Out-of-Pocket Costs and Payments in Autologous and Implant-Based Breast Reconstruction: A Nationwide Analysis.

BACKGROUND: Many factors influence a patient's decision to undergo autologous versus implant-based breast reconstruction, including medical, social, and financial considerations. This study aims to investigate differences in out-of-pocket and total spending for patients undergoing autologous and implant-based breast reconstruction. METHODS: The IBM MarketScan Commercial Databases were queried to extract all patients who underwent inpatient autologous or implant-based breast reconstruction from 2017 to 2021. Financial variables included gross payments to the provider (facility and/or physician) and out-of-pocket costs (total of coinsurance, deductible, and copayments). Univariate regressions assessed differences between autologous and implant-based reconstruction procedures. Mixed-effects linear regression was used to analyze parametric contributions to total gross and out-of-pocket costs. RESULTS: The sample identified 2079 autologous breast reconstruction and 1475 implant-based breast reconstruction episodes. Median out-of-pocket costs were significantly higher for autologous reconstruction than implant-based reconstruction ($597 vs $250, P < 0.001) as were total payments ($63,667 vs $31,472, P < 0.001). Type of insurance plan and region contributed to variable out-of-pocket costs (P < 0.001). Regression analysis revealed that autologous reconstruction contributes significantly to increasing out-of-pocket costs (B = $597, P = 0.025) and increasing total costs (B = $74,507, P = 0.006). CONCLUSION: The US national data demonstrate that autologous breast reconstruction has higher out-of-pocket costs and higher gross payments than implant-based reconstruction. More study is needed to determine the extent to which these financial differences affect patient decision-making.

Technical Refinements and Outcomes Assessment in Prepectoral Pocket Conversion After Postmastectomy Radiotherapy.

BACKGROUND: Several studies show how submuscular breast reconstruction is linked to animation deformity, shoulder dysfunction, and increased postoperative chest pain, when compared to prepectoral breast reconstruction. In solving all these life-impairing side effects, prepectoral implant pocket conversion has shown encouraging results. OBJECTIVES: The aim of this study was to propose a refinement of the prepectoral implant pocket conversion applied to previously irradiated patients. METHODS: We conducted a retrospective study on 42 patients who underwent previous nipple- or skin-sparing mastectomy and immediate submuscular reconstruction, followed by radiotherapy. We performed fat grafting sessions as regenerative pretreatment. Six months after the last fat graft, we performed the conversion, with prepectoral placement of micropolyurethane foam-coated implants. We investigated the preconversion and postconversion differences in upper limb range of motion, Upper Extremity Functional Index, and patient satisfaction with the breast and physical well-being of the chest. RESULTS: We reported a resolution of animation deformity in 100% of cases. The range of motion and the Upper Extremity Functional Index scores were statistically improved after prepectoral implant pocket conversion. BREAST-Q scores for satisfaction with the breast and physical well-being of the chest were also improved. CONCLUSIONS: The refined prepectoral implant pocket conversion is a reliable technique for solving animation deformity and improving quality of life in patients previously treated with submuscular reconstruction and radiotherapy.

Prevalence, clinical characteristics, and management of silicone lymphadenopathy: A systematic review of the literature.

INTRODUCTION: Implant-based breast augmentations and reconstructions are one of the most common surgical procedures performed by plastic surgeons in the United States, which has rapidly increased in popularity since the 2000s. Silicone lymphadenopathy (SL) is a complication of breast implants that involves migration of silicone to nearby soft tissue/lymph nodes. Data on its clinical features and management is scarce. METHODS: SL-related search terms were used to find articles in 3 databases. Of 598 articles, 101 studies met the inclusion criteria. Demographics, clinical presentation, workup, and management data were analyzed. RESULTS: Of 279 cases of SL and 107 with information on initial diagnosis, 35 (33%) were incidental. The most common symptom was painless lymphadenopathy, followed by painful lymphadenopathy. 251 (95%) and 13 (5%) patients had silicone and saline implants, respectively. 149 (68%) patients had implant rupture. Axillary lymphadenopathy was the most affected region (136 cases, 72%), followed by internal mammary (40 cases, 21%), cervical/supraclavicular (36 cases, 19%), and mediastinal (24 cases, 13%) regions. 25% of patients underwent fine-needle aspiration, 12% core needle biopsy, and 59% excisional biopsy. 32% of cases underwent explantation and/or implant exchange. The most common indication for surgery was implant rupture. Histology showed multinucleated giant cells, large histiocytes, and silicone accumulation. CONCLUSIONS: SL is a complication associated with breast implants. The majority of patients are asymptomatic, and most cases are managed conservatively. Minority need a biopsy and surgical interventions due to abnormal imaging, persistent symptoms, and/or implant rupture. Workup and management should be tailored to the patient.

Sonographic Assessment of Breast Implants Using Strain Elastography and Shear Wave Elastography in an Animal Model.

BACKGROUND/AIM: To date, magnetic resonance imaging (MRI) remains the gold standard for diagnosing breast implant rupture. As MRI is an expensive procedure with limited availability, the improvement of sonographic assessment is desirable. A potentially useful tool in this regard is elastography. To evaluate the diagnostic benefits of strain elastography and shear wave elastography under standardized conditions we developed an animal model. MATERIALS AND METHODS: An animal model was created by preparing an implant site in a chicken breast, imitating tissue layers covering a breast implant after mastectomy. Different broken and intact implants were inserted. Thereby, measurements were performed using strain elastography and shear wave elastography. For strain elastography, the resulting images were investigated on repeated patterns. The data generated by shear wave elastography were analyzed for significant differences between the ruptured and intact implants. RESULTS: The animal model using chicken breast generated realistic images and measurements comparable to those of a human breast. Hence, ruptured and intact implants could be compared under standardized conditions. Statistical analysis showed no significant difference between intact and ruptured implants with respect to the data generated by shear wave elastography. Qualitative analysis using strain wave elastography showed different patterns between intact and ruptured implants in the animal model. Intact implants showed a characteristic sonographic image of three layers in certain levels. CONCLUSION: Shear wave elastography does not seem to produce reliable data for the evaluation of breast implants, whereas qualitative analysis using strain elastography might be a useful tool to improve diagnostic accuracy.

Post-mastectomy Breast Reconstruction With Gas vs Saline Tissue Expanders: Does the Fill Type Matter?

The most common reconstruction technique following mastectomy is a 2-stage technique that involves tissue expansion followed by definitive implant-based reconstruction (IBR). Tissue expanders (TEs) have classically used saline for initial fill; however, TEs with an initial gas fill (GTE)-including the CO2-based AeroForm (AirXpanders, San Francisco, CA) TE and TEs initially filled with atmospheric air-have been increasingly used in the past decade. We aimed to compare the outcomes in breast reconstruction for tissue expanders initially filled with saline vs gas. PubMed was queried for studies comparing gas- and saline-filled tissue expanders (STEs) used in IBR. A meta-analysis was performed on major postoperative outcomes and the required expansion and definitive reconstruction time. Eleven studies were selected and included in the analysis. No significant differences existed between tissue expansion with GTEs vs STEs for 11 of the 13 postoperative outcomes investigated. Out of the complications investigated, only the risk of infection/cellulitis/abscess formation was significantly lower in the GTE cohort (odds ratio 0.62; 95% CI, 0.47 to 0.82; P = .0009). The time to definitive reconstruction was also significantly lower in the GTE cohort (mean difference [MD], 45.85 days; 95% CI, -57.80 to -33.90; P < .00001). The total time to full expansion approached significance in the GTE cohort (MD, -20.33 days; 95% CI, -41.71 to 1.04; P = .06). A cost analysis considering TE cost and infection risk determined that GTE use saved a predicted $2055.34 in overall healthcare costs. Surgical outcomes for both fill types were predominantly similar; however, GTEs were associated with a significantly decreased risk of postoperative infection compared to saline-filled TEs. GTEs could also reduce healthcare expenditures and require less time until definitive reconstruction after placement.

Outcome analysis and assessment of the lower pole expansion following breast augmentation with ergonomic implants: Optimizing results with patient selection based on 5-year data.

BACKGROUND: Silicone implants have gone through adaptations to improve esthetic outcomes. With the progress of technology, including gel rheology, different properties have been introduced. Ergonomic style implants (ESI) feature enhanced rheological properties and provide a shaped contour with a round base. OBJECTIVES: This study investigated outcomes for ESI in breast augmentation concerning lower pole stretching (LPS) and implant stability and describes an algorithm to assist in decision-making. METHODS: A total of 148 patients (296 breasts) underwent breast augmentation with ESI; this procedure was indicated in patients with good skin quality and <6 cm between the nipple-areola complex and the inframammary fold. RESULTS: The mean patient age was 29.6 years (range: 19-39), and 93 patients (62.8%) underwent primary breast augmentation with demi/full projection (average volume of 245 cc [175-375 cc]). Axillary incision and subfascial pocket were indicated in 115 (77.7%) and 72 (48%) cases, respectively. Average LPS values were 32.2% (24.91 mm) and 10.86% (9.42 mm) at up to 10 days and 10 days to 12 months postprocedure, respectively. Patients were followed for a mean of 29.9 ± 26.4 months (range: 6-66). Complication rates per breast and per patient were 5% and 10%, respectively, and included subcutaneous banding in the axilla (1.6%), implant displacement (1.2%), and wound dehiscence (0.8%). No cases of infection, seroma, or rippling complications were observed. CONCLUSIONS: The present decision-making algorithm summarizes the process involved in breast augmentation using ESI and is intended to help standardize decisions. With correct planning, long-lasting outcomes can be achieved due to favorable interactions between ESI and the patient's tissues.

Robotic Versus Conventional or Endoscopic-assisted Nipple-sparing Mastectomy and Immediate Prosthesis Breast Reconstruction in the Management of Breast Cancer: A Prospectively Designed Multicenter Trial Comparing Clinical Outcomes, Medical Cost, and Patient-reported Outcomes (RCENSM-P).

OBJECTIVE: To compare the clinical and patient-reported outcomes of minimal access and conventional nipple-sparing mastectomy (C-NSM). The secondary outcomes investigated included medical costs and oncological safety. BACKGROUND: Minimal-access NSM has been increasingly applied in the treatment of patients with breast cancer. However, prospective multicenter trials comparing robotic-assisted NSM (R-NSM) versus C-NSM or endoscopic-assisted NSM (E-NSM) are lacking. METHODS: A prospectively designed 3-arm multicenter, nonrandomized trial (NCT04037852) was conducted from October 1, 2019 to December 31, 2021, to compare R-NSM with C-NSM or E-NSM. RESULTS: A total of 73 R-NSM, 74 C-NSM, and 84 E-NSM procedures were enrolled. The median wound length and operation time of C-NSM was (9 cm, 175 minutes), (4 cm, and 195 minutes) in R-NSM, and (4 cm and 222 minutes) in E-NSM. Complications were comparable among the groups. Better wound healing was observed in the minimal-access NSM group. The R-NSM procedure was 4000 and 2600 United States Dollars more expensive than C-NSM and E-NSM, respectively. Wound/scar and postoperative acute pain evaluation favored the use of minimal access NSM over C-NSM. Quality of life in terms of chronic breast/chest pain, mobility, and range of motion of the upper extremity showed no significant differences. The preliminary oncologic results showed no differences among the 3 groups. CONCLUSIONS: R-NSM or E-NSM is a safe alternative if compared with C-NSM in terms of perioperative morbidities, especially with better wound healing. The advantage of minimal access groups was higher wound-related satisfaction. Higher costs remain one of the major limiting factors in the widespread adoption of R-NSM.

One-Stage Implant-Based Breast Reconstruction With Polyurethane-Coated Device: Standardized Assessment of Outcomes.

BACKGROUND: Nipple-sparing mastectomies (NSMs) and implant-based breast reconstructions have evolved from 2-stage reconstructions with tissue expansion and implant exchange to direct-to-implant procedures. In this study, we tested safety and efficacy of polyurethane-based implants according to standard assessment tools. OBJECTIVES: This study aimed to test safety and feasibility of polyurethane-coated implants with standardized assessment employing internationally acknowledged evaluation criteria. METHODS: Cases of NSMs followed by breast reconstruction in 1 stage with immediate prepectoral polyurethane-coated implant placement were retrospectively reviewed. Preoperative characteristics of the population have been collected. Adherence to quality assurance criteria of the Association of Breast Surgery-British Association of Plastic Reconstructive and Aesthetic Surgeons was verified. Complications were assessed with the Clavien Dindo classification, modified for the breast. Rippling, implant rotation, and malposition were also evaluated. RESULTS: Sixty-three consecutive patients underwent 74 NSMs and immediate breast reconstruction with micro polyurethane foam-coated anatomic implants. In 5 cases we had unplanned readmissions with return to the operating room under general anesthesia (6.7%) and implant loss within 3 months from breast reconstruction (5 implants, 6.7%). Postoperative complications according to Clavien Dindo were grade 1 in 6 cases (8.1%), grade 2 in 3 cases (4%), and 3b in 5 cases (6.7%). CONCLUSIONS: Polyurethane-coated implants may prevent rotation and malposition and capsular contracture in the short term. Unplanned readmission rates and implant loss rates in the short term may be slightly higher.See the abstract translated into Hindi, Portuguese, Korean, German, Italian, Arabic, Chinese, and Taiwanese online here: https://doi.org/10.1093/asj/sjad301.

Morphological Aesthetics Assessment of the Predicted 3D Simulation Results and the Actual Results of Breast Augmentation.

BACKGROUND: Although three-dimensional (3D) simulations are becoming more common in preoperative breast augmentation planning, this does not necessarily imply that the simulated results are highly accurate. OBJECTIVES: We aimed to evaluate the accuracy of the 3D simulation technique by comparing the differences in breast morphology between the 3D prediction model and the actual results. METHODS: The simulation and actual postoperative results of 103 patients who underwent breast augmentation were analyzed retrospectively. Therefore, a 3D model was created, and the parameters of line spacing, nipple position, breast projection, surface area, and volume were evaluated. Furthermore, consider the difference in chest circumferences and breast volume. RESULTS: In comparison with the simulation results, the actual results had a mean increase in the nipple to the inframammary fold (N-IMF) of 0.3 cm (P < 0.05) and a mean increase in basal breast width (BW) of 0.3 cm (P < 0.001), a difference that was not statistically significant in patients with larger breast volumes. There was a significant difference in the mean upper and lower breast volume distribution between simulated and actual breasts (upper pole 52.9% vs. 49.2%, P < 0.05, and lower pole 47.1% vs. 50.8%, P < 0.001). However, it was not statistically significant in patients with larger chest circumferences. CONCLUSIONS: Our study shows that 3D simulation has uncertainties related to the patient's chest circumference and breast volume. Therefore, these two critical factors must be considered when using simulation assessment in preoperative planning. LEVEL OF EVIDENCE III: 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 .

Financial Toxicity in Breast Implant-Associated Anaplastic Large Cell Lymphoma.

BACKGROUND: Financial toxicity is a growing concern due to its considerable effects on medical adherence, quality of life, and mortality. The cost associated with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is substantial from diagnosis to treatment, including adjuvant therapy and surgery. This study aims to assess the prevalence of financial toxicity in BIA-ALCL patients. METHODS: We performed a cross-sectional, survey-based study on women with confirmed cases of BIA-ALCL from December 2019 to March 2023. The primary study outcomes were financial toxicity measured by Comprehensive Score for Financial Toxicity (COST) score and patient-reported financial burden measured by the responses to the Evaluation of the Financial Impact of BIA-ALCL survey. Lower COST scores signify higher financial toxicity. Responses were linked to patient data extracted from the medical records. RESULTS: Thirty-two women treated for confirmed BIA-ALCL were included. Patients were all White and were diagnosed at a median age of 51 years (range, 41-65 years). The mean COST score was 27.9 ± 2.23. Lower COST scores were associated with receipt of radiotherapy ( P = 0.033), exceeding credit card limits ( P = 0.036), living paycheck to paycheck ( P = 0.00027), requiring financial support from friends and family ( P = 0.00044), and instability in household finances ( P = 0.034). CONCLUSIONS: Financial toxicity is prevalent in BIA-ALCL patients and has a substantial impact on patient reported burden. Insurance denial is frequent for patients with a prior history of cosmetic augmentation. Risk assessments and cost discussions should occur throughout the care continuum to minimize financial burden.

ADMs and synthetic meshes improve implant-based breast reconstruction aesthetics, but at what cost?

Acellular dermal matrices (ADMs) have shown promise for use in reconstructive breast surgery as they improve aesthetic outcomes and decrease capsular contracture rates. However, concerns about their use remain because of the higher cost and complication profile. We report a single institution's implant-based-reconstruction (IBR) experience between 2007 and 2021, including cases performed by 51 plastic surgeons. For each stage of IBR, data on age, comorbidities, type of mesh used, and acute complications were collected. Of 1379 patients who underwent subpectoral IBR, 937 received an ADM or synthetic mesh as part of their reconstruction. 256 patients out of 264 treated with prepectoral IBR received an ADM or mesh. Infection and wound dehiscence rates were highest for patients who underwent prepectoral IBR with ADM. Both subpectoral and prepectoral IBR with ADM were associated with higher rates of infection and wound complications compared to without ADM or mesh, but only the difference among the subpectoral cohort reached statistical significance. Prepectoral IBR with ADM or mesh had the lowest rates of capsular contracture and aesthetic reoperations. Although the use of Vicryl® mesh in subpectoral IBR was associated with a higher risk of capsular contracture and skin flap necrosis compared to reconstruction with ADMs (10.53% versus 3.29%; p < 0.05), Vicryl® was associated with fewer aesthetic revisions. Our study demonstrated that prepectoral IBR with ADM or mesh resulted in the fewest aesthetic reoperations and the lowest rates of capsular contracture. Infection and wound dehiscence rates were notably higher for patients who had reconstruction with ADM.

Predicting Mastectomy Skin Flap Necrosis: A Systematic Review of Preoperative and Intraoperative Assessment Techniques.

Mastectomy skin-flap necrosis (MSFN) is one of the most feared complications of immediate implant-based breast reconstruction (IIBR). Traditionally, mastectomy skin-flap viability was based only on surgeons' clinical experience. Even though numerous studies have already addressed the patients' risk factors for MSFN, few works have focused on assessing quality of breast envelope. This review investigates mastectomy's flap viability-assessment methods, both preoperative (PMFA) and intraoperative (IMFA), to predict MSFN and its sequalae. Between June and November 2022, we conducted a systematic review of Pubmed/MEDLINE and Cochrane electronic databases. Only English studies regarding PMFA and IMFA applied to IIBR were selected. The use of digital mammography, ultrasound, magnetic resonance imaging, and a combination of several methods before surgery was shown to be advantageous by several authors. Indocyanine performed better than other IMFA, however both thermal imaging and spectroscopy demonstrated novel and promising results. Anyway, the best prediction comes when preoperative and intraoperative values are combined. Particularly in prepectoral reconstruction, when mastectomy flaps are essential to determine a successful breast reconstruction, surgeons' clinical judgment is insufficient in assessing the risk of MSFN. Preoperative and intraoperative assessment techniques play an emerging key role in MSFN prediction. However, although there are several approaches to back up the surgeon's processing choice, there is still a dearth of pertinent literature on the subject, and more research is required.

Does the Type of Reconstruction Matter? A Propensity Score Analysis of Immediate Postmastectomy Implant and Flap Reconstruction.

BACKGROUND: No randomized controlled trials have compared implant and flap reconstruction. Recently, worse longitudinal outcomes have been suggested for flap reconstruction. The authors compared long-term oncologic outcomes of postmastectomy breast reconstruction using propensity score matching. METHODS: A retrospective study of postmastectomy reconstruction was achieved using the Weill Cornell Breast Cancer Registry between 1998 and 2019. Patients were matched using propensity scores based on demographic, clinical, and surgical characteristics. Kaplan-Meier estimates, Cox-regression models, and restricted mean survival times (RMST) were used to evaluate patient outcomes. RESULTS: Before matching, 1395 implant and 586 flap patients were analyzed. No difference in overall survival and recurrence were observed. Multivariable models showed decreased survival for Medicare/Medicaid [hazard ratio (HR), 3.09; 95% CI, 1.63 to 5.87; P < 0.001], pathologic stage II (HR, 2.98; 95% CI, 1.12 to 7.90; P = 0.028), stage III (HR, 4.88; 95% CI, 1.54 to 15.5; P = 0.007), 11 to 20 lymph nodes positive (HR, 3.66; 95% CI, 1.31 to 10.2; P = 0.013), more than 20 lymph nodes positive (HR, 6.41; 95% CI, 1.49 to 27.6; P = 0.013). RMST at 10 years after flap reconstruction showed 2 months of decreased survival time compared with implants (9.56 versus 9.74 years; 95% CI, -0.339 to -0.024; P = 0.024). After matching, 563 implant and 563 flap patients were compared. Reconstruction was not associated with overall survival and recurrence. RMST between implant and flap reconstruction showed no difference in each 5-year interval over 20 years. CONCLUSION: Postmastectomy breast reconstruction was not associated with a difference in long-term oncologic outcomes over a 20-year period. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Comment on the Invited Discussion on "Assessment of Risk Factors for Rupture in Breast Reconstruction Patients with Macrotextured Breast Implants".

We here present a few comments on the invited discussion of Dr. van Heijningen on the paper "Assessment of Risk Factors for Rupture in Breast Reconstruction Patients with Macrotextured Breast Implants". Dr. van Heijningen made some reservations regarding paper conclusions due to the high dropout rate, the adopted exclusion criteria and the location and mechanism of implant rupture. First of all, a high dropout rate is not unbeknown to researchers in surveys-based studies and may be expected when recalling in 6 months a population observed during last 20 years. In our study data are missing at random not affecting the risk of bias, while the population accurately depicts the people we care, mainly but not only reconstructive. Patients who did not respond to the questionnaire could not participate to the survey, while those who did not hold recent imaging were excluded because of the risk of false negative due to possible silent rupture, accounting to 10% in some reports. MRI imaging often shows that implants fold back on their selves when capsular contracture reduces implant pocket. As the use of the underwire bra prevents implant inferior displacement, repeated muscular contraction may worsen implant folds and the chronic wear-and-tear mechanism may be responsible for the rupture. Finally, folding is presumably easier to occur at the upper quadrants where anatomical implant shell is thinnest and gel concentration reduced than the opposite, therefore is not surprising that the higher percentage of ruptures is located in the upper implant quadrants.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 .

Delayed-immediate breast reconstruction: An assessment of complications and outcomes in the context of anticipated post-mastectomy radiotherapy.

INTRODUCTION: The detrimental effects of post-mastectomy radiotherapy on breast reconstruction are well known. We report our experience with a delayed-immediate approach involving an initial subcutaneous implant with definitive reconstruction after adjuvant radiotherapy. METHODS: Patients were identified retrospectively from hospital, theatre and implant registry records. Details regarding demographics, cancer pathology, surgical data and oncological therapies were collected. Primary outcomes included complication rates of first-stage surgery and time to definitive reconstruction. RESULTS: A total of 115 patients underwent mastectomy and temporary subcutaneous implant (36 nipple sparing) between 2008 and 2019. Five were smokers with eleven having a body mass index > 30. The median age was 46 years (27-76 years) and tumour size 50 mm. Almost 95% underwent radiotherapy, 82% chemotherapy and 70% had axillary node clearance. Median mastectomy weight was 464 g (123-1300 g) with median temporary implant volume 375 cc (180-655 cc). Complications of first-stage surgery at three months included 5.2% implant loss (n = 6), 14.8% infection rate, 17.4% readmission rate and 10.4% returned to theatre. Reconstructive failure occurred in four cases (3.5%). A total of 76 patients completed definitive reconstruction, including 26 autologous, 21 latissimus dorsi with implant, and 28 implant-only reconstructions. The median time to reconstruction following the completion of radiotherapy was 12 months. This increased in those who had implant complications (28 vs. 15 months) or radiotherapy (16 vs. 10 months) versus those without. CONCLUSIONS: Delayed-immediate breast reconstruction using a temporary subcutaneous implant has been shown to be a safe, feasible and potentially beneficial method than simple mastectomy and delayed reconstruction with a complication rate comparable to that of immediate implant reconstruction.

Assessment of Risk Factors for Rupture in Breast Reconstruction Patients with Macrotextured Breast Implants.

BACKGROUND: Breast implants (BI) are widely used in plastic surgery, though they are not lifetime devices. Average life before rupture is reported to be around 10-15 years. No consensus exists regarding which factors are involved. OBJECTIVES: Following FDA recommendations, this study aims at identifying potential risk factors by evaluating their effect on BI rupture cases. METHODS: In this observational study, 763 BI patients were operated between 2003 and 2019, with a mean implant indwelling of 12.2 years. Patients that returned for follow-up were administered a questionnaire regarding postoperative lifestyle and habits. Implant rupture rate was 15.1%, while BI lifespan was 10.1 years. We obtained complete data from 191 breast implant patients (288 implants). Twenty-three potential risk factors were evaluated and divided in four categories: patient-related, surgery-related, postoperative complications/symptoms, and postoperative care/lifestyle habits. Odds Ratio (OR) for each factor was calculated. Linear regression analysis was calculated for those with a significant OR. RESULTS: We report 120 patients (195 implants) with intact and 71 (93 implants) with ruptured devices. BIs were macrotextured in 95.1% of cases (86.8% Allergan BIOCELL). OR was significant for underwire bra use (OR: 2.708), car seat belts (OR: 3.066), mammographic imaging (OR: 2.196), weightlifting (OR: 0.407) and carry-on heavy purses and backpacks (OR: 0.347). CONCLUSION: Wearing underwire bras, seat belts and undergoing mammography increases the risk of rupture. Weightlifting and carry heavy bags do not increase that risk. Implant rupture is directly linked with time of indwelling. Postoperative recommendations in BI patients should consider findings from our study, though larger multicenter studies should be encouraged. LEVEL OF EVIDENCE IV: 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 .

Prospective Study of Clinical Outcomes From a Breast Implant Assessment Service.

BACKGROUND: Breast augmentation remains the commonest cosmetic surgical procedure worldwide, in spite of recent regulatory action. OBJECTIVES: The aim of this study was to evaluate women with breast implants attending a breast implant assessment clinic and to capture clinical and implant data in women presenting to the service. METHODS: Patients were enrolled prospectively between January 2018 and December 2021. Clinical, implant, and practitioner data were recorded. Patients reported satisfaction on size, shape, and overall outcome as well as the presence or pain. Radiological evaluation, where indicated, was performed and data were included on these findings. RESULTS: A total of 603 patients were assessed. Their mean age was 42.7 years and mean age at implantation was 29.1 years. The most common complications were capsular contracture followed by pain, waterfall deformity, and double bubble, with rupture/contracture rates increasing after the 10-year mark. The risk of double bubble was significantly lower if patients were operated on by certified practitioners (odds ratio = 0.49, P = 0.011). There was almost universally poor awareness of the risks of breast implants in patients presenting for evaluation. CONCLUSIONS: This study has shown benefit in a breast implant assessment clinic to gather information on adverse events and patient-reported outcomes following breast implant surgery. Having appropriately trained and certified practitioners perform cosmetic augmentation significantly lowers the risk of implant malposition and deformity. Any adverse event occurring within 5 years of initial surgery should be flagged as a mandatory reportable clinical indicator and trigger further investigation.