The increasing number of premium IOL options for correcting both near and distance vision raise important risk management and informed consent issues for ophthalmologists. More one-on-one counseling of patients is required than with traditional monofocal IOLs. The following recommendations promote patient safety and reduce liability exposure in cataract surgery and refractive lens exchange (RLE).
INFORMED CONSENT
Preoperative counseling, careful patient selection, and timing of the informed consent process are fundamental to managing the medicolegal risk associated with these surgical procedures. Cataract surgeons are ethically obligated to inform their patients in advance of surgery about the positive and negative aspects of premium IOL implantation, educate patients about what they can expect regarding postoperative vision, and spend face-to-face time discussing all possible IOL options and potential outcomes.
The best way to avoid a lawsuit is by not creating or fueling patients' unreasonable expectations. Patients young and old alike must understand that they will not have perfect vision at all distances after surgery. Premium IOLs may not be appropriate for individuals with inflexible expectations or for those with strict professional visual acuity requirements, such as commercial airline pilots. Patients in these two categories present a potential liability because their dissatisfaction with suboptimal visual results could lead to litigation.
During the informed consent process, it is important to verbally emphasize that the selection of the correct implant is not an exact science, despite the sophisticated equipment used. Caution patients that eyeglasses, refractive surgery, or repositioning or exchanging of the IOL may be required if the postoperative visual outcome is significantly different from what was intended. Charges related to these additional procedures should also be clearly explained, both orally and in writing, so that there is no misunderstanding if such measures are required.
PREOPERATIVE COUNSELING
Numerous topics must be covered before surgery, and I advise that you document all discussions in patients' medical records. For instance, when presenting IOL options to patients, discuss whether the lenses are approved by the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA). In the case of a recently approved IOL, surgeons must inform patients that unanticipated problems may occur, as there may not yet be substantial documentation of long-term outcomes and adverse effects.
Surgeons must also offer patients the option of monovision. Demonstrate what the patient's monovision experience may be like by using contact lenes or glasses. Should the patient express interest in monovision, explain the possible difficulties with depth perception that may occur.
Additionally, explain to the patient that the goal of multifocal IOLs is to reduce his dependence on glasses or contact lenses at distance and near but that there is no guarantee that this will be fully achieved. Disclose the common side effects associated with multifocal IOLs, including reduction of contrast sensitivity, reduced vision in dim light, halos, decreased contrast sensitivity, and difficulty driving at night. Patients must understand before surgery that if an intraoperative complication should take place, a monofocal IOL may have to be implanted instead of the multifocal lens.
Finally, if the surgery center at which you practice does not perform LASIK or PRK, the surgeon should provide patients with a list of refractive surgeons in the area in the event that they require further refractive correction. Similarly, patients must be told whether refractive surgery, spectacles, or other forms of residual refractive error correction will be included in the total fee for cataract surgery with IOL implantation.
Use a questionnaire to determine patients' personality traits and identify inappropriate patients for a specific procedure. As you discuss patients' responses with them, assess their emotional stability. Clarify to patients that removing a cataract will not cure any sight-threatening disease of the eye that may be found in a high myope, such as peripheral retinal degeneration. Nor will an improvement in vision eradicate depression or discontent with one's life circumstances. Patients taking antidepressants and those in high-stress occupations such as an engineer, pilot, doctor, or lawyer often have unrealistic expectations regarding the extent to which surgery will change their lives. Poor candidates for multifocal IOLs include those who drive long distances at night or perform visually intensive work. These patients should be counseled to consider a monofocal IOL with reading glasses.
The office staff will typically spend more time with patients than the ophthalmologist. If a member of the staff reports inappropriate behavior by a patient, heed that information as a warning. Should something go wrong in surgery, these patients may become unreasonable and difficult to deal with. From a risk management perspective, it is best to avoid performing surgery on these patients if possible.
If advertising is legal in your country, promotional materials must not present false or misleading messages to the consumer. Inappropriate marketing can weaken the surgeon's ability to defend against a claim or lawsuit because the information presented in advertisements is often discussed during the informed consent process.
CONCLUSION
The variety and complexity of premium IOL options warrant ophthalmologists to carry out comprehensive preoperative counseling to reduce their liability exposure. The informed consent and risk management recommendations offered here are steps that ophthalmologists can take to protect themselves and ensure that their patients are knowledgeable and safe.
Richard L. Abbott, MD, is the Thomas W. Boyden Endowed Chair in Ophthalmology and Health Sciences Professor, Cornea and External Diseases, at the University of California, San Francisco, and is a Research Associate for the Francis I. Proctor Foundation in San Francisco. He is a member of the Ophthalmic Mutual Insurance Company Board and a consultant to Santen, Inc. Dr. Abbott may be reached at tel: +1 415 502 6265; e-mail: richard.abbott@ucsf.edu.
