LASIK Liberty for Everyone!

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Letter from Dr. Paul Glass

Dr. Paul Glass, a LASIK surgeon and medical Doctor signed this letter (click here) indicating that "there is NO patient benefit for reuse [of the blades used for LASIK] and there is a very high risk of harm to the patient".  "Reusing a microkeratome blade used on another patient is far too risky for patients." 

Last Updated on Friday, 26 May 2006 10:05 Read more...
 

Alert

Urgent Public Health Alert!

If you have been in contact with ANYONE who has had LASIK, please provide them with this Public Health message.  Please consider signing the Petition to STOP Reusing Blades for LASIK Surgery. Everyone has the right to LASIK Liberty at http://www.petitiononline.com/12340000/petition.html.  

Please email This e-mail address is being protected from spambots. You need JavaScript enabled to view it with any questions or comments.

Will the FDA, CDC, FTC or other Federal agency issue a warning, consumer advisory, or Public Health Alert about the unnecessary risks to the public health from the reuse of Microkeratome blades for LASIK?

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).

I was totally shocked when the CDC infectious disease contact said there is a patient benefit from Doctors saving money by reusing single-use, disposable blades (even if it exposes patients to potential harm without sterilization).  The FDA working group met and requested a full copy of that survey article below that indicates that 21% of Doctors admitted they reuse microkeratome blades for LASIK.

Is there a limit to how many patients a blade can be reused on?  How many patients was each blade used on in the clinical trials?  The FDA has Not even responded to these questions yet.  How long does it take to answer simple questions like these?

Most respondents (78.7%) changed the microkeratome blade between patients while 49% in Europe and 36.4% in Oceania preferred to change the microkeratome blade between eyes. These preferences were similar to those in the 2003 survey. The microkeratome blade was changed after 2 or more patients by 11 .l% of Asian respondents and 55.0% of Latin American respondents, which was similar to the pattern in the 2003 survey (17.5% and 50.0%, respectively). http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15721716&query_hl=1

I think reuse of the Microkeratome blades explains why so many people have bad problems after LASIK.  LASIK is known to cause many observable long term debilitating complications.

"About a third of complications result from surgeon errors"..."Another third is from technique or equipment problems. The final third comes from unexplainable reasons." http://www.gazettearchives.com/health2002/_disc4/000001d3.htm

The Lasik Liberty message is do Not count on anything FDA "approved" as actually being used safely.  The FDA approves that something can be used safely even after sending warning letters that the research violated Federal laws (e.g., Title 21, see jurisdiction).  After approval, a Doctor can use the device however they like- even if it is OBVIOUSLY injurious and the FDA will Not even investigate.  Most civil attorneys will not investigate, local authorities do Nothing, and State Health departments may not even return phone calls.  The FDA's position is that once the FDA approves that it is possible to use a device safely, the FDA's approval somehow voids its own authority to regulate the device in the future (the FDA does Not regulate anything a medical Doctor does- even violations of Federal laws).  How does FDA approval remove the FDA from further consideration of how the device is actually used- especially if the use spreads infectious diseases and frequent permanent, life-long injuries that effect the public health of millions of American Citizens?

Read more to find out why Nothing has been done by the FDA or the CDC to even Warn the public or Doctors to stop this preventable threat to the public health Even though the FDA knows these medical devices are being used unsafely and Over 8 million US citizens have had LASIK. 

I am Not making this up- the FDA set up a working group that has Not reached any conclusions after months of "review", but someone at the FDA stated they decided a long time ago there is No Federal juridiction to even investigate this known problem.  I asked the FDA and the CDC to review this website for accuracy and I have Not received any requests for modifications.  The FDA and the CDC requires that donors be prescreened before their tissue is used on other patients, but Not for LASIK.  If other patients' tissue gets in or under your cornea during LASIK (that can never be removed) and causes an immune system response, the Doctors prescribe an immune system suppressant marketed under the trade name Restasis (see http://en.wikipedia.org/wiki/Ciclosporin). 

Coincidentally, the sales revenue from Restasis is increasing dramatically.  For the full year of 2004, Allergan estimates: "Restasis® sales between $75 million and $95 million."  http://www.shareholder.com/agn/ReleaseDetail.cfm?ReleaseID=127576 "Allergan reported first quarter 2006 net sales of Restasis of $66 million, representing a 77% increase over 2005" http://ir.inspirepharm.com/phoenix.zhtml?c=120779&p=irol-newsArticle_print&ID=853914&highlight=

The CDC has investigated similar public health issues.  For instance,

"FDA spokesmen say risk of serious infection is fairly remote, though an agency advisory adds the caveat that the "actual infectious risk is unknown." ..."The FDA forbids body-harvesting firms from cutting up cancerous and diseased corpses. In all cases, harvesters are supposed to screen cadavers based on age and cause of death, and harvested tissue is tested for disease and treated with antiviral or antibacterial agents.... "We know that they obtained these bodies in a fraudulent way and off the scale of acceptable practice," FDA spokesman Stephen King said."

Note that the Daily News broke the scandal, not the FDA or the CDC.

http://www.washingtonpost.com/wp-dyn/content/article/2006/01/27/AR2006012701569.html 

Here's another one the FDA and CDC knew about for a long time.
"Given the association between Fusarium keratitis and MoistureLoc, Bausch & Lomb (Rochester, New York) announced its decision to voluntarily recall and permanently remove this contact lens solution from the worldwide market on May 15, 2006. Contact lens wearers should immediately discontinue use of this solution and consult an eye-care professional regarding use of an appropriate alternative product for cleaning or disinfecting lenses. "

"report possible cases to state health departments or to CDC at telephone, 800-893-0485. Reports should also be submitted to the FDA via MedWatch at telephone, 800-FDA-1088; fax, 800-FDA-0178; or mail, MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online at http://www.fda.gov/medwatch/report.htm. "
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm55d519a1.htm?s_cid=mm55d519a1_e

Last Updated on Wednesday, 14 June 2006 17:50 Read more...
 

Exhibit List

The following Exhibits were presented to the FDA and are presented here as evidence that reusing Blades for LASIK surgery is within the jurisdiction of the FDA and the Federal government to investigate. 

The FDA knows that many Doctors are reusing the blades even contrary to what the FDA approved as "safe".  see http://www.lasikliberty.com/index.php?option=com_content&task=view&id=15&Itemid=1

Apparently, two Doctors in CA admitted to reusing a single blade on multiple patients and were placed on probation by the medical board, and I believe the penalty should be higher than this decision.

"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. "

"Class Action o/b/o 2,700 former LaserVue patients. In a settlement to an investigation brought by Medical Board of California (MBC), defendants admitted that their protocol was to rinse and reuse a blade on up to 4 eyes.  MBC concluded that defendants departed from standard of care and placed them on probation." (see http://www.lasikinfocenter.net/Webpages/Ongoing%20Litigation%20Against%20RS%20Webpage.htm).

If the FDA has No jurisdiction to regulate an already approved medical device that is known to be used unsafely and contrary to the public health, then what's the point of approving these devices as safe in the first place? What do they actually review during the medical device reviews?

How many people would resist saving over $1million by taking some extra risk (for someone else, not themself) if no one would do anything about it?

Last Updated on Friday, 19 May 2006 09:14 Read more...
 

Jurisdiction

----- Original Message -----
From: Michael Patterson
To: FDA CDRH Ombudsman
Subject: Request to clarify Federal and FDA jurisdiction, and to notify local and state authorities regarding legal issues and Jurisdiction over the regulation of Federal law regarding FDA approved medical devices.

As we discussed today, here is my

Request to clarify Federal and FDA jurisdiction, and to notify local and state authorities regarding legal issues and Jurisdiction over the regulation of FDA approved medical devices.

I believe that the working group and petitions I have sent in to the FDA may be the last opportunity the FDA will have to protect the public health from the misuse of these FDA approved medical devices.  The issues I'm discussing with the FDA extend to the reuse and reprocessing of ALL FDA approved medical devices.  My requests, petitions and emails do Not ask the FDA to do anything more or anything less than to regulate the SAME types of users and practitioners (medical Doctors and their technicians) that the FDA has in fact regulated before these Devices were approved.  The same problems the FDA pointed out that occured before devices were FDA approved and before clinical trials are in fact occuring with the same or similar FDA approved medical devices. 

Last Updated on Friday, 26 May 2006 07:59 Read more...
 

AskLASIKDoctors

Please ask every Doctor you can contact to support the Petition to STOP Reusing Blades for LASIK Surgery. Everyone has the right to LASIK Liberty. see http://www.petitiononline.com/12340000/petition.html

If you are a Medical Doctor, Please review Dr. Glass' letter (click here) and the Other Doctors opinions below and email your opinion to This e-mail address is being protected from spambots. You need JavaScript enabled to view it along with any additional comments you would like to make.  All emails from Medical Doctors will be posted here. Please join the other LASIK Doctors by emailing your opinion to be posted here. 

Dr. Huang agrees at least in part, see http://www.lasikliberty.com/index.php?option=com_content&task=view&id=24&Itemid=43

 

Dr. Wang agrees with Dr. Glass, see http://www.lasikliberty.com/index.php?option=com_content&task=view&id=26&Itemid=43 

 

Dr. Salz completely agrees with Dr. Glass's position on this topic and has nothing more to add, see http://www.lasikliberty.com/index.php?option=com_content&task=view&id=27&Itemid=43

 

Dr. Stojanovic emails "I thought that absolutely nobody reuses microkeratome blades in this day and age. It is so obviously wrong that it does not deserve any explanation." see http://www.lasikliberty.com/index.php?option=com_content&task=view&id=39&Itemid=43  

 

 

Apparently, two Doctors in CA admitted to reusing a single blade on multiple patients and were placed on probation by the medical board, and I believe the penalty should be higher than this decision.

 

My hope is that the medical boards, appropriate government agencies (e.g., the FDA and CDC), and any other appropriate regulatory authorities investigate and stop harmful patient practices as soon as possible.  As many as eight million patients have had LASIK so far.


 

My hope is that the medical boards, appropriate government agencies (e.g., the FDA and CDC), and any other appropriate regulatory authorities investigate and stop harmful patient practices as soon as possible.  As many as eight million patients have had LASIK so far.


Last Updated on Wednesday, 24 May 2006 18:02 Read more...
 

FDA Working Group

The FDA working group met and requested a full copy of that survey article below that indicates that 21% of Doctors admitted they reuse microkeratome blades for LASIK.

Is there a limit to how many patients a blade can be reused on?  How many patients was each blade used on in the clinical trials?  The FDA has Not even responded to these questions yet.  How long does it take to answer simple questions like these?

Last Updated on Friday, 19 May 2006 16:07 Read more...
 

House Investigation

Please contact your local and Federal Representatives to ask them to investigate and pass new laws to regulate the obviously unsafe use of all FDA approved medical devices.  The House has investigated and there have been discussions of new legislation.

In general, the reuse or reprocessing of single use devices on multiple patients is a serious concern (see http://reform.house.gov/UploadedFiles/121605\%20FDA\%20Medical\%20Device\%20Letters.pdf )."

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"

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.

For every LASIK surgery, every patient MUST have new microkeratome components (e.g., blades and cannulas).  Reusing microkeratome components that come into contact with blood or the cornea on multiple patients is not within the practice of medicine for patients in the United States let alone within the standard of care for any Medical Doctor (for any medical procedure including LASIK).  There is NO patient benefit for reuse and there is a very high risk of harm to the patient. 

Based on my review of the risks associated with reusing microkeratome blades or cannulas on multiple patients (especially without proper sterilization), this practice can spread infectious diseases (e.g., DLK, HIV, hepatitis, CJD, etc.) as well as corneal infections (a complication that does lead to loss of eye and blindness).  Proper sterilization of the microkeratome blades with regard to CJD prions is not practical and the blades do come into contact with the eye and blood (which are considered highly infectious tissue).  The microkeratome then inserts the tissue into the eye of any other patients it comes into contact with.  

Last Updated on Thursday, 18 May 2006 20:50
 

Flap Damage

I think many of the problems from reusing microkeratome blades go unreported.  LASIK is reported to cause many problems so there is no debate that they occur.  Some Doctors state they have Never had many of these flap problems in ANY patient.  Are these the Doctors who use new microkeratome blades?  The FDA and the CDC will Never find out because they claim to have no jurisdiction.  So what if a few million people have these problems unnecessarily? 

The question is how often do these problems occur and how much more likely are they to occur with a reused microkeratome blade (with or without sterilization) versus a new microkeratome blade?  No one knows the answer to these questions.  There is no way to ethically do a controlled clinical trial because the blades should Never be reused (this is my opinion- there may actually be some published clinical trials with reused blades).

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?

Because the cornea is clear, transparent tissue some Damage to the cornea may Not be readily apparent even after a thorough exam by an eye Doctor.  More sensitive equipment and diagnostic tests are Not available in most eye Doctors' offices and are only available to a select few Doctors.  Even if self-paying without insurance, these tests can only be ordered after with a medical diagnosis (which some Doctors are reluctant to provide without prior objective evidence).  Doctors are required to file Medical Device Reports with the FDA and are Not expected to record everything.  Furthermore, many infectious diseases have no symptoms for years (including Aids/HIV and mad cow disease, CJD can only be detected after death). 

Here is a list of a few, not all, of the eye problems I have had that were Not detected by one Doctor or diagnostic device or the other. The details regarding why these were Not always detected by the Doctors are discussed below.  All of these problems could be caused by Not following the Microkeratome Operators manual insructions and/or reusing the microkeratome blades.

1.  A 1.3 x 3mm scar and "clumps" of something under the flap (one measuring ~40um, 5 x 8) as measured by a confocal microscope exam.

2.  Thin, irregular, uneven flaps and epithelium as observed only by an Artemis Ultrasound exam (see below).  "The Bowman’s membrane interface is irregular in character, with occasional breaks, indicative of microfolds or striae." (Two Doctors who did FDA clinical trials said there was "NO striae" just before I had the artemis exam).  Multiple Microkeratome cuts as observed only by the Artemis and removal of the epithelial layer during a follow-up surgery. 

"When I mechanically remove the epithelium, there were 2 semicircular demarcation lines, one indicating the outer limit of a LASIK flap, and the other about 2 mm inside the outer line and extending for about 3 mm superiority.  This most likely represents a second, incomplete LASIK flap."

3.  Mebomian Gland Dysfunction and Keratitis- Diffuse Lamelar Keratitis (DLK), Punctate Epithelial Keratitis (PEK) and superficial punctate keratitis (SPK) resulting from LASIK-induced dry eye syndrome.

4.  Severe loss of vision quality including 4 diopters of spherical aberrations (Not sure which test showed this because the Doctor cancelled my appointments, but could be the Interwave which is Only used by a few Doctors in the entire country- who work in just one location). 

Last Updated on Tuesday, 23 May 2006 01:30 Read more...
 

AAO Policy

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]."

"Use them once and throw them away, or resterilize them and use them again? Increased FDA oversight of companies that reprocess single-use devices is sparking an uproar."

"It’s an issue mired in economics and politics—and patient safety. And while the focus thus far has been primarily on disciplines like cardiology and interventional radiology, ophthalmology has not escaped scrutiny."

For instance, several years ago, Northern California–based LaserVue Eye Center was involved in a widely publicized lawsuit alleging it reused microkeratome blades that could have potentially exposed patients to infectious diseases or uneven flaps. The lawsuit stemmed from an investigation by the California Department of Health, which found that the center’s surgeons had rinsed and reused microkeratome blades and hand pieces instead of sterilizing them.

The health department’s investigation revealed that microkeratome blades were rinsed with sterile water and reused on a second patient provided that 1) with the first patient, the blade worked properly and there was no visible bleeding and 2) less than 30 minutes elapsed between patients. The microkeratome assembly was rinsed and reused for up to four consecutive patients. While no actual infections were reported, the department required the eye center to notify some 2,700 LASIK patients that their surgeons had rinsed and reused the blades.

While this is a rare and extreme case of misuse, it does raise the question of whether the reuse and reprocessing of single-use devices should be more tightly regulated. At this time, the Academy does not have a formal policy on the issue. Several aspects of single-use devices and the practice of ophthalmology should be considered before any guidelines are developed, noted Richard L. Abbott, MD.

“First of all, this is an issue where there are no absolutes,” he said. “What may be applicable for one type of single-use device, for example a microkeratome blade, may not be relevant for another device, for instance a phacoemulsification tip. Second, we need to take into consideration several issues, including whether the design of the instrument or device is amenable to reuse, whether it can be appropriately sterilized, whether reuse will compromise its function in any way—potentially altering outcomes—and whether the device will perform at the same level with the same quality for multiple uses given proper sterilization techniques. But again, this needs to be determined on a case-by-case basis.”

http://www.aao.org/aao/news/eyenet/feature1/feature1_oct.htm

lasikFlap2

Last Updated on Tuesday, 23 May 2006 02:29
 

DrGlass

If you are a Medical Doctor, Please review Dr. Glass' letter here and email it to This e-mail address is being protected from spambots. You need JavaScript enabled to view it along with any additional comments you would like to make.  If you disagree with anything, then email that and I'll post it here too- I would like to hear your opinion either way.  Put your name and contact information at the bottom of the letter in place of Dr. Glass' so it's clear that you agree with all of it- for instance, it's important to point out that reusing blades does Not constitute the practice of medicine.

All emails from Medical Doctors will be posted here. Would you mind also forwarding it to other Doctors for their signatures too (for a quick digital email signature?  If they're willing to share it, then I'll print it out and put up a website so people can see that multiple Doctors agree but NOTHING has been done by anyone to make blade reuse on multiple patients STOP NOW!

My hope is that with enough citizen petitions and emails from medical Doctors that the medical boards, appropriate government agencies (e.g., the FDA and CDC), and any other appropriate regulatory authorities investigate and stop harmful patient practices as soon as possible.  As many as eight million patients have had LASIK so far.

Last Updated on Friday, 26 May 2006 09:59 Read more...
 

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