Management of Symptomatic Patients with Textured Implants

Proper management of symptomatic textured implant patients is critical to identify and treat associated oncologic disease. Textured surface breast implants were first introduced more than 50 years ago in an effort to decrease high rates of capsular contracture and implant malposition observed with f...

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Veröffentlicht in:Plastic and reconstructive surgery (1963) 2021-05, Vol.147 (5S), p.58S-68S
Hauptverfasser: Asaad, Malke, Offodile, Anaeze C., Santanelli Di Pompeo, Fabio, Bevers, Therese B., Stelly, Sharon, Carew, Lori A., Barnea, Yoav, Miranda, Roberto N., Butler, Charles E., Clemens, Mark W.
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container_end_page 68S
container_issue 5S
container_start_page 58S
container_title Plastic and reconstructive surgery (1963)
container_volume 147
creator Asaad, Malke
Offodile, Anaeze C.
Santanelli Di Pompeo, Fabio
Bevers, Therese B.
Stelly, Sharon
Carew, Lori A.
Barnea, Yoav
Miranda, Roberto N.
Butler, Charles E.
Clemens, Mark W.
description Proper management of symptomatic textured implant patients is critical to identify and treat associated oncologic disease. Textured surface breast implants were first introduced more than 50 years ago in an effort to decrease high rates of capsular contracture and implant malposition observed with first-generation smooth surface breast implants. Textured implants were dominant over smooth devices in the United States in the late 1990s, but they fell out of favor for newer-generation smooth implants, while texture remained the dominant selling implants worldwide until recently. A class I device recall by the US Food and Drug Administration in 2019 precipitated a removal of the highest selling implant worldwide, Allergan Biocell, due to a disproportionately increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Operative strategies, such as bacterial control at the time of textured implant insertion, have not been credibly shown to affect or prevent the future development of BIA-ALCL. BIA-ALCL patients require complete surgical excision of their disease, whereas textured implant patients who are otherwise asymptomatic do not require surgical removal. For suspicious cases, diagnostic testing with CD30 immunohistochemistry should be performed before any surgical intervention. Capsules are evaluated with 12 strategic regional biopsies in a standardized approach. If surgeons are revising or exchanging textured implants, they may reasonably consider a total capsulectomy, though this is not advocated by the Food and Drug Administration or national societies, and has not been shown to mitigate future risk of BIA-ALCL. The purpose of this article is to review data on and outcomes for textured surface implants, disease-associated risk, and the management strategy for revisionary surgery and device surveillance.
doi_str_mv 10.1097/PRS.0000000000008047
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Textured surface breast implants were first introduced more than 50 years ago in an effort to decrease high rates of capsular contracture and implant malposition observed with first-generation smooth surface breast implants. Textured implants were dominant over smooth devices in the United States in the late 1990s, but they fell out of favor for newer-generation smooth implants, while texture remained the dominant selling implants worldwide until recently. A class I device recall by the US Food and Drug Administration in 2019 precipitated a removal of the highest selling implant worldwide, Allergan Biocell, due to a disproportionately increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Operative strategies, such as bacterial control at the time of textured implant insertion, have not been credibly shown to affect or prevent the future development of BIA-ALCL. BIA-ALCL patients require complete surgical excision of their disease, whereas textured implant patients who are otherwise asymptomatic do not require surgical removal. For suspicious cases, diagnostic testing with CD30 immunohistochemistry should be performed before any surgical intervention. Capsules are evaluated with 12 strategic regional biopsies in a standardized approach. If surgeons are revising or exchanging textured implants, they may reasonably consider a total capsulectomy, though this is not advocated by the Food and Drug Administration or national societies, and has not been shown to mitigate future risk of BIA-ALCL. 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BIA-ALCL patients require complete surgical excision of their disease, whereas textured implant patients who are otherwise asymptomatic do not require surgical removal. For suspicious cases, diagnostic testing with CD30 immunohistochemistry should be performed before any surgical intervention. Capsules are evaluated with 12 strategic regional biopsies in a standardized approach. If surgeons are revising or exchanging textured implants, they may reasonably consider a total capsulectomy, though this is not advocated by the Food and Drug Administration or national societies, and has not been shown to mitigate future risk of BIA-ALCL. 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ispartof Plastic and reconstructive surgery (1963), 2021-05, Vol.147 (5S), p.58S-68S
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source MEDLINE; Journals@Ovid Complete
subjects Breast Implantation - legislation & jurisprudence
Breast Implants - adverse effects
Breast Neoplasms - etiology
Breast Neoplasms - surgery
Device Removal - methods
Disease Management
Equipment Failure
Female
Humans
Lymphoma, Large-Cell, Anaplastic - etiology
Lymphoma, Large-Cell, Anaplastic - surgery
Mammaplasty - methods
Medical Device Recalls
Patient Education as Topic
Postoperative Complications - surgery
Prosthesis Design
Retrospective Studies
Risk
Silicone Gels
Surface Properties
Triage
Truth Disclosure
title Management of Symptomatic Patients with Textured Implants
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