Breast Implant
다른 이름: 가슴 보형물, 보형물
A breast implant is a silicone-shell medical device filled with silicone gel or saline that is placed to enlarge or reconstruct the breast.
가슴 보형물은 몇 년마다 교체해야 하나요?
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.
핵심 사실
| 항목 | 값 | 출처 |
|---|---|---|
| US FDA-approved types and age limits | 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.기준 2019년 10월 23일 | [2]governmentTypes of Breast ImplantsU.S. Food and Drug Administration |
| Expected lifespan | Not a lifetime device. The longer implants are in place, the more likely they are to need removal or replacement.기준 2023년 3월 8일 | [3]governmentThings to Consider Before Getting Breast ImplantsU.S. Food and Drug Administration |
| Detecting silent rupture (silicone gel) | MRI is the most effective method. Ultrasound is an acceptable alternative for screening patients without symptoms.기준 2023년 12월 14일 | [4]governmentRisks and Complications of Breast ImplantsU.S. Food and Drug Administration |
| US labeling guidance | Final FDA guidance issued September 2020 (docket FDA-2019-D-4467) on patient labeling content and format, including a boxed warning기준 2020년 9월 1일 | [5]governmentBreast Implants – Certain Labeling Recommendations to Improve Patient Communication (Final Guidance)U.S. Food and Drug Administration |
| FDA first linked implants to ALCL | 2011기준 2019년 10월 23일 | [6]governmentQuestions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)U.S. Food and Drug Administration |
| BIA-ALCL medical device reports to FDA | 1,380 reports (US and non-US), including 64 deaths. Median time to diagnosis was 8 years after implantation. reports기준 2024년 6월 30일 | [7]governmentMedical Device Reports of Breast Implant-Associated Anaplastic Large Cell LymphomaU.S. Food and Drug Administration |
| BIA-ALCL reports by implant surface | Textured 1,010 (73%); smooth 40 (3%, only one with no known history of textured implants); not specified 330 (24%) reports기준 2024년 6월 30일 | [7]governmentMedical Device Reports of Breast Implant-Associated Anaplastic Large Cell LymphomaU.S. Food and Drug Administration |
| Notable recall | In 2019 the FDA asked Allergan to voluntarily recall its Natrelle BIOCELL textured breast implants기준 2023년 12월 15일 | [8]governmentBreast ImplantsU.S. Food and Drug Administration |
| South Korea (MFDS) classification | 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. | [9]government추적관리대상 의료기기 안내 (의료기기전자민원시스템)Ministry of Food and Drug Safety (Korea) |
| South Korea BIA-ALCL safety measures | 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 implantation기준 2019년 8월 28일 | [10]government[안전성정보] 식약처, 유방보형물 이식환자 안전관리 대책 마련식품의약품안전처 |
| Device type | Silicone shell filled with silicone gel or saline; regulated medical device | [1]governmentBreast enlargement (implants)NHS (UK National Health Service) |
| Known risks | Rupture, capsular contracture, need for imaging adaptations, possible replacement | [1]governmentBreast enlargement (implants)NHS (UK National Health Service) |
개요
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.
근거와 주장
공식 주장은 제공자의 진술이며, 별도 표시가 없는 한 worldwiki가 검증한 것이 아닙니다.| 주장 | 유형 | 근거 | 출처 |
|---|---|---|---|
| Breast implants are not lifetime devices and may require replacement. | risk | 높음 | Breast enlargement (implants) |
참고 출처
독립 출처 비율 100% (10/10)- 등급 A · governmentBreast enlargement (implants) — NHS (UK National Health Service) · 확인일 2026년 11월 12일 · 근거 페이지
- 등급 A · governmentTypes of Breast Implants — U.S. Food and Drug Administration · 확인일 2026년 11월 12일 · 근거 페이지
- 등급 A · governmentThings to Consider Before Getting Breast Implants — U.S. Food and Drug Administration · 확인일 2026년 11월 10일 · 근거 페이지
- 등급 A · governmentRisks and Complications of Breast Implants — U.S. Food and Drug Administration · 확인일 2026년 11월 12일 · 근거 페이지
- 등급 A · governmentBreast Implants – Certain Labeling Recommendations to Improve Patient Communication (Final Guidance) — U.S. Food and Drug Administration · 확인일 2026년 11월 10일 · 근거 페이지
- 등급 A · governmentQuestions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) — U.S. Food and Drug Administration · 확인일 2026년 11월 12일 · 근거 페이지
- 등급 A · governmentMedical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma — U.S. Food and Drug Administration · 확인일 2026년 11월 12일 · 근거 페이지
- 등급 A · governmentBreast Implants — U.S. Food and Drug Administration · 확인일 2026년 11월 12일 · 근거 페이지
- 등급 A · government추적관리대상 의료기기 안내 (의료기기전자민원시스템) — Ministry of Food and Drug Safety (Korea) · 확인일 2026년 11월 10일 · 근거 페이지
- 등급 A · government[안전성정보] 식약처, 유방보형물 이식환자 안전관리 대책 마련 — 식품의약품안전처 · 확인일 2026년 11월 12일 · 근거 페이지