Breast Implant
别名: 보형물, 가슴 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.
关键事实
| 属性 | 值 | 来源 |
|---|---|---|
| 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.截至 2019年10月23日 | [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.截至 2023年3月8日 | [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.截至 2023年12月14日 | [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 warning截至 2020年9月1日 | [5]governmentBreast Implants – Certain Labeling Recommendations to Improve Patient Communication (Final Guidance)U.S. Food and Drug Administration |
| FDA first linked implants to ALCL | 2011截至 2019年10月23日 | [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. reports截至 2024年6月30日 | [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%) reports截至 2024年6月30日 | [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 implants截至 2023年12月15日 | [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 implantation截至 2019年8月28日 | [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) |
概述
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.
证据与声明
官方声明是服务方的陈述,除非另有标注,否则未经 worldwiki 验证。| 主张 | 类型 | 证据 | 来源 |
|---|---|---|---|
| Breast implants are not lifetime devices and may require replacement. | risk | 高 | Breast enlargement (implants) |
参考来源
独立来源比例 100% (10/10)- 等级 A · governmentBreast enlargement (implants) — NHS (UK National Health Service) · 访问于 2026年9月20日 · 证据页
- 等级 A · governmentTypes of Breast Implants — U.S. Food and Drug Administration · 访问于 2026年9月19日 · 证据页
- 等级 A · governmentThings to Consider Before Getting Breast Implants — U.S. Food and Drug Administration · 访问于 2026年9月20日 · 证据页
- 等级 A · governmentRisks and Complications of Breast Implants — U.S. Food and Drug Administration · 访问于 2026年9月19日 · 证据页
- 等级 A · governmentBreast Implants – Certain Labeling Recommendations to Improve Patient Communication (Final Guidance) — U.S. Food and Drug Administration · 访问于 2026年9月20日 · 证据页
- 等级 A · governmentQuestions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) — U.S. Food and Drug Administration · 访问于 2026年9月19日 · 证据页
- 等级 A · governmentMedical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma — U.S. Food and Drug Administration · 访问于 2026年9月19日 · 证据页
- 等级 A · governmentBreast Implants — U.S. Food and Drug Administration · 访问于 2026年9月19日 · 证据页
- 等级 A · government추적관리대상 의료기기 안내 (의료기기전자민원시스템) — Ministry of Food and Drug Safety (Korea) · 访问于 2026年9月20日 · 证据页
- 等级 A · government[안전성정보] 식약처, 유방보형물 이식환자 안전관리 대책 마련 — 식품의약품안전처 · 访问于 2026年9月19日 · 证据页