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.

A Comparison of BREAST-Q Scores between Prepectoral and Subpectoral Direct-to-Implant Breast Reconstruction.

BACKGROUND: Subpectoral breast implant placement has in recent history predominated in breast reconstruction, but there has been more recent adoption of prepectoral implant reconstruction. There has been limited study to date of patient-reported outcomes comparing the two techniques. METHODS: Patients who underwent direct-to-implant breast reconstruction between 2013 and 2018 were included in this retrospective cohort study. Eligible patients were asked to complete BREAST-Q domains comparing quality of life and satisfaction. Descriptive, t test, chi-square test, and multivariate linear regression analyses were performed to compare BREAST-Q scores. Significance was defined as p ≤ 0.05. RESULTS: There were 64 patients (114 breasts) who underwent prepectoral reconstruction and 37 patients (68 breasts) who underwent subpectoral reconstruction. Among the 101 women (182 breasts), there were no significant differences between BREAST-Q scores and implant position for the Satisfaction with Breasts domain (adjusted p = 0.819), Psychosocial Well-being domain (adjusted p = 0.206), or Physical Well-being Chest domain (adjusted p = 0.110). The subpectoral implant cohort was associated with higher scores, 53 versus 47, for the Sexual Well-being module (adjusted p = 0.001). CONCLUSIONS: Patients undergoing direct-to-implant breast reconstruction had comparable BREAST-Q satisfaction scores for most modules regardless of implant plane. The subpectoral implant cohort scored higher for sexual well-being.

An Analysis of Ptosis following Subfascial Breast Augmentation: Calculations That Explain Dogma.

BACKGROUND: Implant placement can improve ptosis due to the position of the nipple, inframammary crease, and base of the breast acting together. The interrelationship between these was quantified via changes in morphometry following subfascial augmentation, and explains the circumstances under which dogma holds true. METHODS: One hundred seventy-five patients underwent a series of static measurements before and 3 months after subfascial breast augmentation. Ptosis in the nipple and base of the breast was calculated before and after surgery. RESULTS: All measurements except that of the the lateral sternal margin increased after surgery. All grades of ptosis reduced following surgery. There was lowering of the base in grade 1 patients, but not for other grades. Increased base ptosis correlated with reduced lateral sternal margin (1.9 cm compared with 2.9 cm; left, H5 = 24.7, p < 0.01; right, H5 = 24.5, p < 0.01). Implant volume did not correlate with change in ptosis at the nipple or base. Reduced ptosis was associated with implants that are a narrow match of implant to breast (0.52 to 0.95) (left, H5 = 28.3, p < 0.01; right, H5 = 24.9, p < 0.01). Decreasing ptosis correlated with lower lateral sternal margin compared to breasts that increased ptosis. Change in ptosis following surgery does not correlate with having children. CONCLUSIONS: Subfascial placement has varying effects on ptosis. Non-ptotic or mildly ptotic breasts appear to improve due to a disproportionate descent of the inframammary crease relative to the nipple and base. Patients with little breast tissue are more susceptible to an increase in "bottoming out," particularly if broad implants are used. A ratio matching implant to the base width has predictive value on outcome. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Effects of general anesthesia on quality of recovery after transaxillary endoscopic breast augmentation: A randomized controlled trial.

BACKGROUND: Types of general anesthesia may affect the quality of recovery, but few studies have investigated the quality of postoperative recovery, and none has focused on patients undergoing breast augmentation. METHODS: This prospective, parallel, randomized controlled study enrolled 104 patients undergoing transaxillary endoscopic breast augmentation. Eligible patients were randomly assigned to receive inhalation anesthesia (IH, n = 52) or total intravenous anesthesia (TIVA, n = 52). Quality of recovery was assessed on the first and on the second postoperative days using the 15-item Quality of Recovery questionnaire (QoR-15). Baseline demographic, clinical characteristics, and operative data were also collected. RESULTS: The IH and TIVA groups had similar QoR-15 total scores on the first postoperative day (P = .921) and on the second postoperative day (P = .960), but the IH group had a significantly higher proportion of patients receiving antiemetics than the TIVA group (53.6% vs 23.1%, P = .002). Multivariate analysis revealed that the type of general anesthesia was not significantly associated with QoR-15 total scores on the first postoperative day (ß = 0.68, P = .874) and with QoR-15 total scores on the second postoperative day (ß = 0.56, P = .892), after adjusting for age, BMI, operation time, steroids use, and antiemetics use. CONCLUSION: For the patients undergoing transaxillary endoscopic breast augmentation, the type of general anesthesia did not significantly impact the quality of recovery. Both IH or TIVA could provide good quality of recovery demonstrated by high QoR-15 total scores. The results suggested that the type of general anesthesia may not be the most critical factors of quality of recovery in the patients undergoing transaxillary endoscopic breast augmentation.

Breast Device Surgery in Australia: Early Results from the Australian Breast Device Registry.

BACKGROUND: The Australian Breast Device Registry (ABDR) is a clinical quality registry designed to monitor the performance of breast devices; and the quality and safety of breast device surgery. OBJECTIVE: To report on breast device surgery characteristics across Australia. METHODS: Participants were registered patients in the ABDR from 2012 to 2018. Results are described using percentages, mean and median. Revision rates were calculated using survival analysis methods. RESULTS: A total of 37,603 patients were registered and had undergone reconstruction (post-cancer 15.1%, risk-reducing mastectomy 3.4% and developmental deformity 2.4%) or cosmetic augmentation (74.7%) procedures. The majority of breast implant devices were silicone filled with textured surface (reconstruction 74.0% and augmentation 64.0%). Sub-pectoral plane was the most common for both reconstruction (60.1%) and augmentation (76.6%) procedures. For reconstruction surgery, the most common surgical incision was previous mastectomy scar (44.0%) and inframammary (31.8%), and for augmentation, it was inframammary (83.4%). Intraoperative/postoperative antibiotic usage for reconstruction was 85.8% and augmentation was 89.4%. Revision incidence due to complication at 12 months post-cancer reconstruction was 5.1%, risk-reducing reconstruction 5.7% and developmental deformity implants 4.5%. Revision incidence due to complication at 12 months after augmentation procedure was 1.1%. Patient-reported outcome measures (PROMs) indicate high levels of satisfaction at 1 year for augmentation and reconstruction procedures. CONCLUSION: We report on early data from the ABDR and reflect on the uptake of the registry by surgeons and patients. The registry also benefits from international collaborative approaches to addressing challenges and is committed to facilitate international post-market surveillance.

Breast reconstruction patterns from a Swedish nation-wide survey.

OBJECTIVES: The overall aim of the Swedish Breast Reconstruction Outcome Study was to investigate national long-term outcomes after mastectomy with or without breast reconstruction. The current report evaluates breast reconstruction (BR) patterns in Sweden over time. MATERIALS AND METHODS: This is a cross-sectional, registry-based study where all women operated with mastectomy 2000, 2005, 2010 were identified (N = 5853). Geographical differences in type of BR were investigated using heatmaps. Distribution of continuous variables were compared using the Mann-Whitney U test, categorical variables were compared using the chi-square test. RESULTS: Mean age at survey was 69 years (SD=±11.4) and response rate was 50%, responders were on average six years younger than the non-responders and had a more favourable tumor stage (both p < 0.01). Of the 2904 responders, 31% (895/2904) had received a BR: implant-based in 58% (516/895)autologous in 31% (281/895). BR was immediate in 20% (176/895) and delayed in 80% (719/895) women. Women with BR were on average one year older, more often had a normal BMI, reported to be married or had a partner, had a higher educational level and a higher annual income when compared to those without BR (all p < 0.001). The independent factors of not receiving BR were older age and given radiotherapy. CONCLUSIONS: To our knowledge, this is the first national long-term follow-up study on women undergoing mastectomy with and without BR. Around 30% of the survey responders have had a BR with a significant geographical variation highlighting the importance of information, availability and standardisation of indications for BR.

Impact of Physician Payments on Microvascular Breast Reconstruction: An All-Payer Claim Database Analysis.

BACKGROUND: Rates of autologous breast reconstruction are stagnant compared with prosthetic techniques. Insufficient physician payment for microsurgical autologous breast reconstruction is one possible explanation. The payment difference between governmental and commercial payers creates a natural experiment to evaluate its impact on method of reconstruction. This study assessed the influence of physician payment differences for microsurgical autologous breast reconstruction and implants by insurance type on the likelihood of undergoing microsurgical reconstruction. METHODS: The Massachusetts All-Payer Claims Database was queried for women undergoing immediate autologous or implant breast reconstruction from 2010 to 2014. Univariate analyses compared demographic and clinical characteristics between different reconstructive approaches. Logistic regression explored the relative impact of insurance type and physician payments on breast reconstruction modality. RESULTS: Of the women in this study, 82.7 percent had commercial and 17.3 percent had governmental insurance. Implants were performed in 80 percent of women, whereas 20 percent underwent microsurgical autologous reconstruction. Women with Medicaid versus commercial insurance were less likely to undergo microsurgical reconstruction (16.4 percent versus 20.3 percent; p = 0.063). Commercial insurance, older age, and obesity independently increased the odds of microsurgical reconstruction (p < 0.01). When comparing median physician payments, governmental payers reimbursed 78 percent and 63 percent less than commercial payers for microsurgical reconstruction ($1831 versus $8435) and implants ($1249 versus $3359, respectively). Stratified analysis demonstrated that as physician payment increased, the likelihood of undergoing microsurgical reconstruction increased, independent of insurance type (p < 0.001). CONCLUSIONS: Women with governmental insurance had lower odds of undergoing microsurgical autologous breast reconstruction compared with commercial payers. Regardless of payer, greater reimbursement for microsurgical reconstruction increased the likelihood of microsurgical reconstruction. Current microsurgical autologous breast reconstruction reimbursements may not be commensurate with physician effort when compared to prosthetic techniques. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.

Elective Revisions after Breast Reconstruction: Results from the Mastectomy Reconstruction Outcomes Consortium.

BACKGROUND: Rates of breast reconstruction following mastectomy continue to increase. The objective of this study was to determine the frequency of elective revision surgery and the number of procedures required to achieve a stable breast reconstruction 2 years after mastectomy. METHODS: Women undergoing first-time breast reconstruction after mastectomy were enrolled and followed for 2 years, with completion of reconstruction occurring in 1996. Patients were classified based on the absence or presence of complications. Comparisons within cohorts were performed to determine factors associated with revisions and total procedures. Mixed-effects regression modeling identified factors associated with elective revisions and total operations. RESULTS: Overall, 1534 patients (76.9 percent) had no complications, among whom 40.2 percent underwent elective revisions. The average number of elective revisions differed by modality (p < 0.001), with abdominally based free autologous reconstruction patients undergoing the greatest number of elective revisions (mean, 0.7). The mean total number of procedures also differed (p < 0.001), with tissue expander/implant reconstruction patients undergoing the greatest total number of procedures (mean, 2.4). Complications occurred in 462 patients (23.1 percent), with 67.1 percent of these patients undergoing elective revisions, which was significantly higher than among patients without complications (p < 0.001). The mean number of procedures again differed by modality (p < 0.001) and followed similar trends, but with an increased mean number of revisions and procedures overall. Mixed-effects regression modeling demonstrated that patients experiencing complications had increased odds of undergoing elective revision procedures (OR, 3.2; p < 0.001). CONCLUSIONS: Breast reconstruction patients without complications undergo over two procedures on average to achieve satisfactory reconstruction, with 40 percent electing revisions. If a complication occurs, the number of procedures increases. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.

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.

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.

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.

Is There a Preferred Incision Location for Nipple-Sparing Mastectomy? A Systematic Review and Meta-Analysis.

BACKGROUND: The incidence of nipple-sparing mastectomy is rising, but no single incision type has been proven to be superior. This study systematically evaluated the rate and efficacy of various nipple-sparing mastectomy incision locations, focusing on nipple-areola complex necrosis and reconstructive method. METHODS: A systematic literature review was performed according to the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines identifying studies on nipple-sparing mastectomy where incision type was described. Pooled descriptive statistics meta-analysis of overall (nipple-areola complex) necrosis rate and nipple-areola complex necrosis by incision type was performed. RESULTS: Fifty-one studies (9975 nipple-sparing mastectomies) were included. Thirty-two incision variations were identified and categorized into one of six groups: inframammary fold, radial, periareolar, mastopexy/prior scar/reduction, endoscopic, and other. The most common incision types were inframammary fold [3634 nipple-sparing mastectomies (37.8 percent)] and radial [3575 nipple-sparing mastectomies (37.2 percent)]. Meta-analysis revealed an overall partial nipple-areola complex necrosis rate of 4.62 percent (95 percent CI, 3.14 to 6.37 percent) and a total nipple-areola complex necrosis rate of 2.49 percent (95 percent CI, 1.87 to 3.21 percent). Information on overall nipple-areola complex necrosis rate by incision type was available for 30 of 51 studies (4645 nipple-sparing mastectomies). Periareolar incision had the highest nipple-areola complex necrosis rate (18.10 percent). Endoscopic and mastopexy/prior scar/reduction incisions had the lowest rates of necrosis at 4.90 percent and 5.79 percent, respectively, followed by the inframammary fold incision (6.82 percent). The rate of single-stage implant reconstruction increased during this period. CONCLUSIONS: For nipple-sparing mastectomy, the periareolar incision maintains the highest necrosis rate because of disruption of the nipple-areola complex blood supply. The inframammary fold incision has become the most popular incision, demonstrating an acceptable complication profile.

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.

Evolving Trends in Textured Implant Use for Cosmetic Augmentation in the United States.

BACKGROUND: Breast implants have evolved for decades. In 2011, the U.S. Food and Drug Administration identified an association between textured breast implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The purpose of this study was to identify the trends of textured implant use since that time. METHODS: Maintenance of Certification tracer data were queried between 2011 and 2015 for cosmetic breast augmentation cases submitted by American Board of Plastic Surgery diplomates. A nested random effects logistic regression analysis was used to identify associations between variables. RESULTS: Eleven thousand seven hundred sixteen breast augmentations were performed by 880 unique surgeons. The overall proportion of cases using textured implants increased steadily from 2.3 percent in 2011 to 13.0 percent in 2015 (p < 0.001). The proportion of surgeons whose cases included both textured and smooth implants increased (from 6.2 percent to 24.3 percent), as did those using only textured implants (from 0.4 percent to 4.4 percent) (p < 0.001). Significance remained after controlling for form-stable implants, suggesting an alternative motivation for use of textured implants. Subglandular cases (20.5 percent) were more likely to use a textured implant than submuscular (8.4 percent) or dual-plane (7.8 percent) (p < 0.001) cases. CONCLUSIONS: Maintenance of Certification tracer data represent a random sampling of American Board of Plastic Surgery-certified plastic surgeons spanning the gamut of practice settings. Despite ongoing education regarding the association of BIA-ALCL with textured implants, American Board of Plastic Surgery diplomates have trended toward increased use of textured implants for cosmetic breast augmentation since 2011. This finding does not appear to be driven by the introduction of anatomical implants during the study period.

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.

Immediate Implant-Based Breast Reconstruction with Acellular Dermal Matrix: A Comparison of Sterile and Aseptic AlloDerm in 2039 Consecutive Cases.

BACKGROUND: Sterile ready-to-use acellular dermal matrix, introduced as an alternative to aseptic freeze-dried acellular dermal matrix for implant-based breast reconstruction, has been investigated in a limited number of studies. This study compared outcomes in implant-based breast reconstruction with ready-to-use and freeze-dried acellular dermal matrix. METHODS: The authors analyzed patients undergoing implant-based breast reconstruction with either freeze-dried or ready-to-use acellular dermal matrix, including demographics, clinical variables, and outcomes. An a priori power analysis was performed and logistic regression modeling was used to quantify the effect of acellular dermal matrix on outcomes while controlling for potential confounders. RESULTS: A total of 1285 consecutive patients undergoing 2039 immediate prosthetic breast reconstructions constituted the population: 612 (n = 910 breasts) with freeze-dried matrix and 673 (n = 1129 breasts) with ready-to-use acellular dermal matrix. The freeze-dried matrix cohort had a significantly higher rate of explantation compared with the ready-to-use matrix cohort (18.0 percent versus 12.0 percent; p = 0.0036), but surgical-site infection, wound dehiscence, mastectomy flap necrosis, seroma, and hematoma did not differ significantly between groups. On multivariate regression, patients undergoing reconstruction with freeze-dried matrix, compared to ready-to-use matrix, did not have higher odds of experiencing surgical-site infections (OR, 1.064; p = 0.7455), but did have higher odds of explantation (OR, 1.570; p = 0.0161). Tobacco use (OR, 2.809; p = 0.0002) and body mass index (OR, 1.054; p < 0.0001) were also independent predictors of explantation. CONCLUSION: Immediate implant-based breast reconstruction with sterile ready-to-use acellular dermal matrix has a comparable overall safety profile and a lower rate of prosthetic explantations compared with aseptic freeze-dried acellular dermal matrix. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Ten-year Core Study Data for Sientra's Food and Drug Administration-Approved Round and Shaped Breast Implants with Cohesive Silicone Gel.

BACKGROUND: In March 2012, the United States Food and Drug Administration approved Sientra's application for premarket approval of its portfolio of round and shaped silicone gel breast implants based on data from the largest silicone gel breast implant study to date. This article presents the results of Sientra's Core Study at the conclusion of 10 years. METHODS: The Sientra Core Study was a 10-year, open-label, prospective, multicenter clinical study designed to assess the safety and effectiveness of Sientra's breast implants in augmentation and reconstruction. A total of 1,788 patients (3,506 implants) were enrolled, including 1,116 primary augmentation, 363 revision-augmentation, 225 primary reconstruction, and 84 revision-reconstruction. RESULTS: Across all cohorts, the rate of rupture by patient was 8.6%, the rate of Baker grade III/IV capsular contracture was 13.5%, and the rate of reoperation was 31.5%. The rate of capsular contracture was statistically significantly lower for textured devices [9.0%; 95% confidence interval (CI), 7.0-11.5%] compared with smooth devices (17.5%; 95% CI, 14.9-20.4%). There were no cases of breast implant-associated anaplastic large cell lymphoma. Primary reasons for reoperations included capsular contracture (18.8%), and style/size change (19.3%), with over 50% of the reoperations due to cosmetic reasons. CONCLUSION: The 10-year results of Sientra's Core Study support a comprehensive safety and effectiveness profile of Sientra's portfolio of round and shaped breast implants.

Risk Factor Analysis for Capsular Contracture: A 10-Year Sientra Study Using Round, Smooth, and Textured Implants for Breast Augmentation.

BACKGROUND: Despite the increased understanding of surgical best practices, capsular contracture remains the most commonly reported complication and reason for reoperation following breast implant surgery. This study provides a long-term update to a previous investigation of potential contributing risk factors for capsular contracture in primary augmentation patients. METHODS: The data used for this analysis include 5,122 implants in 2,565 primary augmentation patients implanted by 34 surgeons based on long-term results from Sientra's clinical study. Potential risk factors, including patient and implant attributes, surgery characteristics, pocket irrigation, and postsurgery characteristics, were analyzed using frequency and multivariate models. RESULTS: A total of 333 capsular contracture events in 224 patients were reported. The overall Kaplan-Meier rate for capsular contracture was 10.8% by device through 10 years. Results from the multivariate analysis found 8 factors to be independently associated with capsular contracture (implant placement, implant surface, incision site, hematoma or seroma development, device size, surgical bra, steroid, and antibiotic pocket irrigation; all P values < 0.05). Results from correlation analysis found 2 of the 8 factors to be more strongly associated with early onset capsular contracture events, compared with those occurring after 2 and 5 years of implantation (implant surface and steroid pocket irrigation). CONCLUSION: The results of this large-scale, multivariate analysis identified several significant risk factors for capsular contracture, including device features (smooth surface, smaller size), surgical factors (periareolar incision, subglandular placement, antibiotic irrigation), the development of hematoma/seroma, and the use of a surgical bra.