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

NCT ID: NCT07059104

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2028-12-31

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. 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. 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. 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. 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. 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. 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?

Researchers will compare the patients to women who have the same type of reconstructive breast surgery but have not had bariatric surgery previously.

The study will use prospectively collected data from seven registers: The Scandinavian Obesity Surgery Register (SOReg), The Swedish Breast Implant Register (BRIMP), the Swedish National Quality Register for Breast Cancer (NKBC), the Swedish National Diabetes Register (NDR), Statistics Sweden (SCB), the Swedish inpatient register, and the Swedish National Prescribed Drug Register.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Breast implant after weight loss surgery

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

Breast augmentation

Intervention Type: PROCEDURE

Breast augmentation with an implant

Breast implant controls

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

Breast augmentation

Intervention Type: PROCEDURE

Breast augmentation with an implant

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.

Breast reconstruction after mastectomy

Intervention Type: 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.

Breast reconstruction after mastectomy

Intervention Type: PROCEDURE

Breast reconstruction after mastectomy

Interventions

Breast augmentation

Breast augmentation with an implant

Intervention Type: PROCEDURE

Breast reconstruction after mastectomy

Breast reconstruction after mastectomy

Intervention Type: PROCEDURE

Other Intervention Names

Breast enlargement; Augmentation mastopexy; breast implant; post-bariatric breast reconstruction; DIEP flap; implant-based breast reconstruction; risk reducing mastectomy; immediate breast reconstruction; delayed breast reconstruction; autologous breast reconstruction; therapeutic mastectomy

Eligibility Criteria

Inclusion Criteria

Inclusion in Soreg and thereafter inclusion in either BRIMP or NKBC

Exclusion Criteria

-

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emma Hansson, professor, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

Västra Götalandsregionen

Gothenburg, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Emma Hansson, Professor, MD, Phd, MA

Role: CONTACT

emma.em.hansson@vgregion.se

+46313421000

Facility Contacts

Emma Hansson, Professor, MD, PhD

Role: primary

emma.em.hansson@vgregion.se

+46313421000

References

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 Oct 8;111:145-155. doi: 10.1016/j.bjps.2025.10.004. Online ahead of print.

Reference Type: DERIVED

PMID: 41151312 (View on PubMed)

Other Identifiers

284398

Identifier Type: -

Identifier Source: org_study_id