Prospective Controlled Cohort Study of the Incidence, Trajectory, and Clinical Correlates of Persistent Systemic Symptoms in Women With and Without Silicone Breast Implants
3. september 2026 opdateret af: Research Inc
This prospective controlled cohort will enroll women before primary aesthetic breast surgery.
Women receiving silicone implants will be compared with women undergoing nonimplant mastopexy or reduction.
Standardized systemic symptom, psychosocial, quality-of-life, and local breast assessments will be collected before surgery and through five years.
The primary outcome is the incidence of a prespecified, adjudicated persistent new-onset multisystem symptom phenotype.
Revision, explantation, local implant complications, and symptom changes after implant removal will also be evaluated.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Detaljeret beskrivelse
The study addresses limitations of revision-only registry analyses by measuring symptoms before any implant exposure, including a contemporaneous nonimplant surgical control group, and applying a prespecified research phenotype rather than relying only on surgeon judgment or participant-requested BII labeling.
Both cohorts will complete the same validated symptom and psychosocial battery at baseline, during early recovery, and annually through five years.
Persistent cases will undergo multidisciplinary adjudication and clinically appropriate evaluation for alternative diagnoses.
Implant complications, revision indications, and device characteristics will be recorded.
A nested subcohort will measure symptom trajectories before and after explantation or exchange.
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: +57 301 6918526
- 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: +57 321 8119802
- E-mail: direccion.medica@iqinterquirofanos.com
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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 planning primary aesthetic breast surgery, enrolled before receiving silicone implants or before a nonimplant breast procedure such as mastopexy or reduction.
Beskrivelse
Inclusion Criteria:
- Female sex and age 18 years or older.
- Planning primary aesthetic breast augmentation with silicone implants or planning nonimplant aesthetic breast surgery such as mastopexy or reduction.
- No prior permanent breast implant.
- Completion of the full baseline systemic-symptom and psychosocial assessment before surgery.
- Ability to participate in annual follow-up for five years.
- Written informed consent.
Exclusion Criteria:
- Breast reconstruction after cancer, prophylactic mastectomy, congenital deformity, or major trauma.
- Known active autoimmune, inflammatory, neurologic, endocrine, infectious, or malignant condition expected to cause major systemic symptom change, unless the final protocol intentionally includes and stratifies these conditions.
- Current pregnancy or breastfeeding.
- Prior permanent breast implant or tissue expander.
- Inability to complete validated questionnaires in the authorized language.
- Planned simultaneous major surgery expected to dominate systemic recovery beyond the prespecified postoperative window.
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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Silicone Breast Implant Cohort
Women who independently choose primary aesthetic augmentation with silicone implants after standard counseling.
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Implant characteristics include manufacturer/lot when available, texture, shape, volume, pocket plane, incision route, and laterality.
Exposure is chosen as clinical care before enrollment and is not assigned by the study.
Linked arm/group(s): Silicone Breast Implant Cohort.
A locked battery will include validated measures of fatigue, pain interference, cognitive function, physical function, anxiety, depression, global health, and breast/body satisfaction.
Proposed instruments include PROMIS short forms and BREAST-Q scales, subject to final licensing and language validation.
Linked arm/group(s): Silicone Breast Implant Cohort, Nonimplant Breast Surgery Control Cohort.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of an Adjudicated Persistent New-Onset Multisystem Symptom Phenotype
Tidsramme: 10 years
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Proportion of participants who develop new or clinically meaningful worsening in at least two prespecified systemic symptom domains, persisting for at least 6 months, beginning after the initial 3-month postoperative recovery window, and not better explained by an alternative diagnosis after blinded adjudication.
The final domain list and thresholds will be locked before enrollment.
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10 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of Revision or Explantation Attributed to Systemic Symptoms
Tidsramme: 10 years
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Proportion undergoing implant exchange or explantation for participant-reported systemic symptoms or clinician-recorded BII/ASIA indication, reported separately from local complications and elective aesthetic reasons.
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10 years
|
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Change in Systemic Symptom Burden After Explantation or Exchange
Tidsramme: 10 years
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Within-person change in the prespecified symptom and PROM scores from the pre-revision assessment to 3, 6, and 12 months after explantation or exchange.
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10 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
- Ribeiro PDC, Sato EI. Autoimmune/autoinflammatory syndrome induced by adjuvants: a focus on silicone. Clin Rheumatol. 2022 Nov;41(11):3275-3283. doi: 10.1007/s10067-022-06274-0. Epub 2022 Jul 7.
- Ferreira S, Barros AS, Marques M. Breast Implant Illness: Symptoms, Outcomes with Explantation and Potential Etiologies-A Systematic Review and Meta-analysis. Aesthetic Plast Surg. 2025 Dec;49(23):6600-6620. doi: 10.1007/s00266-025-05142-x. Epub 2025 Aug 11.
- Spit KA, Scharff M, de Blok CJ, Niessen FB, Bachour Y, Nanayakkara PW. Patient-reported systemic symptoms in women with silicone breast implants: a descriptive cohort study. BMJ Open. 2022 Jun 9;12(6):e057159. doi: 10.1136/bmjopen-2021-057159.
- Tervaert JWC, Shoenfeld Y, Cruciani C, Scarpa C, Bassetto F. Breast implant illness: Is it causally related to breast implants? Autoimmun Rev. 2024 Jan;23(1):103448. doi: 10.1016/j.autrev.2023.103448. Epub 2023 Sep 13.
- Shivarov V, Yordanov A, Ivanova M, Tsoneva E. Breast Implant Illness and Autoimmune/Inflammatory Syndrome Induced by Adjuvants: Mechanistic Rationale and a Practical Multidisciplinary Diagnostic Algorithm. J Clin Med. 2026 Jul 21;15(14):5721. doi: 10.3390/jcm15145721.
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
3. september 2026
Først indsendt, der opfyldte QC-kriterier
3. september 2026
Først opslået (Faktiske)
9. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 024
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
no contempled in the patient informed concent
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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