Nearly 1.4 million patients each year undergo Lasik surgery, which is now a $2 billion industry. Last week, however, the FDA recognized that it had little to no information about adverse life events from people who are undergoing Lasik surgery. The reason is not the lack of events, but most likely because the adverse events are not reported. The FDA, the Defense Department and the National Eye Institute are teaming up to run a three-year program to gauge how many Lasik surgery patients suffer from post-Lasik operation problems. The FDA’s press relase regarding the FDA’s Quality of Life Project can be found here along with information about how to report Lasik related probelms and side effects.
At the same time as the FDA announcement last week about the quality of life program, the FDA issued warning letters to 17 Lasik sugery centers who accept walk-in patients reminding them of their obligation to report poor outcomes and any surgery-related medical complaints from patients who have Lasik surgery at their facilities. The letters were issued after FDA inspections of the facilities found that they had no system for collecting and transmitting to the FDA data on patients’ reports of post surgical “adverse events.”
The FDA website provides a number of helpful resources about Lasik surgery, including a Lasik surgery checklist (which should help patients avoid Lasik malpractice), which includes various tips and other advice for those considering Lasik surgery, such as:
Know what makes you a poor candidate
Career impact - does your job prohibit refractive surgery?
Cost - can you really afford this procedure?
Medical conditions - e.g., do you have an autoimmune disease or other major illness? Do you have a chronic illness that might slow or alter healing?
Eye conditions - do you have or have you ever had any problems with your eyes other than needing glasses or contacts?
Medications - do you take steroids or other drugs that might prevent healing?
Stable refraction - has your prescription changed in the last year?
High or Low refractive error - do you use glasses/contacts only some of the time? Do you need an unusually strong prescription?
Pupil size - are your pupils extra large in dim conditions?
Corneal thickness - do you have thin corneas?
Tear production - do you have dry eyes?
Know all the risks and procedure limitations
Over-treatment or under-treatment - are you willing and able to have more than one surgery to get the desired result?
May still need reading glasses - do you have presbyopia?
Results may not be lasting - do you think this is the last correction you will ever need? Do you realize that long-term results are not known?
May permanently lose vision - do you know some patients may lose some vision or experience blindness?
Dry eyes – do you know that if you have dry eyes they could become worse, or if you don’t have dry eyes before you could develop chronic dry eyes as a result of surgery?
Development of visual symptoms - do you know about glare, halos, starbursts, etc. and that night driving might be difficult?
Contrast sensitivity - do you know your vision could be significantly reduced in dim light conditions?
Bilateral treatment - do you know the additional risks of having both eyes treated at the same time?
Patient information - have you read the patient information booklet about the laser being used for your procedure?
Know how to find the right doctor
Experienced - how many eyes has your doctor performed LASIK surgery on with the same laser?
Equipment - does your doctor use an FDA-approved laser for the procedure you need? Does your doctor use each microkeratome blade only once?
Informative - is your doctor willing to spend the time to answer all your questions?
Long-term care - does your doctor encourage follow-up and management of you as a patient? Your preop and postop care may be provided by a doctor other than the surgeon.
Be comfortable - do you feel you know your doctor and are comfortable with an equal exchange of information?
Know preoperative, operative, and postoperative expectations
No contact lenses prior to evaluation and surgery - can you go for an extended period of time without wearing contact lenses?
Have a thorough exam - have you arranged not to drive or work after the exam?
Read and understand the informed consent - has your doctor given you an informed consent form to take home and answered all your questions?
No makeup before surgery - can you go 24-36 hours without makeup prior to surgery?
Arrange for transportation - can someone drive you home after surgery?
Plan to take a few days to recover - can you take time off to take it easy for a couple of days if necessary?
Expect not to see clearly for a few days - do you know you will not see clearly immediately?
Know sights, smells, sounds of surgery - has your doctor made you feel comfortable with the actual steps of the procedure?
Be prepared to take drops/medications - are you willing and able to put drops in your eyes at regular intervals?
Be prepared to wear an eye shield - do you know you need to protect the eye for a period of time after surgery to avoid injury?
Expect some pain/discomfort - do you know how much pain to expect?
Know when to seek help - do you understand what problems could occur and when to seek medical intervention?
Know when to expect your vision to stop changing - are you aware that final results could take months?
Make sure your refraction is stable before any further surgery - if you don’t get the desired result, do you know not to have an enhancement until the prescription stops changing?
If you have undergone Lasik surgery and believe that you may be a victim of Lasik malpractice, contact a Lasik malpractice lawyer today for a free and confidential legal evaluation at info@consumerinjurylawyers.com or (877) 779-1414.