LASIK Worries Prompt Discussion of AlternativesApr 29, 2008 | Parker Waichman LLP
Complaint Letters About LASIK And Food & Drug Administration.
Federal regulators have received 140 complaint letters about LASIK and Food & Drug Administration (FDA) advisers are recommending the FDA clarify LASIK warnings. LASIK—laser-assisted in situ keratomileusis—involves cut a flap in the cornea, via laser, for corneal reshaping with another laser to correct nearsightedness, farsightedness and, sometimes, astigmatism. There are no guarantees of 20/20 vision and long-term safety remains unknown.
LASIK is not for everyone, especially those with misshapen or excessively thin cornea, early cataract formation, big pupils, dry eyes, or underlying conditions such as lupus or rheumatoid arthritis. LASIK risks include lost vision, painful dry eye, glare, and night-vision problems. Serious complications affect about one percent of the cases and FDA estimates place customer dissatisfaction at five percent. Aggressive marketing makes patients falsely believe clear sight is guaranteed, complained Dr. Jayne Weiss of Detroit's Kresge Eye Institute, who chaired the FDA advisory panel.
One in four patients seeking LASIK is deemed a poor candidate. It’s unclear how many patients are appropriately screened; some forge ahead anyway. "Some patients are just not a cornea laser eye surgery patient," stresses Dr. Kerry Solomon of the Medical University of South Carolina, a spokesman for the American Society for Cataract and Refractive Surgery. "There are still other options for them.... And some are, quite frankly, better suited to staying with their glasses and contacts."
Pre-LASIK Laser Called Surface Ablation.
Pre-LASIK laser called Surface Ablation or Wavefront-Guided PRK (photorefractive keratectomy) does not require cutting a flap into the cornea—the flap cuts nerve receptors that critics say never fully return to normal, thus increasing the risk of painful dry eye—a laser reshapes the cornea's surface. Patients occasionally suffer haze as corneas heal, not a LASIK risk. Wavefront-guided PRK uses computer software that provides a three-dimensional map, allowing surgeons to see subtle corneal irregularities, minimizing but not eliminating LASIK and PRK side effects. Those with thin corneas or corneal irregularities can be better PRK candidates and PRK can offer better night vision; however, it takes a few weeks of healing, with eye drops for the discomfort, before sharper vision emerges.
CK, or conductive keratoplasty, corrects farsightedness or astigmatism by beaming radiofrequency waves around the cornea's edge.
Phakic Intraocular Lenses are hard plastic lenses implanted in the eye in front of the natural lens and are for severe nearsightedness, so bad that correction cannot be accomplished with laser. This procedure refocuses light entering the eye for improved distance vision; because the natural lens stays in place, patients can retain close-up vision. Long-term effects are unknown. Warnings of rare problems include retinal detachment, infections, or increased cataract risk.
Refractive Lens Exchange replaces the patient's lens with an artificial lens and is essentially cataract surgery offered to cataract-free people who want LASIK but are bad candidates. Lens options include a multi-focal type that allows for distance and reading vision. Retinal detachment is a risk.
Corneal Rings are transparent crescents the thickness of a contact lens implanted to form a ring around the cornea's edge. Called Intacs, their slight weight flattens the cornea without permanently destroying tissue. While they're only for mild nearsightedness, they can be removed if patients suffer side effects, such as glare.
Need Legal Help Regarding Side Effect of LASIK Surgery