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Summary Background Indocyanine green angiography (ICGA) reduces ischemic complications by assessing mastectomy flap perfusion intraoperatively. However, outcomes of ICGA can be surgeon-dependent due to its relative novelty. We aimed to determine whether patient outcomes improved with the adoption of ICGA over time. Methods We conducted a single-institution retrospective study of mastectomy patients between March 2012 (date of ICGA introduction) and October 2016. We included patients who underwent immediate expander-based reconstruction with intraoperative ICGA, followed by second-stage permanent implant placement. Patients were chronologically sorted into 3 groups, of 45 patients each, based on the date of ICGA. Complications and reconstruction wait times (time between initial expander placement and subsequent final reconstruction) amongst the 3 groups were evaluated. Using the Cochran–Armitage test for trend, we tested the change in median adjusted expander fill volumes (expander fill volume in milliliter per gram of breast removed) over time. Results We identified 135 patients. Rates of ischemic complications significantly decreased (Group 1, 36%; Group 2, 22%; Group 3, 11%; p = 0.03), despite significantly increasing median adjusted expander fill volumes (Group 1, 0.46 mL/g; Group 2, 0.63 mL/g; Group 3, 0.76 mL/g; p = 0.003) over time. The rates of unexpected returns to the operating room across the 3 groups were not significantly different. The median reconstruction wait time was significantly reduced in the later groups (Group 1, 146 days; Group 2, 122 days; Group 3, 87 days; p = 0.01). Conclusions Outcomes for mastectomy with immediate expander-based reconstruction were found to improve with increasing case volume after implementation of ICGA.

This chapter details breast reconstruction following breast surgery. Over the past decade the number of women choosing reconstruction with tissue expanders and implants has steadily increased, while the percentage of women having autologous reconstruction has plateaued or fallen off. The authors explain the use of tissue expanders and implants and detail the advancements made in the ability to evaluate tissue in real-time intervals. Additional advances in technique, implant design, acellular dermal matrix, and fat grafting have improved the aesthetic results of breast reconstruction even further, and these techniques are discussed in detail. The authors address patient-specific indications and contraindications, the use of acellular dermal matrix, the assessment of the defect and perfusion, patient markings, room setup, and operative technique.

Background Fat grafting is a common procedure in plastic surgery. A major limitation is unpredictable graft retention, in part caused by inadequate oxygen delivery during the early posttransfer period. Methods The authors present a bioengineered approach to the design of a fat graft based on mathematical theory, which can estimate the limitations of oxygen delivery. To simplify the problem, four variables were defined: (1) recipient-site oxygen partial pressure; (2) adipose tissue oxygen permeability; (3) adipose tissue oxygen consumption rate; and (4) fat graft size. Recipient-site oxygen partial pressure and adipose tissue oxygen permeability were estimated from literature, whereas adipose tissue oxygen consumption rate was measured using stirred microchamber technology. Calculations were performed in both spherical and planar geometry to calculate the maximum allowable fat graft size from an oxygen delivery standpoint. Results As expected, planar geometry is less favorable for oxygenation but represents a realistic configuration for a fat graft. Maximum allowable fat graft thickness is only approximately 1 to 2 mm at external oxygen partial pressures of 10 to 40 mm Hg; any thicker and an anoxic or necrotic core likely develops. Given a reasonably large surface area and assuming several planes of injection, the maximum allowable fat graft volume is tens of milliliters. Conclusions A systematic bioengineered approach may help better design a fat graft. Applying principles of mass transfer theory can predict whether a fat graft has a favorable chance of surviving from an oxygen delivery standpoint and can direct the development of strategies for improved fat graft oxygenation.

Background Fat grafting is a common procedure in plastic surgery but associated with unpredictable graft retention. Adipose tissue (AT) "product" quality is affected by the methods used for harvest, processing and transfer, which vary widely amongst surgeons. Currently, there is no method available to accurately assess the quality of AT. Objectives In this study, we present a novel method for the assessment of AT product quality through direct measurements of oxygen consumption rate (OCR). OCR has exhibited potential in predicting outcomes following pancreatic islet transplant. Our study aim was to reapportion existing technology for its use with AT preparations and to confirm that these measurements are feasible. Methods OCR was successfully measured for en bloc and postprocessed AT using a stirred microchamber system. OCR was then normalized to DNA content (OCR/DNA), which represents the AT product quality. Results Mean (±SE) OCR/DNA values for fresh en bloc and post-processed AT were 149.8 (± 9.1) and 61.1 (± 6.1) nmol/min/mg DNA, respectively. These preliminary data suggest that: (1) OCR and OCR/DNA measurements of AT harvested using conventional protocol are feasible; and (2) standard AT processing results in a decrease in overall AT product quality. Conclusions OCR measurements of AT using existing technology can be done and enables accurate, real-time, quantitative assessment of the quality of AT product prior to transfer. The availability and further validation of this type of assay could enable optimization of fat grafting protocol by providing a tool for the more detailed study of procedural variables that affect AT product quality.

The global breast implant business was invented and configured by American plastic surgeons. In 2012, the first shaped silicone implants were approved in the United States by the Food and Drug Administration. It is the peculiar historical course of implant usage in America that has deprived US plastic surgeons of the opportunity to become experts in the use of this device. Most studies indicate significant safety benefits to using shaped devices, despite the technical challenges involved in their use. Upon approval, adoption of the devices has been slow in the United States, running the risk that American plastic surgery may lose the intellectual and clinical practice hegemony it has enjoyed for over 50 years in this area of the specialty. To continue to maintain leadership in the field of breast surgery, US surgeons should evaluate this new modality and either join the global trend or present data to contradict it.

Mastectomy flap necrosis is a major complication in patients undergoing tissue expander-based reconstruction. This study compared the complication rates following mastectomy and immediate reconstruction with intraoperative indocyanine green (ICG) angiography evaluation to those with clinical assessment only. We performed a single-institution retrospective study of mastectomy patients who underwent immediate tissue expander-based reconstruction between September 2009 and December 2013. ICG angiography was adopted in March 2012. The rates of complications in the ICG and clinical assessment only groups were compared. Factors associated with complications were identified with the Fischer exact test and univariate analysis. A total of 114 patients were identified; clinical assessment only, 53 patients; ICG angiography, 61 patients. The overall complication rates were not significantly different between the two groups (ICG angiography, 50.8 %; clinical assessment, 43.4 %; p = 0.46). There was no significant difference in the rates of unexpected return to the operating room, cellulitis, hematomas, and seromas. The overall rates of flap necrosis were not significantly different (ICG angiography, 27.9 %; clinical assessment, 18.9 %; p = 0.28). However, the rates of severe flap necrosis were significantly lower with intraoperative ICG angiography (4.9 %) than with clinical assessment only (18.9 %, p = 0.02). On univariate analysis, breast weight (≥500 g) was significantly associated with increased rates of severe flap necrosis (p = 0.04), whereas body mass index, age, smoking status, prior breast surgery, history of radiation therapy, and receipt of nipple-sparing mastectomy were not. We observed that the implementation of intraoperative ICG angiography was associated with a significant decrease in the rate of severe flap necrosis.

Background: On April 7, 2009, the International Committee for Quality Assurance, Medical Technologies and Devices in Plastic Surgery (IQUAM) issued its 8th Position Statement. IQUAM is a professional medical and scientific organization committed to the surveillance of existing and new technologies and devices in plastic surgery. IQUAM periodically reviews and evaluates updated international literature and studies and scientific data, and recommends standards of treatment for plastic surgery devices and technologies. IQUAM proscribes potentially deleterious use of products, devices, and technologies, or their unintended application or application for unsuitable indications. Methods: Presentations of an international panel of experts made during the Transatlantic Innovations Symposia in Paris, in April of 2009, were reviewed by an advisory board that prepared the position statement for distribution to plastic surgeons and regulatory bodies. The advisory panel was international in nature and included plastic surgeons with expertise in the specific areas evaluated. Results: Three clinical areas of greatest concern to plastic surgeons were evaluated for efficacy and safety: silicone breast implants, tissue engineering, and injectable therapies. Conclusion: Specific recommendations designed to increase clinical safety and patient education for informed consent were made in each area.

Background: in April of this past year, Transatlantic Innovations brought a variety of organizations and industry together for an international exchange of ideas, new technology, and current trends in plastic surgery. Methods: The meeting was highly interactive and included audience response devices. The focus was on 10 major areas: (1) new surgical techniques; (2) composite allografts versus conventional techniques, facing the future; (3) interspecialty collaboration versus competition; (4) the business of plastic surgery, best practices; (5) the image of the plastic surgeon, branding yourself; (6) medical tourism; (7) publicity; (8) the regulation of innovation, U.S. Food and Drug Administration and European Medicines Agency perspective; (9) the future of plastic surgery, cutting edge technologies; and (10) applications and controversies in fat grafting. The meeting concluded with the 8th International Committee for Quality Assurance, Medical Technologies and Devices in Plastic Surgery Consensus Conference with the development of a consensus statement. Results: Through an interactive audience response system, additional questions and attitudes were asked of the audience and, in real time, international differences were identified, which led to further discussions from panelists. Responses were identified in three major groups: European Union, North America, and the Rest of the World. Responses and data are included in this article. Conclusions: The meeting brought participants, industry, regulators, and educators from both sides of the Atlantic. The interaction of these groups in these outlined topics brought a unique perspective to the meeting and, in the end, volumes of data. We have more in common than we believe. It is our anticipation that as we as plastic surgeons move forward, we can use these interactions to help our own practices but more specifically the specialty as a whole. (Plast. Reconstr. Surg. 126: 316, 2010.)

Background : Reliable and valid assessment instruments in aesthetic surgery are a vital factor in assessing patient satisfaction with physical appearance. Appearance and satisfaction assessments are needed to adequately evaluate quality of life related to changes in the female breast across a variety of surgical interventions. The Breast Evaluation Questionnaire was designed to assess satisfaction with breast attributes. Methods : The Breast Evaluation Questionnaire is a 55-item assessment that was validated on 1244 women seeking augmentation mammaplasty. Results : Subscales of the Breast Evaluation Questionnaire include comfort not fully dressed, comfort fully dressed, and satisfaction with breast attributes. The questionnaire has been demonstrated to be valid and reliable for assessing these factors. Conclusions : The assessment is easy to administer and interpret and is recommended for assessing outcomes among breast augmentation patients, breast reconstruction patients, mastectomy patients, lumpectomy/breast-sparing surgery patients, breast reduction patients, and patients who have sustained trauma or injury to their breasts.

Analysis of complication data derived from the Breast Reduction Assessment: Value and Outcomes (BRAVO) study, a 9-month prospective, multicenter trial, is presented.Data derived from 179 patients were analyzed, including bivariate associations between complications and single predictor variables (Fisher's exact test or chi-square testing) or continuous variables (two-sample t test) and, finally, logistic regression.The overall complication rate was 43 percent (77 patients). Simple, bivariate analysis linked preoperative breast volume, shoulder strap grooving, and a vertical incision with an increased incidence of complications (p0.05, 0.02, and 0.02, respectively). Delayed wound healing, the most common complication, correlated directly with average preoperative breast volume (p0.045), average resection weight/breast (p0.027), and smoking (p0.029) and inversely with age (p0.011). Vertical incision techniques were associated with an increased complication frequency (p0.05) without a link to specific complications. Logistic regression analysis associated resection weight as the sole variable for increased risk of complications (p = 0.05) and with absolute number of complications [mean resection weight of 791 g for patients without complications versus 847, 882, and 1752 g for patients with one, two, and three complications, respectively (p = 0.0022)]. Each 10-fold increase in resection weight increased the risk of complication 4.8 times and increased the risk of delayed healing 11.6 times.Complication data revealed several significant features: (1) resection weight correlated with increased risk and absolute number of complications; (2) delayed healing correlated directly with resection weight and inversely with increasing age, anesthesia times, and preoperative Short Form-36 bodily pain score; (3) a vertical incision may be associated with increased incidence of complications but requires further analysis; and most importantly, (4) the presence of complications had no negative effect on improvement in Short Form-36 and Multidimensional Body-Self Relations Questionnaire scores.

Outcomes following autologous fat grafting continue to be unpredictable. The lack of a standardized protocol for fat harvest, processing, and transplant produces variable graft retention rates. Plastic surgeons historically have relied on trial and error to modify their techniques.1 To optimize fat grafting protocols, systematic evaluation of each procedural step for its specific impact on adipose tissue (AT) viability is critically needed. Many assays have been developed to measure AT viability, but most measurements are neither accurate nor quantitative, are operator dependent, and have not helped correlate fat grafting protocols (or changes to protocols) with outcomes.1 AT viability has been estimated through visual assessment, membrane integrity staining, conventional histology, or special staining for apoptosis or mitochondrial function; all these techniques are largely semiquantitative, because the outcome still depends on the individual operator's evaluation of results. The …

The alar scroll (the interval structure between the upper and lower lateral cartilages) has been an overlooked important component of nasal anatomy and rhinoplasty. The functional roll and consequences of destroying the integrity of the scroll are discussed. Among other features, the scroll provides rigidity to the area of the internal nasal valve. It also provides tip support. The need to avoid excessive disruption of the scroll is discussed. Preservation of the scroll is suggested when possible. Surgical approaches to the alar scroll and reestablishment of scroll functions are reviewed. The use of buttress grafts proves particularly helpful. These techniques are described for both the open and closed approach.

Our center undertook an industry-funded, outcomes-based, multicenter, retrospective review to evaluate the safety and efficacy of saline-filled breast implants. Our review was part of a pre-market approval review process mandated by the U.S. Food and Drug Administration. The design of our review was modeled on a Plastic Surgery Educational Foundation outcomes study previously conducted by our center. For this study, several significant changes were made to our previous protocol, including improved patient tracking, stronger biostatistical support, and a mandatory 10-year minimum patient follow-up period. Physician-reported and patient-reported data on 450 patients with 882 saline-filled breast implants placed between January 1, 1980, and June 30, 1986, were obtained. Mean patient follow-up period was 13.0 years. Most implants (93.9 percent) were placed for breast augmentation. Seventy-four percent were placed in a submammary position; 25.6 percent, subpectorally; and 0.2 percent, subcutaneously. The overall complication rate was 20.2 percent. Reoperation for capsular contracture or implant deflation was necessary in 104 of 450 patients (23.1 percent). Deflation occurred in 73 implants (8.3 percent) and was underreported according to the physicians' record review alone. This deflation rate is higher than the 5.5 percent previously reported by our center. However, 26 of these 73 deflations (35.6 percent) occurred in a single cohort of patients at one center using Surgitek saline implants. If this cohort is excluded, the deflation rate drops to 5.8 percent, a figure more consistent with data published in the literature and found in our previous study. Of the 73 deflations, spontaneous deflation was reported for 50 (74.6 percent), and the remainder were iatrogenic. Actuarial survival of the non-Surgitek implants was 98.4 percent to 99.8 percent at 5 years and 96.9 percent to 98.9 percent at 10 years (95 percent confidence interval). Risk factors for implant deflation included the use of Surgitek saline-filled implants (odds ratio = 17.5, p < 0.01), use of Heyer-Schulte and Mentor model 1800 implants (odds ratio = 3.0, p < 0.01), and implant size greater than 450 cc (odds ratio = 1.01, p < 0.02). Risk factors for capsular contracture included submammary implant position (odds ratio = 2.05, p = 0.03) and implant size greater than 450 cc (odds ratio = 1.01, p < 0.01). Overall, satisfaction was high: 93 percent of patients were "satisfied" or "very satisfied" with their implants. As in our earlier study, risk factors for patient dissatisfaction were reconstruction after mastectomy (odds ratio = 7.6, p = 0.011), significant breast firmness (odds ratio = 6.2, p < 0.001), and patient desire for smaller implants (odds ratio = 3.0, p = 0.020). In conclusion, our review provides additional outcomes-based evidence that saline-filled breast implants remain a safe, effective alternative to silicone gel-filled models.

Secondary rhinoplasty can be avoided by careful analysis of the preoperative anatomy, the patient's goals, and meticulous execution of the rhinoplasty. In addition, knowledge of the problems that more commonly cause revision will allow the surgeon to avoid these pitfalls. In this article, we concentrate on the most likely causes of a secondary rhinoplasty in the dorsum, lobule, and airway and how to avoid them.

Determining the preoperative functional and aesthetic anatomy has been of critical importance to surgeons planning nasal procedures. Beyond skilled clinical examination, few objective studies exist to aid the surgeon. Magnetic resonance imaging (MRI) represents a potentially excellent method for precise anatomic imaging of the nose. Unlike computed tomography (CT) and conventional x-rays, MRI involves no radiation. Similar to CT, however, MRI can provide computer-enhanced three-dimensional and quantitative airway data. Full-head MRI has proven sensitivity in evaluation of tumors of the brain and sinuses and is the imaging modality of choice for many soft-tissue tumors. Due to the relatively high cost of conventional full-head MRI scanning ($600 to $1200 per scan), MRI of the nose utilizing full head scanning technique has been limited. The recent development of small field of view surface coils has enabled higher-resolution nasal scans at a fraction of the scanner time and cost ($200 to $500) of conventional MRI scans. We have developed a protocol utilizing a small field of view coil which results in reproducible high-resolution nasal scans requiring less than 6 minutes of scanner time. This protocol has been used in both the diagnosis and follow-up of patients with traumatic and congenital nasal and septal deformities. Image resolution obtained using the protocol is significantly better than with conventional coils. This technique is excellent for both diagnosing and documenting nasal anatomy and pathology.

A 33-year-old man suffered from locally recurrent malignant fibrous histiocytoma of his left thigh unresponsive to previous excision, radiation therapy, chemotherapy, and hyperthermic treatment. He underwent radical hemipelvectomy for cure. Because of extensive tumor involvement, a free flap consisting of his distal left leg based on the popliteal artery was utilized to close the defect. Both the tibia and fibula were removed from their periosteal sheaths, and the foot was excised from the flap. The popliteal artery and vein were anastomosed to the iliac vessels. The flap survived, and the patient was discharged home after physical rehabilitation. We suggest that uninvolved portions of the distal leg may be utilized as a free flap to successfully close hemipelvectomy defects in selected patients when conventional pedicle flaps are unavailable.

A prospective longitudinal study of chest-wall deformity after tissue expansion for breast reconstruction was performed in 19 women. CT imaging was a sensitive method for detecting occult deformity. Using a semiquantitative scale for measuring deformity, all patients and 94 percent of expanders had some thoracic abnormality after tissue expansion. Rib and chest-wall contour changes were observed under 81 and 68 percent of the expanders, respectively. Routine chest roentgenograms were not a sensitive method for evaluating these deformities. The magnitude of deformity after unilateral expansion was not significantly different from that after bilateral expansion. Linear regression analysis indicated that early periprosthetic capsular contracture was negatively correlated with chest wall deformity. Only one patient experienced a clinically noticeable complication from chest compression--transient postexpansion exertional dyspnea. After removing the expanders and placing permanent implants along with capsulotomy, the mean deformity index decreased by 57 percent after 10.5 months median follow-up, which was highly significant (p less than 0.001). Our findings suggest that chest-wall deformity is a common occurrence after tissue expansion in patients undergoing breast reconstruction and is usually of minor clinical significance.

When soft tissue losses in the hand require flap reconstruction, local tissue is preferred. Distant flaps should be reserved for major or unusually complex tissue losses which preclude the use of local flaps. We have used the rectus abdominis muscle as either a pedicled or a free flap with an overlying split thickness skin graft for several such complex soft tissue problems. Functional and cosmetic results have been excellent with minimal donor site morbidity. While not the initial choice for distant tissue used in hand reconstruction, the rectus abdominis muscle can solve several complex soft tissue problems in the hand.

In 2005, convincing safety and efficacy data were presented, resulting in the approval of Mentor MemoryGel Implants, with conditions.The 1007 women enrolled in the 10-year, multicenter, Mentor Core MemoryGel Study were distributed into four cohorts: 551 primary augmentation patients, 146 revision-augmentation patients, 251 primary reconstruction patients, and 59 revision-reconstruction patients. Preoperatively and postoperatively, study instruments and physical examinations were administered to assess medical history, patient satisfaction, quality of life and body image, connective tissue disease diagnosis, rheumatology symptoms, and chest size change to determine the efficacy of surgery.Safety assessments included complication rates and rates of reoperation. Results at 3 years were reported at the U.S. Food and Drug Administration panel. Results indicate that the risk of any complication (including reoperation) at some point through 3 years after implant surgery is 36.6 percent for primary patients, 50.1 percent for revision-augmentation patients, 49.4 percent for primary reconstruction patients, and 47.5 percent for revision-reconstruction patients. Suspected rupture rates reported from the magnetic resonance imaging cohort were 0.5 percent for primary augmentation, 7.7 percent for revision-augmentation, 0.9 percent for primary reconstruction, and 0 percent for revision-reconstruction. Only two implants, in a single patient, were found surgically to be ruptured. There were 4.7 percent primary and 12.3 percent revision-augmentation patients who had their implants removed, with patient choice and severe capsular contracture being the most common reasons.The data demonstrated safety and efficacy of the devices, but also indicate that a focus must be placed on better education and technique to improve clinical outcomes in the future.

Background: Two-year safety and efficacy data were presented to the Canadian Therapeutic Products Directorate Scientific Advisory Panel, in Ottawa, Ontario, Canada. Methods: The 955 women enrolled in the 10-year, multicenter, Mentor MemoryGel study were distributed into four cohorts: 572 augmentation patients, 123 revision-augmentation patients, 191 reconstruction patients, and 69 revision-reconstruction patients. The surgeons in the study received an intensive clinical educational program in addition to the protocol. Results: Mentor’s 2-year study results indicate that the risk of any complication or reoperation at some point through 2 years after implant surgery is 24.5 percent for primary augmentation patients, 30.2 percent for revision-augmentation patients, 42.9 percent for primary reconstruction patients, and 41.8 percent for revision-reconstruction patients. The rupture rates reported from the magnetic resonance imaging cohort were 0 percent for all groups. Patients reoperated on at least one time were as follows: 9.4 percent for primary augmentation, 12.8 percent for revision-augmentation, 27.3 percent for primary reconstruction, and 19.4 percent for revision-reconstruction. Also, 2.4 percent of primary augmentation patients, 7.3 percent of revision-augmentation patients, 8.9 percent of primary, and 11.6 percent of reconstruction patients had their implants removed, with patient choice and capsular contracture being the most common reasons. Conclusions: The data from the Mentor CPG Gel Study resulted in approval of these implants for general use on October 20, 2006. The educational program resulted in improved clinical outcomes and probably should be required for all surgeons using the devices.

It may seem quite surprising to most of the plastic surgeons around the world that the Americans are the last to be able to use silicone gel implants without significant restrictions being placed on them. The FDA Advisory Panel recommended approval of the devices in the spring of 2005, and the Agency issued “Approvable” letters in the summer of the same year to the two domestic manufacturers of the devices. Despite this scientific foundation for these devices, they were not finally approved until November of 2006. The round devices have not been approved, and it is felt that the shaped devices, currently so popular in Europe, will not be evaluated for at least a year after final approval of the round devices.

Roger K. Khouri, Thomas M. Biggs Your Natural Breasts: A Better Way to Augment, Reconstruct, and Correct Using Your Own Fat. Tallahassee, FL: San Pedro Publishing; 2012. ISBN-10: 0615695809 Aesthetic Surgery Journal 's book review section generally focuses on scholarly works, but Your Natural Breasts: A Better Way to Augment, Reconstruct, and Correct Using Your Own Fat , while academic in scope and presentation, was written primarily for prospective patients of augmentation and reconstruction procedures rather than for medical professionals. Despite its intended readership, the book—an introduction to autologous fat grafting for breast enhancement or reconstruction—will be stimulating for clinicians interested in the topic of fat grafting. The authors of this book are 2 of the most widely recognized names in lipotransfer-based breast surgery. Dr Roger Khouri is an accomplished microsurgeon and reconstructive surgeon who educates physicians on the technology used for autologous and large-volume fat transfer. Dr Thomas Biggs is a pioneer in implant-based breast reconstruction, the former editor of several plastic surgery journals, and an advocate of international surgical education. The book's title tells prospective patients that they are the intended audience and prepares them to learn why Khouri and Biggs recommend this method of fat grafting over …

The authors evaluated existing and new criteria for defining the medical necessity for breast reduction surgery. Two cohorts of women (those requesting breast reduction surgery [N = 266] and a group of controls [N = 184]) completed a questionnaire including breast-specific symptom severity, the Short Form 36, the EuroQol, the McGill Pain Questionnaire, and the Multidimensional Body Self Relations Questionnaire. To evaluate prediction validity, the most widely accepted decision criteria and a new definition of medical necessity were applied to the data set to determine whether women meeting the definition had more favorable outcomes than those who did not as measured by validated self-report instruments. For existing criteria, women not meeting and meeting the criterion gained equal benefit from surgery. Women meeting the new definition (2 of 7 physical symptoms all or most of the time) had significantly greater improvement scores on 4 of the 5 health burden measures compared to women not meeting this definition. The authors conclude that medical necessity for breast reduction surgery is better defined by self-report of symptoms than by existing criteria.

In this report, the authors evaluate the effectiveness of breast reduction in alleviating the symptoms of macromastia by comparing baseline and postoperative health status using a series of well-validated self-report instruments. The study had a prospective design with a surgical intervention group and two control groups: a hypertrophy control group with bra cup sizes D or larger and a normal control group with bra cup sizes less than D. The effectiveness of nonsurgical interventions in relieving the symptoms of macromastia was also evaluated, both in the operative subjects and in the control groups. Surgical candidates and controls completed a self-administered baseline survey that consisted of the following validated and standardized instruments commonly used to evaluate outcomes: SF-36, EuroQol, Multidimensional Body-Self Relations Questionnaire (MBSRQ), and the McGill Pain Questionnaire (MPQ). A specially designed and validated instrument, the Breast-Related Symptoms (BRS), was also used. There were also questions about prior nonsurgical treatments, comorbid conditions, bra size, and a physical assessment. Additional information obtained on the operative subjects included surgical procedure data, resection weight, and complications. Approximately 6 to 9 months postoperatively, surgical subjects completed the same questionnaire as described above, and a final physical assessment was performed. The cohort included 179 operative subjects with matched preoperative and postoperative data sets, 96 normal controls and 88 hypertrophy controls. The women were predominantly Caucasian, middle-aged, well educated, and employed. Fifty percent of the operative subjects reported breast-related pain all or most of the time in the upper back, shoulders, neck, and lower back preoperatively compared with less than 10 percent postoperatively. Operative subjects and hypertrophy controls tried a number of conservative treatments, including weight loss, but none provided adequate permanent relief. Compared with population norms, the preoperative subjects had significantly lower scores (p < 0.05) in all eight health domains of the SF-36, and in the mental and physical component summary scores. After surgery, the operative subjects had higher means (better health) than national norms in seven of the eight domains and improved significantly from presurgical means in all eight domains (p < 0.05). Before surgery, the operative subjects reported high levels of pain with a Pain Rating Index (PRI) score from the MPQ of 26.6. After surgery, pain was significantly lower with a mean PRI score of 11.7, similar to that of our controls (mean PRI score, 11.2). Regression analysis was used to control for covariate effects on the main study outcomes. Among the operative subjects, benefits from breast reduction were not associated with body weight, bra cup size, or weight of resection, with essentially all patients benefiting from surgery.Breast hypertrophy has a significant impact on women's health status and quality of life as measured by validated and widely used self-report instruments including the SF-36, MPQ, and EuroQol. Pain is a significant symptom in this disease, and both pain and overall health status are markedly improved by breast reduction. In this population, conservative measures such as weight loss, physical therapy, special brassieres, and medications did not provide effective permanent relief of symptoms.

The etiology of capsular contracture is unclear and probably multifactorial. This review covers the literature on several proposed contracture factors, including filler material, implant placement, surface texture, and bacterial infection. The pilot study's goal was to test the feasibility of a data collection form, which could be used in a scaled-up study analyzing multiple surgeon's records. The goal of the expanded version of this study will be to determine the efficacy of available interventions for capsular contracture, including surveillance. The Breast Implant Public Health Project, LLC (BIPHP), piloted a retrospective review of outcomes in women who had interventions to relieve capsular contracture or had chosen a wait-and-watch approach. An evaluation of the efficacy of various treatments can help women decide if they want to pursue treatment at all and, if so, which treatment might offer them the best solution. BIPHP researchers (E.E.A., M.E.) developed a data collection form after reviewing records of three surgeons (B.C., W.P., V.L.Y.). During the data collection using the same records, we tested a randomization process to identify women with capsular contracture who underwent various interventions, including a wait-and-watch strategy, and those who had no mention of any intervention or waiting approach. Data were gathered on a total of 90 breasts with capsular contracture (scored Baker I-IV or qualitatively), of which 45 underwent a total of 102 interventions for capsular contracture. Interventions were classified as "closed capsulotomy," "surgical," or "watchful waiting." Closed capsulotomy was performed most often (47%), followed by surgery (29%) and watchful waiting (21%). Presurgical Baker scores averaged higher in breasts that underwent surgery (3.1) than for watchful waiting (2.5) or closed capsulotomy (2.3). Though closed capsulotomies had 100% of outcomes scoring "improved" or "same," 58% of the breasts underwent the procedure more than once, suggesting that the favorable outcome was short-lived. The wait-and-watch approach resulted in scores of either "same" or "worse"; surgery (open capsulotomy, repositioning, or capsulectomy) resulted in 79% improved, 16% same, and 5% worse outcomes in breasts with outcomes listed. In all intervention procedure categories, outcomes were frequently unavailable; they were noted only 60% of the time (52/87). The missing 40% may have resulted from the doctor's failure to note it in the chart, satisfied patients not returning for additional treatment, or dissatisfied patients seeking treatment elsewhere. Generally, the data collection forms and procedures were workable; however, we uncovered issues to address in the scale-up of this pilot study: (1) the outcome report rate was 60%; (2) though Baker scores are commonly used to evaluate the degree of capsular contracture, it seems that grade I may have different meanings for different surgeons, which would need to be clarified; (3) participating surgeons will need to divulge standard-of-care items that they may not have included in medical records, but routinely performed (e.g., patient massage, use of prophylactic antibiotics); and (4) records were initially separated by "implant," then researchers realized that a more useful collection would be by "breast." The latter approach captures the history of the breast in one record, which may be more important to contracture than the differences in implants. With the modifications discussed, the study can be scaled up to encompass as many records as necessary to achieve robust statistical power. These data will add to the existing literature regarding factors associated with capsular contracture and identify factors that affect the successful outcome of capsular contracture interventions.

This pilot study's goal was to test the feasibility of a data collection form which will be used in a scale-up study analyzing multiple surgeons' records. The goal of this expanded study will be to develop identifying factors for women who are at greater risk for having ruptured implants and, if necessary, target them for screening, surveillance, or intervention. In the pilot study, we compared factors associated with implant rupture in women with and without rupture. Similar studies have considered one or a few factors at a time and, generally, have given little attention to implant generation. We developed a data collection form after reviewing records of three surgeons. A total of 92 records was collected and analyzed. An important feature in the pilot was to compare the results of patients whose implants the surgeons had both implanted and explanted (n = 34) with those of patients whose implants the surgeons had only explanted (n = 55) (unknown = 3). This comparison could show if including all explantation patients in a surgeon's practice would bias the sample; however, based on this pilot data, concerns regarding this type of bias seem to be minimal. Similar amounts of data (e.g., implant information, history of capsular contracture, etc.) were collectable on patients whose surgeons both implanted and explanted them (87%) and who had different surgeons for implantation and explantation (84%). Though the data from this limited sample cannot offer firm conclusions on rupture associations, a few factors stood out: size of implants (38. 3% of ruptured versus 15.9% of intact implants were 100-200 cm3), history of mammography (46.8% of ruptured versus 24.4% of intact had mammograms, which is likely due to older women with older implants having more mammograms), and history of closed capsulotomy (85.1% of ruptured versus 68.9% of intact). Interestingly, additional procedures performed on the breast (e.g., scar revision, wound repair, etc.) did not affect rupture: both the ruptured and the intact groups had an average of 1.7 procedures performed. The data collection form tested very well in this pilot study. Also, including all patients in the study sample, instead of excluding those who received their implants elsewhere, did not change the results. Though there are not enough data to draw any firm conclusions regarding rupture factors, the collection instrument was rigorously tested and should perform well in an expanded study.

In 1993, the Plastic Surgery Educational Foundation commissioned the senior author (Cunningham) to design an 11-center retrospective cohort outcomes study to obtain physician- and patient-reported data on saline-filled breast implants. Data were obtained from 504 patients with 995 saline-filled breast implants placed between January 1, 1980 and December 31, 1989, with a mean follow-up of 6 years. Most (93.8 percent) saline-filled breast implants were placed for breast augmentation. Of the 504 patients, 104 (20.6 percent) required reoperation for open capsulotomy or for replacement or removal of a deflated implant. Complications occurred in 22 patients (4.4 percent), with hematoma being most common. Implant deflation occurred in 55 implants (5.5 percent) and affected 51 patients (10.1 percent) but was underreported by chart abstraction alone. Risk factors for implant deflation included underfilling the implant by more than 25 cc (odds ratio 3.3, p = 0.0400), the use of model 1800 saline-filled breast implants (odds ratio 3.1, p = 0.0010), intraluminal antibiotics (odds ratio 2.6, p = 0.0183), and intraluminal steroids (odds ratio 2.4, p = 0.0711). Based on 44 of 55 saline-filled breast implants with known deflation dates, actuarial survival is 95.7 to 98.0 percent at 5 years and 90.2 to 95.2 percent at 10 years (95 percent confidence interval). Significant periprosthetic capsular contracture affected 103 patients (20.4 percent) during follow-up. Risk factors for capsular contracture included omitting intraluminal antibiotics (odds ratio 16.7, p = 0.0001), omitting intraluminal steroids (odds ratio 12.5, p = 0.0001), submammary placement of the saline-filled breast implant (odds ratio 7.8, p = 0.0001), and use of antibiotics in the implant pocket (odds ratio 6.1, p = 0.0001). Overall patient satisfaction with saline-filled breast implants was rated as high by 94.2 percent, and 94.8 percent of patients would choose saline-filled breast implants again. Dissatisfaction with their saline-filled breast implants was more frequent in patients with significant breast firmness (odds ratio 22.9, p = 0.0001), those undergoing prophylactic mastectomy (odds ratio 8.2, p = 0.0005), and those desiring smaller implants (odds ratio 6.9, p = 0.0001). In conclusion, saline-filled breast implants are a safe alternative to silicone gel-filled breast implants and demonstrate a high rate of patient satisfaction. Underfilling of saline-filled breast implants should be avoided because it contributes to deflation. Although intraluminal antibiotics and steroids protect against capsular contracture, they also contribute to saline-filled breast implant deflation. The incidence of capsular contracture is decreased by placing the saline-filled breast implant in the subpectoral position. Finally, patients should be aware of the possible need for reoperations related to their implants.

During sonographic evaluation of silicone breast implants for possible rupture, we have frequently encountered several patterns of linear echoes within the implants. To our knowledge, the significance of this finding has not been established in the literature. The purpose of this study was to determine whether internal echoes are significant in predicting implant rupture.Thirty-three patients with 64 silicone implants were prospectively entered into a study that included gray-scale sonography of the implants and subsequent surgical removal. Echo patterns within the implants were retrospectively evaluated on hard-copy films and compared with the integrity of the implant at surgery.Three categories of internal echo patterns were identified: "thick linear echoes." "thin linear echoes," and "commas." One or more of these echo patterns were seen in 57 (89%) of the 64 implants. Thick linear echoes were seen in 23 (36%) of the 64 implants, thin linear echoes were seen in 33 (52%) of the 64 implants, and commas were seen in 47 (73%) of the 64 implants. All echo patterns were seen in intact and ruptured implants with nearly equal frequency. We found no statistical significance for any echo pattern in predicting whether an implant was ruptured or intact. Of the 64 implants, four were entirely free of internal echoes. All four implants were intact.A variety of linear echoes can be seen in most silicone breast implants on gray-scale sonography. The presence or absence of linear echoes is not useful in predicting implant rupture. Complete absence of internal echoes, while highly predictive of an intact implant, is infrequently seen.

Long-term safety data are important in the evaluation of possible adverse health outcomes related to silicone breast implants. The authors evaluated long-term symptoms and conditions and medication use among 190 Danish women with cosmetic silicone breast implants compared with 186 women who had undergone breast reduction surgery and with 149 women from the general population. Breast implant and reduction surgeries were performed from 1973 to 1988 at one public hospital and one private plastic surgery clinic. Among women with breast implants, the average implantation time was 19 veers, 60 percent (n = 114) had only one implantation, and 10 percent (n = 19) had undergone explantation before the time of study (1997 to 1998). The authors found no material differences in self-reported diseases or symptoms among study groups, except for breast pain, which was reported nearly three times as often by women with implants than by women with breast reduction (odds ratio, 2.8; 95 percent confidence interval, 1.4 to 5.3). Approximately 80 percent of women in each study group reported at least one symptom. No consistent differences were observed in the seroprevalences of antinuclear antibodies or other autoantibodies. Self-reported use of psychotropic drugs was higher among women with breast implants than among either control group. The authors conclude that long-term cosmetic breast implantation may cause capsular contracture and breast pain but does not appear to be associated with other symptoms, diseases, or autoimmune reactivity. The authors' finding of excess use of drugs for treatment of depression and anxiety among women with breast implants may warrant further investigation.

A double-blind prospective placebo controlled trial of intraluminal lidocaine for pain relief after tissue expansion was performed in 18 women undergoing breast reconstruction. In contrast to others' claims of effective analgesia, no difference in the incidence of immediate or late pain after expansion could be demonstrated between 100 mg of lidocaine and placebo. The overall incidence of early pain was 8%. This was significantly less frequent than late pain, which occurred after 36% of all expansions. Postexpansion pain (early or late) was reported after nearly one-half of all expansions, most of which was ascribed to late pain. The incidence of pain did not significantly depend on the temporal progression of breast expansion, nor was there a difference in the incidence and prevalence of pain for patients undergoing unilateral versus simultaneous bilateral expansion.

The association between melanoma and giant congenital nevocellular nevus has been well documented, although controversy still exists regarding the precise incidence. The following patient report illustrates the excision of malignant melanoma arising from a giant congenital nevocellular nevus in a 4-month-old infant. The child had malignant melanoma with deep dermal involvement diagnosed by incisional biopsy with positive margins. She underwent subsequent en bloc resection of the original biopsy site and nevus. The reexcision specimen showed no evidence of malignancy. No adjuvant chemotherapy was used. The child is disease free at 5 years. It is possible that very young children (infants) with melanoma arising in a giant congenital nevocellular nevus may have a good prognosis.