Final opinion on the safety of breast implants in relation to anaplastic large cell lymphoma: Report of the scientific committee on health, emerging and environmental risks (SCHEER).

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) was requested by the European Commission (EC) to provide a scientific opinion on the safety of breast implants in relation to anaplastic large cell lymphoma (ALCL). There are several types of textured breast implants; surface textures of breast implants are not all manufactured in the same way, and breast implants with diverse surface textures may also present different benefits. The magnitude of the risk per type of textured implant is difficult to establish due to the low incidence of the breast implants associated anaplastic large cell lymphoma (BIA-ALCL). Therefore, risk assessments per implant type are needed. Overall SCHEER considers that there is a moderate weight of evidence for a causal relationship between textured breast implants and BIA-ALCL, particularly in relation to implants with an intermediate to high surface roughness.The pathogenic mechanisms are not fully elucidated; current hypotheses include genetic drivers, chronic inflammation resulting either from bacterial contamination, shell shedding of particulates, or shell surface characteristics leading to friction, or by implant associated reactive compounds. Reporting of new BIA-ALCL cases by the national clinical registries is critically important to obtain a better estimate of the risk of BIA-ALCL for patients with a breast implant.

Meta-analysis of prepectoral implant-based breast reconstruction: guide to patient selection and current outcomes.

PURPOSE:  This meta-analysis provides a large-scale comparison of prepectoral vs. subpectoral implant-based breast reconstruction, with primary outcomes of patient safety and efficacy. METHODS: Literature review was performed via PRISMA criteria, 33 studies met inclusion criteria for prepectoral review and 13 studies met inclusion criteria for meta-analysis. Patient characteristics and per-breast complications were collected. Data were analyzed using Cochrane RevMan and IBM SPSS. RESULTS: In 4692 breasts of 3014 patients that underwent prepectoral breast reconstruction, rippling was observed as the most common complication, followed by seroma and skin flap necrosis. Meta-analysis demonstrated statistically significant decrease in odds of skin flap necrosis and capsular contracture in prepectoral groups compared to subpectoral groups. Odds of infection, seroma, and hematoma were equal between the two groups. CONCLUSIONS: Prepectoral breast reconstruction has surged in popularity in recent years. This review and large-scale analysis corroborates current literature reporting a favorable safety profile with emphasis on patient selection. Variability in skin flap thickness and vascularity mandates thoughtful selection of patients whose overall health and intra-operative skin flap assessment can tolerate a muscle-sparing reconstruction.

Does Choice of Reconstruction Type Affect Survival in Patients With Metastatic Breast Cancer?

BACKGROUND: To compare the breast cancer-specific survival (BCSS) and overall survival (OS) between patients who underwent implant or tissue reconstruction after mastectomy with distant metastatic breast cancer (MBC). MATERIALS AND METHODS: Using the Surveillance, Epidemiology, and End Results database, we enrolled 371 female MBC cases diagnosed during the years 2004-2014. Patients were subdivided into implant (176) and tissue groups (195) for survival comparison between the two groups. The end points were BCSS and OS. Comparisons of the distribution of clinicopathologic characteristics were evaluated by chi-square test and Fisher exact test. Survival outcomes were compared by Kaplan-Meier model and multivariate Cox regression model for known clinicopathologic variables in both the entire population and in the reconstruction cohorts. RESULTS: In the entire cohort, patients with implant exhibited distinctly better BCSS (log rank, P = 0.002) and OS (log rank, P = 0.001) than patients with tissue reconstruction. Multivariate Cox regression model revealed that patients, who received prosthetic implants, were married, and progesterone receptor-positive group showed better survival rates in BCSS and OS. In addition, after stratification of the implant group and tissue groups according to clinicopathologic variables, the survival rate of patients in the implant group was higher than that in the tissue reconstruction group under the influence of factors, such as married, estrogen receptor-negative, nonradiotherapy, and chemotherapy. CONCLUSIONS: Our study provides further survival evidence supporting the practice of mastectomy with prosthetic implant reconstruction in patients with MBC under certain conditions.

Prepectoral Versus Subpectoral Direct to Implant Immediate Breast Reconstruction.

BACKGROUND: Implant-based reconstruction is currently the most common postmastectomy breast reconstruction modality with over 86,000 procedures performed in 2017. Although various methods for reconstruction techniques have been described, partial subpectoral implant placement with or without acellular dermal matrix coverage remains the most popular approach. Recently, prepectoral implant placement has gained increased recognition as a method that avoids some of the potential morbidities of submuscular implant placement. Currently, few studies have examined the outcomes of performing this approach. The purpose of this study was to evaluate and compare the outcomes of prepectoral and subpectoral direct to implant (DTI) immediate breast reconstruction. METHODS: Data from a prospective cohort of consecutive patients undergoing prepectoral DTI immediate breast reconstructions at our institution from February 2016 to November 2017 were collected. The incidence of complications such as mastectomy skin flap necrosis, seroma, hematoma, infection, implant loss, and unexpected reoperation were recorded and compared with a cohort of consecutive patients who underwent subpectoral DTI immediate breast reconstruction from May 2014 to July 2015. RESULTS: One hundred twelve prepectoral DTI immediate breast reconstructions were performed on 62 patients. Four breasts (4.4%) were diagnosed with infection. There were 8 breasts (7.1%) that suffered from mastectomy skin flap necrosis (5 partial thickness necrosis, 3 full thickness necrosis). There was 1 implant loss related to full thickness necrosis that required salvage with autologous tissue reconstruction. Prepectoral breast reconstruction had less esthetic revisions and comparable complications when compared with the historical subpectoral cohort. CONCLUSIONS: When compared with the subpectoral DTI approach, prepectoral DTI breast reconstruction grants favorable complication rates and improved esthetic outcomes. Prepectoral DTI breast reconstruction is a safe modality that should be considered in any patient who is a candidate for immediate breast reconstruction.

Breast Implant Prevalence in the Dutch Female Population Assessed by Chest Radiographs.

BACKGROUND: Breast implant-related health problems are a subject of fierce debate. Reliable population-based estimates of implant prevalence rates are not available, however, due to a lack of historical registries and incomplete sales data, precluding absolute risk assessments. OBJECTIVES: This study aimed to describe the methodology of a novel procedure to determine Dutch breast implant prevalence based on the evaluation of routine chest radiographs. METHODS: The validity of the new method was first examined in a separate study. Eight reviewers examined a series of 180 chest radiographs with (n = 60) or without (n = 120) a breast implant confirmed by a computed tomography or magnetic resonance imaging scan. After a consensus meeting with best-performing expert reviewers, we reviewed 3000 chest radiographs of women aged 20 to 70 years in 2 large regional hospitals in the Netherlands in 2015. To calculate the national breast implant prevalence, regional prevalence variations were corrected utilizing the National Breast Cancer Screening Program. RESULTS: Eight reviewers scored with a median sensitivity of 71.7% (range, 41.7%-85.0%) and a median specificity of 94.6% (range, 73.4%-97.5%). After a consensus meeting and a reevaluation by best-performing expert reviewers, sensitivity was 79.9% and specificity was 99.2%. The estimated national prevalence of breast implants among women between 20 and 70 years was 3.0%, ranging from 1.7% at 21 to 30 years to 3.9% between 51 and 60 years. CONCLUSIONS: The novel method in this study was validated with a high sensitivity and specificity, resulting in accurate prevalence estimates and providing the opportunity to conduct absolute risk assessment studies on the health consequences of breast implants.

Breast Implant-Associated Anaplastic Large Cell Lymphoma: What the Primary Care Physician Needs to Know.

This manuscript aims to outline the pertinent epidemiology, presentation, diagnosis, and treatment of patients who present with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as it pertains to primary care, such that the primary care physician (PCP) is able to appropriately care for patients with breast implants and counsel on risks of BIA-ALCL.

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.

Impact of Contralateral Symmetry Procedures on Long-Term Patient-Reported Outcomes following Unilateral Prosthetic Breast Reconstruction.

BACKGROUND: One aim of unilateral postmastectomy breast reconstruction (BR) is to restore symmetry with the contralateral breast. As such, unilateral prosthetic reconstruction often requires a contralateral symmetry procedure (CSP). There is sparse literature on the impact of CSPs on long-term patient-reported outcomes (PROs) such as satisfaction and health-related quality of life (HRQoL). This study aims to describe PROs following CSPs, using a validated PRO tool, BREAST-Q. The hypothesis is that CSPs are associated with greater patient-reported satisfaction and HRQoL. METHODS: This study is a single institutional analysis of prospectively collected BREAST-Q scores of patients who underwent unilateral prosthetic BR during 2011 to 2015. Women 18 years and older with BREAST-Q scores measured ≥ 9months after BR with or without CSP(s) at the time of expander replacement were included. Patients were classified into four subcohorts: augmentation, mastopexy, reduction, and no symmetry procedure (controls). Sociodemographic, clinical characteristics, and BREAST-Q scores were analyzed. Multivariable linear regression was performed. RESULTS: Of 553 patients, 67 (12%) underwent contralateral augmentation, 68 (12%) mastopexy, 93(17%) reduction, and 325 (59%) were controls. Mean follow-up time was 52 months. Satisfaction with breast and outcomes were higher in the augmentation compared with the control groups (p = 0.01). On multivariable analysis, augmentation remained an independent predictor of satisfaction with breast (p = 0.04). Physical well-being scores were lower for contralateral mastopexy and reduction compared with the controls with a trend toward statistical significance on multivariable models. Psychological and sexual well-being was similar across groups. CONCLUSION: Prosthetic reconstruction with contralateral breast augmentation was associated with greater satisfaction with breast and reconstructive outcome. In contrast, breast reduction and mastopexy procedures demonstrated equivalent satisfaction with breasts compared with controls but may be associated with lower physical well-being. Such information can be used to improve the shared decision-making process for women who choose unilateral prosthetic BR.

Long-Term Outcomes in Breast Augmentation in Trans-Women: A 20-Year Experience.

BACKGROUND: Breast augmentation in trans-women requires special consideration and thorough preoperative planning. OBJECTIVES: This study aimed to present our long-term outcome and experience gained over the past 21 years. METHODS: Trans-women who have undergone breast augmentation since 1995 were reviewed for primary surgery, type of incision, implant site, implant size and shape, and revisions. RESULTS: A total of 138 patients with a follow-up of 4.6 years (range, 2.0-13.3) were included. In 112 patients (82.4%), the inframammary incision was chosen. Subpectoral implantation was performed in 70 patients (51.5%). Round breast implants (91 patients, 66.9%, P = 0.010) with low projection (103 patients, 75.7%, P < 0.001) were favored. The implant size used during 2011-2016 of 363.3 ± 97.3 cc was significantly increased as compared to the implant size reported during 1995-1999 (mean difference, +142.1 cc, P < 0.001) and 2000-2004 (mean difference, +113.5 cc, P < 0.001). Simultaneously, revision rates dropped significantly over time (52.9% during 1995-1999 as compared to 6.9% during 2011-2016, P < 0.001). Overall, request for larger implants was the most common indication for revision (13 patients, 9.4%) after 6 months (range, 4.0-18.7). At revision, implant volume was 355.4 ± 132.8 cc, showing significant increase of 107.0 ± 48.1 cc as compared to primary implants (+30.0%, P = 0.048). CONCLUSIONS: Request for larger breast implants was the most common reason for revision. Depending on the various degrees of breast tissue growth due to hormonal therapy, whenever applicable, we recommend round, low projection implants with a mean size of 360 cc in the prepectoral pocket.

Two-Staged Implant-Based Breast Reconstruction: A Long-Term Outcome Study in a Young Population.

Background and objectives: Differences in patient anatomy and physiology exist between young and older patients undergoing breast reconstruction after mastectomy. Breast cancer has been described as being more aggressive, more likely to receive radiation, contralateral mastectomy, as well as bilateral reconstruction in young patients. Our purpose is to report long-term experience on two-staged implant-based breast reconstruction (IBR) in young females, with complication sub-analysis based on obesity and adjuvant radiation. Materials and Methods: Retrospective chart review of all consecutive young patients who underwent two-staged IBR at our institution, between 2000 and 2016, was performed. Patients between 15 and 40 years old with least 1-year follow-up were included. Univariate logistic regression models and receiver operating characteristic (ROC) curves were created. Results: Overall 594 breasts met our inclusion criteria. The mean age was 34 years, and the median follow-up was 29.6 months. Final IBR was achieved in 98% of breasts. Overall, 12% of breasts had complications, leading to explantations of 5% of the devices. Adjuvant radiation was followed by higher rates of total device explantations (p = 0.003), while obese patients had higher rates of total complications (p < 0.001). For each point increase in BMI, the odds of developing complications increased 8.1% (p < 0.001); the cutoff BMI to predict higher complications was 24.81 kg/m2. Conclusions: This population demonstrates high successful IBR completion and low explantation rates. These data suggest that obese women and those with planned adjuvant radiation deserve special counseling about their higher risk of complications.

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.

National Breast Reconstruction Utilization in the Setting of Postmastectomy Radiotherapy.

Background Immediate breast reconstruction (IBR) is often deferred, when postmastectomy radiotherapy (PMRT) is anticipated, due to high complication rates. Nonetheless, because of robust data supporting improved health-related quality of life associated with reconstruction, physicians and patients may be more accepting of tradeoffs. The current study explores national trends of IBR utilization rates and methods in the setting of PMRT, using the National Cancer Database (NCDB). The study hypothesis is that prosthetic techniques have become the most common method of IBR in the setting of PMRT. Methods NCDB was queried from 2004 to 2013 for women, who underwent mastectomy with or without IBR. Patients were grouped according to PMRT status. Multivariate logistic regression was used to calculate odds of IBR in the setting of PMRT. Trend analyses were done for rates and methods of IBR using Poisson regression to determine incidence rate ratios (IRRs). Results In multivariate analysis, radiated patients were 30% less likely to receive IBR (p < 0.05). The rate increase in IBR was greater in radiated compared with nonradiated patients (IRR: 1.12 vs. 1.09). Rates of reconstruction increased more so in radiated compared with nonradiated patients for both implants (IRR 1.15 vs. 1.11) and autologous techniques (IRR 1.08 vs. 1.06). Autologous reconstructions were more common in those receiving PMRT until 2005 (p < 0.05), with no predominant technique thereafter. Conclusion Although IBR remains a relative contraindication, rates of IBR are increasing to a greater extent in patients receiving PMRT. Implants have surpassed autologous techniques as the most commonly used method of breast reconstruction in this setting.

Long-Term Safety of Textured and Smooth Breast Implants.

In this review, the authors provide a 20-year review and comparison of implant options and describe the evolution of breast implant surface textures; compare available implant surfaces; present long-term safety data from the 10-year US-based Core clinical studies; list the key benefits and risks associated with smooth and textured implants; and provide perspectives on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The authors explore the key benefits and risks associated with all available devices so that optimal and safe patient outcomes can be achieved.

Halo and spillover effect illustrations for selected beneficial medical devices and drugs.

BACKGROUND: Negative news media reports regarding potential health hazards of implanted medical devices and pharmaceuticals can lead to a 'negative halo effect,' a phenomenon whereby judgments about a product or product type can be unconsciously altered even though the scientific support is tenuous. To determine how a 'negative halo effect' may impact the rates of use and/or explantation of medical products, we analyzed the occurrence of such an effect on three implanted medical devices and one drug: 1) intrauterine contraceptive devices (IUDs); 2) silicone gel-filled breast implants (SGBI); 3) metal-on-metal hip implants (MoM); and 4) the drug Tysabri. METHODS: Data on IUD use from 1965 to 2008 were gathered from the Department of Health and Human Services Vital and Health Statistics and peer-reviewed publications. Data regarding SGBI implant and explantation rates from 1989 to 2012 were obtained from the Institute of Medicine and the American Society of Plastic Surgeons. MoM implant and explantation data were extracted from the England and Wales National Joint Registry and peer-reviewed publications. Tysabri patient data were reported by Elan Corporation or Biogen Idec Inc. Data trends for all products were compared with historical recall or withdrawal events and discussed in the context of public perceptions following such events. RESULTS: We found that common factors altered public risk perceptions and patterns of continued use. First, a negative halo effect may be driven by continuing patient anxiety despite positive clinical outcomes. Second, negative reports about one product can spill over to affect the use of dissimilar products in the same category. Third, a negative halo effect on an entire category of medical devices can be sustained regardless of the scientific findings pertaining to safety. Fourth, recovery of a product's safety reputation and prevalent use may take decades in the U.S., even while these products may exhibit widespread use and good safety records in other countries. CONCLUSIONS: We conclude that the 'negative halo effect' associated with a stigma, rather than an objective risk-benefit assessment of medical products can increase negative health outcomes for patients due to reduced or inappropriate product usage.

Longitudinal Ultrasound Study of Breast Implant Rupture Over a Six-Year Interval.

BACKGROUND: Silicone gel-filled implants as opposed to saline-filled breast implants are the most commonly used breast implants in Europe, and this has recently also become the case in the United States. Modern implants have a multiple layer silicone shell and high to very high levels of cohesive silicone gel inside. Although breast magnetic resonance imaging is at present considered the gold standard imaging method for breast implant rupture detection, breast ultrasound (US) imaging is still the first-step investigation in Europe. The aim of this study was to verify whether or not the stepladder sign at US is still associated to intracapsular rupture among the last generation silicone breast implant. MATERIALS AND METHODS: In this study, 156 patients presenting for breast augmentation, mastopexy with implants and breast reconstruction for a total number of 303 breast implants inserted were enrolled. A preoperative breast ultrasonography was performed, and patients underwent a routine US scan every 6 months for 24 months to evaluate the implant status. A final US evaluation 6 years after implantation was also performed. RESULTS: Stepladder signs were seen at 6 years in 170 implants (56%) of the examined implants at US scan, and only 2 implants showed signs of possible rupture because of severe distortion of the implant profile with or without external silicone collection. A third ruptured implant was detected at magnetic resonance imaging by the presence of breach of the shell at the posterior surface of the implant with small external silicon collection and was eventually confirmed at surgery. Therefore, the overall rupture rate found at the United States at 6 years was about 1% (3 of 303 implants). According to our findings, the stepladder sign at the United States is no longer associated to intracapsular rupture. CONCLUSIONS: Plastic surgeons, patients, and financial departments of hospitals would also be delighted to know that surgeons should not take patients back to theater for implant explantation when aging signs are not associated with a visible breach of the implant shell or external silicone collections.

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.