21: Applying Proved Processes: Clinical Case Studies

Chapter 21 Applying Proved Processes: Clinical Case Studies



Introduction and Background


Patient outcomes and the patient experience ultimately determine the quality, efficacy, and safety of all surgical processes. Historically, most peer reviewed and published articles, book chapters and books on breast augmentation have focused on surgical techniques. Validation usually consists of a small number of short-term, selected case results photographs, with even further selected views of each patient. Surgeon education and professional presentations have allowed and promoted similar practices that encourage subjectivity and opinion over quantifiable data and scientifically valid conclusions. The result for patients has been an unenviable track record over the past three decades according to FDA premarket approval (PMA) data from independently supervised studies. Reoperation rates of 15–20% or more in just 3 years following augmentation remain unchanged over three decades according to data from the latest PMA studies,1 and a majority of breast augmentation patients continue to experience unnecessarily prolonged recovery times.


History indicates that improvement in patient recovery, the patient experience, reoperation rates, and long-term patient outcomes do not result from surgeons’ viewing and discussing case results photographs. As the case studies in this chapter demonstrate, visual assessment of images can be very misleading without accompanying objective clinical measurements. Photographs are not the best measure of quality of surgery that determines the patient experience and patient outcomes. The best quality photographs do not provide objective data that are critical to scientifically evaluate the processes that determine patient outcomes. Photographs invariably encourage surgeon subjectivity and opinion based premises in lieu of objective, science based conclusions. Surgeons cannot evaluate critical processes in surgeon education, informed consent, tissue assessment, implant selection, and decision processes from any photograph.


If photographs have any scientific validity, the photographs must be directly linked to objective data from prospectively designed studies in consecutive case series. Photographic views must be standardized and show at least five views of the patient. Ideally, the objective data and data collection from prospective, consecutive series studies should be supervised by an independent clinical review organization (CRO). If these criteria are satisfied, surgeons can begin to scientifically interpret photographic documentation of results instead of continuing to promote subjective opinions.


No professional journal or book has ever published a large number of cases from a consecutive series of breast augmentation photographic results from a study that was independently supervised and monitored by a CRO. More importantly, no publication has ever offered surgeons the opportunity to correlate photographic results with sequential, objective tissue measurements. In the December 2006 issue of Plastic and Reconstructive Surgery Journal, the author published a prospective, consecutive series of his first 50 cases from the FDA PMA study for the Allergan Style 410 anatomic, form stable, cohesive silicone gel implant.2 This study focused on the processes that enabled a zero percent reoperation rate at 3 years’ followup in the series.


The photographs of case results that follow in this chapter are cases from this unique series of 50 consecutive patients with up to 7 year followup. At each followup interval, measurements are listed that correlate with the critical tissue assessment measurements from the TEPID™,3 and High Five™,4 systems. Followup intervals vary by patient, and are listed with each series of images. Five views of each patient at each followup interval are presented to preclude any selection bias. Squeeze and supine views of patients were taken at 1 year followup.


Surgeons are familiar with various categories of breast types that are in common use, including, for example, “tight envelope”, “loose envelope”, glandular ptotic, pseudoptotic, constricted lower pole, and other categories. Each of these categories has been traditionally based on subjective or visual parameters instead of objective, quantifiable measurements. This series of cases, combined with future studies that collect objective tissue measurement data, provide surgeons with a unique opportunity to more accurately and scientifically categorize breast types and correlate process outcomes with quantifiable tissue characteristics.



Principles and Ground Rules Applied in Case Studies


Readers can use the case studies in this chapter in many different ways. The most superficial and least productive use of these case studies is a cursory pictorial review of results accompanied by a completely subjective assessment of the visual results. A more constructive, educational, and productive process is to study each case individually and in depth after reading Chapters 2–8 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8.


Every patient in these case studies was a participant in the Allergan FDA PMA study for the Allergan Style 410, textured, anatomic, form stable, cohesive silicone gel filled implant. Each patient received comprehensive information on all available implant types with accompanying manufacturer and scientific data about each type, following the patient educational processes detailed in our earlier publications.2–4


The following principles are applied to the cases presented in this chapter:


1. All patient case studies are from a 50 consecutive case series with a zero percent reoperation rate at 3 years’ followup in an FDA PMA study supervised by an independent CRO.

2. No patient in the case studies or in the series developed a Class 3 or 4 capsular contracture at 3 years’ followup.

3. No patient in the series had a failed implant device or any other device related sequelae that required reoperation.

4. All patients in the series completed all records for the PMA study during their period of followup, and completed additional breast measurements and patient satisfaction studies developed by the author.

5. All 50 patients resumed full normal activity within 24 hours postoperatively. More than 80% of patients were able to go out to dinner the evening of surgery.

6. Interval High Five™ measurements are located to the left of five view photographs at each indicated followup interval.

7. Visual impressions from preoperative and intraoperative photographs are subjective and relatively meaningless unless and until the visual observations are confirmed by and correlated with objective, quantifiable, clinical measurements.

8. As explained in detail in Chapter 7 and again in this chapter, no surgeon can ever make breasts exactly symmetrical. Attempting to place more volume in the smaller breast to make sizes similar is a common error. The smaller breast has a smaller skin envelope. When the smaller envelope is full, it is full, and attempting to put more volume in that breast must result in more bulging superiorly and/or laterally. This creates a shape difference in most patients that is much more apparent compared to a size difference that every woman already has and that the eye is accustomed to seeing. The author required more than 15 years to learn and follow this concept.

9. Prioritizing soft tissue coverage using the High Five™ System criteria for pocket location and the form stable Allergan Style 410 FM implant, no patient at any duration of followup up to 7 years developed any visible rippling or visible implant edges in any location.

10. Surgeons and patients categorically cannot accurately judge breast implant size in a patient from any photograph or combinations of photographs. Photographs, therefore, are not an accurate or valid tool for preoperatively choosing breast implant size, and should never be used for this purpose without the patient receiving the above information and signing appropriate informed consent documents and disclaimers.
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Related posts:

2: Ten Essentials 6: Implants and Implant–Soft Tissue Dynamics 17: Managing Problems and Patient and FDA Concerns 4: Anatomy for Augmentation: Cadaver and Surgical 8: Implant Pocket Locations 11: The Inframammary Approach for Augmentation

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Jul 23, 2016 | Posted by in Aesthetic plastic surgery | Comments Off on 21: Applying Proved Processes: Clinical Case Studies

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