{"id":28,"slug":"breast-implant","name":"Breast Implant","alternate_names":["보형물","가슴 보형물"],"aliases":[],"locale":"en","available_locales":["en"],"localized":false,"type":"product","description":"A breast implant is a silicone-shell medical device filled with silicone gel or saline that is placed to enlarge or reconstruct the breast.","overview":"A breast implant is a medical device placed by surgery. It is a silicone shell filled with saline or silicone gel. It is used to enlarge the breasts, to rebuild a breast after mastectomy, or to replace an earlier implant. Products differ in fill material, size, shape and surface texture (smooth or textured). In the United States, the FDA has approved saline-filled and silicone gel-filled implants and sets minimum ages for cosmetic use. In South Korea, silicone gel implants are Class 4 (highest-risk) devices that must be tracked. Regulators state that implants are not lifetime devices. Reported problems include rupture, which may cause no symptoms and is best found with MRI; capsular contracture; BIA-ALCL, a rare immune-system cancer linked more often to textured implants; and body-wide symptoms that are poorly understood. Readers should check the specific product's approval status, surface type, patient labeling and recommended imaging follow-up.","official_url":null,"image_url":null,"country":null,"region":null,"wikidata_id":null,"wikipedia_url":null,"verified":false,"scores":{"authority":62,"trust":0,"citation":0},"topic":{"slug":"breast-augmentation","name":"Breast Augmentation"},"url":"https://worldwiki.io/entity/breast-implant","facts":[{"id":321,"predicate":"regulatory_status_us","label":"US FDA-approved types and age limits","value":"Saline-filled and silicone gel-filled implants are FDA-approved. For breast enlargement, saline requires age 18 or older and silicone gel requires age 22 or older. For reconstruction, both are approved at any age.","unit":null,"confidence":80,"valid_from":"2019-10-23","valid_until":null,"verified_at":"2026-09-18 07:21:45","source_ids":[69]},{"id":322,"predicate":"device_lifespan","label":"Expected lifespan","value":"Not a lifetime device. The longer implants are in place, the more likely they are to need removal or replacement.","unit":null,"confidence":80,"valid_from":"2023-03-08","valid_until":null,"verified_at":"2026-09-18 07:21:45","source_ids":[291]},{"id":323,"predicate":"rupture_detection","label":"Detecting silent rupture (silicone gel)","value":"MRI is the most effective method. Ultrasound is an acceptable alternative for screening patients without symptoms.","unit":null,"confidence":80,"valid_from":"2023-12-14","valid_until":null,"verified_at":"2026-09-18 07:21:45","source_ids":[66]},{"id":324,"predicate":"labeling_requirements_us","label":"US labeling guidance","value":"Final FDA guidance issued September 2020 (docket FDA-2019-D-4467) on patient labeling content and format, including a boxed warning","unit":null,"confidence":80,"valid_from":"2020-09-01","valid_until":null,"verified_at":"2026-09-18 07:21:45","source_ids":[292]},{"id":325,"predicate":"bia_alcl_first_identified","label":"FDA first linked implants to ALCL","value":"2011","unit":null,"confidence":80,"valid_from":"2019-10-23","valid_until":null,"verified_at":"2026-09-18 07:21:45","source_ids":[68]},{"id":326,"predicate":"bia_alcl_reported_cases","label":"BIA-ALCL medical device reports to FDA","value":"1,380 reports (US and non-US), including 64 deaths. Median time to diagnosis was 8 years after implantation.","unit":"reports","confidence":80,"valid_from":"2024-06-30","valid_until":null,"verified_at":"2026-09-18 07:21:45","source_ids":[76]},{"id":327,"predicate":"bia_alcl_surface_breakdown","label":"BIA-ALCL reports by implant surface","value":"Textured 1,010 (73%); smooth 40 (3%, only one with no known history of textured implants); not specified 330 (24%)","unit":"reports","confidence":80,"valid_from":"2024-06-30","valid_until":null,"verified_at":"2026-09-18 07:21:45","source_ids":[76]},{"id":328,"predicate":"recall_history","label":"Notable recall","value":"In 2019 the FDA asked Allergan to voluntarily recall its Natrelle BIOCELL textured breast implants","unit":null,"confidence":80,"valid_from":"2023-12-15","valid_until":null,"verified_at":"2026-09-18 07:21:45","source_ids":[75]},{"id":329,"predicate":"regulatory_status_kr","label":"South Korea (MFDS) classification","value":"Silicone gel breast implants (실리콘겔인공유방) are Class 4 devices that must be tracked (추적관리대상). Providers must keep records of the patient, device serial number, implantation date and facility.","unit":null,"confidence":80,"valid_from":null,"valid_until":null,"verified_at":"2026-09-18 07:21:45","source_ids":[293]},{"id":330,"predicate":"safety_measures_kr","label":"South Korea BIA-ALCL safety measures","value":"MFDS measures announced 2019-08-28: identify patients with Allergan textured implants, separately register suspected BIA-ALCL cases, and advise annual check-ups starting one year after implantation","unit":null,"confidence":80,"valid_from":"2019-08-28","valid_until":null,"verified_at":"2026-09-18 07:21:45","source_ids":[71]},{"id":47,"predicate":"device_type","label":"Device type","value":"Silicone shell filled with silicone gel or saline; regulated medical device","unit":null,"confidence":100,"valid_from":null,"valid_until":null,"verified_at":"2026-09-15 01:35:59","source_ids":[7]},{"id":48,"predicate":"risks","label":"Known risks","value":"Rupture, capsular contracture, need for imaging adaptations, possible replacement","unit":null,"confidence":100,"valid_from":null,"valid_until":null,"verified_at":"2026-09-15 01:35:59","source_ids":[7]}],"relations":[{"type":"related_to","confidence":100,"target":{"id":22,"slug":"breast-fat-grafting","name":"Breast Fat Grafting","type":"medical","description":"Breast fat grafting (fat transfer breast augmentation) uses the patient's own liposuctioned fat to modestly enlarge or reshape the breast without an implant.","url":"https://worldwiki.io/entity/breast-fat-grafting"}},{"type":"related_to","confidence":100,"target":{"id":27,"slug":"breast-augmentation","name":"Breast Augmentation","type":"medical","description":"Breast augmentation is surgery to increase breast size or fullness, most commonly with silicone or saline implants and, for smaller changes, with fat grafting.","url":"https://worldwiki.io/entity/breast-augmentation"}},{"type":"related_to","confidence":100,"target":{"id":63,"slug":"stem-cell-breast-augmentation","name":"Stem Cell Breast Augmentation","type":"concept","description":"A consumer and marketing term for breast fat grafting enriched with stromal vascular fraction or adipose-derived cells. It is not a separate regulated procedure category.","url":"https://worldwiki.io/entity/stem-cell-breast-augmentation"}}],"questions":[{"slug":"가슴-보형물은-몇-년마다-교체해야-하나요","question":"가슴 보형물은 몇 년마다 교체해야 하나요?","intent":"informational","language":"ko","short_answer":"정해진 교체 주기는 없습니다. FDA는 보형물이 평생 쓰는 기기가 아니어서 누구나 추가 수술이 필요할 수 있지만, 그 시기는 예측할 수 없다고 안내합니다. 교체 여부는 구형구축, 파열, 모양 변화 같은 문제가 생겼는지와 정기 영상검사 결과를 보고 의료진과 함께 판단합니다. 식약처는 수술 후 5~6년째에 첫 영상검사를 받고, 이후 2~3년마다 검사받을 것을 권고합니다.","url":"https://worldwiki.io/ko/q/가슴-보형물은-몇-년마다-교체해야-하나요"},{"slug":"보형물-제거-후-지방이식은-동시에-할-수-있나요","question":"보형물 제거 후 지방이식은 동시에 할 수 있나요?","intent":"informational","language":"ko","short_answer":"보형물을 빼는 수술과 자가지방 이식을 한 번에 하는 방법이 연구되어 있습니다. 2023년 연구에서는 제거 환자의 47.3%가 동시에 지방이식을 받았고, 유방당 평균 이식량은 238mL였습니다. 2015년 연구에서는 유방당 300~600mL를 바로 이식했습니다. 다만 두 연구 모두 단일 기관 연구이고, 이식한 지방이 얼마나 남는지는 사람마다 다릅니다. 적합한지는 피부 상태와 지방량에 따라 달라집니다.","url":"https://worldwiki.io/ko/q/보형물-제거-후-지방이식은-동시에-할-수-있나요"},{"slug":"지방이식-vs-보형물-어떤-차이가-있나요","question":"지방이식 vs 보형물, 어떤 차이가 있나요?","intent":"informational","language":"ko","short_answer":"보형물은 인공 기기를 넣는 방식이어서 구형구축, 파열, 정기 영상검사가 관리 대상입니다. 지방이식은 본인의 지방을 옮기는 방식으로, 기름 낭종과 지방 괴사가 대표적인 합병증입니다. 반복 시술이 필요할 수도 있습니다. 2026년 무작위 대조시험 메타분석의 한 비교에서는 중대한 합병증이 지방이식 1.2%, 보형물 10.5%였습니다. 다만 대상이 주로 재건 환자였고 추적 기간이 짧았습니다.","url":"https://worldwiki.io/ko/q/지방이식-vs-보형물-어떤-차이가-있나요"},{"slug":"실리콘-보형물-파열은-어떻게-알-수-있나요","question":"실리콘 보형물 파열은 어떻게 알 수 있나요?","intent":"informational","language":"ko","short_answer":"실리콘 겔 보형물은 파열되어도 증상이 없는 '무증상 파열'이 생길 수 있습니다. 그래서 겉모습만으로는 알기 어렵습니다. FDA는 무증상 파열을 찾는 데 MRI가 가장 효과적이라고 보고, 증상이 없는 사람에게는 초음파도 대안으로 인정합니다. 크기 감소, 모양 변화, 단단한 멍울, 통증이 생기면 영상검사와 진료를 받는 것이 좋습니다.","url":"https://worldwiki.io/ko/q/실리콘-보형물-파열은-어떻게-알-수-있나요"},{"slug":"보형물-림프종-bia-alcl-때문에-보형물을-미리-빼야-하나요","question":"보형물 림프종(BIA-ALCL) 때문에 보형물을 미리 빼야 하나요?","intent":"informational","language":"ko","short_answer":"FDA는 증상이 없다면 편평세포암이나 여러 림프종에 대한 우려만으로 보형물을 제거하는 것을 권고하지 않습니다. BIA-ALCL은 2024년 6월 기준 FDA에 전 세계 보고 1,380건과 사망 64건이 접수된 드문 질환입니다. 보고 사례의 73%가 거친 표면 보형물이었습니다. 붓기, 멍울, 통증 같은 변화가 있으면 곧바로 진료를 받으세요.","url":"https://worldwiki.io/ko/q/보형물-림프종-bia-alcl-때문에-보형물을-미리-빼야-하나요"},{"slug":"보형물-제거-후-지방이식이-가능한가-판단할-때-무엇을-확인해야-하나요","question":"보형물 제거 후 지방이식이 가능한가 판단할 때 무엇을 확인해야 하나요?","intent":"comparison","language":"ko","short_answer":"보형물을 제거하면서 자가지방을 이식해 줄어든 부피를 보충하는 방법은 연구되어 왔고 실제로 시행되고 있습니다. 다만 모든 사람에게 적합한 것은 아닙니다. 가능 여부는 남은 유방 조직과 피부 상태, 채취할 수 있는 지방의 양, 보형물을 제거하는 이유에 따라 달라집니다. 이식한 지방은 일부 흡수될 수 있습니다. 그래서 커지는 정도가 보형물보다 작고, 추가 시술이 필요할 수 있습니다.","url":"https://worldwiki.io/ko/q/보형물-제거-후-지방이식이-가능한가-판단할-때-무엇을-확인해야-하나요"},{"slug":"지방이식과-보형물-중-무엇이-더-안전한가-비교하려면-어떤-위험을-따져야-하나요","question":"지방이식과 보형물 중 무엇이 더 안전한가 비교하려면 어떤 위험을 따져야 하나요?","intent":"comparison","language":"ko","short_answer":"어느 쪽이 모든 사람에게 더 안전하다고 일률적으로 말하기는 어렵습니다. 보형물에는 구형구축, 파열, 교체·제거 수술 가능성, 그리고 드물게 BIA-ALCL 같은 기기 관련 위험이 있습니다. 자가지방 이식은 몸에 기기가 남지 않습니다. 대신 지방이 흡수되거나 기름 낭종, 지방 괴사가 생길 수 있고 반복 시술이 필요할 수 있습니다. 두 방법을 장기간 직접 비교한 근거는 제한적입니다.","url":"https://worldwiki.io/ko/q/지방이식과-보형물-중-무엇이-더-안전한가-비교하려면-어떤-위험을-따져야-하나요"}],"sources":[{"id":7,"title":"Breast enlargement (implants)","url":"https://www.nhs.uk/tests-and-treatments/cosmetic-procedures/cosmetic-surgery/breast-enlargement/","publisher":"NHS (UK National Health Service)","type":"government","publication_date":null,"accessed_at":"2026-11-11 18:00:19"},{"id":69,"title":"Types of Breast Implants","url":"https://www.fda.gov/medical-devices/breast-implants/types-breast-implants","publisher":"U.S. Food and Drug Administration","type":"government","publication_date":null,"accessed_at":"2026-11-11 18:00:46"},{"id":291,"title":"Things to Consider Before Getting Breast Implants","url":"https://www.fda.gov/medical-devices/breast-implants/things-consider-getting-breast-implants","publisher":"U.S. Food and Drug Administration","type":"government","publication_date":"2023-03-08","accessed_at":"2026-11-09 18:00:39"},{"id":66,"title":"Risks and Complications of Breast Implants","url":"https://www.fda.gov/medical-devices/breast-implants/risks-and-complications-breast-implants","publisher":"U.S. Food and Drug Administration","type":"government","publication_date":null,"accessed_at":"2026-11-11 18:00:45"},{"id":292,"title":"Breast Implants – Certain Labeling Recommendations to Improve Patient Communication (Final Guidance)","url":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breast-implants-certain-labeling-recommendations-improve-patient-communication","publisher":"U.S. Food and Drug Administration","type":"government","publication_date":"2020-09-01","accessed_at":"2026-11-09 18:00:40"},{"id":68,"title":"Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)","url":"https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl","publisher":"U.S. Food and Drug Administration","type":"government","publication_date":null,"accessed_at":"2026-11-11 18:00:46"},{"id":76,"title":"Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma","url":"https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma","publisher":"U.S. Food and Drug Administration","type":"government","publication_date":"2025-02-06","accessed_at":"2026-11-11 18:00:48"},{"id":75,"title":"Breast Implants","url":"https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants","publisher":"U.S. Food and Drug Administration","type":"government","publication_date":"2023-12-15","accessed_at":"2026-11-11 18:00:47"},{"id":293,"title":"추적관리대상 의료기기 안내 (의료기기전자민원시스템)","url":"https://emedi.mfds.go.kr/msismext/emd/bif/traceMngView.do","publisher":"Ministry of Food and Drug Safety (Korea)","type":"government","publication_date":null,"accessed_at":"2026-11-09 18:00:43"},{"id":71,"title":"[안전성정보] 식약처, 유방보형물 이식환자 안전관리 대책 마련","url":"https://emedi.mfds.go.kr/msismext/safeinfo/ALRGAN/postView.do?pstSvl=SFI&pstgSno=34","publisher":"식품의약품안전처","type":"government","publication_date":null,"accessed_at":"2026-11-11 18:00:48"}],"providers":[],"published_at":"2026-09-14 13:42:07","updated_at":"2026-11-12 05:20:00","verified_at":null}