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

Regarding LASIK, the FDA expects patients to somehow be able to determine which Doctors are the most competent?  What do you think your Doctor would say the next time you go in for a shot or surgery and you ask how competent they are or if they reuse their needles and equipment on multiple patients without sterlization?

“So much of the outcome has to do with patient selection ... and physician experience and competence,” says FDA's Beers. http://www.cbsnews.com/stories/2003/06/02/health/main556625.shtml

The FDA states that the outcome depends on physician experience and competence so the FDA knows that some physicians do Not use the FDA approved medical devices in a way that reliably produces the best outcomes.

The FDA knows that FDA approved medical devices are Not being used according to the labeling and licensing of the medical devices the FDA "approved" to be "safe" Only if used as indicated.  The FDA will Not investigate even if thousands of patients are unnecessarily injured for life.  

The FDA states that they have No jurisdiction over medical Doctors no matter how unsafely the Doctors use the devices even if the Doctors knowingly spread infectious diseases like HIV/Aids, Mad Cow disease, Hepatitis, Herpes, etc.  The FDA states that they regulate these approved medical devices under Federal laws and the FDA has issued consumer advisories and Black Box warnings about many things they regulate, but the FDA will Not do the same for ANY approved medical device licensed for use only by Medical Doctors. 

In my opinion, Reusing microkeratome blades for LASIK on millions of US citizens must stop immediately.  Reuse also appears to be an off-label use or even violation of the FDA approval. Worse yet, the patients are exposed to the contaminated blades without resterilization.  I think patients should be properly educated and informed prior to having LASIK surgery.

In light of present day Medical ethics, patients should be given true informed consent by a licensed medical professional.  Reusing a microkeratome blade used on another patient is not prudent and far too risky for patients.  No patient should be subjected to a reused medical device that is labeled single use, and disposable even if the patient has informed consent.  Reusing blades without patient informed consent violates many medical ethical principles. In my opinion, there is NO patient benefit from reusing Microkeratome Blades on multiple people.  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).  

Reuse has a very high risk of harm to the patient, is not prudent and is far too risky for patients.  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.  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. 

In addition, 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.  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). 

Reusing blades without patient informed consent violates many medical ethical principles including HHS IRB guidelines (see http://www.hhs.gov/ohrp/irb/irb_appendices.htm), The Declaration of Helsinki "It is the mission of the physician to safeguard the health of the people" (see http://www.hhs.gov/ohrp/irb/irb_appendices.htm#j6 ), the Belmont Report "Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms. " (see http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm ) and the THE NUREMBERG CODE "The voluntary consent of the human subject is absolutely essential."  "The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury." (see http://www.hhs.gov/ohrp/irb/irb_appendices.htm#j5). 

What are they waiting for?   

Bausch & Lomb Hit Hard by Eye Infections

Friday May 19, 5:25 am ET
By Ben Dobbin, AP Business Writer 

"ROCHESTER, N.Y. (AP) -- Bausch & Lomb Inc. made a big blunder when federal regulators revealed in April they were investigating links between its new-formula contact lens cleaner and a rare fungal infection known to cause blindness: It waited three days before withdrawing ReNu with MoistureLoc from the U.S. market."

"After a month of exhaustive testing, the company issued a worldwide recall Monday, acknowledging for the first time that its $100 million-a-year solution appeared to be the "root cause" behind an unusual spike in Fusarium keratitis infections in U.S. and Asian markets supplied from its factory in Greenville, S.C.

At last count, the CDC said about two-thirds of 122 confirmed cases of the infection in the United States involved lens wearers who reported using MoistureLoc -- and their medical outcomes are often unnerving."

http://biz.yahoo.com/ap/060519/eye_fungus_fallout.html?.v=4 

There is a SIGNIFICANT risk of difficulty with vision both during the day and at night after LASIK.  For instance, the FDA approved LASIK as "safe" even with high known rates of monocular diplopia (double vision or severe ghosting in one or both eyes).

Monocular diplopia related to asymmetric corneal topography after laser in situ keratomileusis. J Refract Surg. 2001 Nov-Dec;17(6):652-7.
Takei K, Sano Y, Achiron LR, Carr JD, Stulting RD, Thompson KP, Waring GO 3rd.

see http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11758983&dopt=Abstract