem to be a plan to handle some of the more difficult problems that are created." Reported adverse effects, including cases in which the problems are permanent, include starbursts, halos, glare double-vision, and night blindness.

Waxler said he feels bad when he hears of patients' bad experiences. "One of the patients asked me, 'Don't you feel bad?' and I said, 'I did the best I could with the folks that were all around us,'" he said. "But in hindsight, it wasn't good enough. It wasn't good enough." He says he now believes that FDA erred in not setting tougher standards for LASIK outcomes, but doesn't think the devices should be pulled from the market. However, he called on FDA to make manufacturers and surgeons be more forthcoming with patients about potential side effects.

FDA told the network that it "considers LASIK to be reasonably safe and effective when used as intended," and said it disagreed with Waxler's contention that problems were overlooked at the time the procedure was approved. The agency also said it has been cracking down on false and misleading advertising and will be following up with providers who have inadequate adverse event reporting systems.

Last year, Waxler told FDA Webview that CDRH "screwed up" in not establishing a standard for acceptable adverse events reported from clinical studies (see story). The problem, he said, was that CDRH lacked in-house LASIK expertise and incorrectly judged the significance of adverse events, which an advisory committee had said should be less than 1% of all procedures, but turned out to be higher than 5%.

"We were getting advice from very renowned ophthalmologists, more renowned than anyone we had in the agency," he said. "We dropped the ball with regard to re-treatments with in excess of 10% re-treatment rates because there was a great deal of pressure from individual doctors who said they had the freedom as a physician to re-treat when they felt it was necessary for the sight of the patient. We waffled on that, we collapsed on that issue. In some of the clinical trials we were very tough on particular companies that came in with high re-treatment rates, and none of that got translated into a requirement for all the manufacturers. So I think we screwed up. It's very difficult to get them to admit there's been an error. I just think that's not going to happen until there's such a crisis that they're forced to do so."

Watch video:

February 19, 2010

From the article: A state regulatory agency is barring a Chicago ophthalmologist from performing Lasik eye surgeries in Illinois, one of a number of disciplinary actions taken against the doctor on Friday.

After finding that Dr. Nicholas Caro had engaged in unprofessional conduct and gross negligence, the Illinois Department of Financial and Professional Regulation suspended his medical license for 30 days, placed him on probation for a minimum of 3 years and banned him from performing procedures aimed at changing the curvature of the cornea, which includes Lasik surgeries.

The agency also fined him $10,000, the maximum allowed per violation.

Read article at www.chicagotribune.com/news/local/ct-met-bad-eye-doctor-20100219,0,2101781.story

Learn more about Nicholas Caro, M.D. at:
Dean Andrew Kantis
Founder
www.LifeAfterLasik.com
"Hurt LASIK Patient Network"

Laurie Shrieves v. Quentin Franklin, M.D., and LCA-Vision, Inc. d/b/a LASIKPlus
Virginia Circuit Court for the City of Chesapeake

Case No. CL 10000278-00

DR. QUENTIN FRANKLIN AND LASIKPLUS SUED FOR LASIK MALPRACTICE - On February 5, 2010, plaintiff, Laurie Shrieves, filed suit against Quentin Franklin, M.D., and LCA-Vision, Inc., d/b/a LASIKPlus, in the Virginia Circuit Court for the City of Chesapeake, for the negligent performance of LASIK surgery on Ms. Shrieves. On June 29, 2008, Ms. Shrieves came under the care and treatment of Dr. Franklin for the purpose of having LASIK surgery on both eyes at LCA-Vision, Inc., d/b/a LASIKPlus. The complaint alleges, among other things, that Dr. Franklin was negligent when he performed the LASIK surgery more than three millimeters off center of the pupil. As a result, Ms. Shrieves' cornea became abnormal and developed a decentered ablation. A decentered ablation refers to when the laser treatment removes tissue from an area outside of the intended surgical zone. Laser ablations that are off-center can cause visual symptoms, including glare, halos, ghost images, and blurred vision. Consequently, Ms. Shrieves' vision has suffered severely.

The plaintiffs are represented by Todd J. Krouner, from Pleasantville, New York, and Thomas Shuttleworth of Shuttleworth, Ruloff, Swain, Haddad & Morecock, P.C., from Virginia Beach, Virginia. Mr. Krouner represents victims of LASIK surgery throughout the United States. Mr. Shuttleworth has extensive experience in litigating medical malpractice actions.

A copy of plaintiffs' complaint is available at www.krounerlaw.com. For further information, please contact Todd J. Krouner, Esq., at (914) 238-5800, or Thomas Shuttleworth, Esq., at (757) 671-6020.

Cincinnati.com 2/7/2010
By Laura Baverman

Excerpt:

Thomas plans to combat the decline in Lasik (Laser-Assisted In Situ Keratomileusis) procedures by adding new services such as in-depth eye exams, cosmetic eyelash enhancement and, potentially, cataract surgery... Compounding the economic problems, the U.S. Food and Drug Administration cracked down last year on Lasik reporting requirements. After visits to 14 LasikPlus centers, the agency requested that the company's policies for reporting side effects be expanded... Anti-Lasik activists are as vocal as ever. They insist corporations like LCA are out for profits at the expense of their patients' most vital sense. "These large Lasik mills have a lot at stake and great incentive to conceal side effects and problems," says Paula Cofer, a Florida woman who has spoken out against the surgery since hers went awry in 2000. "It's all about profit. It's not about treating a medical need. It's an unnecessary surgery."

Read article at: http://news.cincinnati.com/article/20100207/BIZ01/2070373/1076/biz/LCA-Vision+looks+for+light+at+end+of+economic+tunnel

A brief synopsis of my problems after Lasik surgery in May of 2009...

I was having trouble reading and using my computer at the age of about 43, I'm 48 now by the way and the problem became worse requiring me to constantly change to reading glasses throughout the day. I'm a reserve Deputy Sheriff and work full-time for [redacted] so I'm in the field all day and every day and changing from sun glasses to reading glasses started to become quite problematic. WOW,  what I would do to have those problems back after the absolute devastation to my life after being assured that the glasses would go and no contacts ever by my Lasik Doctor and her staff.

I was treated for Mono-vision by the Lasik Dr. and found out later that she should have tried contacts or glasses first before performing the lasik mono-vision correction which has completely ruined my life. The last 9 months of my life has been pure hell and nightmares.

I'm currently suffering from extreme dry-eye, red-eye, painful-eye, lost vision up close, lost vision at night and extreme sensitivity to sun light after I was assured how safe the procedure was and I was told their track record was perfect by the Dr. and her staff and I would be without glasses or contacts. This sure seemed like a great thing especially after reading all the wonderful lasik info (on-line) that I researched before going forward with the procedure. I'm sure no one chooses to get lasik to destroy their vision and comfort but that's what happened to me and now I'm suffering badly every day and need help.

My life as a respected Police officer and my hobbies of fishing, scuba diving, surfing, working out at the gym, bicycling and living my life happily are now over and its been all Doom and Gloom for me and I have even considered suicide but a very close and loving friend has kept me from doing this. I would rather go blind and live in pain and anguish than to not see her again. At least that's what I feel today but I came very close a few different nights.

I've read your web-site and spoke to you and hope you can help me to bring my life back on track.  I'm sickened and disturbed that lasik is continuing to go on in this country and apparently the FDA doesn't have a clue. I wish I knew all the facts beforehand but I didn't. I went by what was on the Radio, TV, the internet, the information provided by the Lasik Dr. and her staff and now I'm really suffering. Boy, what I would do for those reading glasses back!  Thank you for taking the time to listen....

Happy LASIK patients may not realize or acknowledge the harm they suffered from LASIK for years; nonetheless, the damage is there. Medical research demonstrates (a) that the LASIK flap never heals and may be accidentally dislodged for the rest of a patient's lifetime, (b) that the cornea is permanently weakened and may develop ectasia weeks, months, or years later, leading to vision loss, (c) that corneal nerves which stimulate tear production are severed and destroyed during LASIK, and that these nerves never fully recover -- potentially leading to permanent dry eye disease, (d) that having LASIK causes problems in the future for glaucoma screening and cataract surgery -- prompting the FDA to recommend that LASIK patients obtain a copy of their LASIK medical record, (e) persistent decrease in corneal cells (keratocytes) -- it is unknown how this decrease affects long-term viability of the cornea, and (f) that visual quality at night is permanently reduced after LASIK, even when the patient has 20/20 or better daytime vision. To add insult to injury, visual outcomes of LASIK decline over time. "LASIK success" is like saying "the surgery was a success but the patient died".

From the article: But there have been an increasing number of complaints from unhappy patients who say they have experienced significant problematic complications after Lasik. They've been reporting that problems like dry eye, glare, double vision and starbursts (blurring around objects) have impaired their ability to function day-to-day and significantly affected their quality of life, says Dr. Malvina Eydelman of the Food and Drug Administration. In response, the FDA has decided to investigate further...Paula Cofer of Tampa, Fla., has experienced many of these problems.

Link to read/listen: http://www.npr.org/templates/story/story.php?storyId=122360078

Paula Cofer, FDA Patient Representative, served on the April 25, 2008 FDA Ophthalmic Devices Panel in Gaithersburg, MD.  The meeting was called to discuss issues concerning post-market experiences with LASIK. 

Ms. Cofer expressed several concerns about the safety and long-term consequences of LASIK, and asked for changes to the labeling of excimer lasers. 

Read some of Ms. Cofer's statements, which are found in the April 25, 2008 panel meeting transcript:  Click here

The FDA called a public meeting in April 2008 to discuss issues concerning patients' experiences with LASIK.  Several weeks prior to meeting, the American Society of Cataract and Refractive Surgery (ASCRS) -- a professional group of LASIK and cataract surgeons -- issued a press release² announcing findings of a literature review led by Kerry Solomon, M.D. alleging a "95.4% global LASIK satisfaction rate". The full text of the article was not published until April 2009.  Nineteen articles representing only 2,199 patients were retained by the authors in this "LASIK world literature review"³, although 16 million patients had undergone LASIK worldwide according to the press release. Eighty four percent (16/19) of the articles used questionnaires that were not validated.     

Solomon et al report; "Although this database [of 19 articles] 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."  In other words, the authors chose not to disclose complication rates.  Only two articles in the literature review actually report quality of life after LASIK... one is a study of 100 patients in Bihar, India,⁴ and the other is a study of 49 patients in Ireland.⁵ In the study performed in India, the reason the females sought LASIK was to enhance marriage prospects. All levels of satisfaction in this review, ranging from "very" to "somewhat" were grouped and reported as "satisfied" patients.

An inspection of articles cited in the 'global LASIK literature review' reveals alarmingly high LASIK complication rates:

• "Twenty four percent of patients reported glare and night vision problems postoperatively." O'Doherty M, O'Keeffe M, Kelleher C. Five year follow up of laser in situ keratomileusis for all levels of myopia. Br J Ophthalmol 2006;90:20 -3.

• "Overall, 30.0% of the subjects reported experiencing halos, 27.2% reported glare, and 24.5% reported starbursts." Bailey MD, Mitchell GL, Dhaliwal DK, et al. Patient satisfaction and visual symptoms after laser in situ keratomileusis. Ophthalmology 2003;110:1371- 8.

• "Commonly reported symptoms included eye soreness in 43 patients (44.3%), tearing in 20 (20.8%), itching in 38 (39.6%), and moderate dryness or worse in 28 (20.8%)." Schmidt GW, Yoon M, McGwin G, et al. Evaluation of the relationship between ablation diameter, pupil size, and visual function with vision-specific quality-of-life measures after laser in situ keratomileusis. Arch Ophthalmol 2007;125:1037-42.

• "Night vision was considered worse or much worse than before surgery by 33.8% of patients....After surgery, 40.9% of patients reported experiencing more difficulty with night driving than before surgery." Tahzib NG, Bootsma SJ, Eggink FA, Nabar VA, Nuijts RM. Functional outcomes and patient satisfaction after laser in situ keratomileusis for correction of myopia. J Cataract Refract Surg. 2005 Oct;31(10):1943-51.

• "Twenty-nine percent reported reduced night vision clarity following LASIK and 27% noted more eye dryness following LASIK." CLAO J. 2001 Apr;27(2):84-8. Patient satisfaction after LASIK for myopia. Miller AE, McCulley JP, Bowman RW, Cavanagh HD, Wang XH.

As shown, articles in this 'global LASIK literature review' database that reported dry eyes and night vision problems confirm double-digit rates of these serious complications of LASIK.  Although Solomon et.al. did not report the incidence of dry eyes and night vision problems, they do state that poor quality of life scores after LASIK were associated with "regression, dry eye, poor vision in low light, and halos at night" -- a fact conveniently missing from Dr. Solomon's "95.4% of LASIK patients are satisfied" sound bite.  

Curiously, the FDA gave ASCRS advanced notice of the planned public meeting on LASIK⁶ - enough time to conduct a "LASIK world literature review" and prepare talking points for the media.  The spin generated by ASCRS surrounding this public meeting included misleading statements such as, "The FDA reaffirms that LASIK is both safe and effective".  At the public meeting, Dr. Solomon was asked by FDA consultant, Jayne Weiss, M.D., for clarification concerning FDA's role in ASCRS' public statement and literature review.  Dr. Solomon admitted, "This was independent from the FDA or the National Eye Institute. Yes, ma'am."

In 1994 as LASIK was being introduced, Dr. Leo Maguire of the Mayo Clinic cautioned against using patient satisfaction as a measure of success. He said: "A keratorefractive patient may simultaneously be happy with the result of surgery and have degraded vision - how can refractive surgery be a potential public health problem if patients are happy with the results?  Inherent in this question is the assumption that a patient without complaint is a patient without optical degradation. That argument does not hold up to closer scrutiny. The keratorefractive literature contains disturbing examples of patients who have visual handicaps that place themselves and others at significant risk for nighttime driving accidents and yet they are happy with the results."⁷

A Consumer Reports survey of LASIK patients finds that LASIK falls short of expectations for most who had the procedure. This Consumer Reports survey of laser eye surgery patients, which was published online in August 2009 (www.consumerreports.org) found that "nearly two-thirds said they were disappointed to find that they still had to wear glasses or contact lenses at least occasionally". Fifty-three percent of the respondents reported at least one side effect after surgery, and 22 percent were still experiencing side effects six months later. Nearly a quarter (24 percent) of "not highly satisfied" respondents said they regretted not learning more from people who had laser eye surgery before them.

Likely, surgeons are focusing on patient satisfaction to divert attention away from high complication rates inherent in the LASIK procedure.

Physicians have an obligation to place patient welfare over any personal profit motives. However, highly lucrative outpatient surgical procedures such as LASIK eye surgery have created a new breed of physician/entrepreneurs who are willing to simply sell what is profitable to a trusting and unsuspecting public. These 'salesmen' are masquerading as healers.

References

1. Mayo E. The Human Problems of an Industrial Civilization. New York, NY, MacMillan, 1933.

2. Accessed 10/12/2009 at

http://www.ascrs.org/press_releases/ASCRS-TO-PARTICIPATE-IN-AND-CO-FUND-STUDY-ON-POST-LASIK-QUALITY-OF-LIFE-WITH-US-FOOD-AND-DRUG-ADMINISTRATION.cfm.

3. 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.

4. Akhaury RK, Verma NP, Kumar R. Patient motivation for laser in situ keratomileusis in the state of Bihar. J Refract Surg. 2004;20(suppl):S727-9.

5. O'Doherty M, O'Keeffe M, Kelleher C. Five year follow up of laser in situ keratomileusis for all levels of myopia. Br J Ophthalmol 2006;90:20 -3.

6. EyeWorld Week Vol. 13 No. 7 March 10, 2008. Accessed 10/11/2009 at

http://www.eyeworld.org/ewweek.php?id=507.

7. Maguire LJ. Keratorefractive surgery, success, and the public health. Am J Ophthalmol. 1994 Mar 15;117(3):394-8.

Excerpt:

In the Federal Register of September 12, 2008 (73 FR 53028), FDA published a notice announcing the opening of a public docket to receive information and comments on the post market experience associated with the use of laser-assisted in situ keratomileusis (LASIK) devices, as well as information regarding potential barriers that may exist in providing the agency with feedback regarding LASIK procedures. Interested persons were invited to submit comments by September 14, 2009. At this time, the agency is reopening the docket to continue to receive public comments. Information and comments submitted to the docket will assist us in identifying ways in which we can improve our public outreach efforts regarding the safety and effectiveness of LASIK devices.

Link to notice: http://edocket.access.gpo.gov/2009/E9-27222.htm

###

Editors note: The comment period has been extended to November 15, 2010.  Instructions for submitting comments to the public docket may be found at the following link:
http://www.lasikcomplications.com/FDA-LASIK-Docket.html

FDA Public Health Advisory Sought on LASIK Hazards

11/06/2009

"The FDA's mission is to serve and protect the public, not to serve industry," says a 126-signatory letter to CDRH acting director Jeffrey M. Shuren, seeking a public health advisory on "the high incidence of adverse events and long-term consequences associated with LASIK surgery." The five-page 11/2 letter, signed mainly by injured patients, says that when FDA approved the LASIK indication for several excimer lasers in 1998, "little was known about long-term safety and efficacy of the procedure." It cites former CDRH ophthalmic surgical branch chief Morris Waxler as saying FDA was under enormous industry pressure to approve LASIK and the agency "failed to require proper scientific assessment of long-term safety and efficacy ... in an apparent attempt to appease powerful ophthalmologists who lobbied for approval."

The letter cites a 2007 published study of 12 Summaries of Safety and Effectiveness for laser approved between 1998 and 2004, which found that six months after LASIK, 17.5% of patients reported halos, 19.7% glare, 19.3% night-driving problems, 21% dry eyes worse than before surgery. FDA last year denied a citizen petition for a LASIK ban based on these data, contending that it contained no data and the agency was precluded by law from acceding to petitions seek enforcement action.

The letter contends that the body of literature on adverse LASIK events has been growing for the past 10 years, and that a "huge disconnect" exists between ophthalmologists who perform LASIK and the LASIK patient population regarding what constitutes a LASIK-related adverse event. "What a patient considers a bad outcome is often dismissed as an expected 'side effect' by the surgeon who performed the procedure," the letter says, adding: "Risk of intractable dry eyes after LASIK is downplayed in the informed consent process."

The letter says research published in 2005 and 2007 now demonstrates that in 100% of eyes treated, the corneal flap never fully heals, "exposing patients to life-long risk of traumatic flap dislocation and increased risk of eye infection." In addition, a 2006 study demonstrated that "Biomechanical strength of the cornea is reduced after LASIK, which may lead to sight-threatening corneal ectasia months or years after surgery."

Intraocular pressure measurements are falsely low after LASIK, according to a 2008 study, leading to possibility of vision loss from undiagnosed glaucoma. "LASIK causes error in calculation of lens power for cataract surgery, exposing patients to poor vision after cataract extraction," the letter says, citing a 2007 study.

Citing widespread, heavy advertising of LASIK to the public, the letter says there "has been little, if any enforcement of regulations governing LASIK advertising. The overwhelming majority of LASIK advertising is misleading and unsubstantiated."
 

Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 1-888-INFO-FDA

FDA Announces Plans for LASIK Quality of Life Project
Agency also Announces Warning Letters Issued to LASIK Facilities

The U.S. Food and Drug Administration today announced the launch of a collaborative study with the National Eye Institute and the U.S. Department of Defense to examine the potential impact on quality of life from Laser-Assisted In Situ Keratomileusis (LASIK), a surgical procedure that uses an eximer laser to permanently change the shape of the cornea.

The goal of the LASIK Quality of Life Collaboration Project is to determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems.

Funded by the government agencies, the project is composed of three phases. The objective of Phase 1, which began in July 2009, is to design and implement a Web‑based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK, some of which may relate to the safety of the lasers used in the LASIK procedure.

Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center.

Phase 3 will be a national, multi-center clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population. Patient enrollment in Phases 2 and 3 have yet to begin but plans are underway. Phase 3 is expected to end in 2012.

The results of the project will help identify factors that can affect quality of life following LASIK and potentially reduce the risk of adverse effects that can impact the surgical outcome. If any of these factors are related to the safety or effectiveness of the lasers used in LASIK surgery, the FDA will evaluate whether any action is necessary. The project is part of the FDA's ongoing effort to better monitor and improve the safety and effectiveness of the lasers used in LASIK surgery.

"This study will enhance our understanding of the risks of LASIK and could lead to a reduction in patients who experience adverse effects from the procedure," said Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health.

The FDA also announced that it issued warning letters to 17 LASIK ambulatory surgical centers after inspections revealed inadequate adverse event reporting systems at all the centers. The inspections did not identify problems with the use of the LASIK devices at these facilities.

Under legislation passed in 1990, user facilities, which include nursing homes, outpatient clinics and ambulatory surgical centers, must report device-related deaths to the FDA and to the device manufacturer. They also must report device-related serious injuries to the manufacturer or to the FDA if the manufacturer is not known. Requirements include having a written protocol for adverse event reporting.

The FDA inspected ambulatory surgical facilities that perform LASIK over the past several months and additional inspections are pending. The FDA regulates ophthalmic lasers used in LASIK, including monitoring their continued safety and effectiveness by analyzing reports on their post-market use.

"Many people in the U.S. undergo LASIK procedures," said Shuren. "Ambulatory surgical centers that perform LASIK must maintain a robust reporting system as required by law. Reporting adverse events to the FDA is critical to better understand the safety and effectiveness of ophthalmic lasers used in LASIK procedures and to enable the FDA to take appropriate actions where the lasers do not meet safety and effectiveness requirements."

For more information:

The FDA's Web site on LASIK:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/default.htm

FDA Guidance: Medical Device Reporting for User Facilities:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095266.pdf

###

This press release is published on the FDA web site at:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186858.htm

Related links:

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm187351.htm

http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM187357.pdf