FDA Hears Testimony On LASIK Outcomes
Written by William Goldstein, MD
Nearly ten years after its arrival in the United States, and more than 3 years after FDA approval, LASIK surgery is coming under fire from some patients who have suffered complications or experienced poor outcomes.
Today, the FDA heard testimony from patients who were dissatisfied with their LASIK surgery. Their complaints ranged from mild visual distortion, to pain, to severe activity-limiting visual halos and glare. One distraught parent read a suicide note from their child who described six years of eye pain and blurred vision.
The vast majority of patients have near perfect vision after LASIK surgery. In fact, the procedure has been quoted by many as having a 99% satisfaction rate. Patients are, by and large, overjoyed with their results. Of course, like any surgery, LASIK has its downsides and patients need to be aware of the risks before they pursue this type of surgery.
Surgeons in the U.S. perform about 700,000 LASIK cases every year, and the surgery is a popular means of reducing the need for glasses and contact lenses worldwide. But the limitations and risks of this surgery have lead many physicians to expand their practice to include other alternatives, such as Implantable Contact Lenses. It has been recommended it as an alternative to LASIK in Michigan for many patients. The Visian ICL offers the benefits of vision correction, while avoiding some of the problems that LASIK can cause. Patients who are not candidates for surgery due to dry eyes, or extreme degrees of nearsightedness can feel secure that their most common complications are not an issue with this technology.
Ultimately, the FDA testimonies brought one thing into focus. Patients and surgeons need to be highly aware of the potential for serious problems when proceeding with LASIK surgery. The FDA is recommending that surgeons do a better job of informing their patients, and providing pictures or diagrams of certain symptoms like glare and halos to help patients better understand the true implications.
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