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.

Breast Implant Selection: Consensus Recommendations Using a Modified Delphi Method.

BACKGROUND: Geographical differences in breast implant selection approaches exist, and clinical data to guide the process are limited. Developing knowledge of implant-related risk factors further complicates the process. This analysis aimed to establish expert consensus on considerations for breast implant selection in Australia and New Zealand based on practice patterns in those countries. METHODS: A modified Delphi method was used to gain consensus from experts in breast augmentation surgery in Australia and New Zealand. Panelists anonymously completed an initial questionnaire on current considerations in implant selection, discussed a summary of their responses in a live meeting, and completed a final consensus survey based on their live recommendations. RESULTS: Seven panelists completed the final consensus survey. Consensus recommendations included ensuring consideration of proper surgical technique (pocket formation, positioning of implant) and patient tissue and anatomical characteristics, weighing relative expected results of various surface textures, sizes, and degrees of cohesivity, and careful contemplation of the migration risk. CONCLUSIONS: This modified Delphi exercise provided consensus recommendations on the key factors involved in implant selection from the perspective of plastic surgeons with practices in Australia and New Zealand. A primary recommendation was that the choice of implant for each patient should be individualized to patient tissue and anatomical characteristics.

Breast Reconstruction Following Breast Implant-Associated Anaplastic Large Cell Lymphoma.

BACKGROUND: Standard of care treatment of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) involves surgical resection with implant removal and complete capsulectomy. We report a case series of BIA-ALCL reconstruction with proposals for timing and technique selection. METHODS: We retrospectively reviewed and prospectively enrolled all BIA-ALCL patients at 2 tertiary care centers and 1 private plastic surgery practice from 1998 to 2017. Demographics, treatment, reconstruction, pathology staging, patient satisfaction, and oncologic outcomes were reviewed. RESULTS: We treated 66 consecutive BIA-ALCL patients and 18 (27%) received reconstruction. Seven patients (39%) received immediate reconstruction, and 11 (61%) received delayed reconstruction. Disease stage at presentation was IA (T1N0M0 disease confined to effusion or a layer on luminal side of capsule with no lymph node involvement and no distant spread) in 56%, IB in 17%, IC (T3N0M0 cell aggregates or sheets infiltrating the capsule, no lymph node involvement and no distant spread) in 6%, IIA (T4N0M0 lymphoma infiltrating beyond the capsule, no lymph node involvement and no distant spread) in 11%, and III in 11%. Types of reconstruction included smooth implants (72%), immediate mastopexy (11%), autologous flaps (11%), and fat grafting (6%). Outcomes included no surgical complications, but 1 patient progressed to widespread bone metastasis (6%); ultimately, all patients achieved complete remission. Ninety-four percent were satisfied/highly satisfied with reconstructions, whereas 6% were highly unsatisfied with immediate smooth implants. CONCLUSIONS: Breast reconstruction following BIA-ALCL management can be performed with acceptable complications if complete surgical ablation is possible. Immediate reconstruction is reserved for disease confined to capsule on preoperative positive emission tomography/computed tomography scan. Genetic predisposition and bilateral cases suggest that BIA-ALCL patients should not receive textured implants. Autologous options are preferable for implant adverse BIA-ALCL patients. Patients with extensive disease at presentation should be considered for 6- to 12-month delayed reconstruction with interval positive emission tomography/computed tomography evaluation.

Breast Implant-Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand: High-Surface-Area Textured Implants Are Associated with Increased Risk.

BACKGROUND: The association between breast implants and breast implant-associated anaplastic large cell lymphoma (ALCL) has been confirmed. Implant-related risk has been difficult to estimate to date due to incomplete datasets. METHODS: All cases in Australia and New Zealand were identified and analyzed. Textured implants reported in this group were subjected to surface area analysis. Sales data from three leading breast implant manufacturers (i.e., Mentor, Allergan, and Silimed) dating back to 1999 were secured to estimate implant-specific risk. RESULTS: Fifty-five cases of breast implant-associated ALCL were diagnosed in Australia and New Zealand between 2007 and 2016. The mean age of patients was 47.1 years and the mean time of implant exposure was 7.46 years. There were four deaths in the series related to mass and/or metastatic presentation. All patients were exposed to textured implants. Surface area analysis confirmed that higher surface area was associated with 64 of the 75 implants used (85.3 percent). Biocell salt loss textured (Allergan, Inamed, and McGhan) implants accounted for 58.7 percent of the implants used in this series. Comparative analysis showed the risk of developing breast implant-associated ALCL to be 14.11 times higher with Biocell textured implants and 10.84 higher with polyurethane (Silimed) textured implants compared with Siltex textured implants. CONCLUSIONS: This study has calculated implant-specific risk of breast implant-associated ALCL. Higher-surface-area textured implants have been shown to significantly increase the risk of breast implant-associated ALCL in Australia and New Zealand. The authors present a unifying hypothesis to explain these observations.

Results from the ASPIRE study for breast reconstruction utilizing the AeroForm™ patient controlled carbon dioxide-inflated tissue expanders.

BACKGROUND: Therapeutic or prophylactic mastectomy is often indicated for women with breast cancer, or for those at a high risk of developing cancer due to familial history or genetic mutations. Favorable aesthetic and psychological results make prosthetic reconstruction of the breast with placement of tissue expanders followed by permanent implant a popular choice for women diagnosed with breast cancer. This study describes the results of the ASPIRE trial, the objective of which was to provide supportive data to demonstrate the performance and safety of the AeroForm™ System in a population with broader selection criteria than previous studies. Results of the earlier PACE clinical studies (PACE 1 and 2) demonstrated that the AeroForm™ System could be used safely and effectively to achieve the desired expansion necessary for successful breast reconstruction. In the current ASPIRE trial described in the paper, performance of the device was evaluated by successful tissue expansion and exchange to breast implant(s) unless precluded by a non-device related event. Safety data was evaluated based on reported adverse events. METHODS: A prospective, single center, open-label study in which subjects who met the inclusion criteria and agreed to participate were enrolled and implanted with the AeroForm expander either at the time of mastectomy (immediate) or sometime after mastectomy (delayed). In the event of a bilateral procedure, the expander was implanted in each side. Subjects were followed until the explant of the tissue expander(s) and exchange for silicone or saline breast implant(s). RESULTS: Thirty-four expanders were placed in 21 subjects in the clinical trial; the average age of subjects was 49.7 ± 8.6 years with average BMI of 26.1 ± 4.7. Bilateral procedures accounted for 62% of the total and 88% of the reconstructions were completed with a latissimus dorsi flap (anterior approach) per the investigators standard procedure. Four (12%) of the cases (12%) were completed in two subjects using an inferior dermal flap. Overall success rate was 94% (32/34 breasts) with no device related reconstruction failures. Two subjects failed reconstruction, one due to infection and one due to wound healing issues, both requiring unilateral expander removal and revision surgery. However, successful second stage reconstruction was completed in both subjects in a delayed procedure. CONCLUSION: The ASPIRE trial reports confirmatory data in a more inclusive patient population than the previous PACE 1 and 2 trials, indicating that the AeroForm Expander, provides a time-saving, needle-free, safe and effective method of tissue expansion for breast reconstruction. There were no device related complications that precluded the subjects from achieving the study goal of a permanent implant exchange. Reported complications are similar to those reported in the literature for tissue expansion procedures. Further development may enable a single dose controller to operate both expanders in a bilateral patient and increase the size range offered with this promising technology.

Patient-activated controlled expansion for breast reconstruction using controlled carbon dioxide inflation: confirmation of a feasibility study.

BACKGROUND: Women with breast cancer or those at high risk of developing breast cancer because of familial history of the disease or genetic mutations are frequently indicated for therapeutic or prophylactic mastectomy. Prosthetic reconstruction of the breast with placement of tissue expanders followed by implants offers favorable aesthetic and psychological results while adding only minimal additional surgical intervention. This study describes the confirmatory phase of an earlier feasibility trial that involved seven women who successfully underwent patient-activated controlled expansion for breast reconstruction with 10 AeroForm patient-controlled tissue expanders. METHODS: A prospective, open-label, single-arm, single-surgeon confirmatory study in Perth, Australia, evaluated outcomes of two-stage breast reconstruction using the investigational device. Each subject administered a preset 10-cc dose of carbon dioxide gas using a remote dosage controller, three times each day, with a 3-hour lockout between doses until full expansion was achieved. RESULTS: Thirty-three women with breast cancer, family history, or predisposition because of the BRCA1 or BRCA2 gene mutation underwent pedicled latissimus dorsi flap procedures with placement of 61 carbon dioxide-based tissue expanders. The mean number of days for subjects to achieve desired expansion was 17 ± 5. Operating the dosage controller was described by the surgeon as very easy in 94 percent of the cases and by 97 percent of the subjects. No serious adverse events were reported. CONCLUSION: This study confirms that the AeroForm breast tissue expander has demonstrated the ability to provide, relative to saline expanders, a needle-free, patient-controlled, convenient, and time-saving method of tissue expansion. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

The accuracy of intraoperative subareolar frozen section in nipple-sparing mastectomies.

BACKGROUND: Intraoperative subareolar frozen sections are used to assess the nipple areolar complex's suitability for preservation for patients selected for nipple-sparing mastectomy. We aim to investigate the accuracy and value of the frozen section compared to formal histopathologic results. METHODS: In our 5-year retrospective study, 52 candidates for nipple-sparing mastectomies had subareolar frozen sections analyzed intraoperatively for malignant or atypical duct changes. Women were considered for nipple-sparing mastectomy if their primary breast malignancy was greater than 3 cm from the nipple-areolar complex and not multifocal in nature. Frozen-section results were compared to the formal histopathologic results, allowing analysis of the sensitivity, specificity, and predictive value. Causes of false negatives (negative frozen-section findings, positive histopathology findings) were then examined. RESULTS: Of 52 frozen sections, 47 (90%) yielded negative results and 5 (10%) yielded positive results. Of the 47 negative results, 39 were true negatives while 8 were false negatives. Of the 5 positive results, all were true positives with no false positives. Therefore, the positive predictive value of subareolar frozen section is 100%, negative predictive value 83%, sensitivity 38%, and specificity 100%. Of the 8 false negatives, 4 (50%) were due to sampling errors, 3 (37.5%) were due to interpretation errors, and 1 (12.5%) was due to diathermy artifact. CONCLUSION: Intraoperative subareolar frozen section is a specific but nonsensitive test. It is useful in nipple-sparing mastectomy because in 10% of cases a positive result allows immediate nipple and areolar excision. Its low sensitivity and negative predictive value means that 15% of patients will need a subsequent nipple and areolar excision. Eighty-five percent of patients can, however, have a single-stage excision.

Patient journeys: the process of clinical redesign.

*Clinical process redesign is a successful improvement method that has been used to increase access to health services in 60 public hospitals across New South Wales, and at Flinders Medical Centre (FMC) in South Australia. *The method focuses on the patient journey as the primary improvement locus, and uses process mapping to identify the value-adding steps in that journey; it involves redesign teams identifying and eliminating non-value-adding steps to improve flow and reduce delays in access to emergency and elective care. *The method engages clinicians, managers, patients and carers, and delivers real gains in health care delivery. *This article outlines the clinical process redesign programs being used by NSW Health and at FMC.

Clinical process redesign for unplanned arrivals in hospitals.

*Emergency department performance had been deteriorating in NSW Health facilities and at Flinders Medical Centre before a fundamentally new approach involving a redesign method, additional bed capacity and more rigorous hospital performance management was applied. *Redesign was undertaken in over 60 hospitals in New South Wales. *Numerous disconnections and misalignments in the process of care delivery have been uncovered during the diagnostic phase of this redesign. *Solutions addressed the entire patient journey through the hospital, to produce smoother patient flow along the continuum of care. *To achieve a sustained improvement in performance, numerous solutions must be simultaneously implemented in each hospital. *With this multipronged approach, a turnaround in NSW emergency access performance has been achieved in the face of rising demand for services; the improvement has continued over 3 years. *This article reports on our findings from system-wide redesign for unplanned hospital attendances.

Applying clinical process redesign methods to planned arrivals in New South Wales hospitals.

*Competing demands of planned and unplanned arrivals present major challenges for hospitals. *Applying clinical process redesign methods to the planned patient journey allows management to recognise the blocks and inefficiencies in the journey and facilitates the development of solutions for improvement. *Redesign of the planned patient journey in New South Wales has promoted the expansion of the extended day-only model of care, reformed the waiting times policy, standardised patient preadmission assessment and preparation, and targeted operating theatre use. *Improved performance management at Area Health Service and local facility levels has accompanied the redesign of planned arrival processes. *The results in redesign of surgery undertaken by the Area Health Services in 96 NSW hospitals have been impressive, with results within 2 years of commencing the clinical services redesign program showing: a 97% reduction in the numbers of patients in Category 1 (admission desirable within 30 days) whose surgery was overdue, from 5308 in January 2005 to 135 in June 2007; and a 99% reduction in the number of patients who have waited > 365 days for surgery, from 10 551 in January 2005 to 84 in June 2007. *Improved surgical service efficiency, safety and quality justify the continuation of the redesign program.

Implementing and sustaining transformational change in health care: lessons learnt about clinical process redesign.

*Clinical process redesign has enabled significant improvements in the delivery of health care services in emergency departments and elective surgery programs in New South Wales and at Flinders Medical Centre in South Australia, with tangible benefits for patients and staff. *The principles used in clinical process redesign are not new; they have been applied in other industries with significant gains for many years, but have only recently been introduced into health care systems. *Through experience with clinical process redesign, we have learnt much about the factors critical to the success of implementing and sustaining this process in the health care setting. *The key elements for success are leadership by senior executives, clinical leadership, team-based problem solving, a focus on the patient journey, access to data, ambitious targets, strong performance management, and a process for maintaining improvement.

Health services under siege: the case for clinical process redesign.

*Public health services are struggling to cope with rising demand. *Strain on health services manifests as longer waiting lists for surgery, queuing in the emergency departments, increased rates of adverse events, and delays in discharge, particularly for older patients. *Traditional responses are not resolving these problems. *Analysis shows that the day-to-day system processes underlying clinical care are poorly designed and do not produce a well planned, well coordinated patient journey. *Numerous disconnections along the continuum of care have a cumulative effect in obstructing patient flow and causing frustration for patients and staff. *Rigorous clinical process redesign methods can significantly improve performance, even in the face of rising demand.