National Breast Implant Registry in Italy. Competent Authority Perspective to Improve Patients’ Safety

Campanale, Antonella; Ventimiglia, Marco; Minella, Daniela; Sampaolo, Letizia; Iachino, Achille; Lispi, Lucia

doi:10.57604/prrs-005

Cited by 14 publications

(11 citation statements)

References 10 publications

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“…In 2019, the Italian Ministry of Health declared that there are no sufficient reasons to recommend the withdrawal from commercial availability of the textured implants. Moreover, the same Italian Ministry of Health affirmed that there is no indication to surgically remove the smooth or textured implant in the absence of clinical suspicion of BIA-ALCL [ 88 ]. It is strongly recommended to have a clear and transparent conversation with the patient, in order to inform her on the possible risks and benefits of each procedure, to achieve a shared decision to remove the implant and the periprosthetic capsule.…”

Section: Discussionmentioning

confidence: 99%

Clinical recommendations for diagnosis and treatment according to current updated knowledge on BIA-ALCL

Longo

Napoli²,

Curigliano³

et al. 2022

The Breast

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Section: Discussionmentioning

confidence: 99%

Clinical recommendations for diagnosis and treatment according to current updated knowledge on BIA-ALCL

Longo

Napoli²,

Curigliano³

et al. 2022

The Breast

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“…In recent years, recent studies have shown safety 22 , efficacy, and patient satisfaction following pre-pectoral breast reconstruction 23 ; however, further studies with longer follow-ups are needed to evaluate longterm outcomes. Mastectomy had increased in rate thanks to various factors such as better detection of multicentric tumors, widespread prophylactic mastectomies and improved quality of breast reconstruction [24][25][26] .…”

Section: Discussionmentioning

confidence: 99%

The Use of Exashapetm Bioshield Pocket in Prepectoral Breast Reconstruction: A Preliminary Experience

Mazzocchi

Sigorini

Cerciello

et al. 2022

PRRS

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Objective. In the few latter, immediate breast reconstruction, performed with prepectoral positioning of implants, is assuming an increasinglly important role in the tumor recovery process for most women. With this study we want to describe our experience in prepectoral immediate breast reconstruction using Exashape, a new pre-shaped bilayer acellular dermal matrix derived from bovine pericardium. Methods. Twenty-one patients with breast cancer were enrolled and went under momo-(5) or bilateral ( 16) nipple sparing mastectomy, for a total of 37 reconstructed breasts. All the implants have been assembled with Exashape and positioned over the pectoralis major muscle. All the patient answered to BREAST-Q questionnaire in preoperative time six months after surgery. Results. This preliminary study showed a reduction of implant's exposure time and risk of bacterial contamination, a decreased risk of injury to the implant and an easy assembly and positioning. Of Twenty-one patients enrolled for this study, only five patients had complication: four resolved after surgical revision of scars and one with implant loss. BREAST-Q resulted overall satisfaction with breasts, psychosocial well-being, and sexual well-being were all significantly increased (p < 0.05) and chest discomfort got significantly worse (p < 0.05). Conclusions. Although further studies would be useful to validate our result. We can say that Exashape TM has proved to be useful in breast reconstruction, allowing a good aesthetic and functional result.

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“…Minimally invasive approach and local anaesthesia seem to better preserve immune functions; and should be preferred also for oncoplastic surgery with advantages in oncological and infectiology terms despite the lack of high-level evidence [33][34][35] . Conversion from local to general anaesthesia can be required due to anxiety and agitation although awake oncoplastic surgery was well tolerated by the patients with satisfaction at the end of the procedure.…”

Section: Discussionmentioning

confidence: 99%

Feasibility and Safety of Awake Oncoplastic Surgery for Breast Cancer

Vanni

Pellicciaro

Materazzo

et al. 2022

PRRS

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Background. In the last two decades oncoplastic breast surgery has emerged as a new technique requiring longer time and more complex breast dissection and remodelling. Advantages of awake surgery have been demonstrated in literature, but oncoplastic surgery, due to its complexity, is usually performed under general anaesthesia. The aim of this study is to evaluate feasibility and safety of awake oncoplastic surgery. Materials and methods. Retrospective observational study on patients who underwent awake oncoplastic surgery from January 2019 to December 2020. Collected data included tumour staging, Estrogen receptor (ER), Progesterone receptor (PR) and Ki67 index, age, BMI, ASA, type of oncoplastic surgery, surgical time, complications, aesthetic outcome evaluated at 6 months by the two breast senior surgeons rated on a five-point scale, patient's satisfaction valuated at 6 months by Breast-Q ® questionnaire. Results. 14 patients were included in the study. Patients' satisfaction was great in term tolerability of awake regimen and satisfaction with the result, as shown using Breast-Q test. Also, surgeon satisfaction was acceptable. No anaesthesiologic compliance were reported in the case series. Conclusions. Oncoplastic awake surgery is feasible and safe also for level II oncoplasty in well selected patients performing local anaesthesia.

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National Breast Implant Registry in Italy. Competent Authority Perspective to Improve Patients’ Safety

Cited by 14 publications

References 10 publications

Clinical recommendations for diagnosis and treatment according to current updated knowledge on BIA-ALCL

Clinical recommendations for diagnosis and treatment according to current updated knowledge on BIA-ALCL

The Use of Exashapetm Bioshield Pocket in Prepectoral Breast Reconstruction: A Preliminary Experience

Feasibility and Safety of Awake Oncoplastic Surgery for Breast Cancer

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