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April 25, 2008 Ophthalmic Panel Meeting PDF Print E-mail

Video Testimony on LASIK, Depression, and Suicide From the April 25th, 2008 Special Hearing of the FDA's Ophthalmic Devices Panel

"The FDA's capacity to oversee the refractive surgery industry is in my opinion no different than the doctors who have tarnished it. The FDA has been ineffective in overseeing investigational studies, ineffective in enforcing the policies mandated for the industry, and ineffective in providing thus far the protection that many of us here today should have had." - As stated in my presentation (below).

On April 25th, 2008, the FDA's Ophthalmic Panel held an open public meeting to address 'Quality of Life' issues after Refractive Surgery. Among the presenters were Gerry Dorrian, whose son took his own life in 2007 as a result of his complications. David Shell help up charts depicting his distorted vision.

The 'positive side' was shown as well. The military spoke stating this was one of the best procedures available for those in the field. Doctors brought in patients potraying lasik as a miracle.

The panel was made aware that refractive surgery had a complication rate of about 5%. Think about it: If 1 million people had the procedure done, then that means 50,000 (5%) were damaged. Majority rules though, so 50,000 doesn't mean anything to the FDA. What about 5 million? That would make 250,000 people with complications! When I hear that the FDA is influenced by financial interest, you get no argument, especially since I've seen how they work!!!

As the FDA wants information on quality of life, I say give it to them. Anyone who's had a complication from refractive surgery send them your story. Let them know what your life is like now. And if you're sending it to them, copy, paste, and send a copy to me because I simply don't trust them!

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LasikFDA LAUNCHED PDF Print E-mail

Simply stated, its mission is "to expose deceit, corruption, and collusion by the FDA and the LASIK industry. You've read the hype about the 10-minute miracle. Now get the truth."

The cite contends that at that FDA panel meeting, "Insiders acquainted with the FDA approval process for medical devices were horrified as one by one, the presenters alleged deception by individual LASIK surgeons, cover ups perpetrated by medical device manufacturers, and corruption at the level of the FDA itself. Compelling cases were made for massive violations of federal law, the failure of the FDA to monitor surgical facilities for LASIK, and deliberate misclassification of severe complications as simple side-effects, as a means of securing premature FDA approval of the excimer laser.

LINK TO SITE

 
Did the FDA and ASCRS knowingly misrepresent the numbers of bad LASIK outcomes? PDF Print E-mail
Source

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?” (see 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)

Three other sources of information strongly support collusion between ASCRS and FDA. First, prior to the Special Hearing, patients who came to the FDA’s website were encouraged to use a complaint form to report their vision issues and dry eye complaints to the FDA. Unknown to patients, these complaints were held by FDA 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 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 complaint form never counted?  

Third, in November, 2006, the same month the FDA released criticism of its MAUDE reporting system, the FDA approached ASCRS and 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.

 
A Petition to BAN LASIK PDF Print E-mail

Human Geneticist and Biochemist Lauranell Burch has filed a petition with the FDA to ban LASIK. If you have complications from LASIK, you will want to comment. Be sure to include any deception in how LASIK was sold to you, inadequacy of informed consent, denial of your problems by your surgeon and second opinion surgeon, your vision immediately after your surgery and your vision now, and any feelings of depression and suicidal ideation, since these are common in patients with severe complications. You can comment here.

Due to enormous public outcry, the FDA is at last formally receiving general comments on LASIK here.

NOTICE:The FDA is currently assisting the LASIK industry in its medical coverup by censoring many patient comments to the petition, in clear violation of Federal Law. If you do not see your comment reflected, you now know why.

I submitted a response to the petition, as well as comment at another page on the FDA's site the beginning of September (08), to which nothing was posted. I called the FDA to inquire and was told "no individual consumer's response will be posted". In other words, unless you're part of the industry, you have no say! Poor excuses for censorship...

 
Patients feel FDA is disingenuous about interest in LASIK complications PDF Print E-mail

Source

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 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, Mary Weick-Brady, 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?

  

Reference:

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

 
Help IS Available: Just Not In The U.S. PDF Print E-mail

With today's advances in Refractive Surgery available in the United States, more damaged people are coming forward with complications from this procedure. Most complaints are quoted as incompetence, greed, 'assembly line' style surgical suites, lies to the patient, or the simple lack of caring by the doctor. First and foremost of complaints are the lasers! Just to name a few:

Blades getting stuck, broken, or RE-USED (these are supposed to be SINGLE USE BLADES);
Loss of the LASIK flaps (some have adhered to the microkeratome, some have been found ON THE FLOOR!);
Miscalculations by the doctors or techs;

There's no good reason why Americans should be subjected to surgery with lasers inferior to those currently being used in Europe. Have a lasik evaluation and ask the doctor when he'll have a new laser as good as the iVIS from Italy and a topographer equal to the Precisio. Don't let him tell you that the differences are not substantial, because they ARE. Don't settle for inferior equipment when your eyes are at stake. Your vision is too important.

Anyone considering refractive surgery should wait for that technology to become available in the United States. This is most important for patients who've already had refractive surgery and need irregular astigmatism, decentrations, small optical zones and other messes cleaned up. It appears that two doctors are at the forefront at helping those with bad outcomes who seek surgical remediation:

Dr. Ming Wang in Nashville, who is working on obtaining FDA approval* to import the iVIS laser into this country, and Dr. Aleks Stojanovic in Norway, who is already using the newer, better laser.

For more information, see the iVIS TECHNOLOGIES WEBSITE

If I were considering LASIK now, I'd wait because this technology is far superior to the crappy lasers in the U.S. right now. Not to mention our topographers that cannot see the central 1-2 mm of the cornea because the camera is in the way. Who in their right mind can honestly offer a custom treatment when data for the central cornea is being extrapolated?

* As mentioned throughout this section of my website, the FDA has done very little to help those damaged by Refractive Surgery. Apparently, there are no financial interests to the lackeys in the FDA by helping these casualties.

 
Will The FDA Ignore ANOTHER Petition? PDF Print E-mail

The FDA over the years has been ignorant of many requests from those damaged by Refractive surgery. They continue their efforts to promote 'effective' responses, giving false hopes to those requesting help.

This petition involves the use and RE-USE of Microkeratome blades, that are supposed to be single use blades.

How would you feel if the person done before you was HIV+, or had some other contagious disease, and the blade was never changed?

Don't let the FDA tell you this doesn't happen, because it does, and it HAS been proven. Now let's see how effective the FDA is in protecting you!

Please immediately take steps to approve the following Petition: I-VI to insure the safety of Americans regarding the misuses of Lasik going on in America today by refractive surgeons whom are stepping outside the ‘ethical’ limits on many levels regarding ‘breaching the standard of care’ we should all be given. 

  
FDAAccording to " LASIK Eye Surgery: What are the risks?," an article published on the U.S. Food and Drug Administration web site, one of several risks of lasik surgery is the risk that "Some patients may develop severe dry eye syndrome. As a result of surgery, your eye may not be able to produce enough tears to keep the eye moist and comfortable. Dry eye not only causes discomfort, but can reduce visual quality due to intermittent blurring and other visual symptoms. This condition may be permanent."
Ophthalmology TimesAccording to " Awareness facilitates treatment of LASIK-associated dry eye," published in Ophthalmology Times in May 15, 2003), a study shows that "dry eye is both the most common complication after LASIK as well as the most common reason for patient dissatisfaction" and that "up to 80% of patients who undergo LASIK experience symptoms of dry eye postoperatively."
Eric D. Donnenfeld, MDAccording to "Prevention and Management of Post-LASIK Dry Eye," an online medical lecture dated March 2004 given by Eric D. Donnenfeld, MD, dry eye is a potential complication of lasik surgery. His first slide states: "The most common and potentially one of the most devastating ... complications of LASIK is dry eye." A later slide states, "Every patient gets dry eye after lasik." He mentions severing of the corneal nerve as one possible cause of post-lasik dry eye, and also mentions several other possible causes, including specific surgical techniques.
SurgicalEyes.orgAccording to SurgicalEyes.org, undergoing surgery to correct vision is reported to cause or increase dry eye pain for some people. The goal of the Surgical Eyes Web site is to assist people who have had unsuccessful LASIK, PRK, RK, AK, ALK or other elective refractive and laser surgeries.
DryEyeInfo.orgAccording to the DryEyeInfo.Org Web site, people without Sjogren's Syndrome can also have dry eye and thus dry eye pain: "Tear production can also decrease from any condition that decreases corneal sensation.... Causes for decreased corneal sensation include long-term contact lens wear, LASIK eye surgery, trauma to the 5th nerve, and certain viral infections.
LadarVision.comAccording to the LadarVision.com safety page, "People with the following conditions should not have LASIK: ... Blepharitis (inflammation of the eyelids with crusting of the eyelashes....)" (and you might want to also take a look at the other conditions listed on that page). According to the LadarVision.com risks page, "In some cases, LASIK surgery may result in an inability to produce enough tears to keep eyes moist. This complication is the most common among LASIK side effects. Most patients suffer mildly from this for a short period of time.... The condition, however, can cause discomfort and may be permanent."
Sjogren's Syndrome Foundation newsletter (11/02)According to a Japanese study of 290 people who underwent LASIK surgery, some of whom had healthy eyes and some of whom were classified as having dry eyes or probable dry eyes, "patients with dry eyes can have significant dry eye symptoms, which may worsen after [LASIK] surgery. Those with probable dry eyes are also at risk for worsening dry eye criteria."

Read The Petition

 
FDA Does Not Use Advisory Committees Effectively PDF Print E-mail

FDA Does Not Use Advisory Committees Effectively in Approving New Drugs, Public Citizen Writes in Lancet Medical Journal

FDA Follows Committee Recommendations Only 72 Percent of Time, Does Not Present Its Own Reviews 18 Percent of Time

WASHINGTON, D.C. - The U.S. Food and Drug Administration (FDA) is not using its own advisory committees effectively when considering the approval of new drugs, according to a Public Citizen study, the results of which are published in a letter in the current edition of the Lancet medical journal. The study of drug advisory committee meetings found that the FDA overrules the findings of its own advisory panels 28 percent of the time, a figure higher than is generally assumed.

To read the entire press release, click here

Even more, click the 'Read More' button below.

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US FDA: Maybe It's Time for the Hercules Solution... PDF Print E-mail

"The stench at the US Food & Drug Administration (FDA) is unbearable. The FDA, designed to regulate certain industries in the US, has been taken over, in its entirety, by those industries, who operate the agency for their own benefit. There is no argument against this statement. At FDA the tail is wagging the dog. Americans are being regulated by industries. It's the way it is."

Read More

 
The LASIK Report...Will The FDA act? PDF Print E-mail

We all know how the FDA reacts to factual findings...

THE LASIK REPORT

A Call for the Discontinuation of a Harmful Procedure

August, 2006

LASIK is one of the most commonly performed elective surgeries in the United States today. The public perception of LASIK is based largely on advertising, which is intended to entice patients to have surgery without disclosing risks, side effects and contraindications.

The perceived benefits of LASIK surgery are obvious, whereas risks and adverse effects are not. It is unwise to assume that a surgeon who has a financial interest in a patient’s decision to have LASIK will provide adequate informed consent.

LASIK is irreversible and may result in long-term, debilitating complications. There are permanent adverse effects of LASIK in 100% of cases, even in the absence of clinically significant complications. This is unacceptable in the context of an elective surgery when safer alternatives such as glasses or contact lenses exist.

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Guidance for Industry and FDA Staff - A Joke? PDF Print E-mail

Source

Keratome and Replacement Keratome Blades Premarket Notification [510(k)] Submissions

Document issued on: September 18, 2006

For questions regarding this document, contact Everette T. Beers at 301-594-2018 ext. 136 or by email at everette.beers@fda.hhs.gov.

U.S. Department of Health and Human Services Food and Drug Administration

Center for Devices and Radiological Health Diagnostics and Surgical Devices Branch Division of Ophthalmic, Ear, Nose and Throat Devices

Office of Device Evaluation

Contains Nonbinding Recommendations

Preface Public Comment

Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852.

Alternatively, electronic comments may be submitted to http://www.fda.gov/dockets/ecomments. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies Additional copies are available from the Internet at: http://www.fda.gov/cdrh/ode/guidance/ specifc address.html. You may also send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number (1604) to identify the guidance you are requesting.

2 Contains Nonbinding Recommendations

3 Table of Contents

1. INTRODUCTION.................................................................................................................1

The Least Burdensome Approach............................................................................................1

2. BACKGROUND...................................................................................................................2

3. THE CONTENT AND FORMAT OF AN ABBREVIATED 510(K) SUBMISSION....2

4. SCOPE..................................................................................................................................5

5. DEVICE DESCRIPTION....................................................................................................5

6. RISKS TO HEALTH............................................................................................................7

7. PRECLINICAL ASSESSMENT.........................................................................................7

8. SOFTWARE VALIDATION...............................................................................................9

9. ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY...............9

10. MATERIAL CHARACTERIZATION AND BIOCOMPATIBILITY.........................10

11. STERILIZATION...............................................................................................................11

12. LABELING........................................................................................................................11

APPENDIX – INFORMATION FOR REPLACEMENT KERATOME BLADES...............13

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For the Refractive Surgeons who offer Botox PDF Print E-mail

Feb. 8, 2008

FDA's Botox Warning Falls Short  

Statement of Sidney Wolfe, MD, Director of the Health Research Group at Public Citizen

Today, the Food and Drug Administration (FDA) reported that botulinum toxin (available as Botox and Myoboloc) has been linked to adverse reactions, including respiratory failure and death. This announcement comes just two weeks after Public Citizen petitioned the FDA to immediately increase its warnings about the serious risks of using Botox and Myoboloc. Adverse reactions can include paralysis of the respiratory muscles and difficulty swallowing (dysphagia), a condition that can allow food or liquid to enter the respiratory tract and lungs, causing aspiration pneumonia. Our analysis of FDA data found that the makers of the drugs had reported 180 U.S. cases of people developing serious conditions after receiving injections, including 16 deaths.

READ the entire statement.

 
Are you really protected by the FDA? PDF Print E-mail

These reports were asked to be returned because "There was too much information the general public should not be aware of" and "was not only applicable to the Nevyases' study, but all studies" (Quotes were from Les Weinstein, the Ombudsman of the FDA's CDRH division).

The FDA's Mission Statement: The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

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Is Any Laser Really Safe? PDF Print E-mail

UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF NORTH CAROLINA

THIRD PARTY COMPLAINT OF EBW LASER, INC.

GE HEALTHCARE FINANCIAL SERVICES, a component of GENRAL ELECTRIC COMPANY, Plaintiff,
v.

Civil Action No. 1:03CV00514

 
EBW Laser, Inc.

Defendant.
Third Party Plaintiff,
 
v.

ALCON LABORATORIES, INC., and REFRACTIVE HORIZONS, L.P.

 
Third Party Defendants.
 

Defendant, complaining of the Third Party Defendants, alleges and says:

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Speaking of Alcon...AGAIN! PDF Print E-mail

Some very interesting exchanges can be found in FDA transcripts, exchanges which foreshadowed problems that the victims of refractive surgery knew about, but couldn't get anyone to pay attention to, because no one was interested. These transcripts are a matter of online public record, meaning that they are to be permanently warehoused on the FDA servers. Yet, some of these transcripts have mysteriously disappeared. When you write to the webmaster for the FDA, at first they're eager to help you. But eventually, you just get no reply and no documents.

The FDA Alcon Approval Meeting

Background: Meeting was held Aug. 1, 2002 in Gaithersburg, Maryland. The purpose of the meeting was to review the clinical trial results and vote on ALCON's application for FDA approval of CustomCornea wavefront guided LASIK for the correction of myopia up to -7D. The Surgical Eyes Foundation was represented by Ron Link (founder) and David Shell (a patient) during the open public hearing. A letter from an SE participant was read aloud during the open public forum asking that large pupils and dry eyes be listed as contraindications. Below are notable quotes from that meeting, indexed by their page number on the original FDA meeting transcripts. The quote tell a revealing story of an FDA which have more interest in supporting an unethical industry than in protecting patients.

Page 61 - DR. PETTIT (Alcon): The little asterisks indicate those changes that were statistically significant between the preop and the six-month postop interval and you can see that for almost all of the aberration parameters, they're actually slightly higher by a statistically significant amount after surgery than before. The trefoil is actually less after treatment but it's not a statistically significant difference. Now, I should just also mention this is based on a 6.5mm wavefront analysis diameter. This isn't a surprising finding. It's well known that LASIK tends to increase the higher-order aberrations.

Page 65: Dr. Brint (Investigator): As clinicians, we know that prior studies of conventional LASIK in general have shown that higher-order aberrations, particularly spherical aberration which is frequently linked to poor night vision, occasionally may be increased after conventional LASIK. These increased higher-order aberrations after conventional LASIK are pupil-size dependent with larger pupils showing decreased retinal image quality as measured by point spread function and modulation transfer function and visual performance as measured by the clinically useful contrast sensitivity testing and low-contrast visual acuity testing.           (This paragraph is significant to those with large pupils who were not warned, and because there are still doctors saying that pupil size is not a critical measurement prior to surgery.)

Read more...
 
The Lastest Hype: What About Wavefront Results? PDF Print E-mail

There is a 9% dissatisfaction rate.

See the FDA Alcon Meeting link for even more information.

EXCERPT:

DR. GRIMMETT: Dr. Michael Grimmett. I just had an observation and would like to hear if you have a comment. You may have none. There may be no answer. I found it curious that despite a very comprehensive analysis and sophisticated technology, that the patients that were unsatisfied or extremely unsatisfied approximated 9 percent. It's notable that the PERK study (A study of radial keratotomy patients) by comparison, using bear skins and stone knives, had an 11-percent dissatisfaction rate, and I found it curious that one in 10 patients are unsatisfied, despite a phenomenal amount of technology and analysis, and I would like to commend you on a superb analysis and presentation. Do you have a comment why it's still one in 10 despite all the sophisticated technology or is there no answer to that, sir?

DR. PETTIT: No. Well, I don't know everything."

DR. GRIMMETT: Dr. Bradley stated wavefront-guided LASIK does not reduce the level of higher-order aberrations of the preoperative eye, and he also wrote there's no way wavefront-guided LASIK can correct higher-order aberrations and render super-normal vision. That's the second statement. Is that not correct?

DR. BRADLEY: Your memory is better than mine, but I can look at the slide.

DR. GRIMMETT: No, I believe I transcribed it correctly.

DR. BULLIMORE: I agree. This is Dr. Bullimore. I agree with the sentiments of both of those statements. Exactly how the second one is worded, we could come back to, but the first one adequately ??

DR. WEISS: Can you repeat the first one again?

DR. GRIMMETT: Sure. Wavefront-guided LASIK does not reduce the level of higher-order aberrations of the preoperative eye.

DR. WEISS: Would that not be confusing to someone? Wouldn't that be confusing?

DR. GRIMMETT: Michael Grimmett. It may suggest somehow wording in that wasn't it that the higher-order aberrations were 20 percent higher than the preop eye in the wavefront-guided versus what, 80 percent was the number?

PARTICIPANT: Seventy-seven percent.

DR. WEISS: In here, is there any place saying that LASIK itself increases aberrations and that customized corneal ablation increases them less than conventional treatment?

DR. GRIMMETT: I think that's the idea.

DR. WEISS: So maybe we could put that wavefront-guided ablation ??

DR. GRIMMETT: Conventional LADARVision LASIK increases higher-order aberrations by that figure 77 percent while wavefront-guided LASIK increases them by whatever, 20 percent, whatever the number is, or you can say reduces them to a 20-percent level, if you want to use the word "reduces."

DR. BULLIMORE: I would avoid the term "reducing."

DR. WEISS: I would say each of them increases it because basically whether or not you're treating the preexistent or what's induced, the bottom line is you still have more aberrations than you did when you started off.

DR. GRIMMETT: Well, the intent is telling the traffic cop that you're speeding less than the other speeders.

 
The FDA on Clinical Trials PDF Print E-mail

It is well-known that manufacturers of devices (lasers, IOLs, etc.) cherry-pick the so-called top surgeons for clinical trials. It's also well-known that surgeons cherry-pick patients for these clinical trials, including only patients who are likely to have the best outcomes. This is one reason why clinical trials do not really reflect the outcomes that will be seen in the real world in the hands of average surgeons and borderline patients. Let's "listen in" on an FDA panel meeting:

http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3991t1.htm

Quote:

DR. WEISS: I think we have to be careful about this best physicians talking about lack of data. I'm sure these were good docs and good surgeons, but creating this extra godlike category, I think we should take out of the discussion.

DR. BANDEENROCHE: That's a point welltaken. That's a point welltaken. Nonetheless, I mean, we hardly expect better performance in the field than we do in a clinical trial.

DR. McCULLEY: You don't have data to support that statement, do you? Do you have data to support that statement? You do. Okay.

DR. ROSENTHAL: With all kinds of devices.

DR. McCULLEY: All right.

DR. WEISS: What I would then like to lead to is since there's agreement ‑‑

DR. ROSENTHAL: Wait.

DR. WEISS: Yes.

DR. ROSENTHAL: I want to make sure I said the right thing. Once they go out in the field, they tend to have more problems than they do within the clinical trial.

DR. McCULLEY: But you don't have data to support that the people who do the trials are the best of the best.

DR. ROSENTHAL: No.

DR. McCULLEY: I think that is opinion ‑‑

DR. MACSAI: That's my opinion.

DR. McCULLEY: That is Marian's opinion, and it should not be in our discussions.

DR. WEISS: So we're going to take out the "god" factor out of the discussion.

(Laughter.)

Notice how Dr. Rosenthal, Division Director, tried to back up and cover his tracks because he let that comment slip out.

 
Why Not ALL of the Black Box Lasers? PDF Print E-mail

The FDA has been very 'choosy' as to what actions they took against SOME in the LASIK industry regarding 'Black Box' Lasers.

Throughout the FDA section of this site, you'll see the indifferences between what the FDA says, and the actions they TAKE.

The siezure of several lasers does not account for all of the others out there that have damaged numerous people. The FDA has even allowed Ed Sullivan, builder of these lasers, to be involved in conferences with the FDA and the doctors, even AFTER the scrutiny of 'Black Box' lasers.

Below is a video regarding Dr. Nick Caro of Illinois, whose practice has resulted in over 50 lawsuits and siezure of his laser by the FDA. And yet, he's still in practice...

 
FDA Petition PDF Print E-mail

The following petition was sent to the FDA in an effort to stop the increasing number of Lasik casualties.  Although many doctors have abided by the regulations set by the FDA, and have had successful surgeries, there are many based on the reported number of casualties who have not.  Actual counts of those casualties are not known due to non-reported cases.  Since the FDA cannot totally enforce what they mandate, why should these doctors be allowed to put people at such high risk.

Read more...
 
Intacs PDF Print E-mail

With flaws found in LASIK studies, why does the FDA allow doctors who were involved in these studies to continue to do more studies, such as Intacs? Improper data, investigators not properly screening candidates, and lack of responsibility by the Institutional Review Boards who are not 100% efficient are creating casualties who should not be.

If the FDA can believe flawed reports from LASIK research, who's to say the reports from Intacs studies were not flawed as well?

More on INTACS...

FDA Warning
FDA Minutes
More on STAAR #1
More on STAAR #2
 
FDA Inspection Reports of the Nevyas' Facility PDF Print E-mail

Click PAGE # to open page in new window

NOTES: Page numbers with an "l" designate the page as landscape. All BLUE font on this page designate links.

FDA Issued Inspection Report of Nevyas Eye Associates facility dated 11/02/1998:

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FDA Issued Inspection Report of the Nevyas' facility dated 05/10/2001:

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The 2nd inspection resulted in an FDA483 issued by the FDA.

Although the records requested via the FDA's Freedom Of Information Act were redacted (edited), the FDA stated:

 "There is too much information the general public should not be aware of, not only in the Nevyas' study, but in all studies".

This second set was obtained from the FDA's Philadelphia Office, and included not only the Nevyas' facility of 05/2001, but that of Ed Sullivan (Exsull), builder of their laser (see above). The inspection was 2 years after the article written in the Journal of Refractive Surgery (Fall Issue - 1995):

Inspection Report of the Nevyas' facility dated 05/2001 (less edited):

PAGE 1PAGE 2PAGE 3PAGE 4
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More on the FDA and the Nevyas' study

 
Before The Nevyas' Study PDF Print E-mail

It started with Ed Sullivan, the guy who built the 'Nevyas Laser', a man already under scrutiny by the FDA...

"Ed Sullivan, doing business as ExSull, Drexel Hill, Pa, has been put on notice by the FDA that the agency regards him "clearly as a manufacturer with multiple manufacturing sites" subject to FDA rules and regulations and, if he makes another one of these excimer lasers "which are unapproved devices," he will be in violation of the federal Food, Drug and Cosmetics Act and subject to legal penalties, according to top-ranking FDA officials within the national Division of Enforcement." [as written in The Journal of Refractive Surgery - Volume 11 (5) * September/October 1995 * News and can be found at the url address http://www.slackinc.com/eye/jrs/vol115/news1.htm]

And the FDA knew that! From the affidavit Herbert Nevyas submitted to the FDA, it tells of Ed Sullivan building their laser. However, documents show Mr. Sullivan in teleconferences and meetings with the doctors and their liaison with the FDA well after this article was written.

After I received inspection reports even less redacted from the FDA regarding inspections of the Nevyas' facility, the FDA promised "to do what they could to help me", but then refused after copies of the inspection reports were returned. In fact Les Weinstein, the CDRH Ombudsman, outright told me (through his secretary) he could no longer have any communication with me. It seems to me (based on my communications with the FDA) that the FDA was more concerned with being sued by the Nevyases for the information released, then by doing the right thing.

The inspection reports of Sullivan's facility below were obtained via the Freedom Of Information Act.  Regardless of these reports and the articles written concerning 'Homegrown Lasers", is this what the FDA considers "protecting the public's safety"?

Click PAGE # to open pages in new window

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The FDA issued warning letters regarding the lasers Sullivan built, but STILL allowed doctors to further modify and use these devices on people considering LASIK!

Warning Letter 1 <>  Warning Letter 2

 
FDA Related PDF Print E-mail

FDA's LASIK Website

Although I feel the FDA has protected many doctors, companies, and themselves, they still have an informative LASIK Website.

Link To Site

Is ANY Laser really safe?

Not just investigational lasers, but those WITH approval from the FDA...

Alcon lasers

There were a whole bunch of new MDRs filed in the Maude database during December about breakdowns of Ladarvisions. They make interesting reading. Go to:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm

(Type in "ladarvision" and search)

"CUSTOMCORNEA" into the search and got this one:  "Alcon customcornea & ladarvision 4000 wavefront lasik machines were used to preform enhancement surgery on left eye after original lasik in 2003. Enhancement surgery made eyesight worse; nearsighted again with multiple vision effect when looking at point of light. 2nd, 3rd, 4th opinions from other drs confirm irregularities in cornea from enhancement surgery and all of them say that the alcon customcornea wavefront measurement device and the ladarvision laser should not be used for enhancements because the software is not sophisticated enough and is too unstable."  Not only their machines, but their stock as well:

http://finance.messages.yahoo.com/bbs?.mm=

FN&action=m&board=1604339425&tid=acl&sid=1604339425&mid=2932

CODE OF FEDERAL REGULATIONS 812.7

CODE OF FEDERAL REGULATIONS 812.7

And promotion of an Investigational Device.

Read More

FDA Warning for Risk of Dry Eye Complications

 

http://www.fda.gov/cdrh/LASIK/risks.htm

Quote:

Some patients may develop severe dry eye syndrome. As a result of surgery, your eye may not be able to produce enough tears to keep the eye moist and comfortable. Dry eye not only causes discomfort, but can reduce visual quality due to intermittent blurring and other visual symptoms. This condition may be permanent. Intensive drop therapy and use of plugs or other procedures may be required.

 

It does happen!  And the people I've spoken to with these complications let you know the risks are severely down-played by the FDA.  These symptoms are VERY painful!

 

 

And doctors want patients to think that DLK and infectious keratitis just happen for no reason...

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=41874

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=41818

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=25688

Ophthalmic Devices Panel Meetings

 

This FDA panel meeting has a rather disgusting section where concealing the fact that refractive surgery induces dry eye from the consumer is discussed. The panel decided not to require that ALCON disclose that dry eye after refractive surgery is an industry-wide problem... because they hadn't required other LASER companies to include dry eye warnings in their labeling previously. So they claimed it wouldn't be FAIR to ALCON to have to admit in their labelling that refractive surgery induces dry eye. How about being fair to patients so that they can be properly informed about LASIK dry eye BEFORE they decide to have surgery?

Loss of corneal nerve density averaging more than 40% at the 3 year point after LASIK? No thank you!

http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3883t1.doc  

http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3883t1.doc  

This link will allow you to find transcripts of all Ophthalmic Devices Panel meetings. Click on the year, then scroll down and look for Ophthalmic Devices.

http://www.fda.gov/ohrms/dockets/ac/acmenu.htm

Before you start clicking and reading, it helps to know which meetings were called to review lasers for refractive surgery.

Here's a link to the summaries of these meetings from 1997 through 2000:

http://www.fda.gov/cdrh/odp.html

More recent meeting summaries can be found at this link:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/search.cfm

Click on "Ophthalmic Devices Panel", "Past Meetings".

FDA - Your Opinion?

http://www.lasikflap.com/forum/viewtopic.php?p=1769#1769

 “I hate the damn FDA. Its one thing for the laser makers to lie but it's another thing to know that your life ended because the damn FDA was too ignorant, too careless, or too corrupt to want to do it's job to stop them.”    

<<>>

http://www.lasikflap.com/forum/viewtopic.php?t=452 

“the FDA says they dont regulate the practice of medicine. but lying to the FDA in order to perpetrate fraud on the public is not medicine. therefore, it is regulated by the FDA.”

“the FDA says they dont regulate the practice of medicine. but lying to the FDA in order to perpetrate fraud on the public is not medicine. therefore, it is regulated by the FDA.”

“so the FDA can do something if its wants to. the question is whether the FDA itself is so corrupted by special interests that it doesnt want to. my guess is that it is. how else would research that was obviously deceptive make it through the opthalmic devices panel and be approved? if the fda took some kind of action, it might well have to admit to millions of consumers that they are facing long term damage to their vision. it could cause a lot of embarassment. so the fda is silent, just like almost everyone is silent.“

Available to the Public

Available to the Public

Over 1,000 pages of additional documents (now available on CD) are available to the public on request to this website. Please email me for more details.

Need To Contact The FDA?

GOOD LUCK! These wonderful people have helped me extensively ( NOT! ). If you're expecting help, expect a runaround:

Andrew VonEschenbach - ACTING COMMISSIONER OC
andrew.voneschenbach@fda.hhs.gov - 301-827-2410
Les Weinstein - OMBUDSMAN (CDRH)
les.weinstein@fda.hhs.gov – 301-827-7991
Christine Kellerman –SECRETARY (for Les Weinstein) (OA)
christine.kellerman@fda.hhs.gov - 301-827-7975
Matthew Tarosky - SR SUP REGULATORY O
matthew.tarosky@fda.hhs.gov – 240-276-0243
Linda S Kahan - DEPUTY DIRECTOR CDRH
linda.kahan@fda.hhs.gov – 301-827-7975
Everett Beers, Dr. – SUPV GENERAL ENGINEE
everette.beers@fda.hhs.gov - 301-594-2018 x136
Michael Marcarelli – SR SUP REGULAT O
michael.marcarelli@fda.hhs.gov - 240-276-0244
Viola Sellman – SUPV CONSUMER SAFETY OFCR
viola.sellman@fda.hhs.gov - 240-276-0125
Barbera Stellar – PUBLIC HEALTH ADVISOR
barbara.stellar@fda.hhs.gov - 240-276-3150 x144
Timothy Ulatowski – DIR OFFICE OF COMPLIANCE
timothy.ulatowski@fda.hhs.gov - 240-276-0100
Joy Lazaroff – SUPVY PARALEGAL SPECIALIST
joy.lazaroff@fda.hhs.gov – 301-827-7258
Ronald Swann - SUPV CONSUMER SAFETY OFCR
ronald.swann@fda.hhs.gov - 240-276-0115
Mark Weinstein - Assoc. Dep Dir CBER/OBRR
mark.weinstein@fda.hhs.gov - 301-827-3518
Gene Allen – PUBLIC HEALTH ADVISOR
gene.allen@fda.hhs.gov - 240-276-3150 x114
Malvina Eydelman - SUPV MEDICAL OFFICER
malvina.eydelman@fda.hhs.gov - 301-594-2205 x132
Jean Toth-Allen - PHYSICIST
jean.toth-allen@fda.hhs.gov – 301-827-1585
Jerry Dennis – CONSUMER SAFETY OFFICER
jerome.dennis@fda.hhs.gov – 240-276-3330
Linda Lyons Drager (ODE) – SECRETARY (OA)
linda.lyons@fda.hhs.gov – 301-594-2186 x108
Pat Storer – CONSUMER SAFETY TECHNICIAN
patricia.storer@fda.hhs.gov - 301-594-2205 x184
Laurie Lenkel – REGULATORY COUNSEL
laurie.lenkel@fda.hhs.gov - 301-827-3390
Steven Kendall - SUPV CONSUM SAFETY OFFICE
steven.kendall@fda.hhs.gov - 301-594-1162
Susan Setterberg (phila) - REG FOOD AND DRUG DIR
susan.setterberg@fda.hhs.gov - 215-597-8058
Ed McDonald (phila) - CONSUMER SAFETY OFFICER –
edward.mcdonald@fda.hhs.gov – 215-717-3739 x4524
Steven Kane (phila) - CONSUMER SAFETY OFFICER –
steven.kane@fda.hhs.gov – 215-717-3718
Ronald Stokes (phila) - CONSUMER SAFETY OFFICER –
ronald.stokes@fda.hhs.gov – 215-597-4390 x4533

No longer with the FDA or listed on employee directory:

Lester Crawford 
Mark McClellan 
A. Ralph Rosenthal
Levering Keely –
Harold Pellerite –
ROBERT ZIMMERMAN (phila) – REGION SUPV -
DEBRA WOLF –

EMAIL ME

 
CLINICAL TRIALS FOR LASIK FLAWED PDF Print E-mail
Reposted with permission

 

On the subject of LASIK complications, and who knew what and when...let's just say I can't wait for some depositions to go public.

 

Here's something that is public that may interest you. Hopefully you have read it. If you have, you would know that there was a BIT of a clinical trials problem, with VISX being much more, shall we say 'problematic' than Alcon. Now there's an understatement.

 

Now why do you think a company would collect contrast sensitivity data and not report same? Hint, LASIK causes loss of contrast sensitivity in all

patients. Don't want to have to actually tell the victims, er... I mean 'patients' about that, so suppress THOSE DATA!!!

 

Hard to believe that less than 25% of LASIK patients in a clinical study would bother to show up for their follow-up appointments! It is in their medical best interests to be followed for a year. What do you think that huge patient population gone missing has in common? What do you think the patients who were included had in common? Why do you think they lied about 12 month accountability? If you were to derive means of several metrics of outcome measure, do you think the differences between these groups would be statistically significant?

 

How about patients who report being dropped from clinical trials for having bad outcomes?

 

Why the reliance on subjective survey data of symptoms when the technology to gather objective clinical data was available? And then to present inferior subjective survey data on only a subset of patients... in a format that any Stats 101 dropout drooling idiot can easily recognize as bad science! Who set up these 'studies', who was monitoring these clinical trials, who was involved in these clinical trials, and who voted to approve these devices?

 

If your choices in a subjective survey are on a 'better' or 'worse' scale with no actual measure of magnitude, then a patient who sees starbursts that are a bit larger after surgery is scored the same way as the patient who is incapacitated by starbursts from headlights that are larger than the cars that generate them. How much sense does this make?

Read more...
 
The FDA produced this quick and easy loophole to remove embarrassing little omissions from your PMA PDF Print E-mail

- Did you forget a clause forbidding re-use of microkeratome blades?

- Need to change your labeling really fast to cover your behind?

IT is AMAZING how accomodating the FDA can be!

There's MORE...

Read more...
 
Microkeratome Blades, And the FDA PDF Print E-mail

How would you feel if you received an infectious disease or permanent injury caused by the reuse of an FDA "regulated" medical device AFTER the CDC and the FDA knew about an unsafe risk and did nothing?

Many Microkeratome components used for LASIK are licensed, "regulated" and approved by the FDA solely as single-use, disposable medical devices, but the FDA states the FDA has No jurisdiction to enforce Federal laws regarding these FDA approved medical devices.

Hundreds of LASIK Doctors have admitted reusing these single use blades, but none have lost their medical licenses and only a few have even been placed on temporary probation (to my knowledge).

Read More

The FDA does Not regulate the practice of medicine, but the FDA does regulate all users and practitioners of these devices.  Not everything that a medical Doctor does is considered the practice of medicine.  Being a licensed medical Doctor does Not allow a person to break Federal or State laws.

An off-label use of a device explicitly for the potential benefit of a patient (where the benefit clearly outweighs the risk) would be considered a legitimate practice of medicine.  However, when there is no patient benefit and/or the risk outweighs any benefit, then Not following the FDA labeling does Not constitute the practice of medicine By definition.  Part of the definition of the practice of medicine is to put the patients’ best interests ahead of those of the Doctor.

Why isn't any practitioner or user of these FDA "regulated" (Class I) medical devices (whether or Not he/she happens to be a Doctor) who uses them in an unnecessarily risky way or who does Not provide informed patient consent under the FDA’s regulatory authority and jurisdiction?

Read More

The House of representatives has investigated the FDA regarding allowing these harmful practices (as reported in the Washington Post).  "If there is the remotest possibility that a catheter might be used twice, that you could potentially harm a patient, you should not use it," he said. "It's common sense."

"The Washington Post examined thousands of pages of documents, including FDA records, court filings and internal company reports, and was able to document dozens of cases of patient injuries and device malfunctions after single-use devices were reused over the past decade"

Read Their Article

Microkeratome blades get duller every time they are reused which causes irregular flaps made in the cornea, less smooth flaps, epithelial ingrowth, keratitis, and other serious problems.

Read More

The FDA hasn't even responded to a request for humanitarian aid or compassionate use of a medical device.  They don't do anything about Doctors Not providing the Patient Handbooks, violating the labeling (including false advertisements), or Not informing patients they are getting an "off-label" treatment, but when the FDA was asked to simply put in writing that the manufacturer and a Doctor can do a treatment zone .5mm wider than the current 6.5mm maximum approved by the FDA (to come closer to matching an actual pupil size), the FDA would Not put it in writing.  Is that humanitarian or compassionate?

Read More

"IF Doctors who do "second opinions" after LASIK (this is a big business due to all the people with problems) are used to seeing good results from LASIK, then why aren't the Damages from reusing microkeratome blades obvious to them?  As odd as it sounds, many patients have told me their Doctors acted as if they did Not believe what they were telling them about their eyes and vision.  My own statements about my vision and eye pain, etc. do Not appear in many of my medical records, and some Doctors have one diagnosis but Not others (in some cases I initially found out Only by getting copies of my medical records because some of the Doctors did Not tell me they had put these diagnoses in my records).  One Doctor who was on the FDA's Ophthalmic devices panel said the objective evidence (without reviewing my artemis or confocal exams) was Not consistent with what I said about my vision.  I was shocked when he said "I know many patients who would be happy with your vision".  I'm sure that blind people would be happy with my vision, but how does that help with my terrible vision and eye problems that bother me all the time?"

Read More

"LaserVue reused microkeratome blades among patients rather than sterilizing or replacing them.  Former patients may have been exposed to infectious diseases such as HIV or Hepatitis."

Read More

"I must protest - there could never be legitimate reasons for placing patients at incredible risk of HIV, viral hepatitis, or Mad Cow disease - all which can potentially be transmitted via the use of unsterilized sharp instruments. There is absolutely no excuse for this.  It goes against every medical standard and as well goes against the laser centers licensing by OSHA (a governmental organization that certifies that surgery centers are following the appropriate blood borne pathogen.  And I have to say that your organization will lose complete credibility if this type of action is excused.  These surgeons and the laser centers put their patients at severe risk. You can't look back and say no one was injured, so their actions were OK.  Mad Cow Disease (Jacob-Creutzfeld) can be transmitted via the cornea (there are documented cases of patients transmitting this disease following corneal transplants) - and this disease may take 20-40 years to show up.  As well, HIV is known to be present in tears - and blood is not an uncommon sight with LASIK."

Read More

"I thought surely the eye Doctors' Academy (that provides the Doctors with the board certification they put in their bios) would have a policy designed to protect patients' safety.  Think again."

"At this time, the Academy [The American Academy of Ophthalmology] does not have a formal policy on the issue [reusing Microkeratome blades on multiple patients without sterilization]."

Read More

 
FDA Praises Itself To Committee on Govt. Reform PDF Print E-mail

Source

Statement of Daniel Schultz, M.D., Director Center for Devices and Radiological Health Food and Drug Administration U.S. Department of Health and Human Services before Committee on Government Reform House of Representatives  

SEPTEMBER 26, 2006

INTRODUCTION

Mr. Chairman and Members of the Committee, I am Dr. Daniel Schultz, Director, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA or the Agency). I consider device safety to be of utmost importance and appreciate your invitation and the opportunity to discuss this issue. Let me say at the outset that I believe FDA currently has many tools to ensure the safety, effectiveness, and manufacturing quality of reprocessed, single-use devices (SUDs).

FDA has been actively engaged in the SUD reuse issue for some time, and our efforts have included research, outreach, pre-market review, inspections, and compliance investigations. We have held numerous public meetings and conferences with industry, healthcare professionals, and consumers over the years to determine the extent, magnitude, and changing nature of this practice. FDA has carefully evaluated and conducted research to develop the scientific basis for addressing SUD reprocessing. We have inspected third party reprocessors, evaluated and investigated reports of patient injuries, and reviewed numerous pre-market submissions. Taken together, the Agency believes that these efforts have provided, and will continue to provide, reasonable assurance of safety and effectiveness of reprocessed SUDs for patients.

BACKGROUND

I will begin with a brief overview of our regulatory authorities for medical devices. A medical device as defined by Federal law encompasses several thousand health products, from simple articles such as tongue depressors and heating pads, to cutting-edge and complex devices such as implantable defibrillators and robotic equipment for minimally invasive surgery.

The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic (FD&C) Act gave FDA specific authority to regulate the safety and effectiveness of medical devices. Medical devices are assigned to one of three “classes.” Class I is the lowest risk category of device and includes items such as adhesive bandages. Class II, or medium-risk category of device, includes devices such as intravenous catheters and powered wheelchairs. Class III is the highest risk category of device and includes devices such as heart valves and coronary stents.

THE REGULATION OF REPROCESSED SINGLE USE MEDICAL DEVICES

The reprocessing of SUDs is legally permissible in the United States under the FD&C Act. Currently, only Class I and II SUD device types have been cleared by FDA for reprocessing. No Class III SUDs have been cleared/approved for reprocessing.

In August 2000, FDA issued a guidance document for industry and staff entitled “Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals.” This document set forth FDA’s priorities for enforcing pre-market submission and post-market requirements for manufacturers who wished to market reprocessed SUDs. The guidance document stated that any third party or hospital reprocessor should comply with requirements pertaining to: registration and listing, medical device reporting, medical device tracking, medical device corrections and removals, the quality system regulation, labeling, and pre-market submission. Essentially, third party firms and hospitals reprocessing SUDs were placed in the same regulatory framework as original equipment manufacturers (OEMs).

Prior to issuance of this guidance, reprocessing of SUDs was frequently performed by hospital personnel without regulatory oversight or regard to the level of device risk. In addition, many third party reprocessors contracted with hospitals to perform similar tasks and these contractors did not consistently adhere to FDA’s Good Manufacturing Practice Requirements.

CHANGES ENACTED WITH MDUFMA

In 2002, with enactment of the Medical Device User Fee and Modernization Act (MDUFMA), Congress mandated a number of new requirements for SUD reprocessors including, for certain SUDs, the pre-market submission of data to the Agency that exceeded the requirements for OEMs. In addition to the requirements specified in our 2000 Guidance Document, certain reprocessed SUD types that potentially could pose the greatest risk of infection and inadequate performance following reprocessing and that were previously exempt from any pre-market submission requirements, are no longer exempt.  

MDUFMA also created a new type of pre-market submission, called a “pre-market report” (PMR), for Class III reprocessed SUDs that otherwise would have required a pre-market approval application. Among other information, a PMR must include validation data regarding cleaning, sterilization, and functional performance of the reprocessed device to ensure it is substantially equivalent to a legally marketed device. To date, only one PMR has been submitted to the Agency and it was later withdrawn by the firm.

In addition, MDUFMA required a change to FDA’s MedWatch voluntary and mandatory reporting forms (Forms 3500 and 3500A, respectively) to facilitate the reporting of adverse events involving reprocessed SUDs.

Finally, MDUFMA required, as of August 1, 2006, that reprocessed SUDs prominently and conspicuously bear the name, abbreviation, or symbol of the reprocessor on the device itself, on an attachment to the device, or on a detachable label, depending on the physical characteristics of the device and whether the device has been marked by the OEM.

PRE-MARKET REVIEW OF REPROCESSED SUDs

Under the FD&C Act, before introducing a device to market, manufacturers must submit a Notification of Intent to Market a Device (510k) and obtain FDA clearance, unless the device has been exempted. MDUFMA required FDA to identify previously 510(k)-exempt device types that, if reprocessed as a SUD, would now require 510(k) pre-market review, including the submission of validation data. In addition, MDUFMA required that FDA identify SUDs that were already subject to 510(k) pre-market requirements, but that would now also require the submission of validation data. Required validation data include cleaning and sterilization data, and functional performance data demonstrating that each SUD will remain substantially equivalent to its predicate device after the maximum number of times the device is intended to be reprocessed.

The criteria used to determine which reprocessed SUD types would no longer be exempt from pre-market notification requirements and would require 510(k)s with validation data, and which reprocessed SUDs already subject to the 510(k) requirements also would now be subject to the additional requirement of validation data are available on the Internet at: http://www.fda.gov/OHRMS/DOCKETS/98fr/03-10413.html.

Using these criteria, FDA identified all previously exempt “critical” and “semi-critical” devices that were high-risk. These devices would no longer be exempt from 510(k) requirements and SUD reprocessors of these device types would be required to submit 510(k)s with validation data and receive clearance in order to continue marketing these devices.

In addition, the requirements and the lists of devices that were newly subject to these requirements were published in the Federal Register. FDA has added other reprocessed SUD types to these lists as we become aware of information that warrants their inclusion.

On June 1, 2004, FDA issued a revised “Guidance for Industry and FDA Staff; Medical Device User Fee and Modernization Act of 2002, Validation Data in Pre-market Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices.” This document describes the types of validation data that FDA recommends be submitted on cleaning, sterilization, and functional performance of certain reprocessed SUDs to ensure that they are substantially equivalent to the predicate device. Additionally, this document describes the timeframe for FDA’s reviews of these validation data submissions, and what actions the Agency intends to take if it finds a reprocessed SUD to be Not Substantially Equivalent (NSE) to the predicate device.

As of September 2006, FDA has received nearly 200 pre-market notification 510(k) submissions for reprocessed SUDs. These submissions cover from one, to as many as several hundred, device models. Of the almost 200 submissions, approximately 67 percent have been cleared by FDA. The remaining were not cleared for such reasons as inadequate validation data, lack of necessary information from the reprocessor, withdrawal of the application by the submitter, or lack of response to FDA’s request for data. (Approximately 88 percent of 510(k)s for all other devices are cleared and approximately 3.4 percent are found NSE to the predicate device.)

COMPLIANCE ACTIVITIES

FDA’s inspectional program serves as a bridge between pre- and post-market activities. Since 2000, on average, FDA has conducted inspections of reprocessor firms once every two years, a rate considerably higher than the one inspection in four years for OEMs. Of the seven firms currently known to be reprocessing, all have been inspected within the last two years. FDA continues to evaluate newly registered firms to confirm whether they are performing SUD reprocessing and updates its inspectional plan as required.

POST-MARKET SURVEILLANCE FOR REPROCESSED SUDs

Post-market monitoring of device-related adverse events (AEs) and product problems is accomplished through the Medical Device Reporting (MDR) system. MDR reports include deaths, serious injuries, and device malfunctions. Healthcare facilities are required to report deaths suspected to be device-related to both FDA and the manufacturer/reprocessor. They are required to report serious injuries to the manufacturer/reprocessor.

FDA also receives voluntary reports, generally from healthcare professionals, through its MedWatch reporting system. As previously mentioned, under MDUFMA, the MedWatch reporting form 3500A was revised to include a data entry field (D to ask if the device associated with the reported event was a reprocessed SUD. This question was added to the form to enhance the Agency’s ability to quickly identify and investigate reports of problems associated with reprocessed SUDs.

FDA responds to reports of death or serious injury by investigating the report and taking appropriate follow-up actions as needed. Follow-up actions may include enforcement actions and/or the issuance of a public health notification to alert the healthcare community of the Agency’s concerns.

As you know, on January 24, 2006, I and others briefed this Committee about SUD reprocessing. At that time, we provided background information including the current regulatory framework and AE data. Specifically, we searched our Manufacturer and User Facility Device Experience (MAUDE) database for reports from October 22, 2003, to December 13, 2005, that were coded as adverse events associated with reprocessed SUDs. The search produced 176 reports of death, serious injury, and/or device malfunction; however, analysis of these reports did not disclose a clear causative link between a reprocessed SUD and subsequent patient injury or death.

In July 2006, the Agency updated the search to include all reports entered into the MDR, MAUDE, and MedWatch databases between December 2005 and July 2006. FDA has received a total of approximately 434 reports, including MedWatch forms, where the reprocessed SUD field was checked “yes.” Our analysis of these reports determined that many of the devices were not reprocessed SUDs. Rather, they were implanted devices or devices that were designed to be re-usable and, therefore, were not reprocessed SUDs. Of the 434 reports, approximately 65 reports actually involved or were suspected to involve reprocessed SUDs, and were reviewed by FDA. The final analysis of the reports found that the types of adverse events reported to be associated with the use of SUDs were the same types of events that also are being reported for new, non-reprocessed devices. Therefore, it was unclear whether the device, the medical condition of the patient, the medical procedure, or other confounding factors caused or contributed to the adverse event.

FEEDBACK FROM A SAMPLING OF MEDSUN HOSPITAL FACILITIES THAT USE REPROCESSED SUDs

FDA’s Medical Product Safety Device Network (MedSun) is comprised of over 350 hospitals that have been recruited and specifically trained to identify and report device problems. The hospitals in this program are broadly representative of U.S. healthcare facilities. FDA staff talked with representatives from more than 50 of these facilities to obtain feedback on their experience with using reprocessed SUDs.

The MedSun respondents who gave us feedback represented various occupations in hospitals, including materials management, biomedical and clinical engineering, risk management, infection control, surgical services, nursing staff, supply utilization, and equipment management. Staff being interviewed responded overwhelmingly that they view the use of reprocessed SUDs as providing a significant cost savings to their facilities and as being an environmentally sound practice.

There was considerable variation in the devices being reprocessed at the various facilities and the degree of acceptance of this practice by individual practitioners within the facilities. None of the participants we spoke with reported specific problems with SUD-related infections, but they also pointed out that, if an infection occurred, it would be difficult to discern whether the reprocessed SUD was the cause. It also is interesting to note that the participants did not report a greater concern with mechanical problems associated with reprocessed SUDs compared to un-reprocessed SUDs. In general, the participants had a favorable view of reprocessed SUDs used in their facilities. They also stated that they relied heavily on FDA oversight to ensure safety and effectiveness and to provide objective information on reprocessed SUDs.

ONGOING FDA ACTIVITIES

The Agency continues to review and assess the practice of reprocessing SUDs.

CDRH established an active internal work group to ensure that review scientists remain current with the evolving scientific literature and new consensus standards that are relevant to the reprocessing of SUDs.

CDRH has convened a second work group, called the “Post-market Issue Action Team,” to develop a long-term strategy for monitoring, evaluating, and communicating information about reused SUDs.

CDRH continues to submit reprocessor inspection requests to the Office of Regulatory Affairs to schedule inspections of reprocessor facilities to assess conformance with the Quality System Regulation.

CDRH periodically updates its reuse webpage so that healthcare facilities and providers will have current information on legally marketed, reprocessed SUDs. Recently, easy-to-read tables listing FDA requirements for specific reprocessed SUD types were added to the website. In addition, we improved accessibility and added instructions to the publicly searchable FDA pre-market databases. These databases allow the user to search in real-time for recent and past clearances. (http://www.fda.gov/cdrh/reuse/index.html)

CDRH regularly updates guidance to industry and FDA reviewers on validation data requirements for reprocessed SUDS.

CDRH regularly updates the list of reprocessed SUDs subject to the additional pre-market requirements imposed by MDUFMA.

CDRH is conducting research to develop/establish “acceptable” SUD cleaning criteria.

CDRH is collaborating with two local healthcare facilities to help monitor changes in the design of some SUDs and identify new SUDs being reprocessed.

On September 25, 2006, FDA published two rules: the direct final rule for Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data; and a proposed rule for Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data; Companion to Direct Final Rule (proposed rule). These amendments will help ensure that reprocessors submit the data, including cleaning, sterilization, and functional performance data, needed to demonstrate that their device is substantially equivalent to the predicate device.

CONCLUSION

Available data show that SUDs can be reprocessed with a reasonable assurance of safety and effectiveness. FDA believes that reprocessed SUDs that meet FDA’s regulatory requirements are as safe and effective as a new device. The law and regulations in place are designed to protect the public health by assuring that the practice of reprocessing and reusing SUDs is based on sound science. FDA continues to monitor the performance of these devices and to assess and refine our ability to regulate these devices appropriately.

Mr. Chairman, thank you again for the opportunity to address this important topic. I will be happy to answer any questions.

The FDA can only regulate devices, not doctors. That is their claim to protecting themselves against those already damaged by Refractive Surgery.

 
Louisiana Ophthalmologist Fined $1.1 Million by FDA PDF Print E-mail

Louisiana Ophthalmologist Fined $1.1 Million by FDA For Clinical Study Violations

A Lafayette, La., ophthalmologist and eye care center he owns have agreed to pay the federal government a total of $1.1 million in civil money penalties for violating federal laws related to the conduct of clinical studies. The violations involved studies of a laser system built by the ophthalmologist for LASIK treatment of nearsightedness.

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Safety, Warnings, & Product Recalls PDF Print E-mail

Bausch & Lomb - ReNu brand contact lens solution

Source

Reuters - April 10, 2006

WASHINGTON (Reuters) - Bausch & Lomb has stopped shipping its ReNu brand contact lens solution after a number of people using the product reported getting a serious eye infection, the U.S. Food and Drug Administration said on Monday.

The FDA said that 109 cases of the rare but serious infection that may cause loss of vision had been reported to the Centers for Disease Control and Prevention (CDC) from 17 U.S. states. But the agency said during a conference call that it was not aware of a link between the infection and specific products.

PredForte

Is your intraocular pressure being monitored on the Pred Forte? Patients who are on this drug for more than 10 days require ongoing IOP monitoring because of the very real risk of inducing glaucoma. Tonometry is known to give falsely low IOP readings after LASIK, so other measures to assess glaucoma (like GDx optic nerve fiber analysis) appear indicated. Have you noticed any visual field losses?. Are your visual fields even being assesed?

Check out this info on ophthalmic PredForte http://www.drugs.com/PDR/Pred_Forte_Ophthalmic_Suspension.html

Warnings: Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.

Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.

Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.

If this product is used for 10 days or longer, intraocular pressure should be routinely monitored.

Warnings: Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.

Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.

Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.

If this product is used for 10 days or longer, intraocular pressure should be routinely monitored.

By taking this medicine for 6.5 months you are putting yourself at an increased risk for irreversible blindness due to glaucoma. Has your doctor told you this? You need to pin your doctor down regarding what he/she is treating. If not DLK, then what non infectious situation does he/she think he/she is treating. Treating an infectious keratitis with steroids will only worsen the condition.

Also long term topical opthalmic steroids are known to thin the cornea and can lead to corneal perforation.

Also noted here:

Source  

EyeWorld February 2006  

Quote: The potential intraocular side effects of ocular steroids are well known and include a rise in IOP and the formation of cataracts. 

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Declaration of Helsinki PDF Print E-mail

The World Medical Association

Declaration of Helsinki

World Medical Association Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects

Adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 and as revised by the World Medical Assembly in Tokyo, Japan in 1975, in Venice, Italy in 1983, and in Hong Kong in 1989.

Introduction:

It is the mission of the physician to safeguard the health of the people. His or her knowledge and conscience are dedicated to the fulfillment of this mission.

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21 C.F.R. ?? 812.7 & PROMOTION OF AN INVESTIGATIONAL DEVICE PDF Print E-mail

§§ 812.7 Prohibition of promotion and other practices. A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not: (a) Promote or test market an investigational device, until after FDA has approved the device for commercial distribution.

From the Federal Trade Commission:

 

 

From the Food and Drug Administration (FDA):

 

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Understanding pre-market approval: A call for reform at the FDA PDF Print E-mail

Understanding pre-market approval and labeling differences of two leading customized ablation platforms: a call for reform at the FDA

PURPOSE: To analyze the Food and Drug Administration (FDA) pre-market approval reported data for two currently available wavefront-guided excimer laser systems.  

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FDA Document Leaks Revisited PDF Print E-mail

FDA Document Leaks Revisited (Originally published October 1996) 

Source

WASHINGTON WRAP-UP

FDA Document Leaks Revisited

James G. Dickinson

 

After seven months of inaction by FDA's Office of Internal Affairs (OIA), the FBI has taken over investigation of the most serious breach of security at FDA since the generic drug scandal. At the center of the case is last November's leak of proprietary product approval documents belonging to laser manufacturer Visx (Santa Clara, CA) to its competitor Summit Technology (Waltham, MA). Now, it will fall to the bureau to identify and locate the as-yet unknown FDA employee who leaked the documents.

This development, along with questions troubling to anyone who has entrusted secrets to FDA, was revealed at a July 31 hearing of the House Commerce oversight and investigations subcommittee, chaired by Joe Barton (R–TX). "If we can't maintain the confidentiality of documents at the FDA, then we should abolish the FDA," Barton commented.

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Incompetency At Its Best PDF Print E-mail

All of this information is just a fraction of the incompetence of the FDA. The documents supportive of the facts shown, my experiences, and that of other LASIK casualties trying to obtain help from the FDA proves that this government entity is: A COMPLETE WASTE!

I encourage all to become actively involved in helping to put a stop to the ineffective waste of taxpayers' money. The fda has ignored too many people, too many times.

The health, welfare, and protection of the american people are at further risk as long as the fda remains ignorant and ineffective.

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FDA Medwatch Complaints PDF Print E-mail
FDA Medwatch Complaints from 1995 to Present

As compiled from the FDA's Medical Device Reporting (MDR) Database, viewable by clicking the 'Read More' link below.

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