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.
|FDA||According 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 Times||According 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, MD||According 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.org||According 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.org||According 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.com||According 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."|