Medical Specialist Care Utilization Prior to the Explantation of Cosmetic Silicone Breast Implants: A Nationwide Retrospective Data Linkage Study.

BACKGROUND: Explantation is the proposed treatment for breast implant illness (BII). Little is known about which medical specialists are visited and what diagnoses are made before explantation is provided as the treatment. OBJECTIVES: This study investigated medical specialist care utilization in women with cosmetic breast implants who underwent explantation compared to women who chose breast implant replacement surgery and to women without breast implants. METHODS: Retrospective cohort study using data linkage with the Dutch Breast Implant Registry and the Dutch health insurance claims database. Visits to medical specialists were examined over the 3 years before explantation. A total of 832 explantation patients were matched and compared to 1463 breast implant replacement patients and 1664 women without breast implants. RESULTS: Explantation patients were more likely to have visited > 5 different medical specialties compared to both replacement patients (12.3% vs. 5.7%; p < 0.001) and women without breast implants (12.3% vs. 3.7%; p < 0.001). Among explantation patients, women who underwent explantation because of BII were more likely to have visited > 5 different medical specialties compared to women who underwent explantation because of other reasons (25.0% vs. 11.0%; p < 0.001). CONCLUSIONS: Women who underwent explantation of breast implants had higher utilization of medical specialist care in the years before explantation compared to women who underwent breast implant replacement surgery and women without breast implants. Medical specialist care use was especially high among women for whom BII was the registered reason for explantation. These findings suggest further research is needed into the link between BII and the use of medical specialist care. 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 .

Imaging findings after a total reconstructed breast with autologous fat transfer: what the radiologist needs to know.

Autologous fat transfer (AFT) is an upcoming technique for total breast reconstruction. Consequently, radiological imaging of women with an AFT reconstructed breast will increase in the coming years, yet radiological experience and evidence after AFT is limited.The surgical procedure of AFT and follow-up with imaging modalities including mammography (MG), ultrasound (US), and MRI in patients with a total breast reconstruction with AFT are summarized to illustrate the radiological normal and suspicious findings for malignancy.Imaging after a total breast reconstruction with AFT appears to be based mostly on benign imaging findings with an overall low biopsy rate. As higher volumes are injected in this technique, the risk for the onset of fat necrosis increases. Imaging findings most often are related to fat necrosis after AFT. On MG, fat necrosis can mostly be seen as oil cysts. The occurrence of a breast seroma after total breast reconstruction with AFT is an unfavourable outcome and may require special treatment. Fat deposition in the pectoral muscle is a previously unknown, but benign entity. Although fat necrosis is a benign entity, it can mimic breast cancer (recurrence).In symptomatic women after total breast reconstruction with AFT, MG and US can be considered as first diagnostic modalities. Breast MRI can be used as a problem-solving tool during later stage. Future studies should investigate the most optimal follow-up strategy, including different imaging modalities, in patients treated with AFT for total breast reconstruction.

Superior Sensibility after Full Breast Reconstruction with Autologous Fat Transfer.

BACKGROUND: With developments in screening and treatment, survival rates of breast cancer patients are increasing, and so is the number of women opting for breast reconstruction to improve their quality of life. One factor that could play an important role in improving the quality of life is breast sensibility. Therefore, the aim of this study was to explore breast sensibility in participants of the Breast Reconstruction with External Preexpansion and Autologous Fat Transfer versus Standard Therapy trial: an ongoing randomized controlled trial comparing breast reconstruction with autologous fat transfer (AFT) versus implant-based reconstruction (IBR). METHODS: This study was conducted on participants of the Breast Reconstruction with External Preexpansion and Autologous Fat Transfer versus Standard Therapy trial who were at least 12 months after final surgery. Semmes-Weinstein monofilaments were used to measure skin sensibility in breast cancer patients who underwent breast reconstruction with either AFT or IBR following their mastectomy. RESULTS: A total of 46 patients were included in this study, resulting in 62 breast reconstructions (28 AFT breasts and 34 IBR breasts). Significantly higher mean monofilament values were found for skin sensibility after AFT (-0.7; P < 0.001), clinically correlating to "diminished protective function," as opposed to the IBR group, with clinical values indicating "loss of protective function." CONCLUSIONS: In this study, the authors found that breast cancer patients who underwent a mastectomy had a significantly better sensibility of the breast following AFT for total breast reconstruction as compared with IBR. Larger studies that include null measurements are required to further explore these noteworthy results of AFT. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Risk factors for unplanned reoperation during the expansion phase in two-stage breast reconstruction in the Dutch Breast Implant Registry.

BACKGROUND: The majority of postmastectomy breast reconstructions (PMBRs) are currently performed in two stages using a tissue expander (TE). However, complications during the expansion phase occur regularly, leading to unplanned reoperations and/or reconstruction failure. This study aimed to identify risk factors for unplanned reoperation after TE placement, assessed the time until unplanned and planned reoperation, and investigated indications for unplanned reoperation. METHODS: Patient and surgery-related characteristics of patients who underwent two-stage PMBR between 2017 and 2021 were collected from the Dutch Breast Implant Registry (DBIR). Unplanned reoperation was defined as TE explantation followed by either no replacement or replacement with the same or a different TE. Co-variate adjusted characteristics associated with unplanned reoperation were determined using backward stepwise selection and multivariable logistic regression analyses. RESULTS: In total, 2529 patients (mean age, 50.2 years) were included. Unplanned reoperation occurred in 19.4 percent of all registered TEs (n=3190). Independent factors associated with unplanned reoperation were BMI≥25 kg/m 2 (adjusted Odds Ratio [aOR]=1.63;99% Confidence Interval [99%CI]=1.20-2.57 for BMI 25-29.9 kg/m2, aOR=2.57;99%CI=1.74-3.78 for BMI≥30 kg/m 2), low institutional volume (aOR=1.51;99%CI=1.06-2.18), no drains (aOR=2.06;99%CI=1.15-3.60), subcutaneous TE placement (aOR=5.71;99%CI=3.59-9.10), and partial pectoralis major muscle coverage (aOR=1.35;99%CI=1.02-1.79). Age<40 years (aOR=0.49;99%CI=0.32-0.74) and delayed PMBR (aOR=0.35;99%CI=0.19-0.60) reduced the risk of unplanned reoperation. Median time until reoperation was 97 days for unplanned and 213 days for planned reoperation. Deep wound infections were most often registered as indication for unplanned reoperation (34.4 percent). CONCLUSION: This study identified several risk factors for unplanned reoperation which may be used to reduce complications in expander-based PMBR.

Evidence for the use of peri- and post-operative antibiotic prophylaxis in autologous breast reconstruction: A systematic review.

BACKGROUND: Autologous breast reconstruction has become standard of care, but there is no consensus on prophylactic antibiotic regimens for this surgical procedure. This review aims to present evidence on the best prophylactic antibiotic protocol to lower the risk of surgical site infections in autologous breast reconstructions. METHODS: The search was performed in PubMed, EMBASE, Web of Science, and Cochrane Library on 25th of January 2022. Data on the number of surgical site infections, breast reconstruction type (pedicled or free flap) and reconstruction timing (immediate or delayed), as well as data on the type, dose, route of administration, timing, and duration of antibiotic treatment were extracted. All included articles were additionally assessed for potential risk of bias by using the revised RTI Item Bank tool. RESULTS: 12 studies were included in this review. No evidence is found that giving post-operative antibiotics for a prolonged period longer than 24 h after surgery is useful in lowering infection rates. This review could not distinguish between the best choice of antimicrobial agent. DISCUSSION: Although this is the first study that collected current evidence on this topic, the quality of evidence is limited due to a small number of available studies (N = 12) with small study populations. The included studies have high heterogeneity, no adjustment for confounding, and interchangeably used definitions. Future research is highly recommended with predefined definitions, and a sufficient number of included patients. CONCLUSION: Antibiotic prophylaxis up to a maximum of 24 h is useful in lowering infection rates in autologous breast reconstructions.

Effect of Total Breast Reconstruction With Autologous Fat Transfer Using an Expansion Device vs Implants on Quality of Life Among Patients With Breast Cancer: A Randomized Clinical Trial.

Importance: There is a need for a new, less invasive breast reconstruction option for patients who undergo mastectomy in their breast cancer treatment. Objective: To investigate quality of life (QoL) among patients undergoing a new breast reconstruction technique, autologous fat transfer (AFT), compared with that among patients undergoing implant-based reconstruction (IBR). Design, Setting, and Participants: The BREAST trial was a randomized clinical trial conducted between November 2, 2015, and October 31, 2021, performed in 7 hospitals across the Netherlands. Follow-up was 12 months. Referrals could be obtained from general practitioners and all departments from participating or nonparticipating hospitals. The patients with breast cancer who had undergone mastectomy and were seeking breast reconstruction were screened for eligibility (radiotherapy history and physique) by participating plastic surgeons. Patients receiving postmastectomy radiotherapy were excluded. Interventions: Breast reconstruction with AFT plus expansion or 2-phased IBR. Randomization was done in a 1:1 ratio. Main Outcomes and Measures: The statistical analysis was performed per protocol. The predefined primary outcome was QoL at 12 months after final surgery. This was measured by the BREAST-Q questionnaire, a validated breast reconstruction surgery questionnaire. Questions on the BREAST-Q questionnaire are scored from 0 to 100, with a higher score indicating greater satisfaction or better QoL (depending on the scale). Secondary outcomes were breast volume and the safety and efficacy of the techniques. Results: A total of 193 female patients (mean [SD] age, 49.2 [10.6] years) 18 years or older who desired breast reconstruction were included, of whom 91 patients in the AFT group (mean [SD] age, 49.3 [10.3] years) and 80 in the IBR group (mean age, 49.1 [11.0] years) received the allocated intervention. In total, 64 women in the AFT group and 68 women in the IBR group completed follow-up. In the IBR group, 18 patients dropped out mainly due to their aversion to implant use while in the AFT group 6 patients ended their treatment prematurely because of the burden (that is, the treatment being too heavy or tiring). The BREAST-Q scores were higher in the AFT group in all 5 domains and significantly higher in 3: satisfaction with breasts (difference, 9.9; P = .002), physical well-being: chest (difference; 7.6; P = .007), and satisfaction with outcome (difference, 7.6; P = .04). Linear mixed-effects regression analysis showed that QoL change over time was dependent on the treatment group in favor of AFT. The mean (SD) breast volume achieved differed between the groups (AFT: 300.3 [111.4] mL; IBR: 384.1 [86.6] mL). No differences in oncological serious adverse events were found. Conclusions and Relevance: This randomized clinical trial found higher QoL and an increase in QoL scores over time in the AFT group compared with the IBR group. No evidence was found that AFT was unsafe. This is encouraging news since it provides a third, less invasive reconstruction option for patients with breast cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT02339779.

Donor Site Satisfaction Following Autologous Fat Transfer for Total Breast Reconstruction.

BACKGROUND: With evolving breast cancer survival and patient preferences, it is essential that reconstructive surgeons worldwide continue searching for the best reconstruction technique for patients. Autologous fat transfer (AFT) is a relatively new technique for total breast reconstruction that has already proven to be effective and safe with all advantages of autologous tissue. However, little is known about the aesthetic results and satisfaction concerning donor sites. OBJECTIVES: The aim of this study was to measure donor site satisfaction following AFT for total breast reconstruction in breast cancer patients. METHODS: Between May and August of 2021, participants of the BREAST- trial who were at least 24 months after their final reconstruction surgery were invited to complete an additional survey concerning donor sites. The BODY-Q was utilized for data collection. Results of AFT patients were compared with a control group of implant-based reconstruction patients who did not have a donor site. RESULTS: A total of 51 patients (20 control, 31 intervention) completed the questionnaire. Satisfaction with body did not statistically differ between the groups. The most frequent complaint was contour irregularities (31 reports, 60.8%), with the least favorable donor site being thighs (23 reports, 53.5%) in the AFT group. CONCLUSIONS: Satisfaction with body did not differ between breast cancer patients receiving AFT or implant-based reconstruction, meaning that large-volume liposuction does not aesthetically affect the utilized donor sites. Nevertheless, reconstructive surgeons should be aware of possible donor site complications, especially contour irregularities at the thighs, and discuss this with their patients.

Aesthetic Evaluation of Breast Reconstruction with Autologous Fat Transfer vs. Implants.

BACKGROUND: Autologous fat transfer (AFT) seems to be a new minimal invasive method for total breast reconstruction, yet how patients, surgeons, and laymen evaluate cosmesis is lacking. The aim of this study was to evaluate the aesthetic outcome of AFT (intervention group) for total breast reconstruction post-mastectomy, as compared to implant-based reconstruction (IBR) (control group). METHODS: A random and blinded 3D photographic aesthetic outcome study was performed on a selection of 50 patients, scored by three panels: plastic surgeons, breast cancer patients, and laymen. Secondary outcomes included agreement within groups and possible patient characteristics influencing scoring. RESULTS: Breast cancer patients and plastic surgeons did not differ in the aesthetic scores between the treatment groups. In contrast, the laymen group scored AFT patients lower than IBR patients (- 1.04, p < 0.001). Remarkably, mean given scores were low for all groups and overall agreement within groups was poor (ICC < 0.50). Higher scores were given when subjects underwent a bilateral reconstruction and if a mamilla was present. CONCLUSION: Evaluation of aesthetic outcomes varies greatly. Hence, aesthetic outcome remains a very personal measure and this emphasizes the importance of thorough patient counseling including information on achievable aesthetic results before starting a reconstructive procedure. 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 .

Prevalence of Local Postoperative Complications and Breast Implant Illness in Women With Breast Implants.

Importance: It is unknown how often breast implant illness (BII) is the indication for revision in women with silicone breast implants. Objective: To examine how often women with silicone breast implants have their implants explanted or replaced because of BII compared with local postoperative complications. Design, Setting, and Participants: A legacy cohort study on breast implant revision surgery was conducted between April 1, 2015, and December 31, 2020, and a prospective cohort study on breast implantation and revision surgery was conducted between April 1, 2015, and December 31, 2019 (with follow-up until December 31, 2020). Data were obtained from the Dutch Breast Implant Registry. Data analysis was performed from September 2021 to August 2022. Exposures: Silicone breast implant. Main Outcomes and Measures: Breast implant revision with the indication BII or local postoperative complications. Results: All 12 882 cosmetic breast implants (6667 women; mean [SD] age, 50.6 [12.7] years) and 2945 reconstructive breast implants (2139 women, mean [SD] age, 57.9 [11.3] years) in the legacy cohort and all 47 564 cosmetic breast implants (24 120 women, mean [SD] age, 32.3 [9.7] years) and 5928 reconstructive breast implants (4688 women, mean [SD] age, 50.9 [11.5] years) in the prospective cohort were included for analysis. In the prospective cohort, 739 cosmetic breast implants (1.6%) were revised after a median (IQR) time to reoperation of 1.8 (0.9-3.1) years, and 697 reconstructive breast implants (11.8%) were revised after a median (IQR) time to reoperation of 1.1 (0.5-1.9) years. BII was registered as the reason for revision in 35 cosmetic revisions (4.7%) and 5 reconstructive revisions (0.7%) in the prospective cohort, corresponding to 0.1% of the inserted implants. In the legacy cohort, 536 cosmetic revisions (4.2%) and 80 reconstructive breast implant revisions (2.7%) were performed because of BII. Conclusions and Relevance: In this cohort study of women with silicone breast implants, BII was an uncommon indication for revision compared with local complications, both in the short and long term. In contrast to the increasing public interest in BII, these results showed that local complications are a far more common reason for breast implant revision.

Using a Digital Implant Catalog Improves Data Quality and Reduces Administrative Burden in the Dutch Breast Implant Registry.

BACKGROUND: Correct registration of implant characteristics is essential to monitor implant safety within implant registries. Currently, in the nationwide Dutch Breast Implant Registry (DBIR), these characteristics are being registered manually by plastic surgeons, resulting in administrative burden and potentially incorrect data entry. OBJECTIVES: This study evaluated the accuracy of manually registered implant data, possible consequences of incorrect data, and the potential of a Digital Implant Catalog (DIC) on increasing data quality and reducing the administrative burden. METHODS: Manually entered implant characteristics (fill, shape, coating, texture) of newly inserted breast implants in the DBIR, from 2015 to 2019, were compared with the corresponding implant characteristics in the DIC. Reference numbers were employed to match characteristics between the 2 databases. The DIC was based on manufacturers' product catalogs and set as the gold standard. RESULTS: A total of 57,361 DBIR records could be matched with the DIC. Accuracy of implant characteristics varied from 70.6% to 98.0%, depending on the implant characteristic. The largest discrepancy was observed for "texture" and the smallest for "coating." All manually registered implant characteristics resulted in different conclusions about implant performance compared with the DIC (P < 0.01). Implementation of the DIC reduced the administrative burden from 14 to 7 variables (50%). CONCLUSIONS: Implementation of a DIC increases data quality in the DBIR and reduces the administrative burden. However, correct registration of reference numbers in the registry by plastic surgeons remains key for adequate matching. Furthermore, all implant manufacturers should be involved, and regular updates of the DIC are required.

BREAST trial study protocol: evaluation of a non-invasive technique for breast reconstruction in a multicentre, randomised controlled trial.

INTRODUCTION: Pioneers have shown that it is possible to reconstruct a full breast using just autologous fat harvested by liposuction or autologous fat transfer (AFT). This study describes the first multicentre randomised study protocol to thoroughly investigate the effectiveness of AFT to reconstruct full breasts following mastectomy procedures (primarily and delayed). METHODS AND ANALYSIS: This study is designed as a multicentre, randomised controlled clinical superiority trial with a 1:1 allocation ratio. A total of 196 patients (98 patients per treatment arm) are aimed to be included. Patients who wish to undergo breast reconstruction with either one of the two techniques are randomly allocated into the AFT group (intervention) or the tissue-expander/prosthesis group (control). The primary outcome measure for the quality of life is measured by the validated BREAST-Q questionnaire. ETHICS AND DISSEMINATION: Approval for this study was obtained from the medical ethics committee of Maastricht University Medical Centre/Maastricht University; the trial has been registered at ClinicalTrials.gov. The results of this randomised controlled trial will be presented at scientific meetings as abstracts for poster or oral presentations and published in peer-reviewed journals. TRIAL STATUS: Enrolment into the trial has started in October 2015. Data collection and data analysis are expected to be completed in December 2021. TRIAL REGISTRATION NUMBER: NCT02339779.

Autologous Fat Transfer as a Treatment for Peripheral Neuropathic Pain without Apparent Cause.

Neuropathic pain has a far-reaching effect on the daily lives of patients. Recently, autologous fat transfer (AFT) has demonstrated promising results in patients with painful scars or after neuroma excision. However, there is a subgroup of patients who do not show any apparent cause for the pain. We hypothesized that in these patients, AFT alone in the area around the affected nerve might lead to beneficial results. Patients with clearly demarcated neuropathic pain and who had exhausted all other treatment options were referred by a pain specialist. Fourteen patients who met the inclusion criteria received AFT in the area of the affected nerve. Pain scored on the visual analog scale, patient satisfaction, and quality of sleep were recorded before and after surgery. To investigate long-term effects, a second follow-up was planned at least 1 year later. Patient satisfaction was 93% after the first follow-up and 86% after more than 1 year. The mean VAS score was 7.4 before surgery and significantly decreased to 3.8 after autologous fat grafting (P < 0.0001) and 4.3 (P = 0.0017) at long-term follow-up. The quality of sleep improved in 50% of the patients, whereas the remainder indicated no difference. No complications were registered. The results show that AFT alone, even over a longer period of time and in patients refractory to multiple treatment modalities, can be useful to treat peripheral neuropathic pain without apparent cause. For definitive evidence, a larger prospective study is warranted.