Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Rupture
2. september 2026 opdateret af: Research Inc
This prospective dynamic cohort will follow women with intact aesthetic silicone breast implants to evaluate predictors of rupture.
Implant age, pocket plane, incision route, surface texture, and volume will be recorded, and participants will undergo annual clinical and imaging surveillance for up to five years.
Confirmed rupture will require MRI or operative evidence.
Delayed-entry survival models will estimate the independent association of implant and surgical characteristics with rupture risk.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Women with new or existing aesthetic silicone breast implants will enter the cohort only after baseline assessment confirms that the analyzed implant is intact.
Implant and operative characteristics will be verified from device cards and operative records whenever possible.
Annual high-resolution ultrasound will screen for integrity loss, with MRI or surgery used for confirmation under a standardized algorithm.
Implant age will serve as the survival time scale, and prevalent implants will enter at their age on enrollment.
The study will estimate rupture-free survival, symptomatic and silent rupture rates, adjusted predictor effects, and management after detection.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
3000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Juan Velez, MD, Plastic surgeon
- Telefonnummer: +57 3054511588
- E-mail: info@velezlara.com
Studiesteder
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Medellín, Colombia
- Rekruttering
- IQ interquirofanos
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Kontakt:
- juan Velez, MD, Plastic surgeon
- Telefonnummer: +57 3054511588
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Adult women with aesthetic silicone breast implants documented as intact at cohort entry, including new implant recipients and prevalent implant carriers.
Beskrivelse
Inclusion Criteria:
- Female sex and age 18 years or older.
- Aesthetic breast augmentation with permanent silicone implants.
- Known implantation date or sufficiently precise implantation year, pocket plane, incision route, surface texture, and implant volume.
- Both implants or the analyzed implant documented as intact at baseline by the study imaging algorithm.
- Ability to complete annual surveillance for up to five years.
- Written informed consent.
Exclusion Criteria:
- Reconstructive implantation after mastectomy, congenital deformity, or major trauma.
- Tissue expander or nonpermanent device.
- Confirmed rupture at cohort entry for the implant under analysis.
- PIP implant or another recalled device if the final protocol elects to exclude it from etiologic modeling.
- Missing core implant characteristics or implantation date.
- Planned immediate explantation or exchange at enrollment for a reason unrelated to surveillance.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Aesthetic Breast Implant Surveillance Cohort
Women with intact silicone implants at enrollment are followed prospectively.
Pocket plane, incision, texture, volume, and implant age are modeled as exposures rather than recruitment groups.
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Implant-level exposure data include implantation date, laterality, pocket plane, incision route, surface texture, shape, volume, manufacturer/lot when available, primary versus revision placement, and concomitant mastopexy or fat grafting.
Linked arm/group(s): Intact Aesthetic Breast Implant Surveillance Cohort.
Baseline and annual high-resolution ultrasound will assess implant integrity.
Suspicious or indeterminate findings will undergo MRI according to the locked diagnostic algorithm.
Rupture is confirmed by MRI, operative inspection, or both.
Linked arm/group(s): Intact Aesthetic Breast Implant Surveillance Cohort.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Time to First Confirmed Breast Implant Rupture
Tidsramme: From cohort entry through years of prospective follow-up. 10 TO 12 YEARS
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Implant-level time from cohort entry to the first MRI- or surgically confirmed full-thickness implant shell rupture.
Implant age is used as the survival time scale with delayed entry at age on enrollment.
Contralateral implants are accounted for by patient-level clustering.
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From cohort entry through years of prospective follow-up. 10 TO 12 YEARS
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Rupture-Free Survival by Implant Age
Tidsramme: 12 YEARS
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Kaplan-Meier or model-based probability of remaining free of confirmed rupture at prespecified implant ages, using delayed-entry methods.
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12 YEARS
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: juan velez, MD, plastic surgery
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Glener AD, Sergesketter AR, Adams WP Jr. Outcomes of In-Office, High Resolution Ultrasound Silicone Breast Implant Surveillance by Plastic Surgeons. Aesthet Surg J. 2024 Dec 12;45(1):48-55. doi: 10.1093/asj/sjae165.
- Hadad E, Klein D, Seligman Y, Wiser I, Heller L. Sub-muscular plane for augmentation mammoplasty patients increases silicone gel implant rupture rate. J Plast Reconstr Aesthet Surg. 2019 Mar;72(3):419-423. doi: 10.1016/j.bjps.2018.11.009. Epub 2018 Nov 22.
- Hadad E, Sualhi I, Legarda C, Seligman Y, Sorkin A, Dor O, Menashe S, Heller L, Wiser I. Silicone breast implant rupture is more prevalent in the dominant limb side: A retrospective cohort study. J Plast Reconstr Aesthet Surg. 2023 May;80:126-132. doi: 10.1016/j.bjps.2023.02.016. Epub 2023 Feb 20.
- Paolini G, Firmani G, Briganti F, Macino M, Nigrelli S, Sorotos M, Santanelli di Pompeo F. Assessment of Risk Factors for Rupture in Breast Reconstruction Patients with Macrotextured Breast Implants. Aesthetic Plast Surg. 2023 Apr;47(2):517-530. doi: 10.1007/s00266-022-03118-9. Epub 2022 Oct 13.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
12. januar 2014
Primær færdiggørelse (Faktiske)
1. januar 2026
Studieafslutning (Anslået)
15. december 2026
Datoer for studieregistrering
Først indsendt
2. september 2026
Først indsendt, der opfyldte QC-kriterier
2. september 2026
Først opslået (Faktiske)
9. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 020
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
not contempled in the patient informed concent
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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