breast implant; silicone breast implant; augmentation mammoplasty

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Introduction

FDA lifts 14 year ban on silicone breast implants.

Silicone & saline breast implants available.

Silicone implants have superior cosmetic & tactile properties

Indications

Laboratory

Diagnostic procedures

Radiology

Complications

Management

  • not lifetime devices; however duration of use not specified[2]
  • clinicians should be prepared to
    • offer nonsurgical alternatives for comfort & appearance
    • discuss sexual development with adolescents & the wide variation in breast appearances
    • counsel patients before surgery or referral & assess their physical & emotional maturity (mandatory[13])
  • adolescents requesting surgery should be screened for body dysmorphic disorder

More general terms

References

  1. Journal Watch Women's Health Nov 30, 2006
  2. 2.0 2.1 2.2 FDA NEWS RELEASE: June 22, 2011 FDA provides updated safety data on silicone gel-filled breast implants http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm260235.htm
  3. FDA News Release: Feb. 20, 2013 FDA approves new silicone gel-filled breast implant. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm340447.htm
  4. 4.0 4.1 FDA News Release: June 14, 2013 FDA approves a new silicone gel-filled breast implant. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm356990.htm
  5. American Contress of Obsetricians & Gynecologists (ACOG) Committee Opinion. Number 662, May 2016 Breast and Labial Surgery in Adolescents http://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Adolescent-Health-Care/Breast-and-Labial-Surgery-in-Adolescents
  6. 6.0 6.1 6.2 6.3 FDA Safety Alert. Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). March 21, 2017 https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm547622.htm
  7. 7.0 7.1 de Boer M, van Leeuwen FE, Hauptmann M et al Breast Implants and the Risk of Anaplastic Large-Cell Lymphoma in the Breast. JAMA Oncol. Published online January 4, 2018 PMID: https://www.ncbi.nlm.nih.gov/pubmed/29302687 https://jamanetwork.com/journals/jamaoncology/fullarticle/2667737
    McCarthy CM, Horwitz SM. Association of Breast Implants With Anaplastic Large-Cell Lymphoma. JAMA Oncol. Published online January 4, 2018 PMID: https://www.ncbi.nlm.nih.gov/pubmed/29302678 https://jamanetwork.com/journals/jamaoncology/article-abstract/2667734
  8. 8.0 8.1 FDA Update. March 21, 2018 Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm
    FDA Letter to Health Care Providers. Feb 6, 2019 Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)
    Letter to Health Care Providers. https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm630863.htm FDA data on ALCL tied to breast implants. Feb 6, 2019 Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm481899.htm
  9. FDA News Release. March 19, 2019 FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633890.htm
  10. 10.0 10.1 Elia J, Fairchild DG, Di Francesco L Keep Textured Breast Implants on the Market for Now, FDA Advisers Say Physician's First Watch, March 22, 2019 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
    FDA Statement. May 2, 2019 Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health on FDA's new efforts to protect women's health and help to ensure the safety of breast implants. https://www.fda.gov/news-events/press-announcements/statement-fda-principal-deputy-commissioner-amy-abernethy-md-phd-and-jeff-shuren-md-jd-director-fdas
  11. 11.0 11.1 FDA News Release. July 24, 2019 FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market. https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan
    FDA. July 24, 2019 Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma. https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma
  12. 12.0 12.1 Lee KT, Kim S, Jeon BJ et al Association of the Implant Surface Texture Used in Reconstruction With Breast Cancer Recurrence. JAMA Surg. Published online October 7, 2020 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33026424 https://jamanetwork.com/journals/jamasurgery/article-abstract/2771054
    Cassidy MR, Roh DS Is It Time to Abandon Textured Breast Implants for Breast Cancer Reconstruction? JAMA Surg. Published online October 7, 2020 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33026418 https://jamanetwork.com/journals/jamasurgery/fullarticle/2771049
  13. 13.0 13.1 13.2 AMA Morning Rounds. Oct 28, 2021 American Medical Association (AMA)
    Shepherd K FDA requires doctors, manufacturers to disclose breast implant risks to prospective patients. Washington Post. October 27, 2021 https://www.washingtonpost.com/health/2021/10/27/fda-breast-implants-checklist-requirement/
    Perrone M FDA sets stronger safety warnings for breast implants. Associated Press. October 27, 2021 https://apnews.com/article/technology-science-business-lifestyle-health-bd48d3fd05b5815c2e7603db3975ede0
  14. 14.0 14.1 14.2 14.3 Medical Knowledge Self Assessment Program (MKSAP) 19. American College of Physicians, Philadelphia 2021
  15. 15.0 15.1 Harrison P ALCL Increasing Rapidly in US Women as Breast Implants Rise. Medscape. July 21, 2022 https://www.medscape.com/viewarticle/977675
    Kinslow CJ, Kim A, Sanchez GI et al Incidence of Anaplastic Large-Cell Lymphoma of the Breast in the US, 2000 to 2018. JAMA Oncol. Published online July 21, 2022 PMID: https://www.ncbi.nlm.nih.gov/pubmed/35862042 https://jamanetwork.com/journals/jamaoncology/article-abstract/2794631

Patient information

breast implant patient information