Breast Implantation Rates in Israel: Is There a Change in Trend?

BACKGROUND: Breast implant illness (BII) is a rising concern among many patients. Although not fully understood, a connection between silicone breast implants and systemic diseases may be present. This connection may influence the types of breast surgeries performed. OBJECTIVES: To evaluate changing trends in breast surgeries in Israel over time, with regard to implantation, explantation, and implant exchange surgeries. METHODS: In this ecological study, we presented data from four private medical centers in Israel regarding the number of breast implant surgeries performed in the years 2018-2019. Data were collected bi-yearly. The types of surgeries included breast implantation, explantation, and breast implant exchange. RESULTS: When we summed and compared the yearly data, we saw that the number of implantations in 2018 was 2267 (80.1% of breast implant procedures that year), and 1929 (68.9%) in 2019. The number of implant exchanges in 2018 and 2019 was 482 (17.0%) and 608 (21.7%), respectively. In 2018, 80 (2.8%) explantations were performed and 262 (9.4%) in 2019. CONCLUSIONS: There appears to be a trend in the rise of implant removal surgeries in addition to a decrease in breast implantations. One possible reason may be patient concerns of BII. Another reason may be the increased public interest and discussion about systemic effects of breast implants. More research is needed in this field to achieve better understanding of the phenomenon, the reasons behind it, and the possible solutions and ways of treatment.

US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients.

OBJECTIVE: To analyze the long-term safety and efficacy outcomes of patients with breast implants. SUMMARY BACKGROUND DATA: Research is ongoing regarding the safety of silicone breast implants. Despite the number of patients with breast implants followed by United States Food and Drug Administration large postapproval studies (LPAS), this database has not been thoroughly analyzed or reported. METHODS: This is a multicentered, cohort study. LPAS prospectively monitor long-term implant-related outcomes and systemic harms for silicone/saline implants from 2 manufacturers (Allergan and Mentor) placed for primary/revision augmentation/reconstruction. Systemic harms, self-harm, and reproductive outcomes are compared with normative data. Implant-related complications are analyzed by implant composition and operative indication in the short and long terms. RESULTS: LPAS data includes 99,993 patients, 56% of implants were silicone for primary augmentation. Long-term magnetic resonance imaging surveillance is under 5%. Compared with normative data, silicone implants are associated with higher rates of Sjogren syndrome (Standardized incidence ratio [SIR]8.14), scleroderma (SIR 7.00), rheumatoid arthritis (SIR5.96), stillbirth (SIR4.50), and melanoma (SIR3.71). One case of BI-ALCL is reported. There is no association with suicide. In the short term, rupture is higher for saline (2.5% vs. 0.5%, P < 0.001), and capsular contracture higher for silicone (5.0% vs. 2.8%, P < 0.001). At 7 years, reoperation rate is 11.7% for primary augmentation, and 25% for primary/revision reconstruction. Capsular contracture (III/IV) occurs in 7.2% of primary augmentations, 12.7% primary reconstructions, and is the most common reason for reoperation among augmentations. CONCLUSIONS: This is the largest study of breast implant outcomes. Silicone implants are associated with an increased risk of certain rare harms; associations need to be further analyzed with patient-level data to provide conclusive evidence. Long-term safety and implant-related outcomes should inform patient and surgeon decision-making when selecting implants.

Growing Trends of Contralateral Prophylactic Mastectomy and Reconstruction in Young Breast Cancer.

BACKGROUND: The aim of this study was to evaluate the trends of surgical treatments among young patients in T1N0-1M0 stage based on the Surveillance, Epidemiology, and End Results database. MATERIALS AND METHODS: Patients aged less than 40 y diagnosed between 1998 and 2015 were enrolled, with tumors in T1N0-1M0 stage and not located in the central area. Differences in clinical-pathological characteristics were evaluated using chi-square tests. Multivariate logistic regression was used to measure the various factors associated with contralateral prophylactic mastectomy (CPM). Independent prognostic factors were evaluated by Cox model. RESULTS: The total rate of breast-conserving surgery (BCS) was 51.6%, which declined from 64.5% in 1998 to 39.6% in 2015. The total rate of CPM was 22.7%, which increased from 3.7% in 1998 to 38.7% in 2014 despite a decline to 32.7% in 2015. Meanwhile, the rate of reconstruction increased in line with that of CPM, from 9.4% in 1998 to 35.0% in 2015. There was a trend of increasing use of implant-based reconstruction. Significant higher odds of CPM were found in recent year of diagnosis between 2010 and 2015 and in implant-based reconstruction. Patients undergoing CPM had similar survival outcomes compared with those undergoing BCS and unilateral mastectomy, whereas those undergoing BCS had better survival outcomes compared with those undergoing unilateral mastectomy. CONCLUSIONS: A trend of growing preference for CPM and reconstruction was observed among young patients in early stage in recent years without survival benefits. Efforts should be made to promote efficient communication and evidence-based decision-making.

Surgical treatment of young women with breast cancer: Public vs private hospitals.

Disparities in breast cancer treatment have been documented in young and underserved women. This study aimed to determine whether surgical disparities exist among young breast cancer patients by comparing cancer treatment at a public safety-net hospital (BH) and private cancer center (PCC) within a single institution. This was a retrospective study of young women (<45) diagnosed with invasive breast cancer (stage I-III) from 2011-2016. Patient information was abstracted from the breast cancer database at BH and PCC. Demographic variables, surgery type, method of presentation, and stage were analyzed using Pearson's chi-square tests and binary logistic regression. A total of 275 patients between ages 25-45 with invasive breast cancer (Stage I-III) were included in the study. There were 69 patients from BH and 206 patients from PCC. At PCC, the majority of patients were Caucasian (68%), followed by Asian (11%), Hispanic (10%), and African American (8.7%). At BH, patients were mostly Hispanic (47.8%), followed by Asian (27.5%), and African American (10.1%). At PCC, 82% had a college/graduate degree versus 18.6% of patients at BH (P < 0.001). All patients at PCC reported English as their primary language versus 30% of patients at BH (P < 0.001). Patients at PCC were more likely to present with lower stage cancer (P = 0.04), and less likely to present with a palpable mass (P = 0.04). Hospital type was not a predictor of receipt of mastectomy (P = 0.5), nor was race, primary language, or education level. Of patients who received a mastectomy, 87% at BH and 76% at PCC had immediate reconstruction. Surgical management of young women with breast cancer in a public hospital versus private hospital setting was equivalent, even after controlling for race, primary language, stage, and education level.

Lessons Learned From Breast Implant Registries: A Systematic Review.

OBJECTIVE: Over several decades, numerous national and international registries on breast implants went online, aiming to collect prospective data to provide increased safety for patients and surgeons. We performed a review of all published data on breast implant registries to assess availability and quality of data and determine its usefulness and impact. MATERIALS AND METHODS: PubMed, Ovid, and Web of Science were searched to identify all articles containing breast implant registries in English language. The review was registered at PROSPERO (CRD42016041255) and performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. There was no limitation by publication date. RESULTS: Eight hundred ninety-five articles were identified; after removal of duplicates, 536 abstracts were screened on breast implant registries in plastic and reconstructive surgery. Unrelated articles, non-English articles, and not breast implant-related studies were excluded. Twenty breast implant registry-related articles met the inclusion criteria; 7 articles contained actual data on breast implants. Compared with international trends, only a minimal percentage of performed surgical breast augmentations is documented in registries, and the overall data quality and availability were low. CONCLUSIONS: Only a fraction of performed breast augmentations is documented properly in a registry. Currently, there are no published data based on a clinical quality registry. Sustained funding and reliable administrative governmental structures remain crucial to establish an adequate clinical quality registry for breast implants as currently launched in Australia to analyze outcomes and risk factors for an increased patient safety.

Innovations and advancements with prosthetic breast reconstruction.

Prosthetic breast reconstruction has evolved over the years to provide results that now mimic that of a natural breast. This is due to a variety of innovations and advancements related to mastectomy techniques, acellular dermal matrices, autologous fat grafting, and improved breast implants. The evolution of prosthetic breast reconstruction has gone full-circle and included prepectoral placement in the 1970s and 80s, partial or total subpectoral placement from 1985 to 2015, and now gradually trending back to prepectoral. There are several techniques and strategies that now allow for patients to achieve results that are superior to any time over the past 50 years. This manuscript will review the salient aspects of prosthetic breast reconstruction and how its evolution has progressed over the years.

Public Interest in Breast Augmentation: Analysis and Implications of Google Trends Data.

INTRODUCTION: Breast augmentation is the most common aesthetic surgery performed in the United States (US) annually. Analysis of Google Trends (GT) data may give plastic surgeons useful information regarding worldwide, national, and regional interest for breast augmentation and other commonly performed aesthetic surgeries. METHODS: Data were collected using GT for breast augmentation and associated search terms from January 2004 to May 2017. Case volume was obtained from the American Society of Plastic Surgeons (ASPS) annual reports for the calendar year 2005-2016. RESULTS: Trend analysis showed that total search term volume for breast augmentation and breast implants gradually decreased worldwide and in the US over the study period while the search term boob job slowly increased. Univariate linear regression demonstrated a statistically significant positive correlation between average annual Google search volume of "breast augmentation" and the annual volume of breast augmentations performed in the US according to ASPS data (R 2 = 0.44, p = 0.018). There was no significant correlation between national volume of breast augmentations performed and search volume using the terms "breast implants" or "boob job" over time (p = 0.84 and p = 0.07, respectively). In addition, there appears to be country specific variation in interest based on time of year and peaks in interest following specific policies. CONCLUSIONS: To our knowledge, this is the first and only analysis of GT data in the plastic surgery literature to date. To that end, this study highlights this large and potentially powerful data set for plastic surgeons both in the US and around the world. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Current Trends in Breast Augmentation: An International Analysis.

BACKGROUND: Breast augmentation surgery remains the most frequently performed aesthetic surgical procedure worldwide. However, many variations exist regarding preoperative planning, surgical management, and postoperative care. OBJECTIVES: The goal was to evaluate current trends and practices in breast augmentation, with a focus on international variability. METHODS: A questionnaire was sent to over 5000 active breast surgeons in 44 countries worldwide. The survey inquired about current controversies, new technologies, common practices, secondary procedures, and surgeon demographics. The findings and variations were evaluated and correlated to evidence-based literature. RESULTS: There were a total 628 respondents equaling a response rate of approximately 18%. While certain approaches and common practices prevail also on an international basis, there exist several geographic controversies. For example, while almost fifty percent of surgeons in the United States and Latin America never use anatomically shaped implants, in Europe and Oceania most surgeons use them. Similarly, in Latin America, Europe, Asia, and Oceania, over 80% of surgeons use silicone implants only, whereas in the United States only 20% use them - meanwhile US surgeons use the largest implants (78% > 300 cc). Internationally dominant practice preferences include preoperative sizing with silicone implants, as well as the use of inframammary incisions and partial submuscular pockets. CONCLUSIONS: Significant differences exist when comparing most common surgical breast augmentation approaches on an international basis. While certain techniques seem to be universal standards, there still remain several controversies. Further standardizing this most common aesthetic surgical procedure according to evidence-based guidelines will help to improve outcomes.

Factors associated to breast implants and breastfeeding. / Fatores associados à mamoplastia de aumento e o aleitamento materno.

OBJECTIVE: To analyze the association between the surgical characteristics of breast implants, time elapsed since surgery, access route, implant placement and implanted volume and variables related to breastfeeding, type, first 'milk let-down', breast engorgement, pain, lesion, milk production and use of galactagogues. METHOD: A prospective cohort carried out during the hospital stay (12 to 72 hours after delivery), home care (5thto 7thday after delivery) and telephone contact (between the 30thand 32ndday postpartum) of 115 postpartum women with breast implants between 2015 and 2017. RESULTS: The first evaluation identified more frequent use of oral galactagogues (p=0.029) by puerperal women with prepectoral implants, and of oxytocin spray by those with implants up to 270 ml (p=0.040). The second evaluation showed a higher pain score among those with prepectoral implants (p=0.046). Around the 30thday postpartum, the presence of nipple lesion (p=0.021), pain (p=0.025) and a higher pain score (p=0.039) was more frequent among those with mammoplasty performed less than 10 years ago. CONCLUSION: The presence of pain and a higher pain score, the occurrence of lesion and the use of oral and nasal galactagogues were associated with implant placement, implant size and time elapsed since surgery.

Qualitatively understanding patients' and health professionals' experiences of the BRECONDA breast reconstruction decision aid.

OBJECTIVE: Women diagnosed with breast cancer or ductal carcinoma in situ and those with a genetic susceptibility to developing this disease face the challenging decision of whether or not to undergo breast reconstruction following mastectomy. As part of a large randomized controlled trial, this qualitative study examined women's experiences of using the Breast RECONstruction Decision Aid (BRECONDA) and health professionals' feedback regarding the impact of this resource on patients' knowledge and decision making about breast reconstruction. METHOD: Semistructured interviews were conducted with women who accessed the BRECONDA intervention (N = 36) and with their healthcare providers (N = 6). All interviews were transcribed verbatim and subjected to thematic analysis by 3 independent coders. RESULTS: Participants reported an overall positive impression, with all interviewees endorsing this decision aid as a useful resource for women considering reconstructive surgery. Thematic analysis of patient interviews revealed 4 themes: overall impressions and aesthetics; personal relevance and utility; introducing BRECONDA; and advantages and suggested improvements. Analysis of health professionals' interviews also revealed 4 themes: need for BRECONDA, impact of BRECONDA, potential difficulties that may arise in using the decision aid, and recommending BRECONDA to patients. Patients indicated that they derived benefit from this resource at all stages of their decision-making process, with the greatest perceived benefit being for those early in their breast reconstruction journey. CONCLUSION: These findings support the use of BRECONDA as an adjunct to clinical consultation and other information sources.

PREVALENCE AND TYPES OF GENDER-AFFIRMING SURGERY AMONG A SAMPLE OF TRANSGENDER ENDOCRINOLOGY PATIENTS PRIOR TO STATE EXPANSION OF INSURANCE COVERAGE.

OBJECTIVE: Transgender individuals now have many options for medical intervention, including gender-affirmation surgeries. However, it is unknown how common it is for transgender individuals to undergo these surgeries. The purpose of this cross-sectional study was to assess the prevalence of gender-affirming surgeries among transgender patients in 2015, which was immediately prior to insurance changes that made gender-affirming surgery more affordable for Massachusetts residents. METHODS: A retrospective chart review of 99 transgender patients was performed at the Endocrinology Clinic at Boston Medical Center, an urban safety net hospital. The records for 99 transgender subjects who received treatment between 2004-2015, including 28 transmen and 71 transwomen, were examined. The outcome measures were the types of medical interventions chosen by transgender patients, which included hormone therapy, chest surgery, gonadectomy, genital surgery, and facial surgery. RESULTS: Thirty-five percent of subjects had undergone at least one gender-affirming surgery. Transmen were more likely to have had surgery than transwomen (54% vs. 28%). Twenty-five percent of patients had chest surgery, 13% had genital surgery or gonadectomy, and 8% had facial surgery. CONCLUSION: In 2015, a majority of transgender endocrinology clinic patients had not undergone any type of gender-affirmation surgery. Among those who did elect to have a surgery, genital surgery or gonadectomy were uncommon. The low rate of surgery among this sample of transgender patients may be attributable to the financial cost, lack of interest in surgery, or that genital surgery is not a high priority for transgender individuals relative to surgery to change visible features such as face and chest. Abbreviation: HT = hormone therapy.

Trends in Post-Mastectomy Reconstruction in an Asian Population: A 12-Year Institutional Review.

Post-mastectomy breast reconstruction is an integral component of breast cancer treatment. It is often perceived that women in Asian countries have a lower rate of post-mastectomy reconstruction than Western populations. This study describes trends in timing and types of breast reconstruction performed in the largest healthcare provider in Singapore, over a period of 12 years. It also reports on the oncological outcomes and surgical safety. A retrospective review of all patients who underwent post-mastectomy reconstruction from January 2001 to December 2012 at the National Cancer Centre Singapore and Singapore General Hospital was performed. Six hundred and twenty post-mastectomy reconstructions were performed in 579 patients. The proportion of reconstructions increased from 4% in 2001 to 18% in 2012. Younger patients (<50 years old) and those with early stage cancer were more likely to undergo reconstruction. Immediate breast reconstruction was favored by more than 90% of patients. Postoperatively, 9% developed acute surgical complications that were treated surgically; 6% had additional surgery for late complications. Only 4% had delay of adjuvant chemotherapy. At median follow-up of 63 months (range 3-166), loco-regional recurrence was 4%, and distant metastases 8%. Post-mastectomy reconstruction for breast cancer is increasingly performed in our institution. Both younger age and lower stage disease were associated with choice for reconstruction in our study. Low rates of delay to adjuvant therapy were noted, and it may safely be offered to suitable women undergoing mastectomy.

National and Regional Differences in 32,248 Postmastectomy Autologous Breast Reconstruction Using the Updated National Inpatient Survey.

BACKGROUND: The incidence of breast cancer (BC) cases has increased significantly. The number of breast reconstruction (BR) procedures performed has mirrored this trend. Although implant-only procedures remain the most commonly used type of immediate BR, autologous techniques involving donor sites account for approximately 20%. The aim of this study was to assess national and regional trends in different types of autologous BR. METHODS: Using the Nationwide Inpatient Sample database (2008 to 2012), data on BC and mastectomy rates, type of autologous BR, and sociodemographics were obtained and analyzed. Furthermore, national and regional trends over time for autologous BR were plotted and analyzed. RESULTS: A total of 427,272 patients diagnosed with BC or at increased risk of BC were included in the study. A total of 343,163 (80.3%) patients underwent mastectomy and, within this group, 148,700 (43.3%) patients underwent immediate BR. Of these, 32,249 (21.7%) patients underwent an autologous BR (not solely implant based) and 118,258 (78.3%) implant-based BR. Most autologous BRs were performed in the Southern region (37.4%). When stratified into flap types, most pedicled transverse rectus abdominis muscle (TRAM), free TRAM, and other flaps were performed in the Northeast region, whereas most deep inferior epigastric perforator (DIEP) and latissimus dorsi (LD) flaps were performed in the Southern region. Subgroup analysis demonstrated a significant increasing trend for both LD and DIEP flaps, both nationally (P < 0.001) and regionally (P < 0.001). Pedicled TRAM and free TRAM reconstructions decreased significantly both on national and regional level. CONCLUSIONS: Autologous BR demonstrated a significant positive trend over time in the Southern region (P < 0.001). The DIEP and LD flaps increased significantly over time, both nationally and regionally.

Advanced Age Does Not Worsen Recovery or Long-Term Morbidity After Postmastectomy Breast Reconstruction.

PURPOSE: Despite evidence that older women have quality-of-life outcomes similar to younger women after postmastectomy breast reconstruction (PMBR), they rarely receive it. There is a perception that PMBR in older women may result in significant physical morbidity. However, the effects of age on physical morbidity after PMBR have not been studied. This study sought to assess perceptions of recovery from surgery and long-term chest and upper body morbidity in older women who receive PMBR. METHODS: Women with American Joint Committee on Cancer stage 0-III breast cancer who underwent a mastectomy with PMBR between 2005 and 2011 were surveyed to assess their functional health status (DUKE), physical well-being (BREAST-Q), and perceptions of recovery from surgery. Patients were stratified into 2 age groups: older (≥65 years) and younger (<65 years). Outcome scores were compared by mastectomy laterality, reconstruction type, and between age groups. Data were analyzed using χ² and t tests. RESULTS: One hundred eight older and 103 younger patients returned surveys (response rate, 75.4%). The median time from mastectomy to survey was 4 years (range, 1-7). Younger women were more likely to undergo bilateral mastectomy than older women (65.7% vs 32.2%, P < 0.001). Some women (66.9%) underwent implant-only reconstruction and 33.1% underwent autologous reconstruction; there were no significant differences in reconstruction type between age groups. Patients who underwent unilateral and bilateral mastectomy had similar mean BREAST-Q physical well-being scores (79.4 vs 78.9, respectively, P = 0.85). There was no difference in mean physical well-being scores between older and younger patients (80.0 vs 78.5, respectively, P = 0.61). In addition, older patients were less likely to perceive their recovery from PMBR as being difficult than younger patients, though this was not statistically significant (48.2% vs 64.3%, P = 0.07). CONCLUSIONS: Older women who undergo PMBR have physical and upper body well-being that is similar to younger women. In addition, their perception of recovery from PMBR is at least as good as that seen in younger women. Older women contemplating PMBR should be counseled that they are not at higher risk for long-term physical and upper body morbidity from PMBR than are younger women.

Autologous Breast Reconstruction in Women Older Than 65 Years Versus Women Younger Than 65 Years: A Multi-Center Analysis.

BACKGROUND: Autologous breast reconstruction has been shown to have fewer complications and superior outcomes. In the elderly patient population, a paucity of literature on the subject may render the surgeon reluctant to recommend or perform such a procedure. The objective of this study was to compare complications and satisfaction after abdominally based breast reconstruction in patients older than versus younger than 65 years. METHODS: A retrospective study was performed with data from 5 North American centers from 2002 to 2012. Patients who underwent autologous reconstruction were identified retrospectively, and chart review was performed. The BREAST-Q questionnaire was sent to these patients via mail. Patient variables, operative outcomes and BREASTQ results were analyzed. The Pearson χ² and analysis of variance tests were used. Given the number of analyses, a more conservative α of 0.01 was used for each comparison. RESULTS: A total of 1809 patients were included with 1751 patients younger than 65 years and 58 patients aged 65 years or older. Analysis of postoperative complications showed no significant differences between the age groups, though there was a trend toward higher seroma development (17.2% vs 8.1%; P = 0.013) and infection (19.0% vs 10.0%; P = 0.028) in the older group with statistical significance set at P less than 0.01 to account for multiple comparisons. A total of 1809 BREAST-Q surveys were sent with a response rate of 52.5%. Patient satisfaction results were equally high between the 2 age groups. CONCLUSIONS: This is the largest study to compare patients undergoing autologous breast reconstruction older than and younger than 65 years within the same cohort. Women older than 65 years represent a minority and constituted only 3% of patients in this multicenter 10-year review. We have shown that with careful patient selection, abdominally based autologous reconstruction should be considered in the elderly patient population because it is well tolerated and achieves high patient satisfaction.

Cost and outcome analysis of breast reconstruction paradigm shift.

Increased bilateral mastectomy for breast cancer treatment has generated an increased demand for bilateral breast reconstruction. This study examines changing patterns of reconstruction over the last decade to accommodate increased case volume and decreased morbidity associated with reconstruction. A single institution series of 3171 consecutive breast reconstruction cases of more than 10 years was divided into 2 periods, that is, 1999 to 2004 and 2005 to 2010. Bilateral breast reconstruction case volume increased 260% from 1999 to 2004 (n = 237) to 2005 to 2010 (n = 634). Mean patient age at diagnosis decreased by 7 years (P < 0.001). In 2005 to 2010, autologous reconstruction decreased from 60% to 26%, implant-based reconstruction increased from 40% to 74%. There was a noted increase in single-stage implant reconstruction and selective application of perforator flaps for bilateral autologous reconstruction (P < 0.001). Two-staged tissue expander reconstruction accounted for the greatest share of total cost (45%) in the later period. A younger patient demographic and increased case volume were accommodated through increased single-staged and prosthesis-based procedures.

The Austrian breast implant register: recent trends in implant-based breast surgery.

INTRODUCTION: Due to the fact that the number of breast implant surgeries for cosmetic and medical purposes is rising yearly, a discussion about the quality of service for both patients and physicians is more important than ever. To this end, we reviewed the Austrian Breast Implant Register with one specific question in mind: What are the trends? MATERIALS AND METHODS: In the statistical analysis of the Austrian Breast Implant Register, we were able to identify 13,112 registered breast implants between 2004 and 2012. The whole dataset was then divided into medical and cosmetic groups. We focused on device size, surface characteristics, filling material, device placement and incision site. All factors were considered for all examined years. RESULTS: In summary, the most used device had a textured surface (97 %) and silicone gel as the filling material (93 %). The mean size of implants for the cosmetic group was 240 cc, placement was submuscular (58 %) and the incision site was inframammary (67 %). In the medical group, the mean size was 250 cc. Yearly registrations had their peak in 2008 (1,898 registered devices); from this year on, registrations decreased annually. A slight trend away from subglandular placement in the cosmetic group was noted. Also, the usage of implants with polyurethane surface characteristics has increased since 2008. The smooth surface implants had a peak usage in 2006 and their usage decreased steadily from then on whereas the textured surface was steady over the years. DISCUSSION AND CONCLUSION: Keeping the problems related to the quality of breast implants in mind, we could recommend an obligatory national register. Organisations of surgeons and governments should develop and establish these registers. Furthermore, an all-encompassing international register should be established by the European Union and the American FDA (Food and Drug Administration); this might be useful in comparing the individual country registers and also would help in delivering "evidence based" medicine in cosmetic and medical procedures. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Evidence-based evaluation technique to assess augmentation mammaplasty results: a simple method to objectively analyze mammary symmetry and position.

BACKGROUND: Despite the great variety of mammaplasty techniques, outcome assessment remains a challenging issue. OBJECTIVES: The authors devised an objective method to evaluate mammary symmetry based on statistical analysis of objective manual breast measurements and validated the method by applying it to results of a randomized controlled trial on the correction of breast asymmetry. METHODS: Sixty consecutive patients with hypoplastic breasts and small-volume asymmetry were enrolled in the study and randomly assigned to 1 of 2 groups. One group received a fixed-volume implant in 1 breast and an adjustable-volume implant in the other. The other group received 2 fixed-volume implants of different sizes. The differences in specific breast and chest measurements, obtained before surgery and during follow-up, were analyzed statistically with the Wilcoxon signed rank test. RESULTS: Correction of the asymmetry resulted in the reduction of the differences between left and right values for each specific breast measurement. Placement of an adjustable implant on 1 side yielded better symmetry than placement of 2 fixed-volume prostheses of different sizes. Patient and physician satisfaction was high for both groups. CONCLUSIONS: This objective analysis of clinical parameters enables comparing results for different patients in large clinical trials and for the same patient at different follow-up periods. LEVEL OF EVIDENCE: 3.