US FDA Breast Implant Postapproval Studies

Coroneos, Christopher J.; Selber, Jesse C.; Offodile, Anaeze C.; Butler, Charles E.; Clemens, Mark W.

doi:10.1097/sla.0000000000002990

Cited by 237 publications

(108 citation statements)

References 55 publications

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“…The association between silicone breast implants and autoimmune diseases still remains inconclusive considering data from systematic reviews and meta-analyses [ 80 , 81 , 82 ]. A more recent post-approval long-term outcome study on an extremely large cohort suggests that there are higher rates of SS and other autoimmune disorders in patients undergoing silicone breast implants [ 83 ]. This is consistent with case reports dating back 1984 and with the several case series reported over time [ 84 ].…”

Section: Classical Examples Of the Asia Syndromementioning

confidence: 99%

Classical Examples of the Concept of the ASIA Syndrome

et al. 2020

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Autoimmune/inflammatory syndrome induced by adjuvants (ASIA) was first introduced in 2011 by Shoenfeld et al. and encompasses a cluster of related immune mediated diseases, which develop among genetically prone individuals as a result of adjuvant agent exposure. Since the recognition of ASIA syndrome, more than 4400 documented cases have been reported so far, illustrated by heterogeneous clinical manifestations and severity. In this review, five enigmatic conditions, including sarcoidosis, Sjögren’s syndrome, undifferentiated connective tissue disease, silicone implant incompatibility syndrome (SIIS), and immune-related adverse events (irAEs), are defined as classical examples of ASIA. Certainly, these disorders have been described after an adjuvant stimulus (silicone implantation, drugs, infections, metals, vaccines, etc.) among genetically predisposed individuals (mainly the HLA-DRB1 and PTPN22 gene), which induce an hyperstimulation of the immune system resulting in the production of autoantibodies, eventually leading to the development of autoimmune diseases. Circulating autonomic autoantibodies in the sera of patients with silicone breast implants, as well as anatomopathological aspects of small fiber neuropathy in their skin biopsies have been recently described. To our knowledge, these novel insights serve as a common explanation to the non-specific clinical manifestations reported in patients with ASIA, leading to the redefinition of the ASIA syndrome diagnostic criteria.

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Section: Classical Examples Of the Asia Syndromementioning

confidence: 99%

Classical Examples of the Concept of the ASIA Syndrome

et al. 2020

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“…The most common complications are contracture and capsule formation, which occur in about ten percent of cases. 9 , 10 Since the 1960s several cases have been reported associating breast implants to systemic diseases. Several literature reviews have been done in this concern, yet no scientific based evidence has been found.…”

Section: Discussionmentioning

confidence: 99%

Autologous Mastopexy and Autoaugmention of the Breast

Raafat

Ezzat

Khachaba

et al. 2020

Plastic and Reconstructive Surgery - Global Open

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Background: Autologous mastopexy is an alternative for patients with small breasts, ptosis and upper pole hollowness, who desire improvement in their breast shape without using an implant. A variety of techniques have been tried throughout the years. Recently the use of autologous fat grafting (AFG) for breast augmentation increased in popularity and showed satisfying cosmetic outcome in enhancement of size, shape and texture of the breast. Methods: 25 patients with grade 2 ptosis were included in this study. Lower Island Flap Transposition (LIFT) technique was modified and either done alone or in combination with lipofilling, whether at the same setting or as a second stage. Preoperative and postoperative measurements and pictures were documented. Results: Lateral upper pole projection measurements showed an average increase of 28.5% equal to about 1.8 cm. As for the maximum breast projection an increase of about 33% accounting for about 2 cm was documented. Conclusions: This study shows that the combination of LIFT technique after its modification with AFG has proven to be an effective technique with consistent results for patients presenting with grade 2 ptosis and upper pole hollowness. The addition of AFG to the modified LIFT technique can be considered a step forward in achieving autoaugmentation and autologous mastopexy without using implants.

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“…In Latin America, there are no recommendations or policies for surveillance or optimal follow-up of patients with breast implants. 8 Here we detail the results of patient reporting, diagnosis, and follow-up of patients diagnosed with BIA-ALCL in Colombia through the development of a national registry and the multidisciplinary participation of medical society physicians who may encounter patients with BIA-ALCL in their practices.…”

Section: Discussionmentioning

confidence: 99%

Breast Implant–associated Anaplastic Large Cell Lymphoma in Colombia: Report of a Multidisciplinary National Registry

Gomez¹,

Abad

Duque

et al. 2020

Plastic and Reconstructive Surgery - Global Open

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Background: An estimated 43,390 breast augmentation surgeries (86,780 implants) and 1486 breast implant reconstructions are performed annually in Colombia, representing the second-most breast surgery destination in South America, the fourth in the western hemisphere, and the fifth country worldwide. No previous reports have evaluated the incidence of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) epidemiology or outcomes in a Hispanic population. Published data on the incidence of this disease in Colombia are unknown; therefore, a National Joint Multidisciplinary Committee was developed between the Colombian scientific societies of Mastology, Plastic Surgery, Hemato-Oncology, and the Invima (The National Food and Drug Surveillance Institute) to track national cases of BIA-ALCL. Materials and Methods: We performed a retrospective review (survey-based study) of historical cases since 2011–2019, and a prospective collection of all patients with a confirmed World Health Organization diagnosis of BIA-ALCL identified in a newly established National Registry of BIA-ALCL. The trial was approved by Institutional Review Board (IRB). Results: Eighteen cases of BIA-ALCL were identified in Colombia between 2011 and 2019. Hundred percent developed as sequelae of textured implants. Six patients (33.3%) presented either a peri-implant capsule mass or axillary lymph node involvement. Seven (38.9%) required adjuvant chemotherapy most commonly with CHOP regimen. Different brands of implants were associated with our cases. One death (5.6%) was attributed to BIA-ALCL, and one (5.6%) case displayed with relapsed with bone marrow involvement requiring a bone marrow transplantation. Six cases (33.3%) were identified with advanced stage (IIB-IV). Disease-free survival of 92.3% was achieved at 30.8-month follow-up. Conclusions: Colombia has one of the highest volumes of breast surgery and use of textured surface breast implants in the world. This study is the initial report of an implant registry in South America. A high proportion of advanced disease may be a consequence of delayed presentation, lack of disease awareness, and timely access to tertiary cancer centers for diagnosis and treatment. Brands other than Allergan and Mentor were found to be associated with BIA-ALCL in our study.

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US FDA Breast Implant Postapproval Studies

Cited by 237 publications

References 55 publications

Classical Examples of the Concept of the ASIA Syndrome

Classical Examples of the Concept of the ASIA Syndrome

Autologous Mastopexy and Autoaugmention of the Breast

Breast Implant–associated Anaplastic Large Cell Lymphoma in Colombia: Report of a Multidisciplinary National Registry

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