Liability Risks Associated with PRK and the Excimer Laser

By Jean Hausheer Ellis, MD, Richard L. Abbott, MD, Dean C. Brick, MD, and Paul Weber, JD

Digest, Fall, 1996

When the FDA approved the excimer laser for photorefractive keratectomy (PRK) in fall 1995, it opened the door to new liability risks for ophthalmology. Given the elective nature of PRK, the high expectations of patients, and the general public’s misconceptions about refractive surgery, there is significant potential for malpractice claims, particularly as more ophthalmologists incorporate this new technology into their practice. This article discusses some of the “patient-centered” risk management issues that arise with PRK and provides guidelines to help ophthalmologists reduce the likelihood of a claim and better defend claims when they do arise.

Informed Consent and Documentation

Informed consent has evolved into a complex process for the ophthalmologist and patient considering PRK. The ophthalmologist and office staff must counsel and answer prospective patients’ questions. Patients must review patient education booklets and videos, decide between alternative refractive procedures and, if choosing to have PRK, review a long informed consent document. Time spent educating patients and discussing the procedure is well worth the effort, however, as patients who are educated before surgery will be less anxious about the procedure and more likely to have appropriate expectations.

FDA approval of the excimer laser came with a number of conditions concerning patient education and the informed consent process. Under the FDA mandate, as soon as a prospective patient expresses an interest in myopic PRK and prior to undergoing surgery, the patient must first read a patient information booklet. Summit and VISX, the two companies approved to manufacture the excimer laser, explicitly state or infer in their patient education booklets that the patient “should discuss the contents of the booklet with their doctor.” The fact that the prospective patient received this booklet should be documented in the patient’s chart. After the patient has read the booklet, the physician should record any discussion or questions regarding the booklet that the patient had. These booklets cannot be altered or misrepresented in any way and should be used as tools to begin the consent process. Although, the Summit and VISX booklets contain similar information regarding PRK, the patient must be given the correct booklet for the “brand” of excimer laser that will be used. Since PRK patients typically are dilated in the ophthalmologist’s office, it is best to suggest that they take home the required patient information booklet and informed consent documents to read when their eyes are undilated.

The FDA also mandates that, prior to undergoing surgery, prospective patients be informed of the alternatives for correcting their myopia, including eyeglasses, contact lenses, and other refractive surgeries such as radial keratotomy. Although not mandated by the FDA, it is prudent to discuss LASIK and other alternative refractive procedures (“next generation” lasers, “corneal ring,” etc.) with patients who may be appropriate candidates for these emerging procedures. Failure to discuss the alternatives to PRK may be viewed as a breach of the ophthalmologist’s duty to properly inform the patient prior to performing a procedure.

OMIC strongly suggests a separate consent document for PRK. However, informed consent for PRK is not simply the signing of a legal document; it is an ongoing process of information sharing and decision making between the surgeon and patient throughout the treatment process. It involves the surgeon discussing with the patient the key risks of the procedure. These include the fact that the long-term risks of PRK beyond three years are unknown; the procedure is irreversible; and there is the possibility of undercorrection, overcorrection, haze, glare, and astigmatism or inducement of it, as well as loss of best corrected vision and the remote chance of partial or complete loss of vision.

Undercorrection in the range of 20/40 and overcorrection should be demonstrated to the patient with an accompanying note in the record verifying the patient’s willingness to accept an outcome of less than 20/20.

Issues surrounding presbyopia should be explained and demonstrated to patients in the office prior to surgery. This may include the option of monovision. Some experienced PRK surgeons may elect to operate on the dominant eye first as a means of allowing the patient a “trial” period of monovision for a month. Monovision can be simulated prior to surgery by having the patient experiment with disposable contact lenses with monovision power options. The ophthalmologist should document that monovision was demonstrated and discussed with the patient.

Other side effects may be transient but still should be discussed with the patient. These include the possibility of some pain or mild discomfort 24 to 48 hours postoperatively and anisometropia, which can either be induced by PRK or become a temporary problem during the recommended interval between eyes. Surgeons may want to reassure patients that a temporary refractive contact lens in the unoperated eye can help during the potentially awkward time between surgeries.

Ideally, it is suggested that the physician make a brief contemporaneous note indicating that the informed consent discussion took place and that the patient appeared to understand. However, a preprinted statement to this effect in the informed consent document that the physician signs also will suffice. In all cases, it is important that the following be set forth in the informed consent document:

• The recommended procedure, risks, alternatives, and complications were discussed with the patient.
• The patient’s questions were answered and the patient seemed to have a clear understanding of what was discussed.
• No guarantee as to outcome was suggested to the patient.

You can receive a copy of OMIC’s sample Confirmation of Informed Consent for Photo- refractive Keratectomy by faxing your request to 415-771-1810.

Marketing and Advertising Issues

Marketing and advertising of PRK are monitored and regulated by the Federal Trade Commission (FTC). Aside from spawning regulatory investigations by the FTC, improper advertising can adversely impact the informed consent process and create indefensible malpractice claims against surgeons and referring optometrists in comanagement situations. The FDA-mandated guidelines on marketing and advertising of PRK are described to surgeons in PRK certification courses; however, the FTC and FDA continue to update their regulations on PRK and “off-label” issues. These changes occur frequently and are often quite specific and detailed.

The FDA also has stated that discussion of the safety or efficacy of the laser in promotional materials must include sufficient information about the risks and limitations of the procedure. Furthermore, if “material information” is omitted in promotional materials, the ophthalmologist may be subject to scrutiny by the FDA. Common improper promotional statements include the following:

• Claims that cannot be substantiated. “Over 300,000 patients have successfully undergone PRK.” No one knows how many patients have had PRK and certainly no one knows the “success” of these thousands of surgeries.
• Claims that the procedure is “safe and effective.” This is basically guaranteeing that there will be no side effects or complications and that the patient will be corrected to 20/20 every time.
• Claims that patients can throw away their glasses or contacts after the procedure. Patients may need reading glasses and/or spectacles to correct small amounts of over- or undercorrection postoperatively.

Some aggressive marketing consultants are persuading ophthalmologists to use such claims in their advertising to get prospective patients to call the office or come in for an appointment. Even if the patient is given the correct information about the procedure during the appointment, a lawsuit can nonetheless arise. Jurors evaluate the credibility of the ophthalmologist and will take into account that the physician may have made misleading statements in advertising and marketing to get the patient in the door.

Comanagement Issues

Advertising and marketing within comanagement networks may lead to situations where one comanaging partner will be held accountable for improper promotion by the other. For example, a comanaging optometrist may state that all the ophthalmologists he refers to are “board certified refractive surgeons.” This is misleading since there is no board certification for refractive surgery, and in fact, some of the ophthalmologists referred to may not even have taken or passed their boards in ophthalmology. In such cases, it is imperative that the ophthalmologist confront the comanaging partner or entity about such statements. The public perceives the comanaging team as a partnership since everyone shares in the profits arising from the refractive surgery and all are involved in caring for the patient. Naturally, the public also will assume that the ophthalmologist benefits from the marketing efforts of other members of the comanagement team and is therefore responsible if there are misleading statements in their ads.

Good communication is essential to proper comanagement. Optometric comanagement in refractive surgery is a constantly evolving process requiring a commitment to regular and timely communication, orally and in writing, among all members of the professional eye care team. Fax or telephone communication is acceptable but, in either case, it must be documented that such communication took place. It is important that all members of the team agree upon and adhere to standardized guidelines and protocols concerning the preoperative, operative, and postoperative care and management of patients undergoing excimer laser surgery.

The ophthalmologist must personally verify and document that the comanaging optometrist has the requisite education, training, and skill to follow postoperative refractive patients and that such care is within the optometric scope of practice. Otherwise, the ophthalmologist may be exposed to claims of negligent referral if the optometrist is later shown not to have the skills to follow these postoperative patients.

The outcome of the PRK procedure is permanently and profoundly affected by the postoperative pharmacologic care of the patient. Referring optometrists must be able to describe and quantify haze in a meaningful and standardized manner when conferring back with the ophthalmologist so changes in medication can be implemented in a timely fashion. Online computerized technology and computerized corneal topographical mapping should serve to enhance communication in this area between comanaging doctors.

Finally, since optometry is sharing enhanced potential liability in the delegation of postoperative management of PRK patients, the ophthalmologist should be certain that comanaging optometrists carry appropriate malpractice coverage with sufficient limits so the ophthalmologist does not become the “deep pocket” when a claim arises.

Off-Label Use of the Excimer Laser

Off-label use of the excimer laser is becoming more common. Some of the more prevalent off-label uses of the excimer laser include:

• Fewer than three months interval between surgery on each eye.
• Use of a bandage contact lens postoperatively to enhance patient comfort.
• Treatment alternatives for astigmatism and myopia greater than the FDA-approved amounts.
• Bilateral simultaneous PRK.
• Laser assisted in-situ keratomileusis (LASIK).

There are many technological and pharmacological applications for PRK that have not completed U.S. clinical trial studies, but which make good sense clinically and scientifically and are accepted as the standard of care in the community. The patient who could benefit by off-label use of the excimer laser should be educated to understand that the off-label procedure is used by surgeons to improve patient comfort, visual recovery, and satisfactory results following surgery. If the necessary steps are taken to properly inform the patient about the nature of the changes to the underlying PRK procedure, many off-label procedures can be done without fear of substantially increasing liability exposure.

In addition to general PRK patient information materials, the nature and extent of the information given to the patient regarding the off-label procedure depends upon what is to be done. If you are using a bandage contact lens in the postoperative period, a note in the record that you discussed the risks, benefits, and alternatives of using the contact lens should be sufficient. However, if you are planning to perform LASIK, a much more thorough, in-depth discussion, education, and documentation process is necessary so the patient is properly informed that this is an excimer laser procedure that has not been approved by the FDA. This information can be presented in a non-threatening manner; however, it is essential that the patient understand the difference between FDA-approved PRK procedures and off-label procedures that are considered “practice of medicine.”

For an off-label procedure such as LASIK, a separate informed consent document should be created tailored to the risks and benefits of this procedure. Other variations on FDA-approved PRK may warrant only an addendum to the standard PRK document to confirm that the patient understands that some aspect of the procedure and treatment course has not been approved by the FDA. OMIC has developed a number of suggested clauses that can be inserted into a standard informed consent document to address certain off-label uses of the excimer laser. Please fax your request for these suggestions to the Risk Management Department at 415-771-1095.

Finally, before performing an off-label use such as LASIK or bilateral simultaneous PRK, contact your professional liability insurance carrier to ascertain if your policy will cover off-label refractive procedures and what restrictions your carrier may place on your performance of these procedures.

Conclusion

PRK surgery and other uses of the excimer laser can be successfully defended in court provided the surgeon approaches the procedure responsibly and with concern for the patient’s best interests. To help ensure that claims are defensible, guidelines and protocols for refractive procedures and care of the patient should incorporate risk management principles as discussed in this article. OMIC insureds who are considering performing PRK surgery are encouraged to contact the Underwriting Department for further information on PRK coverage.

Comanaging Refractive Surgery Patients (Part 1)

By Paul Weber, JD
OMIC Risk Manager

Digest, Fall, 1999

Comanagement of refractive surgery patients with optometrists is one of the most controversial and divisive topics among ophthalmologists. OMIC has never taken a position for or against patient comanagement, but is concerned that ophthalmologists who are comanaging do so in such a way as to minimize patient injury and reduce the risk of malpractice litigation. This column addresses some of the medical malpractice liability risks that arise when comanaging with optometrists. Future Hotline columns will address other legal risks associated with comanagement, such as allegations of fee splitting, improper referral arrangements, and postoperative treatment of patients who had surgery in Canada.

Q Can optometrists legally comanage refractive surgery patients?
A This depends on whether the optometrist practices in a state in which postoperative care is within the “scope of practice” of optometry. In many states optometrists are permitted to comanage surgical patients, but in others the law is in a state of flux. Ophthalmologists should seek the advice of legal counsel to determine the optometric scope of practice in their state.

Q Can an ophthalmologist be held liable for a comanaging optometrist’s negligent treatment?
A Under certain legal theories, an ophthalmologist can be held liable for an optometrist’s negligence. The theory of vicarious liability holds that if an ophthalmologist and optometrist are in an “apparent partnership” or act as each other’s agents, they share liability if a patient incurs an injury as a result of either party’s negligence. If their conduct causes others to believe they are in a partnership (e.g., joint advertising, billing on the same letterhead, referring to each other as partners to patients), they can be held vicariously liable for the other’s actions. Even if only one party mischaracterizes the relationship as a partnership, the plaintiff still may be able to hold the other party liable under this theory. Therefore, ophthalmologists need to be aware of how comanaging optometrists portray the comanagement relationship to patients and others. This is especially true given the intense marketing surrounding refractive surgery.

The theory of negligent referral applies if an ophthalmologist refers a patient to an unqualified optometrist and the optometrist injures the patient while providing postoperative refractive care. The plaintiff has to prove that the ophthalmologist knew or should have known that the optometrist was unqualified. For example, is there a pattern of negligent performance that would indicate to a reasonable ophthalmologist that the optometrist was unqualified? To avoid claims of negligent referral, an ophthalmologist should check the qualifications, training, and malpractice history of a comanaging optometrist, including a visit to the optometrist’s office to observe how thoroughly the optometrist examines the postoperative refractive patient. To help ensure quality postoperative care, some ophthalmologists sponsor training seminars for their comanaging optometrists to review proper examination of refractive surgery patients and diagnosis of common postop problems.

Q What can an ophthalmologist do to minimize the risk of injury and claims arising from refractive surgery comanagement?
A During the informed consent process prior to refractive surgery, the ophthalmologist should discuss with the patient who will provide the postoperative care. Clearly, the final decision must be left up to the patient, and the ophthalmologist’s input into that decision must be predicated on the patient’s well being. If the patient elects comanagement with an optometrist, this decision and the reasons behind it should be carefully documented in the chart in the event the patient later claims abandonment by the operating ophthalmologist.

Even if the optometrist is allowed to provide postoperative care under applicable law, some states allow the physician to “delegate” only a portion of the postoperative care to a non-physician and require the physician to “supervise” the non-physician’s care. OMIC has developed a postoperative care guideline that follows this rule and advises insureds to place documentation in the patient chart reflecting supervision of the comanaged postoperative care. This could be a signed review of faxed exam reports from the optometrist. The important thing is to make sure supervision occurs and is documented.

Comanaging Refractive Surgery Patients (Part 2)

By Paul Weber, JD
OMIC Risk Manager

[Digest, Winter, 2000]

Bilateral simultaneous LASIK surgery is being offered in Canada for as low as U.S. $999, and American citizens are traveling across the border to take advantage of these alleged “savings.” Various scenarios are now arising in which ophthalmologists in the United States are being asked to provide preoperative and/or postoperative care to these patients. This column addresses some of the risks arising from this new form of comanagement.

Q What are the risks of providing preop and postop care to patients who have surgery in Canada?
A Anytime you enter into an arrangement with a LASIK patient to provide preop and postop care, you are exposing yourself to a possible claim for care you provide that may “cause” or “contribute to” a poor outcome or result. Sometimes it is unclear exactly what caused an “injury” or contributed to a poor result in a LASIK patient. The U.S. ophthalmologist may not know details of the actual surgery (flap thickness, residual bed, etc.). Was it poor surgical technique by the Canadian surgeon? Was it an improper work-up and poor patient selection by the U.S. ophthalmologist? In most states in the U.S., a physician who causes or contributes to an injury can be held liable for negligence. Under the theory of negligent referral, an ophthalmologist in the U.S. can be held liable for the surgical error of a Canadian physician or laser center if the U.S. ophthalmologist actively referred patients to the Canadian physician or center.

Q Can a Canadian physician be sued in a United States court for medical malpractice?
A As a practical matter, it is not likely that a Canadian physician will be sued in the United States for medical malpractice. American courts usually have no jurisdiction over foreign citizens residing outside the U.S., and plaintiff lawyers, who sue physicians on a contingency fee basis, are simply not going to spend a great deal of time chasing a foreign defendant if there is a more readily accessible defendant. If a patient has a poor result after LASIK surgery performed in Canada, the U.S. ophthalmologist who provided the preop or postop care is the most likely target defendant.

Q What can I do to minimize my risk of a claim if I see patients pre and postoperatively who are having LASIK surgery in Canada?
A The most important issue to address with these patients is the scope of care that you agree to provide as well as that which you specifically do not agree to provide. To avoid any misunderstandings, there must be a very carefully drafted informed consent document stating that you are only providing pre and postoperative care and delineating what that care entails. Include a disclaimer statement that you take no responsibility for the outcome of the surgery or surgical services provided in Canada and inform the patient that regulatory oversight and safety guidelines differ in Canada. It is important to realize that even though you are not performing the surgery, you are deciding during the preop evaluation whether the patient is a good candidate for LASIK. Therefore, an informed consent discussion should take place in your office and the patient should sign a document informing of the risks, benefits, and alternatives to the procedure. Otherwise, the patient can claim that it was below the standard of care not to warn of these risks since you knew the preop evaluation was specifically for the purpose of LASIK surgery.

Q Am I required to provide postoperative care to a LASIK surgery patient who simply makes an appointment with my office?
A Even if you already have an established relationship with a patient, there is no “duty” to take on the postop care of another surgeon whether surgery was performed in Canada or the U.S. you do decide to see the patient, all the risks discussed above apply and you will need a carefully written informed consent document defining what postoperative care will and will not be provided.

Q Should I treat a patient who has had a complication or poor result from surgery in Canada?
A This situation is more problematic than the patient who simply shows up for routine postoperative care. First advise the patient of the option of returning to the surgeon for treatment of the complication or enhancement. This may not be possible if the patient presents with an emergent problem requiring immediate treatment; however, once the problem is stabilized, the patient should be advised of this option. If the patient prefers to have you provide further surgery, you must have a comprehensive informed consent discussion to evaluate whether the patient has reasonable expectations and is likely to be a cooperative participant in his or her follow-up care.

Comanaging Refractive Surgery Patients (Part 3)

By Paul Weber, JD
OMIC Risk Manager

[Digest, Spring, 2000]

Some managed care patients who have LASIK at high volume/low cost surgery centers, particularly those outside the United States, attempt to return to their regular ophthalmologist for postoperative care. This is an emerging concern for many ophthalmologists, some of whom believe that by providing postop care, they are rewarding the patient for finding the cheapest surgical deal. Others are afraid that the patient may be unhappy with the surgical outcome and in a litigious state of mind. Although it may seem objectionable to treat these patients, it is necessary to analyze each situation before refusing treatment to avoid exposure to claims of breach of contract or malpractice.

Q Am I obligated to provide postop care to patients who had an elective procedure outside their managed care health plan?
A First analyze the “included and excluded services” in the managed care contract. If it is a capitated contract, there may be exclusions for complications or care following a non-covered service (LASIK, PRK, etc.) delivered outside the plan. Under a capitated contract, it is possible you would have to see the patient and not be compensated beyond the capitated fee you would ordinarily receive under the contract. Unfortunately, postop care can sometimes take up quite a bit of an ophthalmologist’s time, especially if the patient has a complication. If this is not a capitated contract but a reduced fee for service, the contract still controls whether or not you are required to see the patient; however, you would be able to charge your customary reduced fee for services provided.

Q If a patient is referred to me by a primary care physician (PCP), can I ask the PCP to refer the patient to another ophthalmologist in the network?
A This may seem to be an appropriate option, but it needs to be considered carefully since there is a chance of straining the referral relationship. “It is crucial that the ophthalmologist personally speak with the PCP and explain the problem. He can’t just send the patient back, and he can’t have one of the staff call the PCP’s office to talk to a staffer in that practice. It must be physician to physician.” (Gil Weber, April 25, 2000.) Also, there is a risk in simply assuming that the patient’s complaint or reason for referral is solely related to refractive surgery. It may be prudent to see the patient to avoid running the risk of missing a problem unrelated to the refractive surgery.

Q What are my risks if I refuse to see a managed care patient for LASIK postoperative care?
A If you refuse to see a managed care patient, you may be in breach of the managed care contract and risk exposure to contractual damages as set forth in the agreement and/or regulatory action. If you refuse to see a patient who has a specific clinical problem, there is risk of exposure to a medical malpractice lawsuit for delaying or failing to provide treatment.

Q Do I have to provide enhancements to managed care patients who had refractive surgery outside the plan?
A If the patient needs an enhancement to an elective surgery not covered by the health plan, you probably are not obligated to provide such care.

Q Can I encourage managed care patients to go back to the surgeon who performed the procedure?
A You may encourage a patient to go back to the surgeon who performed the original procedure; however, as a practical matter, the surgeon may be in Canada or otherwise not be accessible. In any case, it is prudent to document that the patient was given the choice of returning to the original surgeon but elected not to. OMIC’s model form, Assumption of LASIK Post-Op Care, was created for situations involving American patients who have refractive surgery in Canada but can be adapted for use with any managed care patient by amending the last paragraph concerning fees.

The recent publication of the joint position paper on ophthalmic postoperative care by the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery again draws attention to the importance of documenting that patients were properly informed and consented to post-operative care being provided by someone other than the operative surgeon. OMIC addressed this issue in the Fall 1999 Digest, and OMIC’s model form, Confirmation of Postoperative Comanagement Selection by the Ophthalmologist, can be used to document the patient’s understanding of comanagement of postoperative care. Please contact the Risk Management Department at (800) 562-4652 or riskmanagement@omic.com to request this form or Assumption of LASIK Post-Op Care form.

Paul Weber acknowledges and greatly appreciates the comprehensive analysis of this issue by Gil Weber, MBA, a managed care consultant who can be reached at www.gilweber.com for more information regarding comanagement and other managed care issues.

Informed Consent and Elective Procedures

By Paul Weber, JD, OMIC Risk Manager [Digest, Fall 2001]

The majority of ophthalmologists at a recent OMIC risk management seminar (73%) agreed that elective surgery patients are more likely to sue their surgeon than other patients. Of the more than 300 ophthalmologists in attendance, 64% agreed that physicians have legal duty to determine if an elective surgery patient has “realistic expectations” of what surgery can accomplish. Why do patients who undergo elective surgery seem to present a greater liability risk than other patients? What steps can be taken during the informed consent process to better understand these patients’ expectations?

Q  What characteristics of elective surgery patients impact the informed consent process?

A  Elective surgery patients rarely have a vision threatening condition or compelling clinical reason to undergo the procedure. If things go wrong, it is not unusual for them to claim that the ophthalmologist persuaded or cajoled them into having surgery. Ask elective surgery patients to write on the informed consent document or in the chart itself their own personal reasons for having surgery. This helps them acknowledge their primary role in the decision-making process and makes it difficult for them to later claim that the only reason they went forward with the surgery was because of the “undue influence” of the ophthalmologist and staff. Another factor that distinguishes elective surgery patients is that most elective procedures are not covered by health insurance so patients pay out of pocket. This can become problematic if the patient needs an enhancement or revision after the initial surgery. The informed consent process document should specifically state the possibility of future procedures (enhancements/revisions) to get the desired result or to deal with the complications. The fact that there will be additional costs associated with further treatment should be addressed and documented before embarking upon any elective surgery.

Q What impact does advertising have on informed consent?

A Your own advertising and marketing materials will be brought into court if a lawsuit arises. If a statement in your ad conflicts with your informed consent document, that conflict will be raised as evidence that the patient was not properly informed. OMIC considers refractive surgery advertising such a potentially problematic issue that as part of being underwritten for refractive procedures, insureds must submit their advertising and marketing materials to OMIC for review prior to publication. Insureds who have questions about the appropriateness of their advertising should contact the Risk Management Department at (800) 562-6642, ext. 652.

Q How can I determine if a patient has unrealistic expectations?

A There is no substitute for spending time with a patient to find out what he or she expects from surgery. One busy refractive surgeon makes it a point to ask each patient, “What is the most important thing about your vision?” This helps him to determine if he can deliver what the patient wants. During one pre-LASIK interview of a seemingly perfect candidate, a 58-year old -6.00 D, he discovered that the patient’s favorite hobby was tying flies and that he had won championships in it. To tie them, he had to take off his glasses and work about eight inches in front of his face. When asked what he considered especially important about his vision, the patient replied, “I really like how good my vision is right here.” Had they not had this discussion, this important fact would not have been revealed and the surgeon could have been exposed to a claim of failure to provide informed consent if the patient lost his vision after LASIK.

Q Is there a duty to inform the patient about how postoperative care will be handled?

A Postoperative co-management issues often arise in the context of refractive surgery. If it is known in advance that some portion of the postoperative care will be handled by another provider, this should be communicated to the patient. Many times, a patient chooses to have an elective procedure performed by a particular surgeon and has the reasonable expectation that the surgeon will handle the postoperative care. When this is not the case, the patient may be disappointed and upset, especially if there is a complication or concern about the result. Prior to surgery, the patient should understand and consent to the handling of postoperative care by health care providers other than the surgeon.

Q How should informed consent be handled for off-label procedures?

A It is not uncommon for refractive and cosmetic surgeons to use a drug or device in a manner that has not been approved by the FDA. In such cases, the patient should be informed of the nature of the technique, its scientific basis, its benefits, and any possible drawbacks or criticisms from other practitioners. Other options should be discussed, and the patient should be encouraged to seek a second opinion before proceeding.