"Dry eye occurs when people don’t have either enough tears, or the correct composition of tears, on the surface of their eyes to lubricate the eyes and keep them comfortable.”. . .“If you have dry eye, your eyes can feel persistently gritty, itchy, burning, and painful.”  http://www.theschepens.org/dry_eye_fact_sheet.htm

Take the dry eye test at http://www.dryeye.org/test.htm.  Let me mention some, not all, of just the dry eye problems that may effect these hundreds of  thousands+ of people.  Notice these end in dysfunction or "itis" meaning "Inflammation or disease of" and "Excessive preoccupation with, indulgence in, reliance on, or possession of the qualities of".

Blepharitis, Mebomian or Lacrimal Gland Dysfunction (mebomianitis), conjuntivitis, and kerato­con­junctivi­tis sicca.  Keratitis (Inflammation of the cornea)- Diffuse Lamelar Keratitis (DLK), Punctate Epithelial Keratitis (PEK) and superficial punctate keratitis (SPK).

It is so difficult to grasp the magnitude of the impact that I asked some others who are suffering greatly after LASIK for their comments on how to explain the degree of suffering and constantness of it better.  For additional research and a patient story on the permanent impact on Quality of Life, see http://www.lasikliberty.com/index.php?option=com_content&task=view&id=37&Itemid=57

There are many reasons why LASIK causes dry eye.  From reading the literature and talking with patients my estimate is that if a blade is reused for LASIK, then all patients' eyes are drier after LASIK than before, 10 to 50% of eyes are so permanently dry that they use preservative free (if they're properly informed) eye drops for the rest of their life, and that 10 to 20% of patients are so severely effected by dry eye that it dramatically changes their life forever.  Even without any eye surgery or LASIK, over 3 million people have dry eyes.  Also, most prescription medicaions cause dry eyes which means millions more people have dry eyes even before they have LASIK. 

Saying that "significant" vision loss is "rare" or very rare is not enough for a patient to comprehend the full impact that dry eyes can have on their lives.  Most people do Not understand that Dry eye effects vision.  A relative of mine went through chemo therapy for cancer with all the associated problems (nausea, sickness, etc.).  She complained about dry eye as having the biggest negative impact on her quality of life.  After the dry eye, she had a lot more understanding about what I was going through- if you haven't experienced it, you have no idea just how severe it is.

Over 8 million people have had LASIK so a few hundred thousand people with severe problems are considered "rare" or even "very rare".  My conclusion is that the words very and rare mean something different to me than it does to the Government and medical Doctors- I consider rare to be 1 in 10,000 which is what I was told the total sum of the risk was for LASIK.  8 million people divided by 10,000 means that only 800 people in the US would now have problems after LASIK.  That would be rare, when the blades are reused no one knows for sure how many have permanent problems.  You can look up information on google and see the extensive research and problems for yourself. 

Oddly, some people go from doctor to doctor for years asking for help with eye pain or photophobia without receiving a diagnosis of dry eye, much less being offered any treatment options. If this is true for you, request that you be tested for each of the above conditions (http://www.dryeyepain.com/#DryEye).  Dry eye pain is discussed a lot on the internet too. 

There are many reasons why LASIK causes dry eye.  Saying that "significant" vision loss is "rare" or very rare is not enough for a patient to comprehend the full impact that dry eyes can have on their lives.  Most people do Not understand that Dry eye effects vision.  A relative of mine went through chemo therapy for cancer with all the associated problems (nausea, sickness, etc.).  She complained about dry eye as having the biggest negative impact on her quality of life.  After the dry eye, she had a lot more understanding about what I was going through- if you haven't experienced it, you have no idea just how severe it is.

Most people do Not understand that Dry eye effects vision.  A relative of mine went through chemo therapy for cancer with all the associated problems (nausea, sickness, etc.).  She complained about dry eye as having the biggest negative impact on her quality of life.  After the dry eye, she had a lot more understanding about what I was going through- if you haven't experienced it, you have no idea just how severe it is.

"It's very rare for LASIK to cause permanent, significant vision loss"
Quote is from the websites of many LASIK surgeons.

After LASIK, the cornea may be permanently damaged by using eye drops with preservatives (e.g., visine can no longer be used safely).  Extensive use of Expensive non-preservative eye drops and prescription medications (e.g., restasis and antibiotics) may be required for LIFE (as has been prescribed for me by numerous Doctors).

LASIK has a known COMMON adverse event of causing vision quality problems (including night vision problems and problems during the day) and dry eye that very SERIOUSLY (and irreparably in most cases) impairs ones quality of life forever.  In the Nidek clinical trials, for instance, there were unreasonably high rates of night vision problems (69%) but the FDA approved LASIK WITH reused blades as safe anyway.

“side effects such as dry eyes, night time starbursts, and reduced contrast sensitivity occur relatively frequently."   Ophthalmology. 2002 Jan;109(1):175-87.Dr. I Howard Fine, Past President of the American Society of Cataract
and Refractive Surgery:
"As we all know, LASIK transects the cornea nerves, therefore inducing dry eyes in most patients."
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3806t1.doc

The FDA knows that patients are Not likely to read the FDA's website before surgery (note that in many cases, the drop therapy and plugs do Not fix the problems).

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

I think that a reused blade does Not make a very sharp, smooth, even cut through the corneal nerves severed by LASIK.  During my artemis exam, the cut in my flaps was described as being in a wave where it went up and then down and back up again (~30um to ~100um and back to ~30um) in both eyes.  I believe that a dull blade would also tend to make fine irregularities (e.g., blade "chatter") and make the edges of the flap less smooth (I've actually read this in the literature).  I believe this makes it more difficult for the nerves to grow back as well as they would otherwise.  I was surprised that despite my severe dry eye and gland dysfunction that the confocal exam (see flap damage page) showed typical nerve regrowth post-LASIK.  There are articles showing that the nerve regrowth after several years (up to 10) reaches as much as 80% of that before LASIK, but the shape of the nerves is never the same as before.  Some people have enough tear film while they are young that they do Not notice the loss.  Everyone's eyes get more dry as they get older so I wonder what will happen when they get in their 60s and 70s?  Eye drops are big business now, but for people with severe dry eye after LASIK they are Not sufficient to fix the problem.

There are 2 sets of corneal nerves which provide the important feedback to the glands to tell them the eye is dry and to generate more tears to rewet it.  If the LASIK flap hinge is at the top, then both sets of these nerves are cut.  If the flap hinge is at the side (usually nasally), then only one set of these nerves is cut.  For some reason, top hinged flaps are much more commonly done (maybe because the Hansatome Keratomes do top hinged flaps and more were sold better than others?)- Doctors who reuse blades do Not tell patients to my knowedge about this problem or give them a choice before surgery.

For many people, LASIK also results in dysfunction of the glands themselves that produce the tears and instead of making a nice oily tear film.  Thus, the tears produce painful crusty residue inside and on the edge of the eyelids as well as in the eyes.  This crust stays inside the eyelids (large clumps are referred to as chelazion- there's fancy names for all this stuff) and forms painful blockages of the glands.  On the eyelids, it sticks so strongly like glue that it is Not even possible to remove with the commercial lid scrubs which Doctors say to use for blepharitis (a word for crusty junk on the eyelids and eyelid infections).  This crust is VERY painful and even more painful to try to remove from the eyelids with eyelid scrubs.

Read more: Permanent Dry Eye Diseases

I asked other patients to help explain this better.  See below for another patients' answer.

 

Impact of dry eye symptoms on daily life

 

Patients who said dry eye symptoms interfered with activities most or all of the time (%)

Quality-of-life factors

Loss of confidence 38.6

Decrease of leisure time 35.7

Frustration with daily activities 34.3

Change of activities 25.7

Depression, unhappiness 25.7

Need for assistance 14.3

Missed outings 12.9

Decrease of work time 11.4

Change of work 7.1

Other 22.9

None of the above 27.1

Vision-related activities

Nighttime driving 32.3

Reading 27.5

Working at electronic monitor 25.7

Watching television 17.9

SOURCE: NELSON 2000

http://www.ptcommunity.com/ptjournal/fulltext/PTD_dryeye_pt.pdf

 

Read more: Quality of Life

By common law, I believe this case precedent applies to all 50 states because common law (which is not a tort) is the same everywhere.

Under common law (See Ketchup v. Howard, 2000 WL 174538, Ga. Ct. App. Nov. 29, 2000; http://agg.com/Contents/PublicationDetail.aspx?ID=840).

Do Doctors understand patients' rights to informed consent?  One Doctor emailed me:

"In all of the surgeries I have been involved with, from my time in general surgery to now, consent forms have not listed each individual problem that can occur. If mention is made of the effect of the problem, then there is informed consent. Argument of this point would best be left to the lawyers.” 

Patients are Not adequately provided informed consent about the risks or about known problems. 

Would you risk your eyesite, and physical and mental health for life to save $60 on a blade?  Would you provide informed consent to taking unnecessary risks by reusing a blade- especially given that the surgery is already highly risky (see http://www.fda.gov/cdrh/LASIK/risks.htm and http://www.fda.gov/cdrh/LASIK/when.htm)?

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

After talking with numerous patients, I am very confident that if the treatment zone is smaller than your pupils, then the larger your pupils the less satisfied you will be with LASIK.

One last thing- measuring pupil size accurately is very time consuming because it requires an expensive machine and a minimum of 20 minutes in TOTAL darkness before taking the measurement.  I have talked with numerous patients whose pupils were mismeasured.  Mismeasuring pupil size and Not providing a wide enough treatment zone has become the standard of care for LASIK. 

Surgical Technique:

Ninety-seven percent of respondents would treat a pupil larger than the ablated area in patients with low myopia (<-6.0 diopters [Dl), and 70.1% would treat a pupil larger than the ablated area in patients with high myopia (> -6.0 D).

Read more: Informed Consent

The blades are disposable, single-use devices, but some Doctors reuse them.  Do they think that patients are more disposable than the blades?  Why else would they reuse the blades? 

If the CDC and FDA think patients are disposable then why not the Doctors?

 

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." 

Read more: Letter from Dr. Paul Glass

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 email 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

Read more: Alert

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?

Read more: FDA Working Group

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