worldwiki
对比

Breast Fat Grafting vs Breast Implant

以下事实均来自两个条目页面及其出处。先对比双方都有记录的项,其余并排展示。

两者的关系Breast Fat Grafting — 替代 → Breast Implant

共同项

双方均有记录 1 项
属性Breast Fat GraftingBreast Implant
US regulatory statusFollowing FDA guidance issued in November 2017, autologous fat grafts do not require premarket approval; stromal vascular fraction products receive closer reviewSaline-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.

各自的事实

仅在其中一方有记录的已核实事实。

Breast Fat Grafting

DefinitionFat is taken by liposuction from other parts of the body and injected to enlarge the breasts
Typical donor sitesUsually the abdomen or flanks, though fat can be taken from almost anywhere (surgeon quoted by ASPS)
Typical size increaseSurgeon quoted by ASPS: ideal candidate wants half a cup to one cup; a larger increase may take two to three procedures
Listed risksCysts, infection, microcalcification, death of fat cells (necrosis), and some transferred fat leaving the breast area
Pre-expansion optionSurgeons may recommend an external tissue expansion system in the weeks before surgery
Pooled volume retention54% (95% CI 48.5–59.5%) across 25 studies, follow-up 3–36 months
Retention by fat preparation methodCentrifugation 51.5% vs sedimentation 38.7% pooled retention
Oncologic safety evidenceMeta-analysis of 15 studies (8,541 participants): no difference in overall survival, disease-free survival or local recurrence between patients who had fat grafting after breast cancer surgery and controls
1987 professional positionASPRS (predecessor of ASPS) condemned autologous fat injection for breast augmentation over concerns about cancer detection
2009 ASPS Fat Graft Task ForceConcluded that the literature then available showed no association between fat grafting and higher rates of malignancy
Relevant FDA guidanceSame Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception
Suitable forPeople wanting a relatively small increase in breast size who have enough donor fat (ASPS)
SessionsMore than one session may be needed because part of the graft is resorbed
Imaging noteFat necrosis, cysts and calcifications can appear on mammograms and must be interpreted by a radiologist

Breast Implant

Expected lifespanNot a lifetime device. The longer implants are in place, the more likely they are to need removal or replacement.
Detecting silent rupture (silicone gel)MRI is the most effective method. Ultrasound is an acceptable alternative for screening patients without symptoms.
US labeling guidanceFinal FDA guidance issued September 2020 (docket FDA-2019-D-4467) on patient labeling content and format, including a boxed warning
FDA first linked implants to ALCL2011
BIA-ALCL medical device reports to FDA1,380 reports (US and non-US), including 64 deaths. Median time to diagnosis was 8 years after implantation.
BIA-ALCL reports by implant surfaceTextured 1,010 (73%); smooth 40 (3%, only one with no known history of textured implants); not specified 330 (24%)
Notable recallIn 2019 the FDA asked Allergan to voluntarily recall its Natrelle BIOCELL textured breast implants
South Korea (MFDS) classificationSilicone 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.
South Korea BIA-ALCL safety measuresMFDS 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
Device typeSilicone shell filled with silicone gel or saline; regulated medical device
Known risksRupture, capsular contracture, need for imaging adaptations, possible replacement