17 Managing and Mitigating Risk in Aesthetic Breast Surgery
This chapter is a brief introduction to medical and legal risks in aesthetic breast surgery, which have many components and are very complex. The chapter will address general essential aspects of medical legal risk mitigation, including comprehensive informed consent process recommendations. Additionally, practice management strategies to develop and sustain a successful cosmetic breast surgery practice are presented, such as revisional policy considerations. Specific circumstances to be considered, including augmentation mastopexy, anaplastic large cell lymphoma, capsulectomy/capsulorraphy, breast reduction, and fat injections, will also be highlighted.
17.1 Preoperative Considerations
17.1.1 Preoperative Consultation
A keyword in risk management is “foreseeability.” Foreseeable risks should be determined individually for each patient and addressed with prospective patients as well as taken into consideration for treatment plans. The mitigation of foreseeable risk should, in fact, be considered a guiding principle for the bulk of clinical care.
17.1.2 Patient Selection
Avoiding risk begins with patient selection, and patient selection begins with thorough patient consultation, including conversation as well as physical examination. The informed consent process begins with exactly that: a process in which prospective patients explain their goals and expectations. This is then assessed through the physician’s frame of reference, incorporating the history and physical examination findings. The ongoing interactions and dialogue between surgeon and patient refine these expectations and goals in an attempt to match the procedure most “foreseeable” in achieving those goals.
Some prospective patients are significantly unrealistic and convey unobtainable goals. Others may be unaware of or unable to express their true intentions. The keys are recognizing these observations and attempting to educate the patient about safe, reliable, and predictable goals. Some patients learn from prior consultations not to divulge their true intent for fear of being dismissed. While never guaranteed, direct emphasis on respect and honesty may help patients to disclose their true beliefs.
The ongoing process of complete informed consent, in contrast to the limited act of signing an “informed consent document,” should continue over a period of time during which these dialogues occur to assess these necessary goals honestly. It is generally unwise to see a prospective patient one time and attempt to accomplish, assess, and disclose the informed consent process. Time must remain for questions and answers as well as contemplation to expose goals and expectations fully and to render a determination as to whether these are achievable.
Gorney and Martello have emphasized the importance of the intersection of patient deformity and patient concern, which can be very helpful in assessing patients’ expectations. Prospective patients who have a notable deformity associated with a mindset of “Anything you can do, Doc, would be wonderful” are most acceptable from a patient selection standpoint. Conversely, the patient with a minimal, barely visible deformity associated with the mindset of “I cannot live, work, or enjoy any relationships until this is erased” is a poor candidate for surgery. Those in the middle of the spectrum present the biggest challenges for physicians to assess. 1
17.1.3 Informed Consent
As just highlighted, informed consent is a process involving complete engagement of physician and patient, not merely the signing of pages that purport to reflect this process. Some prospective patients have seen many doctors and yet do not complete an acceptable process of informed consent. Completion of the informed consent documentation signifies that a balance between desiring an outcome and accepting the risks, timing, costs, and commitment to the procedure has been achieved. Specific legal standards apply to designation of appropriate informed consent. The options for standards applying to informed consent are (1) what a reasonable patient needs to know to make an informed decision or (2) what a reasonable physician feels needs to be explained for a patient to make an informed decision. States vary regarding which of these standards is used, and it is important to understand your state’s medical practices law and what standard of informed consent is used. 2
17.1.4 Patient Education
The process of informed consent is an important one, and the better understanding the patient achieves, the better choices are made. The burden of completion lies upon the physician. Effective education is a powerful tool in this endeavor. There are nine recognized learning styles described by Dr. Howard Garner. Three have achieved importance in understanding this process. It behooves the surgeon and his or her team to utilize these three in a discussion.
The first is visual learning. Many patients need to see results, photographs, schematics, or some demonstrative drawing to which they can relate. There are videotapes, booklets, and other sources supplying this information for the many procedures involved in aesthetic breast surgery. One must be cautious about using photographs (either of past results or computer-modified preoperative images) that create or imply a warranty that such result is what the prospective patient will achieve. Likewise, patients often bring in pictures from magazines and the Internet that may be helpful in determining their expectations, but these should not be made part of the medical record.
The second common learning style is auditory. Many patients would rather listen to a detailed story as an explanation about the procedure than look at images. This can often be combined with the third common learning style, kinesthetic. This establishes a personalized story or example to which the prospective patient can directly relate.
Consider the example of a prospective breast augmentation patient. Use of preoperative and postoperative photographs, diagrams of breast anatomy to demonstrate potential planes, videotapes of patient testimonials or even portions of the procedure, and booklets about the perioperative experience certainly provide visual information to the patient. The office team may explain in detail how decisions are made and how the surgery is accomplished as well as what to expect. The physician may employ the kinesthetic aspect by discussing with the prospective patient, for example, her thoughts and experiences during a prior pregnancy when her breasts enlarged to a DD cup size. This patient possesses her own built-in, personalized understanding of how her DD cup size was related to her current goals. The highest prospective patient retention and retention of information likely occurs when all three learning styles are seamlessly incorporated in the informed consent process. 3 , 4 , 5
17.2 Practice Management Pitfalls
17.2.1 Team Approach and Responsibilities
The responsibility of informed consent lies finally with the operating surgeon. It is essential that the entire office team be consistent in messaging, and office staff may provide additional levels of information beyond the physician–patient conversation throughout this process. Surgeons often delegate education to patient coordinators, physician extenders, and nursing personnel, which may be appropriate, but this cannot replace the surgeon’s primary and ultimate responsibility toward ensuring the adequacy of informed consent.
The attempted complete documentation of the informed consent process can be onerous. Even with maximum effort, the medical record could never reflect the entirety of the patient–physician interaction. However, when conflict arises, the contemporaneously completed medical record can be a powerful protection.
17.2.3 Electronic Record
The digital age may provide assistance as well as potential problems as the record is created. The surgeon might remember lengthy discussions addressing risks, hazards, and choices while the record indicates 12 minutes spent in the exam room, implying brief visits in a hurried environment, causing concern should litigation arise. In addition, many digital electronic health records utilize “smart” text that is created by default and may or may not be correct. The busy surgeon may not take the appropriate amount of time to correct misstatements, thus creating an inappropriate record and implying slipshod practices or care. Given the quantity burden of automatic alerts meant to provide protections against medical mistakes, providers have been shown to be prone to overriding them, increasing their liability. Additionally, issues of concurrent or overlapping surgery may be demonstrated through review of time stamps and other information readily available in the medical record. 5 , 6 , 7 , 8 , 9
17.2.4 Revisional Policies
Formally documented, discussed, and signed policies related to responsibilities for costs incurred with the initial surgery as well as for revision surgery, should it be necessary, are likely to be as important as clinical and informed consent documentation. Many approaches exist. One should consider whether the patient or the practice will bear the financial burden of unexpected laboratory and imaging testing (including pathologic review of breast tissue), inpatient admission, or other medical care should complications occur. This raises the question of how one might define a complication. Does an acceptable result but dissatisfied patient qualify? How unacceptable does the result need to be? If further operative procedures are considered, will professional fees be waived? Will the patient or the practice bear the facility and anesthesia fees? Will the patient be obligated to return to the practice for a discount? Who might pay for necessary care at another facility? One also might be able to include social media comment control when offering revision services, potentially waiving a surgical fee for a specific period of time in exchange for limiting social media comments.
17.3 Intraoperative Considerations
“Who, What, When, Where, Why, and How” represent important considerations related to operative considerations in aesthetic breast surgery. Patient scrutiny of the operative process is on the rise. Expectations for the experience of care are changing. Greater emphasis is now placed on who participates and how who does what. Those surgeons in academic practices must explain trainee competence, assistance, and involvement in care, while those surgeons in private practice must be prepared to do the same with physician extenders. Patients may expect to be aware of, for example, physician assistants or residents performing unsupervised incision closure. 10 , 11 Surgeons should also carefully consider where procedures are performed. It is important to understand accreditation for ambulatory surgery centers and accepted standards for types of patients treated and types of procedures performed in office space, ambulatory surgery centers, and hospital facilities. 12 , 13 Differences between hospital outpatient department and ambulatory surgery center fee structures may also be important for both the patient’s and the surgeon’s finances. The when and the why should be confirmed on the day of surgery. The preoperative preparation dictates the surgical planning, but confirmation of absence of change in clinical condition or expectation of outcome and arrangement of appropriate postoperative care and environment must occur just prior to the start of the procedure.
17.4 Postoperative Considerations
The proverb “There’s many a slip ’twixt the cup and the lip” clearly applies to postoperative care in plastic surgery. Careful preoperative counseling and preparation (and documentation of such) regarding expected postoperative dressing, garment, and incision management, activity restrictions, time frames for changes, warning signs and symptoms of complications, and routine and urgent follow-up plans minimize patient questions and caregiver concerns and may even prevent complications. Tools to facilitate these processes exist in the form of printed instructions available from many sources.
17.5 Specific Risks Related to Breast Surgery
17.5.1 Tobacco Cessation
Smoking deserves a special precaution for breast reductions, breast lifts, and implant-based surgery. It is well accepted that nicotine use interferes with blood supply and can certainly negatively affect many aspects of breast surgery, promoting wounds, infections, and capsular contracture. In addition, many smokers cough with anesthesia, further creating possible difficulties in the early recovering period. Cardiovascular risk is also increased. 14 , 15 , 16
Understanding how difficult it is to stop smoking should cause concern in the patient who too readily volunteers that she has quit. Many patients fail to disclose their continued smoking habit or getting secondhand smoke from another. The additional consent documents outlining the severity of complications related to smoking may be argued not to be enough to warrant proceeding. One could argue that a patient cannot consent to a negligent surgery, and the surgeon has a duty to protect the patient—sometimes from herself. Cotinine is a urine test that measures the presence of nicotine metabolites in the patient. It may be wise to establish this test before surgery and be cautious of proceeding if it is positive. This, however, remains an area of debate in plastic surgery. 17 , 18
17.5.2 Breast Implants
There are a number of important considerations when implants are used. Liability can be noted when improper implant choices are made. Patients must be prepared for long term follow-up and maintenance procedures. Silicone consequences and anaplastic large cell lymphoma must be documented to be understood by the patients.
Implant Size and Profile
Dimensional planning, at least including chest measurements, may demonstrate quantifiable effort to assist the patient in development of proper choices of implants. Two common occurrences are noted when reviewing litigation cases. The first is choosing a high-profile implant with its inherent larger volume, leading to stretch deformity and malposition or ptosis. Critics may fault undesirable volume and blame the surgeon for undesirable results. The high-profile implant choice certainly has a place and should be associated with documentation in the medical record supporting that choice. There is a significant difference between a 500mL moderate-profile and a 500-mL high-profile implant. The second is used in an attempt to position the breast higher on the chest. Patients with a longer chest height often seek a higher rest position with more cleavage, which can rarely be achieved. The higher-profile, larger implant choice may initially seem to achieve the goal, but because of its additional weight, the soft tissues stretch and it soon fails. As a result of the negligent implant choice, the plaintiff requires a mastopexy with its inherent scarring and still have a lower breast position on the chest, which would all have been avoided with proper implant selection. Understanding breast shape, size, and the relative influence of components of these on surgical options and outcomes may improve predictability of and satisfaction with results. 19 , 20 , 21
The consultation associated with implant selection should be directly with the prospective patient and include a private discussion without other family or friend “stakeholders.” There are many stories of a partner controlling the discussion, resulting in an inappropriately large choice. After surgery the boyfriend is gone, and now the practice has to interact with an unhappy patient. It has been said that “You earn your living from whom you operate on, but you earn your reputation from whom you don’t.”