Informed Consent

 

Before having laser eye surgery, you’ll be required to sign a document called a consent form.

Informed consent is more than simply signing the form. It is a process of communication between the patient and the surgeon that results in the patient’s agreement to undergo surgery.

In the communications process, the surgeon (not an optometrist, technician, LASIK counselor/coordinator, or other delegated representative), should discuss and explain the findings of the patient’s pre-operative exam, risks and benefits of surgery, and alternatives to the proposed surgery (including glasses and contact lenses).

The patient should have an opportunity to ask questions, so that he or she can make an informed decision whether or not to undergo the procedure. A Patient Information Booklet should be provided to every prospective patient.

For the surgeon, the informed consent process is both an ethical obligation and a legal requirement.

Many laser eye surgery patients feel that they were not fully informed of the risks and consequences of the surgery. Furthermore, patients say that they were assured that potential complications listed on the consent form rarely — if ever — happen. Prospective patients may wrongly believe that being found to be a so-called “good candidate” is assurance of a good outcome, virtually removing all risk.

In 2009, Consumer Reports published findings of a survey of nearly 800 adults who had undergone laser eye surgery. The survey found that 53 percent of patients report at least one side effect after surgery, and 22 percent are still experiencing side effects six months later. You won’t find that in a laser eye surgery consent form!

You may also find long-term consequences of laser eye surgery suspiciously missing from the consent form — consequences such as permanent reduction of corneal biomechanical integrity (with associated risk of corneal ectasia), problems with glaucoma screening and future cataract surgery, and non-healing of the LASIK flap (with associated risk of traumatic flap dislocation and delayed corneal infection). These adverse effects are inherent to the surgery.

The discussion, signing of consent form, and receipt of patient information booklet should happen well before the day of surgery. Some patients have even reported receiving the consent form AFTER they’ve been given an anti-anxiety drug just before surgery, and some don’t even meet the surgeon until that point either. This is a very rushed and un-ethical and also quite widely practised. Even if you recieve your consent form well in advance, you are unlikely to understand the impact and severity of what you are signing. It really is a ‘sign your life away’ contract.

The take-home message: Laser vision correction surgery risks listed in the consent form are very real, and they occur with greater frequency than the surgeon and his staff would like you to believe. Moreover, laser eye surgery “side effects”, such as dry eyes and night vision problems, which occur in about 20% of patients in clinical trials, may be debilitating and permanent. By signing the consent form, you agree to accept sight-threatening risks and common side effects.

LASIK Clinics caught lying on camera

In 2011, a Canadian television news program sent undercover investigators into LASIK clinics and caught clinic staff on camera lying to prospective patients about long-term risks of laser eye surgery.

For more information, read Informed Consent by attorney Todd Krouner.

Read a sample LASIK consent forms, commonly used by laser eye surgeons, and carefully consider if it’s worth risking your eyesight.

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