1. Prioritize evidence based outcomes analysis and surgeon and patient accountability

For the past two decades, most breast augmentation outcomes data in peer reviewed and published studies as well as anecdotal reports indicated a high level of patient satisfaction and low reoperation rates. Surgeons introduced and refined operative techniques including axillary and umbilical incision approaches and endoscopic pocket dissection. During these two decades, however, two things did not improve appreciably—patients’ perioperative experience and recovery, and reoperation rates. Incredibly high reoperation rates within just 3 years of augmentation were exposed in data from FDA saline PMA studies.^12–14 FDA Advisory Panel members and patient advocate representatives strongly criticized these reoperation rates and suggested a need for more scientifically constructed studies, long-term followup, evidence based outcomes analysis, and patient and surgeon accountability including a data registry for augmentation.

Scientific examination of the root causes of high reoperation rates and prolonged patient morbidity in the early postoperative period requires objective data for analysis. Subjective data and terms established a two decade track record of high reoperation rates and little improvement in the patient experience. Truly scientific analysis of objective data, while uncomfortable or even threatening to some surgeons, is the best method to assure optimal patient outcomes and improvement in the patient experience in breast augmentation.

Patient outcomes begin with the surgeon. If the surgeon does not prioritize evidence based outcomes analysis of objective data, the track record suggests that the patient experience, outcomes, and reoperation rates are unlikely to improve. Tissue based clinical analysis and implant selection enable objective outcomes analysis, using objective rather than subjective assessment parameters. Many surgeons oppose data collection and reporting through an independently managed registry. If verifiably advancing patient outcomes and lowering reoperation rates is a priority, mandatory reporting of baseline preoperative objective tissue measurements, operative data, postoperative measurements, and detailed reporting of all reasons for reoperations is the best method to assure objective analysis of processes and outcomes.

2. Prioritize and optimize patient education, informed consent, and patient accountability

Suboptimal outcomes in augmentation frequently result from suboptimal preoperative decisions by the patient and the surgeon. Decisions affect outcomes. The quality of decisions relates directly to the knowledge base of the patient and surgeon and the processes by which they use this knowledge base to make decisions.

Informed consent law mandates that patients make choices and decisions about their care. Surgeons are responsible for providing information to patients about the potential benefits and risks of all available options for treatment. Current scope of patient education in augmentation is highly variable, and depends not only on the information provided to the patient, but whether the patient reads and uses the information, and specifically how the patient uses the information to make choices and decisions.

Most current patient education methods and materials provided by professional organizations and surgeons do not optimally address two specific areas that are critically important to optimizing patient education—verifiability or testing to assess whether patients have assimilated critical information, and proved decision support processes to assure decision making pathways that have been shown to optimize outcomes and minimize reoperation rates (Table 2-2). Regardless of the amount of information provided to patients, absent some form of testing or verification to assure their assimilation of the information, the patient never builds an optimal knowledge base. Absent specific guidance in decision processes using processes that have been shown to improve outcomes, patients are unlikely to make optimal choices that ensure optimal long-term outcomes.

Table 2-2 Patient education basic processes and current deficiencies.

Assuming that surgeons optimize all of the previously mentioned factors, patients may nevertheless make requests, choices, or decisions that may adversely affect their long-term outcomes. A common example is requesting an implant size or dimensions that exceed the base width of available soft tissue coverage, or that may excessively stretch or thin envelope tissues or cause parenchymal atrophy in the future. Surgeons cannot predict or control some of these factors. Patients must be accountable for their requests and choices, provided they have been given optimal education and decision support. Processes to assure this accountability are detailed inChapter 4. A third critically deficient area in patient education and informed consent is documenting patient requests and decisions after optimal education. This documentation can be integrated into the educational process in a staged, repetitive manner that provides information, decision support, and line item documentation of patient choices to assure patient and surgeon accountability.⁷ All of the documents in this system are included in the Resources folder on the DVDs that accompany the book for surgeons to use or modify to suit individual practice preferences.

3. Optimize surgeon education and process implementation using proved educational models, modern technology, verifiability, and surgeon incentives

If optimizing patient outcomes and the patient experience is an objective, surgeons must access and implement proved processes that speed recovery, reduce complication and reoperation rates, and minimize negative effects of implants on patients’ tissues over time.

The track record of 15–20% reoperation rates and two decades of minimal change in the patient’s perioperative experience suggest a need for reexamination of surgeon education processes. Individual surgeon presenters, program chairs, and surgeon questionnaire suggestions currently determine content for most surgeon education venues, instead of defining content to include proved processes that have been shown to positively impact outcomes and reoperation rates in peer reviewed and published studies. Most current surgeon education programs prioritize individual surgeon techniques and preferences and encourage panel discussions or debates that are rarely based on verifiable data that validate proved processes. Professional organizations routinely rely on surgeon questionnaires from one educational venue to make decisions about content and format for subsequent venues, prompting the question of whether those who need to be educated are best qualified to determine content that might best change their two decade old track record.

Meaningful impact to improve outcomes for significant numbers of patients requires a comprehensive approach to surgeon education that integrates essential components of valid education models that have proved successful in industry and medicine. Three critical components are largely absent in current surgeon education and implementation of proved processes: (1) a defined curriculum derived from a knowledge base of reviewed and published processes that have been shown to impact outcomes, (2) verifiability of information exchange by proved testing methodologies (in venues or online), and (3) incentives (positive or negative) to encourage surgeons to implement proved processes (Table 2-3).

Table 2-3 Deficiencies in surgeon education and implementation of proved processes

The roles of professional organizations and implant manufacturers in surgeon education should be non-competitive and complementary, to most logically use resources for optimal effectiveness. While surgeon professional organizations state that they are most qualified to educate surgeons, critics may question their two decade old track record. Addressing the needs mentioned previously may improve that track record. Implant manufacturers have a fiduciary responsibility to their stockholders to promote their products; hence most of their surgeon education program content is product oriented and marketing directed.

Professional organizations and implant manufacturers might more effectively optimize patient outcomes by considering some or all of the following measures:

4. Prioritize and protect patients’ tissues long-term by choosing implant pocket location to assure optimal long-term tissue coverage of the implant and by avoiding implant sizes or projection that are likely to cause excessive stretching, tissue thinning, and parenchymal atrophy

These decision processes are detailed inChapter 9.

Breast implants can have adverse effects on patients’ tissues and increase risks of reoperations or uncorrectable deformities if surgeons and patients make suboptimal preoperative choices and decisions. Excessively large implants can cause excessive stretch or thinning of patient tissues that is irreversible. When combined with normal effects of aging, thinning of soft tissues can compromise skin quality and reduce the efficacy of lifting procedures or other revisional procedures. Excessively projecting implants, especially when used in patients with tight envelopes (anterior pull skin stretch less than 2.5 cm), can cause atrophy of breast parenchyma that is irreversible and that compromises implant coverage and patients’ ability to nurse. No surgical procedure can improve the quality of tissues that have been compromised by excessively large or excessively projecting breast implants.

To minimize risks of tissue compromise or uncorrectable loss of tissue coverage and uncorrectable deformities long-term, patients and surgeons must make optimal decisions preoperatively—carefully selecting breast implant size, dimensions, and projection to optimize long-term soft tissue coverage and minimize risks of excessive tissue stretch, thinning or atrophy. Making optimal decisions requires that surgeons objectively evaluate and consider individual patient tissue characteristics, avoiding arbitrary choices that attempt to drive tissues to a desired result.

Essential principles to protect patients’ tissues and minimize reoperations, negative tissue consequences, and uncorrectable deformities long-term include (Table 2-4):

Table 2-4 Essentials to protect patient tissues from irreversible compromises and uncorrectable deformities