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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast implant after weight loss surgery | Women who have had weight loss surgery and are having breast plastic surgery (benign) |
| |
| Breast implant controls | Women who have not had weight loss surgery and are having breast plastic surgery (benign) |
| |
| 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 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast augmentation | Procedure | Breast augmentation with an implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Drugs | Usage of anticoagulants, pain killers, and antibiotics 3 months before and 3 months after the breast operation. | 6 months |
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Inclusion Criteria:
Inclusion in Soreg and thereafter inclusion in either BRIMP or NKBC
Exclusion Criteria:
-
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Women who have weight loss surgery and then have breast reconstruction.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emma Hansson, Professor, MD, Phd, MA | Contact | +46313421000 | emma.em.hansson@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Emma Hansson, professor, MD, PhD | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Västra Götalandsregionen | Recruiting | Gothenburg | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41219167 | Derived | 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. 2026 Mar 2;46(3):284-290. doi: 10.1093/asj/sjaf234. | |
| 41151312 | 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. |
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| Breast reconstruction after mastectomy | Procedure | Breast reconstruction after mastectomy |
|
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D018427 | Breast Implants |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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