Contents

Search

breast implant; silicone breast implant; augmentation mammoplasty

FDA lifts 14 year ban on silicone breast implants. Silicone & saline breast implants available. Silicone implants have superior cosmetic & tactile properties Indications: 1) cosmetic disorder 2) reconstructive 3) women must be at least 22 years of age Laboratory: - analysis of any peri-implant fluid collections - collected fluid may be serous, non-purulent with anaplastic large cell lymphoma (ALCL) - malignant cells if fount CD30+, ALK- [14] Special laboratory: - fine needle aspiration of fluid detected on breast ultrasound Radiology: - breast ultrasound for symptomatic complication - silicone implants - MRI at 3 years post-operatively, then every 2 years to detect asymptomatic rupture Complications: 1) rupture, breast pain, asymmetry, scarring, infection [2] 2) Institute of Medicine 1999 concludes silcone breast implants NOT associated with increased risk of: a) connective tissue disease b) cancer 3) rare cases of anaplastic large cell lymphoma (ALCL) or anaplastic T-cell lymphoma - more frequently following implantation of breast implants with textured surfaces than with smooth surfaces [6] - median time to diagnosis is 8-9 years after implant placement [14] - identified most frequently in patients undergoing implant revision for late onset, persistent seroma [6] - exact number of cases difficult to determine [6] - number needed to harm: 7000 (by age 75 years) [7] - as of September 30, 2017, FDA had received a 414 reports of breast implant associated-ALCL, including 9 deaths [8] - can be cured with surgery; remove tumor & both implants [14] - the FDA has mandated a black box warning on labeling of all saline- & silicone gel-filled breast implants for an association with anaplastic large cell lymphoma [15] 4) textured breast implants after total mastectomy for breast cancer may increase risk for breast cancer recurrence [12] 5) microtextured breast implants, despite studies showing association with lymphoma, will remain on the market, at least pending more information, an FDA advisory panel has recommended [10,11] 6) chronic medical conditions, including autoimmune diseases, arthralgias, brain fog, ayalgias & chronic fatigue collectively known as breast implant illness [13] 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 - those who screen positive should be referred to a mental healthcare provider [4]

General

general surgery implant

References

  1. Journal Watch Women's Health Nov 30, 2006
  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. 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. 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. 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: 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: 29302678 https://jamanetwork.com/journals/jamaoncology/article-abstract/2667734
  8. 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. 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. 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. 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: 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: 33026418 https://jamanetwork.com/journals/jamasurgery/fullarticle/2771049
  13. 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. Medical Knowledge Self Assessment Program (MKSAP) 19. American College of Physicians, Philadelphia 2021
  15. 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: 35862042 https://jamanetwork.com/journals/jamaoncology/article-abstract/2794631