SUMMARY: 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.

Management of symptomatic patients with textured implants / Asaad, M.; Offodile, A. C.; Santanelli Di Pompeo, F.; Bevers, T. B.; Stelly, S.; Carew, L. A.; Barnea, Y.; Miranda, R. N.; Butler, C. E.; Clemens, M. W.. - In: PLASTIC AND RECONSTRUCTIVE SURGERY. - ISSN 0032-1052. - 147:5(2021), pp. 58-68. [10.1097/PRS.0000000000008047]

Management of symptomatic patients with textured implants

Santanelli Di Pompeo F.;
2021

Abstract

SUMMARY: 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.
2021
breast implantation; breast implants; breast neoplasms; device removal; disease management; equipment failure; female; humans; lymphoma; large-cell; anaplastic; mammaplasty; medical device recalls; patient education as topic; postoperative complications; prosthesis design; retrospective studies; risk; silicone gels; surface properties; triage;truth disclosure
01 Pubblicazione su rivista::01a Articolo in rivista
Management of symptomatic patients with textured implants / Asaad, M.; Offodile, A. C.; Santanelli Di Pompeo, F.; Bevers, T. B.; Stelly, S.; Carew, L. A.; Barnea, Y.; Miranda, R. N.; Butler, C. E.; Clemens, M. W.. - In: PLASTIC AND RECONSTRUCTIVE SURGERY. - ISSN 0032-1052. - 147:5(2021), pp. 58-68. [10.1097/PRS.0000000000008047]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1572080
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