Informed Consent: Medicolegal Considerations in Breast Surgery



Informed Consent: Medicolegal Considerations in Breast Surgery


Neal R. Reisman



Surgery of the female breast remains a high-risk area for medical malpractice. While augmentation mammoplasty remains an increasingly popular surgical procedure, the risk of malpractice liability appears to be increasing, with complaints of scarring, capsular contracture, and improper size implants, to name a few. Although there are many methods to help reduce medical liability, patient selection and the informed-consent process remain the best. In addition, practice trends demonstrate failing loyalty and patient movement from surgeon to surgeon. Risk management need not be a negative impact on the practice. In fact, I believe that a well-presented and informative informed-consent process is a good way to build and maintain a practice, create patient loyalty, and fulfill legal requirements.

A medical malpractice lawsuit may arise from a variety of factors, including failed expectations, negligence, warranty issues, and failure to provide informed consent. Informed consent is not the patient-signed piece of paper, but rather a process during which there is interchange between the physician and his or her staff, the patient, and often her significant other. This chapter addresses this process.

Informed consent is the process during which risks, hazards, alternatives, and more information about a procedure are presented to the patient sufficient to allow the patient to make an informed decision about proceeding with surgery The issues that require discussion in this chapter include the standards for informed consent, what parties may participate in the informed consent process, methods to increase retention and understanding of this process, sample inclusions in the informed-consent process, necessary documentation in the medical record for informed consent, and the impact in a medical negligence lawsuit.


Standards for Informed Consent

What is required to achieve informed consent? There are two main national legal standards for informed consent: the Reasonable Patient Standard and the Reasonable Physician Standard. In addition, certain states have specific added requirements, achieved through tort reform efforts, that must be presented, understood, and agreed by the patient to protect the surgeon against an informed-consent claim. The standards for informed consent depend on the resident state. The majority of states require a Reasonable Patient Standard. This standard establishes that sufficient information be presented such that a reasonable patient can make an informed decision about the procedure. A few states may still require the Reasonable Physician Standard, in which information must be presented based on what a reasonable physician would discuss, enabling the patient to make an informed decision. The burden for informed consent will be one of these, following the practice state.

The majority of states using the Reasonable Patient Standard permit the patient to be interactive in the discussion process; however, the final acceptance level is whether all necessary information has been presented to the hypothetical reasonable patient sufficient to make a decision for surgery. This should not be interpreted as all available information required about the procedure, but as necessary information for this hypothetical reasonable patient to make an informed decision. One can rest assured that if a critical fact is omitted from discussion and the patient develops that complication, the patient will claim she never would have accepted the surgery had she known that critical information. Many surgeons and risk managers suggest a laundry list of complications and facts to cover during the informed-consent process. My only concern is that such a list must be periodically updated to avoid leaving out one additional necessary complication, because an argument might be made that the surgeon intended to omit the added complication: The physician was so complete in developing the list, he or she must have intended to leave that one additional problem out for patient discussion for fear she would never have consented to the procedure had that fact been disclosed.

The Reasonable Physician Standard is somewhat easier to interpret. All necessary information that a reasonable physician would discuss concerning risks, hazards, alternatives, and no treatments concerning the procedure in question must be presented. The argument with this standard may include what has been described as “the battle of the experts.” One expert will state he or she would have included more than what was provided, whereas the other side supports what was done. It is important to understand what standard applies to a given practice area(s) and that the physician develop a system for informed consent to comply.

Last, some states, such as Texas, have legislated panel lists of procedures that require specific state-approved consents. Texas, for example, has two panels: Panel A, requiring specific informed consents, and Panel B, not requiring specific disclosures. It is important to comply with these state requirements because compliance may bar or prevent a claim for failure to provide informed consent if documentation is provided that the specific procedure and its risks were discussed and acknowledged following legislative rules. These state-specific lists are intended to assist with tort reform by preventing claims for lack of informed consent if panel lists are acknowledged and required disclosures made.


Who May Provide Informed Consent?

The main responsibility for informed consent rests with those performing the proposed procedures. The surgeon has the
ultimate responsibility of explaining to the patient the necessary ingredients of informed consent. However, it is acceptable to develop a team approach to cover, explain, demonstrate, or discuss aspects of informed consent. Often a nurse, patient coordinator, or similar employee will add to and provide additional information to the patient after the physician has discussed the surgery and addressed the patient’s concerns. This approach may be established by a variety of combinations. I am aware of practices that start with the nurse or patient counselor providing the necessary information to educate the patient. If the patient then chooses to proceed, the surgeon then has the responsibility to discuss further detail and address expectations. I caution against relying only on the office staff and personnel to provide all information. An argument may be made that these office-based staff do not have privileges to perform the surgery, have not been trained to perform these procedures, and, in fact, have never done so. It ultimately falls on the surgeon to specifically address what he or she will be performing on the patient. There are many components in the informed-consent process that should be discussed. The surgeon need not, and does not, have the duty to explain all to the patient.

The patient’s partner, boyfriend, spouse, or other is an integral part of the informed-consent process. The partner may have ideas and goals different from those of the patient. It is important to ascertain his or her views and how the patient interacts with him or her. Critical issues include size, shape, implant choices, and reasonable expectations. The patient will be influenced by her partner, and all opinions are important as they relate to expectations. Failed expectations are a major reason for medical malpractice lawsuits. False or unreasonable expectations must be dispelled prior to surgery, whether the opinions are held by the patient or her partner. Conflicts in choices of the patient and her partner must be resolved. I am aware of instances of the patient choosing too large an implant size solely based on pressure from a boyfriend. The boyfriend leaves, and now the patient is very unhappy about her result. It may be wise, with patient’s approval and permission, to also involve the partner in the document signing. The team approach will aid in an open discussion from all. Many partners will make comments to the staff and not to the surgeon. Good communication among the team members and alerting of the surgeon to suspected problems is critical. The team approach assumes that someone will discuss and explain necessary information as one’s state dictates. This team presentation lends itself to the different learning styles necessary for patient education and retention, as I now discuss.


Components of Learning Informed Consent

It has commonly been believed that only 35% of information actually discussed is retained in the patient’s memory. Past cardiovascular video recordings of informed consents demonstrated that less than 50% of what was actually presented was retained by the listening patient. This may be old data and not applicable today. Learning is a complex function based on many factors, including visual effects, auditory input, and personalized information, all brought together into some memory pattern. There are nine learning styles that may be used to help people learn and retain more. The three main learning styles are visual, auditory, and kinesthetic.

All three basic learning styles should be used when an informed-consent program is developed. The visual learner requires some schematic or actual photograph to process information. This fact may explain the lower retention statistics of the past when only auditory learning was considered. Visual learners require information that either verbally paints a picture or uses actual drawings and other visual aids. The only concern is not to guarantee that the patient will obtain the same result as shown. The photographic and visual aid information may use patient pictures, sample implants, anatomy pictures, and sizing charts as examples of visual aids.

The auditory learner requires the listened word for processing. Such learners may not relate to a picture but listen intently to information presented. The office should develop a good system to cover the necessary information via this method of learning. If the surgeon, although a wonderful technician, has difficulty communicating, another member of the team should provide this important information. There should be a fluid discussion allowing interaction and questions as the information is presented, processed, and discussed.

The third learning style is that of the kinesthetic learner. Kinesthetic learning requires some personal interaction and relationship between information presented and the patient’s past or current experiences. This learning style is the most difficult to develop and present. An example might be for the multiparous patient seeking breast augmentation to remember when her breasts were engorged during and after pregnancy. The size and shape at that point may help her understand swelling and size issues with breast augmentation. This information is something she can personally relate to, and combined with visual aids and auditory information, her retention should be much better than 35% to 50%.

The goal of informed consent is to enhance patient information and permit the patient to make an informed decision once the necessary information is presented. It is helpful to present information, often through a team approach, that can be remembered and used in the decision process. In addition, the practice will be enhanced by providing the patient an appropriate amount of information presented in a concise fashion. The more all three learning styles are used, the better informed and prepared the patient will be. An old adage is, “If you tell something in advance that occurs, you are smart; if you tell them the same thing after the event, you are making excuses.” It may be important to develop a team to present information in all three learning styles. Not only is the patient’s retention improved, but also she will enjoy the information being presented and it will increase her ability to make an informed decision.


Inclusions of Informed Consent

The materials presented in informed consent for breast augmentation include a variety of discussion points. This chapter is not intended to be a standard of what exactly should be discussed. Rather, it should serve as a guideline for topics that either a reasonable patient requires or a reasonable physician deems necessary. There are patients who would rather not listen to all the “bad” information, and they have that right. This, as well as the patient’s acknowledgment, should be documented. However, most patients want to have as much information as they can. The list that appears later in this section may serve as a guide for the practitioner’s development in the
informed consent process, with further in-depth discussions as needed. It must be remembered that no warranties should be given, expressly or even implied, that would increase liability and risk. The surgeon, patient, and partner should all have realistic expectations. If the expectations cannot be determined, it may be recommended to continue with the informed-consent process until that goal is reached. Unfortunately, there are patients who never reach the goal of an informed-consent process, and it is best to decline their surgery demands.

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Sep 23, 2016 | Posted by in Reconstructive surgery | Comments Off on Informed Consent: Medicolegal Considerations in Breast Surgery

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