Ophthalmologists perform LASIK surgery to improve focusing power by removing corneal tissue and reshaping eyes. LASIK is short for laser-assisted in situ keratomileusis. An older procedure, known as PRK (photorefractive keratectomy), is performed with the same kind of laser. According to the American Academy of Ophthalmology, about 800,000 LASIK or PRK procedures are performed each year.
LASIK is the most common elective surgical procedure in the United States. It has been pronounced safe for most patients by the Food and Drug Administration (FDA), although the FDA has twice sent letters to professionals in the eye care industry reminding them of their legal obligation to include appropriate warnings in their advertising.
When laser surgeons do not follow the FDA’s advice, patients take risks that they do not understand. When laser surgeons are negligent, patients may suffer serious eye injuries. A medical malpractice attorney can help injury victims recover compensation for their loss of vision or other devastating outcomes of LASIK or PRK surgery.
Risks of LASIK Surgery
The FDA warns patients to be wary of eye centers that advertise “20/20 vision or your money back.” In reality, most ophthalmologists say that the goal of LASIK surgery is improved vision, and that 20/20 vision just isn’t possible for many patients. Unfortunately, that isn’t always made clear to patients. Neither is the fact that two-thirds of patients who have the surgery report that they still needed to wear glasses or contact lenses at least occasionally.
About 5 to 10 percent of all patients who receive LASIK or PRK surgery must return for a repeat procedure. The second procedure is necessary when the first surgery either fails to change the shape of the cornea enough or changes it too much. Sometimes the second procedure corrects the problem. Sometimes it doesn’t. Sometimes it makes the problem worse.
Chronic pain caused by irreparable damage to the corneal nerve is one risk of LASIK surgery. According to the FDA, other risks of LASIK surgery include:
- Loss of vision
- Double vision, glare, and other debilitating changes in vision.
- Severe dry eye syndrome.
- Loss of depth perception.
- Failure to achieve improved vision because the ophthalmologist changes the eye’s shape too much or too little.
Whether adequate warnings are possible is doubtful. Laser eye surgery is a relative recent procedure. There are few long-term studies of the risks associated with LASIK, and the studies that deem the risks to be small are generally based on patient questionnaires rather than valid scientific data.
A consumer publication reports that the true rate of risk is unknown because of flaws in the system of reporting adverse events to the FDA. The report notes that “incomplete informed-consent processes and questionable business practices blur the line between practicing medicine and seeking profit.”
Morris Waxler, who led FDA’s ophthalmological-devices unit in 1998 when the FDA approved the first lasers for use in eye surgeries, has since petitioned the FDA to withdraw its approval of those devices. He based the petition on evidence that ophthalmologists hid evidence of LASIK injuries. The FDA denied the petition without reviewing that evidence.
Causes of LASIK Malpractice
Malpractice occurs when an ophthalmologist fails to use the same standard of care that prudent ophthalmologists provide when they perform the same kind of surgery. Carelessness in the performance of laser surgery that leads to an eye injury entitles the injured patient to compensation.
Inadequate training is one cause of LASIK malpractice. Another is that some ophthalmologists simply perform too many procedures to devote sufficient time to each one.
One study determined that ophthalmologists who perform a high volume of LASIK procedures are more likely to commit malpractice. Ophthalmologists who advertise heavily and who treat too many patients are less likely to spend time evaluating patients before surgery. That impairs their ability to assess the risks of surgery for each patient and makes it less likely that they will explain those risks carefully to assure that patients understand them. Busy ophthalmologists are also more likely to delegate patient management duties to optometrists who lack the training required to evaluate a patient’s condition.
LASIK Malpractice Compensation
Patients who have been injured by LASIK surgery may have the opportunity to recover compensation under two circumstances. First, if the surgery was performed negligently, patients have the right to recover compensation for injuries resulting from the negligence.
Second, patients cannot give informed consent to a LASIK procedure unless they have been warned of the risks. In many cases, businesses that provide LASIK surgery fail to provide a complete and accurate statement of the risks. They may also undercut any warnings they give by using advertising materials that portray the surgery as risk-free.
Any patient whose vision has been impaired or lost, who began to suffer chronic eye pain, or who experienced any other injury after LASIK surgery should ask for a case evaluation by a personal injury attorney. Compensation for severe injuries can be substantial, but patients may lose their right to obtain compensation if they do not act promptly after the injury occurs.