Friday, July 02, 2010

Some run through @ LASIK Complications

These are some information that I had explored at lasikcomplications.com. Please do read the following.

***BREAKING NEWS***
5/10/2010: Former FDA chief of ophthalmic devices warns that LASIK risks outweigh benefits. Read letter


4/19/2010: FDAWeb.com editor criticizes FDA regulation of LASIK devices and its relationship with the American Society of Cataract and Refractive Surgery (ASCRS), and criticizes FDA's
decision to collaborate with Department of Defense (Navy) in LASIK study. Read letter

3/30/2010: LASIK Activists Seek Hill Hearings on FDA Inaction (fdaweb.com). Read article


TOP TEN REASONS NOT TO HAVE LASIK SURGERY

http://lasikcomplications.com/TopTenReasons.htm

Ectasia

The link below have the presentation of Ectasia. If you click on the link, you will be able to see pictures of Ectasia.

In the middle of the page, there are also some youtube, showing some LASIK patients who have been suffering (or had suffered) Ectasia after their LASIK surgery.

At the bottom of the page, a doctor hightlighted his conclusion.
"Since a large part of this rigid anterior part of the stroma is either removed (PRK) or intersected (LASIK), it is possible that in the long run patients who underwent refractive surgery may be confronted with optical problems."

http://lasikcomplications.com/ectasia.htm

Late Flap Dislocation after LASIK
The Flap Never Heals

http://lasikcomplications.com/flapdislocation.htm

Dry Eyes

Pictures of dry eyes and youtube.




http://lasikcomplications.com/dryeye.htm

Epithelial Ingrowth

- Pictures of Epithelial Ingrowth
- Conclusion: Epithelial ingrowth after LASIK is not rare

http://lasikcomplications.com/Epithelial_ingrowth.html

Infection After LASIK

- Pictures of Infection

http://lasikcomplications.com/infection.htm

LASIK-Induced Visual Aberrations

Click on those links at this page. There are a lot of images. After I see them, my head is spining. Headache...

http://lasikcomplications.com/simulations.htm

LASIK Flap Disintegrates Upon Lifting for Enhancement




Before You Let Them Cut on Your Eyes.wmv





More Youtube

Eye doctor tells patients that LASIK is a "terrible idea", and warns "don't go near it". CBS News 4/25/2008




Eye doctor has stopped performing LASIK due to long-term concerns - KDKA 2 CBS report



http://lasikcomplications.com/LasikTube.htm


FDA Lasik Hearing: David Snell



Below comment copied from Youtube

LasikComplications, LifeAfterLasik,LasikScam, Lasik-Flap, LasikFraud, LasikSucks4u2, UsaEyes, LasikNightmare, FlawedLasik, LasikSurgeryWebsite, LaserMyEye, MyLasikStory, SurgicalEyes org, DoctorMyEye , LasikLiberty, VisionSimulations, EyeFreedom , NoBlur...Show me another procedure that has this many patient websites trying to WARN YOU to NOT have LASIK and how UNPREDICTABLE it has become, now being an epidemic!! YouTube: FDA LASIK and watch and listen to the estimated 600,000 ruined lives!!!
dkantis 2 years ago

LASIK Complications/Disaster

These are some of the websites that I have visited recently. Do visit them before you make your decision.

http://www.lasikfda.com/

http://lasikcomplications.com/risks.htm

http://lasikdisaster.com/index.htm

Thursday, July 01, 2010

FDA Lasik Hearing: Matt Kotsovolos - He used the latest technology, IntraLase Wavefront



Thank you. My name is Matt Kotsovolos. I had LASIK surgery in 2006 using the current IntraLase Wavefront technology. At the time of my LASIK, I was the Chief Financial Officer at the Duke eye Center in Durham, North Carolina. My surgery was considered a success based on my uncorrected visual acuity now being 20/20. However, for the last two years I have suffered from debilitating and unremitting eye pain as a result of LASIK. The public hears LASIK complication rates quoted by the LASIK industry as ranging from between one to three percent. What the public doesn't know, because the LASIK industry markets this surgery in a most unethical way, is that the complication rate is likely in the 20 to 30 percent range.

Data from the FDA clinical trials for LASIK reveals that the FDA allows laser manufacturers to hide complications such as dry eyes and impaired night vision by reporting these as, quote, "symptoms." The overall percentage of patients reporting these complications in the FDA trials is approximately 20 percent. In April 2007, researchers from Ohio State University College of Optometry published results from a review of FDA clinical trials of the 12 lasers approved for LASIK between 1998 and 2004, including newer wavefront technology. They reported that six months after LASIK, roughly 20 percent of patients experienced worse or significantly worse dry eyes, and six months after LASIK roughly 15 percent experienced worse or significantly worse night vision disturbances.

Recently, the LASIK industry has hired a media consulting firm in its mass circulated results of a global LASIK patient satisfaction rate of 95.4 percent. The LASIK industry wants the public to believe that a high satisfaction rate indicates a low complication rate. However, being satisfied with one's visual outcome and being free of complications are two entirely different matters. Dr. Leo Maquire once wrote the following in an ophthalmology editorial: "The kerato-refractive literature contains disturbing examples of patients who have visual handicaps that place themselves and others at significant risk for nighttime driving accidents, and yet they are happy with their results." One of the most perplexing cases of patient satisfaction comes from a 2007 report of a patient who developed bilateral ectasia, a serious sight-threatening complication which may require corneal transplantation, who was reportedly satisfied with his surgery. As illustrated, patients can suffer significantly complications or "symptoms," and still claim to be satisfied patients. Patient satisfaction surveys in LASIK are guaranteed to lead to skewed results and significant false positive data.

In addition, there is enough evidence for the FDA to investigate that shows the effects of devastating and irreversible physical complications from bad LASIK outcomes often leads to clinical depression. Clinical depression can lead to suicidal ideation. The length between bad LASIK outcomes and suicidal ideation is real. The link is further evidenced by true stories of LASIK patients taking their own lives and leaving suicide notes behind that detail their struggles due to debilitating post-LASIK complications. I have met plenty of people who are depressed and considering suicide because of complications that are currently buried in the device labeling and classified as symptoms or side effects. How is it that patients want to commit suicide because of side effects? Can the Panel before us today explain this? Why was there no research into what constitutes a symptom, and what constitutes a complication? Was it so that the LASIK industry could obtain approval for medical devices that otherwise would never have seen the light of day? Patients do not want to continue to exist as helpless victims with no solutions and no voice.

The LASIK industry wants to use the upcoming quality of life study that will not commence until sometime in 2009 to stall for an extended period of time. The time for stalling is over. I urge the FDA Advisory Panel to recommend placing a moratorium on LASIK until a proper comprehensive study of long term LASIK patient complications and symptoms, including clinical depression, is completed. I ask the FDA to change the labeling for lasers for LASIK once this moratorium is lifted, to report dry eyes and night vision disturbances as complications and not symptoms. Both of these so called symptoms can last for a patient's entire post-LASIK lifetime. Those who are familiar with the phenomena of deep capture understand that over time regulatory agencies end up being controlled by the very industries they are supposed to regulate. The FDA is now controlled and works for the benefit of the LASIK surgeons and LASIK manufacturers. This is easily illustrated by an ASCRS press release on April 7, 2008, a full two weeks before today's hearing. In that press release, the FDA stated that LASIK is safe and effective. Clearly, the fix is in. ASCRS would not have issued such a -- CHAIRPERSON WEISS: Can you please start closing your remarks? MR. KOTSOVOLOS: Yes, thank you. Clearly, the fix is in. ASCRS would not have issued such a press release, had they not known in advance that the FDA was going to dismiss -- CHAIRPERSON WEISS: We are going on to our next speaker, please. Thank you. (Applause.)

Source from: http://www.lasikfda.com/index.php?option=com_content&view=article&id=44&Itemid=53