Implant-based Breast Reconstruction in Post-bariatric Women - a Registry-based National Study

NCT07059104 | Recruiting

• 1 other identifier: 284398
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this national registry-based study is to investigate the prevalence of reconstructive breast surgery and risk factors for surgical complications in women who have had weight loss surgery previously. The main questions it aims to answer are:

1. 1.What is the perceived need for breast implants after weight loss surgery, described as the proportion who have breast implants, and what characteristics, in terms of demographics and surgical details, do the operated women have?
2. 2.In women who have breast enlargement or breast enlargement combined with a lift, are there any differences between the women who have had weight loss surgery and other women regarding complications after the operation and characteristics of the surgery, for example skin incision and choice of implant (for example texture, shape, size)?
3. 3.In women who have delayed breast reconstruction after breast cancer, that is have had their breast/s reconstructed in a separate operation, are there any differences between the women who have had weight loss surgery and other women regarding complications after the operation and characteristics of the surgery, for example in technique used (autologous versus implant-based, choice of implant, such as texture, shape and size), and timing of the surgery? Immediate breast reconstruction is defined as performed at the same time as the mastectomy, and delayed as an operation performed later in a separate operation.
4. 4.In women who have immediate breast reconstruction after breast cancer?, that is have a breast reconstruction at the same time as the mastectomy, are there any differences between the women who have had weight loss surgery and other women regarding complications after the operation and characteristics of the surgery, for example in technique used (autologous versus implant-based, choice of implant, such as texture, shape and size), and timing of the surgery? Immediate breast reconstruction is defined as performed at the same time as the mastectomy, and delayed as an operation performed later in a separate operation.
5. 5.In women who have risk reducing mastectomies, are there any differences between he women who have had weight loss surgery and other women regarding complications after the operation and characteristics of the surgery, for example in technique used (autologous versus implant-based, choice of implant, such as texture, shape and size), and timing of the surgery? Immediate breast reconstruction is defined as performed at the same time as the mastectomy, and delayed as an operation performed later in a separate operation.
6. 6.Are there any identifiable risk factors for complications after breast reconstructive surgery, specific to the women who have had weight loss surgery and other women?

Conditions

Breast Cancer; Breast Reconstruction; Bariatric Surgery; Breast Implant; Breast Implant Infection; Surgical Complication; Mastopexy; Weight Loss

Keywords

plastic surgery; breast augmentation; breast implant; augmentation mastopexy; complications; post-bariatric reconstruction

Outcome Measures

Primary Outcomes (5)

• Frequency of breast plastic surgery following bariatric surgery

  How many of the women who have bariatric surgery later have breast plastic surgery according to national registries.

  10 years. The time frame is longer than the study duration, as it is based on already collected registry-based data.

• Demography

  Demography of the patients compared to the controls (eg. age, BMI, education level, income level, marital status, country of origin, county of residence, employment status, co-morbidity, usage of drugs)

  3 months

• Surgical details

  All surgical details given in BRIMP and in NKBC, eg type of implant, type of reconstruction etc.

  3 months

• Complications and risk factors for complications

  Complications following the surgery and risk factors as defined in the national registers.

  10 years

• Re-operations and risk factors for re-operations

  Any re-operations and risk factors registered in the national registries.

  10 years

Secondary Outcomes (1)

• Drugs

  6 months

Study Arms (4)

Breast implant after weight loss surgery

Women who have had weight loss surgery and are having breast plastic surgery (benign)

Procedure: Breast augmentation

Breast implant controls

Women who have not had weight loss surgery and are having breast plastic surgery (benign)

Procedure: Breast augmentation

Breast reconstruction after weight loss surgery

Women who have had weight loss surgery and are having breast reconstruction after mastectomy (malignant) Subgroups: therapeutic mastectomies, risk-reducing mastectomies,immediate breast reconstruction, delayed breast reconstruction.

Procedure: Breast reconstruction after mastectomy

Breast reconstruction controls

Women who have not had weight loss surgery and are having breast reconstruction after mastectomy (malignant).Subgroups: therapeutic mastectomies, risk-reducing mastectomies, immediate breast reconstruction, delayed breast reconstruction.

Procedure: Breast reconstruction after mastectomy

Interventions

Breast augmentation PROCEDURE

Breast augmentation with an implant

Also known as: Breast enlargement, Augmentation mastopexy, breast implant, post-bariatric breast reconstruction

Breast implant after weight loss surgery; Breast implant controls

Breast reconstruction after mastectomy PROCEDURE

Breast reconstruction after mastectomy

Also known as: DIEP flap, implant-based breast reconstruction, risk reducing mastectomy, immediate breast reconstruction, delayed breast reconstruction, autologous breast reconstruction, therapeutic mastectomy

Breast reconstruction after weight loss surgery; Breast reconstruction controls

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who have weight loss surgery and then have breast reconstruction.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Västra Götalandsregionen

Gothenburg, Sweden

RECRUITING

Related Publications (2)

• Hansson E, Li Y, Grimby-Ekman A, Elander A, Paganini A. Nomogram Risk Prediction Model for Reoperation/Revision in the First 5 Years After Primary Breast Augmentation Following Massive Weight Loss: A Clinical Tool. Aesthet Surg J. 2025 Nov 11:sjaf234. doi: 10.1093/asj/sjaf234. Online ahead of print.

  PMID: 41219167 DERIVED

• Paganini A, Ottosson J, Halle M, Mirzaei N, Gudbjornsdottir S, Grimby-Ekman A, Hansson E. Frequency, demographics, and comorbidity of women with post-bariatric breast implants: A Swedish population-based controlled study. J Plast Reconstr Aesthet Surg. 2025 Dec;111:145-155. doi: 10.1016/j.bjps.2025.10.004. Epub 2025 Oct 8.

  PMID: 41151312 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Weight Loss

Interventions

Breast Implants

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Emma Hansson, professor, MD, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Hansson, Professor, MD, Phd, MA

CONTACT

+46313421000; emma.em.hansson@vgregion.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 10, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)