{"entity":{"id":"breast-implants","kind":"technology","name":"Breast implants for reconstruction (silicone gel, saline and shaped cohesive gel)","aka":["Breast implant","Silicone breast implant","Saline breast implant","Natrelle","MemoryGel","MemoryShape","Motiva","Sientra","Natrelle highly cohesive"],"tldr":"Implants filled with silicone gel or salt water used to rebuild a breast after mastectomy. They are not lifetime devices: some need replacing, and the FDA requires a warning and a checklist that patients read before agreeing to them.","summary":"Breast implants are class III devices in the United States, approved by PMA. Silicone gel-filled implants (product code FTR) include Allergan's Natrelle (P020056) and Mentor's MemoryGel (P030053), both approved on 17 November 2006, Sientra's silicone gel implants (P070004, 9 March 2012, now held by Tiger Aesthetics Medical), Allergan's Natrelle highly cohesive silicone-filled implants (P040046, 20 February 2013) and Mentor MemoryShape (P060028, 14 June 2013), and Motiva SmoothSilk implants (P230005, 26 September 2024). Saline-filled implants (code FWM) are Natrelle saline (P990074) and Mentor's saline-filled and Spectrum implants (P990075), both approved on 10 May 2000.\n\nThe FDA's breast implant page lists the actions that shape choice today: the request of 24 July 2019 that Allergan voluntarily recall Natrelle BIOCELL textured breast implants and tissue expanders from the market; labeling guidance from September 2020 adding a boxed warning and a patient decision checklist; and orders on 27 October 2021 restricting sale and distribution so that patients receive that risk information before surgery. The FDA lists local complications that occur in at least 1 per cent of patients, including capsular contracture, rupture and further operations, and describes the systemic symptoms some patients call breast implant illness. England's Breast and Cosmetic Implant Registry was launched in October 2016 after the high rupture rate of Poly Implant Prothese (PIP) implants and the inability to trace affected women, according to the plastic surgery associations (BAPRAS).","status":"standard-of-care","asOf":"2026-11-04","links":[{"label":"FDA PMA P020056: Natrelle silicone-filled breast implants","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020056"},{"label":"FDA PMA P030053: Mentor MemoryGel silicone gel-filled breast implants","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030053"},{"label":"FDA PMA P070004: Sientra silicone gel breast implants","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P070004"},{"label":"FDA PMA P040046: Natrelle highly cohesive silicone-filled implants","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040046"},{"label":"FDA PMA P060028: Mentor MemoryShape breast implants","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P060028"},{"label":"FDA PMA P230005: Motiva SmoothSilk silicone gel-filled implants","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230005"},{"label":"FDA PMA P990074: Natrelle saline breast implants","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990074"},{"label":"FDA PMA P990075: Mentor saline-filled and Spectrum mammary prostheses","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990075"},{"label":"FDA: breast implants (safety communications and labeling guidance)","url":"https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants"},{"label":"FDA: risks and complications of breast implants","url":"https://www.fda.gov/medical-devices/breast-implants/risks-and-complications-breast-implants"},{"label":"BAPRAS: 20,000 operations recorded on England's Breast and Cosmetic Implant Registry","url":"https://bapras.org.uk/media-government/media-resources/press-releases/20-000-operations-recorded-on-england-s-breast-and-cosmetic-implant-registry"}],"tags":["devices-gaps-2026-11"],"related":[],"cancers":["breast-cancer","breast-implant-associated-alcl"],"sections":["surgery","supportive-care","devices"],"technologies":["rejuv-recon-breast","breast-tissue-expanders","acellular-dermal-matrix-breast","nipple-areola-tattooing","external-breast-prostheses"],"targets":[],"drugs":[],"companies":["establishment-labs"],"institutions":[],"pathways":[],"terms":["breast-reconstruction","bia-alcl","breast-implant-capsule-cancers","breast-implant-illness"],"trials":["ibra-study"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo device gap fill (openFDA, accessdata.fda.gov, NICE, NHS Drug Tariff Part IX, FDA, maker and society pages)","editedOn":"2026-11-04"},"principle":"An elastomer silicone shell filled with silicone gel or saline is placed under or over the chest muscle, often after a tissue expander has stretched the skin, to restore breast volume and shape.","strengths":["Shorter operation and recovery than reconstruction with the patient's own tissue","Range of shapes, sizes and fills"],"limitations":["Not lifetime devices; further operations are common","Capsular contracture, rupture and, with textured surfaces, lymphoma risk","Radiotherapy raises complication rates"],"since":2000},"route":"/technologies/breast-implants/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"},{"id":"breast-implant-associated-alcl","kind":"cancer","name":"Breast implant-associated anaplastic large cell lymphoma","route":"/cancers/breast-implant-associated-alcl/"}],"section":[{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"supportive-care","kind":"section","name":"Supportive Care & Survivorship","route":"/fronts/supportive-care/"},{"id":"surgery","kind":"section","name":"Surgery & Interventional","route":"/fronts/surgery/"}],"technology":[{"id":"acellular-dermal-matrix-breast","kind":"technology","name":"Acellular dermal matrices and meshes in implant reconstruction","route":"/technologies/acellular-dermal-matrix-breast/"},{"id":"rejuv-recon-breast","kind":"technology","name":"Breast reconstruction: implant and autologous, immediate and delayed, and what women report afterwards","route":"/technologies/rejuv-recon-breast/"},{"id":"breast-tissue-expanders","kind":"technology","name":"Breast tissue expanders (saline and carbon dioxide)","route":"/technologies/breast-tissue-expanders/"},{"id":"external-breast-prostheses","kind":"technology","name":"External breast prostheses, mastectomy bras and nipple prostheses","route":"/technologies/external-breast-prostheses/"},{"id":"nipple-areola-tattooing","kind":"technology","name":"Nipple and areola tattooing after breast surgery","route":"/technologies/nipple-areola-tattooing/"}],"company":[{"id":"establishment-labs","kind":"company","name":"Establishment Labs (Motiva)","route":"/companies/establishment-labs/"}],"term":[{"id":"breast-implant-illness","kind":"term","name":"Breast implant illness (systemic symptoms with breast implants)","route":"/terms/breast-implant-illness/"},{"id":"bia-alcl","kind":"term","name":"Breast implant-associated anaplastic large cell lymphoma","route":"/terms/bia-alcl/"},{"id":"breast-reconstruction","kind":"term","name":"Breast reconstruction","route":"/terms/breast-reconstruction/"},{"id":"breast-implant-capsule-cancers","kind":"term","name":"Squamous cell carcinoma and lymphomas in the capsule around breast implants","route":"/terms/breast-implant-capsule-cancers/"}],"trial":[{"id":"ibra-study","kind":"trial","name":"iBRA (implant Breast Reconstruction evAluation)","route":"/trials/ibra-study/"}]}}