“We are only starting to ride the enormous growth curve of LASIK in this country. There will be more than enough surgeries for everyone to benefit if we keep our heads by sharing information openly and honestly and by resisting the temptation to criticize the work of our colleagues when we are offering a second opinion to a patient with a suboptimal result. Who was it who said, ‘When the tide comes in, all the boats in the harbor go up?'”
Patient satisfaction after LASIK, as measured by unvalidated surveys or questionnaires, is neither scientific nor a reliable indicator of LASIK safety or efficacy. LASIK surgeons report high patient satisfaction even in cases with poor night vision and sight-threatening complications. The “Hawthorne effect” 1 proposes that patients may rate their level of satisfaction with the LASIK procedure higher in an effort to please their physician.
Every FDA-approved laser has a document known as “labeling”. Labeling is similar to the package insert or printout you receive when you purchase a prescription drug. It contains important safety information and data from clinical trials. The labeling for lasers contains a Patient Information Booklet, which the FDA requires that all prospective LASIK patients receive prior to surgery. LASIK surgeons routinely fail to provide the booklet, which denies patients access to information that could affect their decision to have the surgery.
In the United States, the Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety of drugs and medical devices. But can you really trust the FDA? The agency has a long history of approving drugs and devices that were later found to cause serious injury and even death. Many FDA-approved products have been withdrawn from the market or recalled by the agency.
This topic overlaps a little with the ‘Are you a candidate?’, but focuses directly on information that the Laser Vision Clinic will give you
Let’s be clear. Modern refractive surgery was not introduced to treat or cure disease, or to address a public health issue or medical need. Refractive surgery serves the interests of eye surgeons and manufacturers of the devices used in refractive surgery. It’s big business!
“Many thousands of eyes have been damaged beyond repair by LASIK devices since the 1990s. Approximately 700,000 eyes will receive refractive surgery with LASIK devices by the end of year 2011. Thus, more than four thousand six hundred (4,630) are projected to face blindness due to surgically thinned and bulging corneas (keratectasia).