Skip to main content
Erschienen in: Journal of General Internal Medicine 1/2022

23.05.2021 | Perspective

Breast Implant Safety: an Overview of Current Regulations and Screening Guidelines

verfasst von: Cayla D. McKernan, MS, PA-C, Joshua Vorstenbosch, MD, PhD, Jacqueline J. Chu, BA, Jonas A. Nelson, MD, MPH

Erschienen in: Journal of General Internal Medicine | Ausgabe 1/2022

Einloggen, um Zugang zu erhalten

Abstract

Breast implant surgery for cosmetic or reconstructive purposes is becoming increasingly common. While the devices used are regulated and approved by the US Food and Drug Administration, all patients with breast implants require continued follow-up. Many patients will seek this care from their primary care providers, especially when follow-up with their plastic surgeon is difficult. It is vital that treating clinicians are knowledgeable about the history of breast implants, routine screening guidelines, and the recent breast implant “hot topics”—breast implant–associated anaplastic large cell lymphoma (BIA-ALCL), connective tissue disease, and breast implant illness. This paper will provide the necessary information for primary care providers to appropriately counsel patients with breast implants to maintain not only their trust, but also their health.
Literatur
1.
Zurück zum Zitat Collett DJ, Rakhorst H, Lennox P, Magnusson M, Cooter R, Deva AK. Current risk estimate of breast implant-associated anaplastic large cell lymphoma in textured breast implants. Plast Reconstr Surg. 2019;143(3S A Review of Breast Implant-Associated Anaplastic Large Cell Lymphoma):30S-40S.CrossRef Collett DJ, Rakhorst H, Lennox P, Magnusson M, Cooter R, Deva AK. Current risk estimate of breast implant-associated anaplastic large cell lymphoma in textured breast implants. Plast Reconstr Surg. 2019;143(3S A Review of Breast Implant-Associated Anaplastic Large Cell Lymphoma):30S-40S.CrossRef
2.
Zurück zum Zitat Rohrich RJ, Kaplan J, Dayan E. Silicone implant illness: science versus myth? Plast Reconstr Surg. 2019;144(1):98-109.CrossRef Rohrich RJ, Kaplan J, Dayan E. Silicone implant illness: science versus myth? Plast Reconstr Surg. 2019;144(1):98-109.CrossRef
4.
Zurück zum Zitat Cronin T, Gerow F. Augmentation mammaplasty: a new “natural feel” prostheses. In: Transactions of the Third International Congress of Plastic Surgery. Amsterdam: Experta Medical Foundation; 1963:41-49. Cronin T, Gerow F. Augmentation mammaplasty: a new “natural feel” prostheses. In: Transactions of the Third International Congress of Plastic Surgery. Amsterdam: Experta Medical Foundation; 1963:41-49.
5.
Zurück zum Zitat Groth AK, Graf R. Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and the textured breast implant crisis. Aesthetic Plast Surg. 2020;44(1):1-12.CrossRef Groth AK, Graf R. Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and the textured breast implant crisis. Aesthetic Plast Surg. 2020;44(1):1-12.CrossRef
6.
Zurück zum Zitat McCarthy CM, Klassen AF, Cano SJ, et al. Patient satisfaction with postmastectomy breast reconstruction: a comparison of saline and silicone implants. Cancer. 2010;116(24):5584-5591.CrossRef McCarthy CM, Klassen AF, Cano SJ, et al. Patient satisfaction with postmastectomy breast reconstruction: a comparison of saline and silicone implants. Cancer. 2010;116(24):5584-5591.CrossRef
7.
Zurück zum Zitat Macadam SA, Ho AL, Cook EF, Jr., Lennox PA, Pusic AL. Patient satisfaction and health-related quality of life following breast reconstruction: patient-reported outcomes among saline and silicone implant recipients. Plast Reconstr Surg. 2010;125(3):761-771.CrossRef Macadam SA, Ho AL, Cook EF, Jr., Lennox PA, Pusic AL. Patient satisfaction and health-related quality of life following breast reconstruction: patient-reported outcomes among saline and silicone implant recipients. Plast Reconstr Surg. 2010;125(3):761-771.CrossRef
8.
Zurück zum Zitat Shen Z, Chen X, Sun J, et al. A comparative assessment of three planes of implant placement in breast augmentation: a Bayesian analysis. J Plast Reconstr Aesthet Surg. 2019;72(12):1986-1995.CrossRef Shen Z, Chen X, Sun J, et al. A comparative assessment of three planes of implant placement in breast augmentation: a Bayesian analysis. J Plast Reconstr Aesthet Surg. 2019;72(12):1986-1995.CrossRef
9.
Zurück zum Zitat Calobrace MB, Schwartz MR, Zeidler KR, Pittman TA, Cohen R, Stevens WG. Long-term safety of textured and smooth breast implants. Aesthet Surg J. 2017;38(1):38-48. Calobrace MB, Schwartz MR, Zeidler KR, Pittman TA, Cohen R, Stevens WG. Long-term safety of textured and smooth breast implants. Aesthet Surg J. 2017;38(1):38-48.
10.
Zurück zum Zitat US Food and Drug Administration. Breast implants - certain labeling recommendations to improve patient communication: guidance for industry and Food and Drug Administration staff. FDA (Food and Drug Administration). https://www.fda.gov/media/131885/download. Published 2020. Updated 9/29/2020. Accessed December 23, 2020 US Food and Drug Administration. Breast implants - certain labeling recommendations to improve patient communication: guidance for industry and Food and Drug Administration staff. FDA (Food and Drug Administration). https://​www.​fda.​gov/​media/​131885/​download. Published 2020. Updated 9/29/2020. Accessed December 23, 2020
11.
Zurück zum Zitat Tang SS, Gui GP. A review of the oncologic and surgical management of breast cancer in the augmented breast: diagnostic, surgical and surveillance challenges. Ann Surg Oncol. 2011;18(8):2173-2181.CrossRef Tang SS, Gui GP. A review of the oncologic and surgical management of breast cancer in the augmented breast: diagnostic, surgical and surveillance challenges. Ann Surg Oncol. 2011;18(8):2173-2181.CrossRef
12.
Zurück zum Zitat Zakhireh J, Fowble B, Esserman LJ. Application of screening principles to the reconstructed breast. J Clin Oncol. 2010;28(1):173-180.CrossRef Zakhireh J, Fowble B, Esserman LJ. Application of screening principles to the reconstructed breast. J Clin Oncol. 2010;28(1):173-180.CrossRef
13.
Zurück zum Zitat Keech JA, Jr., Creech BJ. Anaplastic T-cell lymphoma in proximity to a saline-filled breast implant. Plast Reconstr Surg. 1997;100(2):554-555.CrossRef Keech JA, Jr., Creech BJ. Anaplastic T-cell lymphoma in proximity to a saline-filled breast implant. Plast Reconstr Surg. 1997;100(2):554-555.CrossRef
15.
Zurück zum Zitat Nelson JA, Dabic S, Mehrara BJ, et al. Breast implant-associated anaplastic large cell lymphoma incidence: determining an accurate risk. Ann Surg. 2020;272(3):403-409. Nelson JA, Dabic S, Mehrara BJ, et al. Breast implant-associated anaplastic large cell lymphoma incidence: determining an accurate risk. Ann Surg. 2020;272(3):403-409.
16.
Zurück zum Zitat Cordeiro PG, Ghione P, Ni A, et al. Risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) in a cohort of 3546 women prospectively followed long term after reconstruction with textured breast implants. J Plast Reconstr Aesthet Surg. 2020;73(5):841-846.CrossRef Cordeiro PG, Ghione P, Ni A, et al. Risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) in a cohort of 3546 women prospectively followed long term after reconstruction with textured breast implants. J Plast Reconstr Aesthet Surg. 2020;73(5):841-846.CrossRef
17.
Zurück zum Zitat DeCoster RC, Lynch EB, Bonaroti AR, et al. Breast implant-associated anaplastic large cell lymphoma: an evidence-based systematic review. Ann Surg. 2021;273(3):449-458. DeCoster RC, Lynch EB, Bonaroti AR, et al. Breast implant-associated anaplastic large cell lymphoma: an evidence-based systematic review. Ann Surg. 2021;273(3):449-458.
18.
Zurück zum Zitat Clemens MW, Jacobsen ED, Horwitz SM. 2019 NCCN consensus guidelines on the diagnosis and treatment of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Aesthet Surg J. 2019;39(Supplement_1):S3-S13. Clemens MW, Jacobsen ED, Horwitz SM. 2019 NCCN consensus guidelines on the diagnosis and treatment of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Aesthet Surg J. 2019;39(Supplement_1):S3-S13.
19.
Zurück zum Zitat Nelson JA, McCarthy C, Dabic S, et al. BIA-ALCL and textured breast implants: a systematic review of evidence supporting surgical risk management strategies. Plast Reconstr Surg. 2021;147(5S):7S-13S.CrossRef Nelson JA, McCarthy C, Dabic S, et al. BIA-ALCL and textured breast implants: a systematic review of evidence supporting surgical risk management strategies. Plast Reconstr Surg. 2021;147(5S):7S-13S.CrossRef
21.
Zurück zum Zitat McGuire PA, Deva AK, Glicksman CA, Adams WP, Jr., Haws MJ. Management of asymptomatic patients with textured surface breast implants. Aesthet Surg J Open Forum. 2019;1(3):ojz025. McGuire PA, Deva AK, Glicksman CA, Adams WP, Jr., Haws MJ. Management of asymptomatic patients with textured surface breast implants. Aesthet Surg J Open Forum. 2019;1(3):ojz025.
22.
Zurück zum Zitat Calobrace MB, Mays C. An algorithm for the management of explantation surgery. Clin Plast Surg. 2021;48(1):1-16.CrossRef Calobrace MB, Mays C. An algorithm for the management of explantation surgery. Clin Plast Surg. 2021;48(1):1-16.CrossRef
23.
Zurück zum Zitat McGuire PA, Haws MJ, Nahai F. Breast implant illness: how can we help? Aesthet Surg J. 2019;39(11):1260-1263. McGuire PA, Haws MJ, Nahai F. Breast implant illness: how can we help? Aesthet Surg J. 2019;39(11):1260-1263.
24.
Zurück zum Zitat Sánchez-Guerrero J, Colditz GA, Karlson EW, Hunter DJ, Speizer FE, Liang MH. Silicone breast implants and the risk of connective-tissue diseases and symptoms. N Engl J Med. 1995;332(25):1666-1670.CrossRef Sánchez-Guerrero J, Colditz GA, Karlson EW, Hunter DJ, Speizer FE, Liang MH. Silicone breast implants and the risk of connective-tissue diseases and symptoms. N Engl J Med. 1995;332(25):1666-1670.CrossRef
25.
Zurück zum Zitat Janowsky EC, Kupper LL, Hulka BS. Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases. N Engl J Med. 2000;342(11):781-790.CrossRef Janowsky EC, Kupper LL, Hulka BS. Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases. N Engl J Med. 2000;342(11):781-790.CrossRef
26.
Zurück zum Zitat Tugwell P, Wells G, Peterson J, et al. Do silicone breast implants cause rheumatologic disorders? A systematic review for a court-appointed national science panel. Arthritis Rheum. 2001;44(11):2477-2484.CrossRef Tugwell P, Wells G, Peterson J, et al. Do silicone breast implants cause rheumatologic disorders? A systematic review for a court-appointed national science panel. Arthritis Rheum. 2001;44(11):2477-2484.CrossRef
27.
Zurück zum Zitat Institute of Medicine. Safety of silicone breast implants. Washington, DC: National Academies Press; 1999. Institute of Medicine. Safety of silicone breast implants. Washington, DC: National Academies Press; 1999.
28.
Zurück zum Zitat Adidharma W, Latack KR, Colohan SM, Morrison SD, Cederna PS. Breast implant illness: are social media and the internet worrying patients sick? Plast Reconstr Surg. 2020;145(1):225e-227e. Adidharma W, Latack KR, Colohan SM, Morrison SD, Cederna PS. Breast implant illness: are social media and the internet worrying patients sick? Plast Reconstr Surg. 2020;145(1):225e-227e.
29.
Zurück zum Zitat Sánchez-Guerrero J, Schur PH, Sergent JS, Liang MH. Silicone breast implants and rheumatic disease. Clinical, immunologic, and epidemiologic studies. Arthritis Rheum. 1994;37(2):158-168. Sánchez-Guerrero J, Schur PH, Sergent JS, Liang MH. Silicone breast implants and rheumatic disease. Clinical, immunologic, and epidemiologic studies. Arthritis Rheum. 1994;37(2):158-168.
30.
Zurück zum Zitat Hennekens CH, Lee IM, Cook NR, et al. Self-reported breast implants and connective-tissue diseases in female health professionals. A retrospective cohort study. JAMA. 1996;275(8):616-621.CrossRef Hennekens CH, Lee IM, Cook NR, et al. Self-reported breast implants and connective-tissue diseases in female health professionals. A retrospective cohort study. JAMA. 1996;275(8):616-621.CrossRef
31.
Zurück zum Zitat Kessler DA. The basis of the FDA’s decision on breast implants. N Engl J Med. 1992;326(25):1713-1715.CrossRef Kessler DA. The basis of the FDA’s decision on breast implants. N Engl J Med. 1992;326(25):1713-1715.CrossRef
32.
Zurück zum Zitat Spear SL, Murphy DK, Allergan Silicone Breast Implant US Core Clinical Study Group. Natrelle round silicone breast implants: Core Study results at 10 years. Plast Reconstr Surg. 2014;133(6):1354-1361. Spear SL, Murphy DK, Allergan Silicone Breast Implant US Core Clinical Study Group. Natrelle round silicone breast implants: Core Study results at 10 years. Plast Reconstr Surg. 2014;133(6):1354-1361.
33.
Zurück zum Zitat Hammond DC, Canady JW, Love TR, Wixtrom RN, Caplin DA. Mentor contour profile gel implants: clinical outcomes at 10 years. Plast Reconstr Surg. 2017;140(6):1142-1150.CrossRef Hammond DC, Canady JW, Love TR, Wixtrom RN, Caplin DA. Mentor contour profile gel implants: clinical outcomes at 10 years. Plast Reconstr Surg. 2017;140(6):1142-1150.CrossRef
34.
Zurück zum Zitat Coroneos CJ, Selber JC, Offodile AC II, Butler CE, Clemens MW. US FDA breast implant postapproval studies: long-term outcomes in 99,993 patients. Ann Surg. 2019;269(1):30-36.CrossRef Coroneos CJ, Selber JC, Offodile AC II, Butler CE, Clemens MW. US FDA breast implant postapproval studies: long-term outcomes in 99,993 patients. Ann Surg. 2019;269(1):30-36.CrossRef
35.
Zurück zum Zitat Colwell AS, Mehrara B. Editorial: US FDA breast implant postapproval studies—long-term outcomes in 99,993 patients. Ann Surg. 2019;269(1):39-40.CrossRef Colwell AS, Mehrara B. Editorial: US FDA breast implant postapproval studies—long-term outcomes in 99,993 patients. Ann Surg. 2019;269(1):39-40.CrossRef
36.
Zurück zum Zitat Gunnarsson R, Molberg O, Gilboe IM, Gran JT, PAHNOR1 Study Group. The prevalence and incidence of mixed connective tissue disease: a national multicentre survey of Norwegian patients. Ann Rheum Dis. 2011;70(6):1047-1051.CrossRef Gunnarsson R, Molberg O, Gilboe IM, Gran JT, PAHNOR1 Study Group. The prevalence and incidence of mixed connective tissue disease: a national multicentre survey of Norwegian patients. Ann Rheum Dis. 2011;70(6):1047-1051.CrossRef
37.
Zurück zum Zitat Tang SYQ, Israel JS, Afifi AM. Breast implant illness: symptoms, patient concerns, and the power of social media. Plast Reconstr Surg. 2017;140(5):765e-766e. Tang SYQ, Israel JS, Afifi AM. Breast implant illness: symptoms, patient concerns, and the power of social media. Plast Reconstr Surg. 2017;140(5):765e-766e.
38.
Zurück zum Zitat Magnusson MR, Cooter RD, Rakhorst H, McGuire PA, Adams WP Jr, Deva AK. Breast implant illness: a way forward. Plast Reconstr Surg. 2019;143(3S A Review of Breast Implant-Associated Anaplastic Large Cell Lymphoma):74S-81S. Magnusson MR, Cooter RD, Rakhorst H, McGuire PA, Adams WP Jr, Deva AK. Breast implant illness: a way forward. Plast Reconstr Surg. 2019;143(3S A Review of Breast Implant-Associated Anaplastic Large Cell Lymphoma):74S-81S.
39.
Zurück zum Zitat Lee M, Ponraja G, McLeod K, Chong S. Breast implant illness: a biofilm hypothesis. Plast Reconstr Surg Glob Open. 2020;8(4):e2755.CrossRef Lee M, Ponraja G, McLeod K, Chong S. Breast implant illness: a biofilm hypothesis. Plast Reconstr Surg Glob Open. 2020;8(4):e2755.CrossRef
40.
Zurück zum Zitat Dush DM. Breast implants and illness: a model of psychological factors. Ann Rheum Dis. 2001;60(7):653-657.CrossRef Dush DM. Breast implants and illness: a model of psychological factors. Ann Rheum Dis. 2001;60(7):653-657.CrossRef
41.
Zurück zum Zitat Jewell ML, Jewell HL. Breast implant-associated illness: medicine by belief, so says Dr. Google. Aesthet Surg J. 2019;39(4):NP87-NP89.CrossRef Jewell ML, Jewell HL. Breast implant-associated illness: medicine by belief, so says Dr. Google. Aesthet Surg J. 2019;39(4):NP87-NP89.CrossRef
42.
Zurück zum Zitat Barbosa MR, Makris UE, Mansi IA. Association of breast implants with nonspecific symptoms, connective tissue diseases, and allergic reactions: a retrospective cohort analysis. Plast Reconstr Surg. 2021;147(1):42e-49e.CrossRef Barbosa MR, Makris UE, Mansi IA. Association of breast implants with nonspecific symptoms, connective tissue diseases, and allergic reactions: a retrospective cohort analysis. Plast Reconstr Surg. 2021;147(1):42e-49e.CrossRef
43.
Zurück zum Zitat de Boer M, Colaris M, van der Hulst RRWJ, Cohen Tervaert JW. Is explantation of silicone breast implants useful in patients with complaints? Immunol Res. 2017;65(1):25-36.CrossRef de Boer M, Colaris M, van der Hulst RRWJ, Cohen Tervaert JW. Is explantation of silicone breast implants useful in patients with complaints? Immunol Res. 2017;65(1):25-36.CrossRef
Metadaten
Titel
Breast Implant Safety: an Overview of Current Regulations and Screening Guidelines
verfasst von
Cayla D. McKernan, MS, PA-C
Joshua Vorstenbosch, MD, PhD
Jacqueline J. Chu, BA
Jonas A. Nelson, MD, MPH
Publikationsdatum
23.05.2021
Verlag
Springer International Publishing
Erschienen in
Journal of General Internal Medicine / Ausgabe 1/2022
Print ISSN: 0884-8734
Elektronische ISSN: 1525-1497
DOI
https://doi.org/10.1007/s11606-021-06899-y

Weitere Artikel der Ausgabe 1/2022

Journal of General Internal Medicine 1/2022 Zur Ausgabe

Leitlinien kompakt für die Innere Medizin

Mit medbee Pocketcards sicher entscheiden.

Seit 2022 gehört die medbee GmbH zum Springer Medizin Verlag

Echinokokkose medikamentös behandeln oder operieren?

06.05.2024 DCK 2024 Kongressbericht

Die Therapie von Echinokokkosen sollte immer in spezialisierten Zentren erfolgen. Eine symptomlose Echinokokkose kann – egal ob von Hunde- oder Fuchsbandwurm ausgelöst – konservativ erfolgen. Wenn eine Op. nötig ist, kann es sinnvoll sein, vorher Zysten zu leeren und zu desinfizieren. 

Umsetzung der POMGAT-Leitlinie läuft

03.05.2024 DCK 2024 Kongressbericht

Seit November 2023 gibt es evidenzbasierte Empfehlungen zum perioperativen Management bei gastrointestinalen Tumoren (POMGAT) auf S3-Niveau. Vieles wird schon entsprechend der Empfehlungen durchgeführt. Wo es im Alltag noch hapert, zeigt eine Umfrage in einem Klinikverbund.

Proximale Humerusfraktur: Auch 100-Jährige operieren?

01.05.2024 DCK 2024 Kongressbericht

Mit dem demographischen Wandel versorgt auch die Chirurgie immer mehr betagte Menschen. Von Entwicklungen wie Fast-Track können auch ältere Menschen profitieren und bei proximaler Humerusfraktur können selbst manche 100-Jährige noch sicher operiert werden.

Die „Zehn Gebote“ des Endokarditis-Managements

30.04.2024 Endokarditis Leitlinie kompakt

Worauf kommt es beim Management von Personen mit infektiöser Endokarditis an? Eine Kardiologin und ein Kardiologe fassen die zehn wichtigsten Punkte der neuen ESC-Leitlinie zusammen.

Update Innere Medizin

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.