Concerned about the safety of laser-refractive surgery? Don’t panic. LASIK, LASEK, PRK and all their derivatives are strictly monitored and regulated by the federal government to ensure that they are safe and that their results and possible consequences are accurately described to the public.
The Food and Drug Administration, or FDA, is the federal agency that has the responsibility of inspecting and certifying all drugs and medical techniques and equipment to make sure that they are safe and that they can deliver what their manufacturers promise. This oversight extends to laser-assisted refractive surgery and the equipment used in these procedures.
The FDA is based in Maryland and has more than 200 field offices nationwide. The agency regulates about one quarter of all goods and services bought by consumers in the U.S. each year, or about $1 trillion. This figure includes more than $460 million in food, $275 billion in medication, $60 billion in cosmetic goods and $18 billion in dietary supplements and vitamins.
The agency was established in 1938 by the Food, Drug and Cosmetic act, and its responsibilities and powers have been enhanced and amended many times in the more than 70 years since then. The FDA’s current annual budget is about $2.5 billion.
The FDA has a rigorous trial process to ensure that new products are safe before they’re allowed on the market. The first step is animal testing. If the new drug or product proves safe for animals, a series of tightly controlled human trials are then allowed. The human trials begin with a small group of volunteers, and if the results show that the drug or treatment is reasonably safe, the FDA will then allow broader human trials. Once the FDA determines that sufficient human testing has proven the treatment or equipment to be safe, it will approve the product or procedure.
With regard to laser-assisted refractive surgery, a major duty of the FDA is to inspect and approve the equipment used in the procedures. The FDA approved the first excimer lasers used in laser-assisted refractive surgery in 1989. The first approved procedure was PRK. In the mid-90s, the FDA approved the LASIK treatment.
It’s interesting to note that the LASEK treatment’s use of excimer lasers is not approved by the FDA. The FDA has ruled that the use of the excimer laser in LASEK surgery is an approved off-label use for the device, however. The “off-label” designation refers to uses of medical devices that are legal, but not necessarily approved for the device. In general, the FDA may approve a device for medical use, but it may not approve each procedure it’s used for. This occurs for various reasons, one being that the FDA leaves some issues up to the discretion of physicians. For example, the FDA may have approved the use of defibrilators, but it has not approved each specific use of defibrilators. LASIK itself was originally an off-label procedure.
Laser-assisted refractive surgery remains a field where new innovations are frequently introduced. In fact, the FDA has approved several new instruments for laser assisted refractive surgery over the past decade.
The most recently approved device for laser-assisted refractive surgery is the MEL 80 Excimer Laser System by Carl Zeiss Inc. This new device allows for more accurate surgical work. The FDA approved it in August 2006.
The FDA approved a new LASIK Eye Drape made by ODyssey Medical Inc. in May 2005. This drape provides an added level of protection and reassurance for patients.
In 2003 the FDA approved two devices for Alcon Laboratories Inc. These approvals included the greenlight for the Wavelight Allegretto Wave Excimer Laser System and approval of the laser used in the system.
The FDA approved a new excimer laser for Technolas in 2000. The laser is an update of a device previously used in the Technolas 217A Excimer Laser System.
The FDA’s oversight also extends to patient information. The agency requires laser-assisted refractive surgery providers to give patients brochures informing them of the potential risks of the procedures.
More recently the FDA has used its regulatory role to investigate complaints that LASIK providers aren’t doing enough to inform patients of the potential risks and complications of the surgery. Although the FDA asserts that less than one percent of LASIK patients suffer serious complications from the procedure, it is investigating complaints that providers aren’t weeding out folks who are unsuitable candidates for the procedure.