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Biomedical subjects

John B Tebbetts

Publications and source records attributed to John B Tebbetts.

At least 19 recordsLinked to original sources

Dual plane breast augmentation: optimizing implant-soft-tissue relationships in a wide range of breast types.

In breast augmentation, surgeons usually choose a pocket location for the implant behind breast parenchyma (retromammary), partially behind the pectoralis major muscle (partial retropectoral), or totally behind pectoralis major and serratus (total submuscular). Each of these implant pocket locations has specific indications, but each also has a unique set of tradeoffs. When applied to a wide range of breast types, each pocket location has limitations. Glandular ptotic and constricted lower pole breasts offer unique challenges that often are not solved without tradeoffs when using a strictly retromammary, partial retropectoral, or total submuscular pocket. This article describes specific indications and techniques for a dual plane approach to breast augmentation in several different breast types, introducing techniques that combine retromammary and partial retropectoral pocket locations in a single patient to optimize the benefits of each pocket location while limiting the tradeoffs and risks of a single pocket location. A total of 468 patients had dual plane augmentation between January of 1992 and March of 1998 using the specific techniques of dual plane augmentation described in this article. All patients were treated as outpatients and received general anesthesia. Indications, operative techniques, results, and complications for this series of patients are presented. Dual plane augmentation mammaplasty adjusts implant and tissue relationships to ensure adequate soft-tissue coverage while optimizing implant-soft-tissue dynamics to offer increased benefits and fewer tradeoffs compared with a single pocket location in a wide range of breast types.

Journal Article↗

Achieving a predictable 24-hour return to normal activities after breast augmentation: part II. Patient preparation, refined surgical techniques, and instrumentation.

The goal of this study was to develop practices that would allow patients undergoing subpectoral augmentation to predictably return to full normal activities within 24 hours after the operation, free of postoperative adjuncts. Part I of this study used motion and time study principles to reduce operative times, medication dosages, perioperative morbidity, and recovery times in augmentation mammaplasty. Part II of the study focuses on details of patient education, preoperative planning, instrumentation, and surgical technique modifications that were identified, modified, and implemented to achieve the results reported in part I. Two groups of 16 patients each (groups 1 and 2) were studied retrospectively for comparison to a third group of 627 patients (group 3) studied prospectively. Patients in group 1 had axillary partial retropectoral breast augmentations in 1982-1983, using dissociative anesthesia, blunt instrument implant pocket dissection, and Dow Corning, double-lumen implants containing 20 mg of methylprednisolone and 20 cc of saline in the outer lumen of the implants. Patients in group 2 (1990) had inframammary, retromammary augmentations by using a combination of blunt and electrocautery dissection, Surgitek Replicon polyurethane-covered, silicone gel-filled implants, and general endotracheal anesthesia. Patients in group 3 (1998 to 2001, n = 627) had inframammary partial retropectoral, inframammary retromammary, and axillary partial retropectoral augmentations under general endotracheal anesthesia. Refined practices and surgical techniques from studies of groups 1 and 2 were applied in group 3. Videotapes from operative procedures of groups 1 and 2 were analyzed with macromotion and micromotion study principles, and tables of events were formulated for each move during the operation for all personnel in the operating room. Extensive details of surgical technique were examined and reexamined in 13 different stages by using principles of motion and time studies described in part I of this study to maximize efficiency without any change in quality. Unnecessary or unproductive motions and techniques were progressively eliminated, and essential, productive techniques were streamlined to eliminate wasted time and motion. Instrumentation and surgical techniques were evaluated in detail and modified to minimize bleeding and tissue trauma. Detailed data were presented in part I of this study that document shorter operative times, recovery times, time to discharge home, and time to return to normal activities. This part focuses on the patient education, preoperative planning, instrumentation, and surgical technique changes that were implemented on the basis of the findings in part I of the study. More extensive patient information integrated with staged informed consent resulted in a more in formed and confident patient. Applying motion and time study principles to analysis and refinement of instrumentation and surgical techniques resulted in a substantial reduction in perioperative morbidity and a simpler, shorter 24-hour return to full normal activity for 96 percent of the patients undergoing breast augmentation in group 3 compared with groups 1 and 2. More than 96 percent of patients in group 3 were able to return to normal activities, lift their arms above their heads, lift normal-weight objects, and drive their car within 24 hours after their partial retropectoral breast augmentation. Patient education, preoperative planning, instrumentation, and surgical technique modifications based on motion and time study video analyses reduced surgical trauma and bleeding, reduced perioperative morbidity, and allowed 96 percent of 627 breast augmentation patients in group 3 a predictable return to full, normal activity in 24 hours or less. Specific surgical factors that contributed to these results included (1) prospective hemostasis techniques with a zero tolerance for even the smallest amount of bleeding, (2) strict "no-touch" techniques for periosteum and perichondrium, (3) eliminating all blunt dissection, (4) performing all dissection under direct vision, (5) modified and simplified instrumentation, and (6) optimal use of muscle relaxants during subpectoral dissection.

Journal Article↗

Five critical decisions in breast augmentation using five measurements in 5 minutes: the high five decision support process.

BACKGROUND: Surgeons' decisions impact patient outcomes and implant effects on tissues over time. Tissue assessment systems that provide quantitative, objective data enable objective rather than subjective decisions. First-generation dimensional systems for breast augmentation defined a desired result dimensionally and recommended an implant to force tissues to the desired result. A second-generation system, the TEPID system, defines measurements to match the implant to the patient's tissue characteristics, instead of forcing tissues to a desired result. This study defines a third-generation decision support process that prioritizes five critical decisions, identifies five key measurements, and completes all preoperative assessment and operative planning decisions in breast augmentation in 5 minutes or less. METHODS: Key decision parameters and data from more than 2300 primary augmentations planned using the TEPID system were analyzed to define the five most critical decisions that affect reoperation rates and risks of uncorrectable deformities and to define a decision support process using five critical measurements. RESULTS: In 1664 cases with up to 7 years of follow-up, the overall reoperation rate was 3 percent, and the reoperation rate for implant size exchange was 0.2 percent. The junior author's (Adams) clinical experience includes more than 300 augmentations with up to 6 years of follow-up using this system, with an overall reoperation rate of 2.8 percent. CONCLUSION: The High Five decision support process prioritizes five critical decisions in breast augmentation and enables surgeons to address all preoperative assessment and operative planning decisions in breast augmentation in 5 minutes or less.

Journal Article↗

Achieving a zero percent reoperation rate at 3 years in a 50-consecutive-case augmentation mammaplasty premarket approval study.

BACKGROUND: Excessively high reoperation rates in breast augmentation premarket approval studies are a major concern of patients and the U.S. Food and Drug Administration. Over the past two decades, reoperation rates have remained between 13 and 20 percent at 3 years in three different premarket approval studies for three different types of implant devices, indicating that high reoperation rates are not device dependent. The hypothesis of this study was that implementing specific peer-reviewed and published processes can significantly reduce reoperation rates in a premarket approval study. METHODS: Fifty consecutive primary breast augmentation patients were enrolled in a premarket approval study for the Inamed Style 410 form stable, cohesive gel implant. All patients were treated specifically according to the premarket approval protocol. The series was monitored throughout the study by an independent clinical review organization and by a U.S. Food and Drug Administration inspection of the patient records on site at the author's practice. Specific content and processes were applied to patient management in patient education and informed consent, patient and surgeon decision-making processes, preoperative assessment and operative planning, implant selection based on individual patient tissue characteristics, surgical techniques, and postoperative care techniques. RESULTS: Follow-up was 100 percent (50 of 50 patients) at 1 year, 98 percent (49 of 50 patients) at 2 years (one patient could not be reached), and 94 percent (47 of 50 patients) at 3 years. No reoperations were performed on any patient followed at 3 years in the 50-consecutive-patient series. CONCLUSION: Implementing the peer-reviewed and published processes described in this study, no reoperations were performed in a prospective 50-consecutive-case series of primary augmentation mammaplasty patients in a premarket approval study with 94 percent follow-up at 3 years.

Adult↗

Axillary endoscopic breast augmentation: processes derived from a 28-year experience to optimize outcomes.

BACKGROUND: The axillary approach for breast augmentation has been an option for patients and surgeons for three decades. This article reports a 28-year experience with axillary subpectoral and submammary breast augmentation, and defines proved processes and surgical techniques that have evolved during that experience. METHODS: From 1977 to 2005, 690 patients aged 19 to 64 years (median age, 31 years) chose the axillary augmentation approach for breast augmentation. Eighty-four patients had implants placed in the retromammary pocket location, 294 patients had partial retropectoral placement, and 312 patients had dual plane placement. Preoperative planning and implant selection after 1993 utilized dimensional and tissue-based processes published in this Journal. RESULTS: Using optimal published processes and instrumentation via the axillary approach, surgeons can deliver equally aesthetic results with equal recovery, reoperation rates, and complications compared with every other incision approach. Refinements in surgical techniques and instrumentation enable patients to predictably experience 24-hour return to normal activities after axillary subpectoral or submammary augmentation. CONCLUSIONS: The axillary incision approach for retromammary, partial retropectoral, and dual plane augmentation is an option for patients and surgeons who wish to locate the incision off the breast. Optimal outcomes and 24-hour recovery require a specific surgeon skill set, dimension and tissue-based preoperative planning, and implant selection, defining the desired level of the inframammary fold using proved processes and optimal instrumentation and minimizing tissue trauma and bleeding by implementing proved processes described in this article.

Adult↗

Five critical decisions in breast augmentation using five measurements in 5 minutes: the high five decision support process.

BACKGROUND: Surgeons' decisions impact patient outcomes and implant effects on tissues over time. Tissue assessment systems that provide quantitative, objective data enable objective rather than subjective decisions. First-generation dimensional systems for breast augmentation defined a desired result dimensionally and recommended an implant to force tissues to the desired result. A second-generation system, the TEPID system, defines measurements to match the implant to the patient's tissue characteristics, instead of forcing tissues to a desired result. This study defines a third-generation decision support process that prioritizes five critical decisions, identifies five key measurements, and completes all preoperative assessment and operative planning decisions in breast augmentation in 5 minutes or less. METHODS: Key decision parameters and data from more than 2300 primary augmentations planned using the TEPID system were analyzed to define the five most critical decisions that affect reoperation rates and risks of uncorrectable deformities and to define a decision support process using five critical measurements. RESULTS: In 1664 cases with up to 7 years of follow-up, the overall reoperation rate was 3 percent, and the reoperation rate for implant size exchange was 0.2 percent. The junior author's (Adams) clinical experience includes more than 300 augmentations with up to 6 years of follow-up using this system, with an overall reoperation rate of 2.8 percent. CONCLUSION: The High Five decision support process prioritizes five critical decisions in breast augmentation and enables surgeons to address all preoperative assessment and operative planning decisions in breast augmentation in 5 minutes or less.

Decision Making↗

Decision and management algorithms to address patient and food and drug administration concerns regarding breast augmentation and implants.

During the U.S. Food and Drug Administration's advisory panel hearings to evaluate the premarket approval for conventional silicone gel implants on October 14 and 15, 2003, panel members and patient advocate representatives focused on four specific areas of concern: reoperation rates in primary breast augmentation; levels, depth, and methods of patient education and informed consent; modes, frequency, and management of silicone gel implant device failures, including management of "silent" ruptures; and methods of monitoring and managing symptoms or symptom complexes that may or may not be associated with connective tissue disease or other undefined symptom complexes. These concerns, with a reported 20 percent reoperation rate for primary augmentation within just 3 years, and a lack of concise, definitive management protocols addressing these areas of concern may have contributed to the Food and Drug Administration's rejection of the premarket approval, despite the panel's recommendation for approval. This article presents decision and management algorithms that have been used successfully for 7 years in a busy breast augmentation practice (Tebbetts and Tebbetts). The algorithms have been further expanded and refined by a group of surgeons with diverse experiences and expertise to address the following clinical situations that coincide with concerns expressed by patients and the Food and Drug Administration: implant size exchange, grade III to IV capsular contracture, infection, stretch deformities (implant bottoming or displacement), silent rupture of gel implants, and undefined symptom complexes (connective tissue disease or other). In one practice (Tebbetts and Tebbetts) that uses the TEPID system (tissue characteristics of the envelope, parenchyma, and implant and the dimensions and fill distribution dynamics of the implant), implant selection is based on quantified patient tissue characteristics, pocket selection is based on quantified soft-tissue coverage, and anatomic saline implants have fill volumes that are designed to minimize shell collapse and fold fatigue; in this practice, the algorithms contributed to a 3 percent overall reoperation rate in 1662 reported cases with up to 7 years of follow-up, compared with a 20 percent reoperation rate at 3 years in the 2003 premarket approval study.

Algorithms↗

"Out points" criteria for breast implant removal without replacement and criteria to minimize reoperations following breast augmentation.

Breast augmentation is a totally elective, medically unnecessary procedure, and surgeons and patients must prioritize minimizing tradeoffs, costs, and risks at the primary operation and at reoperations. At the U.S. Food and Drug Administration's advisory panel hearings in October of 2003 to consider approval of conventional silicone gel implants, data documented an overall reoperation rate of 20 percent at just 3 years after primary breast augmentation. Subsequently, the premarket approval was not granted. Similarly high reoperation rates have been reported in previous saline and silicone gel premarket approval studies over the past two decades, demonstrating that high reoperation rates are not device dependent and suggesting a need to reexamine surgical management criteria. Bilateral implant removal without replacement limits additional reoperations in a wide range of clinical situations. Surgeons and patients often prefer other options to avoid removal without replacement, but other options carry a higher tradeoffs, costs, and risks to the patient. If minimizing tradeoffs, costs, and risks of reoperations is a priority, surgeons must define and patients must understand and accept "out points," that is, specific criteria for bilateral implant removal without replacement. Defining out points is challenging. Enforcing them when difficult clinical situations occur is even more challenging. This article presents out points that have been incorporated into staged, repetitive informed consent documents and used in the author's practice for more than 10 years. In peer-reviewed and published reports of more than 1600 patients, these out points criteria, in conjunction with the TEPID system (tissue characteristics of the envelope, parenchyma, and implant and the dimensions and fill distribution dynamics of the implant) of implant and pocket selection based on individual patient quantifiable tissue criteria and surgical techniques that minimize tissue trauma and bleeding, resulted in an overall reoperation rate of 3 percent in 1662 reported cases with up to 7 years of follow-up, compared with the 20 percent reoperation rate at 3 years in the most recent Food and Drug Administration study.

Breast Implants↗

An approach that integrates patient education and informed consent in breast augmentation.

Informed consent requires surgeons to provide information about all available alternatives and their associated risks and tradeoffs to every prospective breast augmentation patient. The informed patient and surgeon then make decisions based on the information the patient has received, clinical parameters that may affect those decisions, and the patient's willingness to accept specific risks and tradeoffs. During the authors' 22 years of clinical practice, substantial changes have occurred in the requirements for adequate informed consent and the methods of ensuring that patients receive it. The numbers of alternatives for augmentation and the relative benefits and risks of each method have changed substantially over the past two decades. Four specific areas of postoperative issues stimulated major changes in the authors' approach to patient education and informed consent: 1) questions or dissatisfaction with implant size postoperatively, 2) questions about financial responsibility for costs associated with untoward events requiring reoperation postoperatively including capsular contracture or other problems, 3) spouses or other concerned parties rendering opinions postoperatively when they had not been involved in the informed consent process, and 4) criteria for whether reoperations were indicated, how many were indicated, and when implant removal without replacement might be most logical. This paper describes an approach that integrates patient education and informed consent in stages by 1) providing detailed, highly specific written and verbal information, 2) utilizing a staged approach to education and informed consent that provides information and requires simultaneous, informed consent in stages, 3) repeating each critical topic at least two or three times during the process, requiring repetitive written documentation by the patient on at least three different occasions, 4) emphasizing patient accountability for choices selected, and 5) organizing the education and informed consent process so that it is clinically practical and also increases thoroughness and documentation while conserving surgeon time. This staged, integrated system of patient education and informed consent uses a comprehensive set of informed consent documents that are available for downloading from the Plastic and Reconstructive Surgery Web site (www.plasreconsurg.org). Before incorporating any of the informed consent documents or statements reported in this paper, each surgeon should seek review by the surgeon's malpractice insurance carrier and by appropriate legal counsel to ensure compliance with state and federal laws applicable to the surgeon's practice. These documents have evolved to prospectively address patient management issues that have occurred over the authors' 22-year experience in augmentation. The documents are not endorsed by ASPS and do not necessarily represent the views of ASPS.

Breast Implantation↗

A system for breast implant selection based on patient tissue characteristics and implant-soft tissue dynamics.

Primary breast augmentation patients have widely varying characteristics of their breast envelope, parenchyma, and adjacent tissues. When preoperative breast implant selection does not specifically address critical soft-tissue parameters individual to each patient, risks of complications increase. Complications that occur from failure to reconcile a patient's wishes for breast size with her individual tissue characteristics include skin stretch and thinning, ptosis, atrophy of parenchyma, implant edge or shell visibility, implant edge or shell palpability, visible traction rippling, "bottoming" deformities, and lateral implant displacement with widening of the intermammary distance. Previous dimensional systems address implant parenchyma base width relative to implant base width, but no published system adequately addresses or attempts to quantitate the third dimension, tissue stretch, that is critical to estimate amount of fill necessary in a wide range of breast and tissue types. This system addresses the tissue characteristics (T) of the envelope (E), the parenchyma (P), and the implant (I), and the dynamics (D) of implant and filler distribution that affect soft tissues. The acronym TEPID summarizes the key factors that determine aesthetic results and occurrence of problems and reoperations following breast augmentation. This simple, efficient, and clinically practical system focuses on only three tissue measurements to estimate implant volume required to fill each patient's existing breast envelope, on the basis of her individual tissue characteristics: base width of the parenchyma, anterior pull skin stretch, and areola- and/or nipple-to-inframammary-fold distance measured under maximal stretch. The surgeon then adjusts initial volume to address differences in degree of skin stretch (anterior pull skin stretch) and contribution of the patient's existing parenchyma to stretched envelope fill, and to address differences in implant dimensions and filler distribution dynamics. To base decisions of implant pocket location on quantifiable soft-tissue coverage thickness, the system measures soft-tissue pinch thickness of the upper pole and at the inframammary fold. Surgeon time required to measure, estimate, and make preoperative implant selection decisions is less than 5 minutes. This system evolved from compiling and reviewing measurements and results from 330 primary breast augmentations from 1996 to 1999, including round and anatomic implant types with smooth shells and two different textured shells. The TEPID system was then used concurrently with the previous dimensional system for patient tissue evaluation and preoperative implant selection in 627 consecutive primary augmentation cases over a 3-year period from January of 1998 to January of 2001. Implant selection that did not comply with the parameters of the system was necessary in only eight cases. The TEPID system is a simple, efficient, and clinically practical method that allows surgeons to base implant selection on clinically quantifiable, individual patient tissue characteristics.

Adult↗