The Process of Informed Consent

Neal R. Reisman MD, JD, FACS

The process of informed consent is very important to the practice of plastic surgery. Not only is it a requirement from a legal standpoint, but it should assist in clarifying goals and expectations. Understanding informed consent is a process and not specifically the document that becomes signed; the process should include not only the surgeon, but the team interacting with the patient. There are legal standards that every jurisdiction adheres to defining requirements in accomplishing informed consent. The majority of states in the United States follow a “reasonable patient” standard which defines informed consent information necessary for a reasonable patient to make an informed decision. The minority standard is what a “reasonable physician” deems appropriate to accomplish informed consent. Such standards do not mean that all information pertinent to a procedure must be discussed but only such information as a reasonable prospective patient would need to understand to make an informed decision. Practices spend much time creating and discussing informed consent. The reality is that there are very few litigation cases specifically lost on a lack of informed consent. It is important to have the consent discussion and documents in the patient’s language. In addition to language issues, the bigger task is having the patient “understand” what the risks, hazards, inherent risks, and concerns are. The understanding of this information becomes the main issue in creating and achieving informed consent. A mere signature at the bottom of the document only demonstrates that the patient signed it and not that it is understood.

Informed consent documents present and discuss death and significant morbidity. It may be difficult for a jury to believe the plaintiff is objecting to a scar or a less than desirable result when they have understood and signed to say that they acknowledge that death is an acceptable risk. The scar seems much less significant. Herein lies the challenge to achieve informed consent, and I suggest to accomplish the legal requirement by going beyond the document itself and using the discussion to better interpret and decide whether goals can be reached.

The reasonable patient would inquire about the different procedures suggested, their complications and inherent risks, anesthesia concerns, drug interactions, cost and expenses, and the risk of doing nothing. It behooves the practice to see the prospective patient more than once and to utilize multiple learning style techniques in providing necessary information. There are many learning styles, but the most common three are visual, auditory, and kinesthetic. Understanding is enhanced when all three styles are incorporated in the informed consent process. Many patients are visual learners and achieve understanding by looking at photographs, schematics, and other tools the patient can see. One must be cautious in not having photographs interpreted as a warranty of results but rather representative of different aspects of the procedure. Demonstrative tools should clearly not be presented as the prospective patient’s result but rather a general representation. Patients may bring in their own photographs of goals and expectations that are helpful in defining their desires, but these should not be made part of or included in the medical record. Auditory learners are the next most common group. The auditory learner listens in great detail to describing information pertaining to the procedure, follow-up, and care. Your words paint a picture for them, achieving a better understanding of the procedure and inherent risks. Often the more detail you can provide in advance, the more comfortable the patient is with the entire event. The third learning style is the kinesthetic learner. This can be more of a challenge in discussing how the procedure specifically relates to the patient and past experiences the patient can recognize. An example might be, when attempting to determine size goals in a breast augmentation, to have the patient reflect on a past pregnancy where breast size dramatically increased. The patient may disclose that they liked their shape as they reached a full C in size, but the full D size they reached was too large. Such a personalized experience and understanding significantly helps the patient in understanding options and achieving their goal.

Achieving informed consent can be a team event. The surgeon has the responsibility to discuss aspects of the treatment; however, some portions can be delegated to the office team nurse or coordinator. In my opinion it is difficult to allow or delegate others beside the surgeon to discuss and obtain informed consent when these non-surgeon team members have not received the training or credentials, or had the privilege to ever perform such surgeries. It is wise to develop a team approach in presenting such information, with the patient coordinator and the nurse confirming and corroborating the surgeon’s discussions.

The details of the informed consent document should reflect the discussions had on the multiple visits prior to the actual procedure. I have chosen to divide the document into general risks and specific procedure risks to help the patient understand what is involved.

General risks of surgery include healing issues, delayed or undesirable results, bleeding, infection, scarring, pain, complications related to anesthesia, cardiac pulmonary, deep venous thrombosis (DVT) and sequelae, allergic reactions, drug reactions, and unsatisfactory results, to name some of the included discussions. Additional general advisories relate to smoking and its negative effect on healing, off-label US Food and Drug Administration issues, the negative effects of sun exposure, and general concerns in the postoperative period relating to travel and family interaction. Additional discussions should include the possible need for additional surgery, the importance of patient compliance, a revision policy covering how long and what, and a separate financial disclosure document covering patient responsibility, cosmetic surgery component, present and future expenses, and cancellation policy. The revision policy should include the period of time after surgery in which a revision will not incur a fee. Ten months after surgery might not be unreasonable for the surgeon to consider a scar revision without additional fees while five years later might be unreasonable. In addition, the limitations of a revision would only cover the performed surgeries and not additional areas or procedures. Revision of an abdominal scar might be appropriate but additional liposuction or a body lift would not be considered a ‘revision’. Lastly it is wise to state the revision policy will only be effective when the patient attends their postoperative appointments and adheres to recommended care. Non-compliance waives the revision policy. A communications consent is important to document and acknowledge how the practice may communicate with the patient. This should include permission for telephone numbers, email choices, texting and cell phone permissions, and social media and other methods. A general consent should also include the use of photographs to be kept by the practice and commercial photograph consent should any patient medical information or likeness be used for marketing, advertising, or educational purposes. The general Health Insurance Portability and Accountability Act (HIPAA) consent would not be adequate for any use beyond practice storage. The commercial consent is specific regarding where the likeness would be used, for how long, and for what purpose.

Specific procedural consent should include technical and specific information relevant to the selected treatment question. This is the area where specific options related to the procedure and patient choices are covered. Inherent risks and complications specific to the procedure should be outlined carefully and in an educational fashion. Choices offered to a patient or demanded by a patient should fall within a peer-approved appropriate selection choice. I have issues with the propriety of less than desirable options being selected by the patient. One might say that a patient cannot consent to a negligent procedure. The surgeon has a duty to protect the patient, sometimes from themselves. Remember that the informed consent standard is a reasonableness standard. That is, what a reasonable physician or a reasonable patient would want to discuss or know for the patient to make an informed decision. Many have utilized a checklist to cover the large amount of information that may be necessary in a complex case. The concern with a large checklist is that one item may be unintentionally omitted. If that is the one complication the patient suffers, the perception may be that it was omitted intentionally. Educational aids to assist with visual, auditory, and kinesthetic learning are valuable. The concern is not to create a warranty, either express or implied. An express warranty includes a specific demonstrative in the medical record that establishes an agreed-upon result. Patients bring pictures from magazines and the Internet as a goal for their expectation. While these are valuable, I would suggest they not be made part of the medical record. Similarly your preoperative and postoperative photographs should clearly represent a range of results and not imply specific results for this patient. An implied warranty can be more confusing, as it relates to expressed concerns and desires the patient has that are not negated or addressed. An example might be an important meeting 2 weeks following surgery that must be attended. Failing to offer rescheduling or a disclaimer that meeting attendance may not be possible may establish an implied warranty that the patient will be able to attend. I like the additional paragraph “no warranties express or implied are included and the patient understands what can and cannot be done and, understanding this, elects to proceed.”

Additional information as part of this informed consent process includes a financial disclosure statement and a surgical revision policy statement. Finances are always significant to the patient, and misunderstandings are quite common. It is important to have a separate document that incorporates expectations of named procedure, estimated time, and fees including surgeon, anesthesia, facility, and any additional costs that may be incurred, such as devices and instrumentation. The patient should understand and acknowledge such a document in advance of the procedure. The revision policy is also important to avoid misunderstandings. Despite best intentions patients may heal quite differently and unexpectedly. I like the revision policy to include an understanding that the patient is required to be compliant and not miss follow-up appointments or postoperative suggestions of care. The surgeon can certainly for some period not charge for agreed revisions, but there may be additional charges for anesthesia, facility, or devices. I do not believe that not billing is an admission of negligence and have advised adding a clause in the policy manual stating “from time to time, as an executive decision, fees may be waived, discounted, or not created.”

There are so many aspects of the informed consent document; I do not want to minimize its importance. I would, however, seize the opportunity to have a robust and complete discussion with the prospective patient about their goals and desires and use this interactive informed consent process to determine if such goals are realistic and achievable. Avoid letting the patient dictate care and procedure selections unless such choices are well within an appropriate peer-accepted range. Failed expectations still remain a leading cause of unhappy patients and litigation. The wise old statement “if I tell you in advance of a complication and you get it, I look smart, where if I tell you the same statements after your complication I’m making excuses” becomes significant when complications occur. Use the informed consent process as an educational tool, recognizing learning styles as well as the dialogue assessing patient goals. Such a process often results in an educated, content, and satisfied patient and a successful postoperative course.