Medical treatments and options are constantly progressing and evolving. Specifically in eye care, knowledge of various therapies has grown by leaps and bounds. Growth in eye treatment awareness has resulted in multiple new approaches and methods in eye care. Pharmaceutical companies and medical providers have commonly used bold and assertive methods aimed at healthcare consumers. Over the past 25 years, companies have used these aggressive strategies to hasten acceptance and generate massive sales of certain products. These campaigns often result in the coercion of eye care providers to carry a certain product or perform a specific operation. These medical providers fear patients viewing them as “out of the loop”. Eye care recipients need to understand all treatment options and cannot afford to be caught up in “hype” in this constantly evolving field. It is very important that patients comprehend all options involving LASIK and are not swayed by current trends in LASIK Eye Surgery.
LASIK patients should evaluate all options concerning surgery. There are multiple facts to consider when choosing LASIK or an alternate treatment option.
In 1989, the first LASIK surgery was performed. The procedure was introduced in the United States a year later. After years of testing, the Food and Drug Administration (FDA) accredited the procedure in 1998. Figures from a Pre-market Approval Application (PMA), consisting of rigorous safety testing and clinical trials, were enough to grant approval. Eye care patients should be aware of the different methods to gain FDA acceptance. FDA approval does not necessarily indicate that the particular drug or procedure has been stringently tested. To be accredited via the PMA process, a treatment is rigorously tested to tested to determine its’ ability to effectively treat actual patients. Another path to acceptance is 510(k) approval. In this method a producer must only provide small amounts of safety information and may still gain FDA approval. Often, surgical tools will be FDA accredited with limited or possibly no actual testing. Under the 501(k) approval system, these items would be legally accepted treatment inside the United States.
Patients receiving LASIK executed with the Excimer Laser should feel confident in the safety of their procedure. This device has undergone comprehensive FDA testing. Other eye surgery tools may not have been rigorously tested. These 501(k) approved devices often perform their actual clinical trials on the first (possibly thousands) patients to receive the treatment. You can’t always believe the “hype” surrounding new products and procedures. Often, they have performed little “real world” testing and cannot be completely trusted.
The only way to truly test any eye care device or procedure is through use by surgeons in actual operations. If these new treatment methods fail to meet the expected results of doctors and patients, they will surely be unsuccessful in the marketplace. If the product meets its’ expected results and standards, than it should easily be sustainable in future healthcare markets.
Although there are few global facts on LASIK, patient license fees given to Excimer laser producers have made LASIK data in the United States obtainable. Since FDA approval in 1998, doctors have performed around 8 million LASIK surgeries. In this time, multiple special interest groups, public relations specialists and malpractice attorneys have attempted to negatively impact the LASIK industry. Their efforts have proven to be futile as a result of LASIK’s solid track record as safe, effective eye correction surgery. Over the last ten years, LASIK has established itself as a beneficial treatment when performed by knowledgeable surgeon and executed on properly chosen patients.