Clinical trial Recruiting at 1 site Observational Women only

Implant-based breast reconstruction after bariatric (weight-loss) surgery

Official title: Implant-based Breast Surgery and Reconstruction Following Bariatric Surgery: an Observational Register-based Study on Prevalence and Risk Factors for Surgical Complications

Run by Vastra Gotaland Region · NCT07059104 · Data updated 2026-11-12

This registry-based project will use national data to see how common breast implants are and whether women who've had bariatric weight-loss surgery have different complication rates after implant-based breast augmentation or reconstruction.

Quick facts

Study typeObservational
SexWomen only
Enrollment20000 (estimated)
SponsorVastra Gotaland Region
Government
Locations1 site (Gothenburg)
StatusRecruiting
StartedJanuary 1, 2025
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedJuly 16, 2025
Trial IDNCT07059104 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Women who have undergone bariatric (weight-loss) surgery and later receive implant-based breast augmentation or implant-based reconstruction who are recorded in the Swedish Soreg registry and in BRIMP or NKBC.

Probably not a fit

Women who are not captured in the specified Swedish registries, who receive non-implant (autologous) reconstruction, or who are male will not be represented and are unlikely to benefit directly from the study's findings.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, registry-based national analysis using the Swedish Soreg registry with linkage to BRIMP and NKBC to identify women who received implant-based breast augmentation or reconstruction and to capture surgical details and complications. The study will compare the proportion of women with implants and describe demographic and operative characteristics, including incision type and implant features (texture, shape, size). It will compare complication rates and surgical characteristics between women with prior bariatric surgery and other women, and will specifically examine delayed reconstruction after mastectomy. Data are derived from routine surgical registries rather than an interventional protocol, enabling large-scale population comparisons.

Why it matters

Potential benefit: If successful, the findings could help surgeons and patients better predict complication risk and choose surgical/implant options tailored to women with prior bariatric surgery.

How similar studies have gone: Smaller single-center and cohort reports have described outcomes after bariatric surgery and breast procedures, but large national registry comparisons of implant-based reconstruction in this population are limited, making this approach relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Inclusion in Soreg and thereafter inclusion in either BRIMP or NKBC

Exclusion Criteria:

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Where it's running

  • Västra Götalandsregionen
    Gothenburg, Sweden
    Recruiting

Study contacts

  • Principal investigator: Emma Hansson, professor, MD, PhD — Sahlgrenska University Hospital
  • Study coordinator: Emma Hansson, Professor, MD, Phd, MA
  • Email: emma.em.hansson@vgregion.se
  • Phone: +46313421000

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.