Understanding the Phenomena of Aging and Rupture of Breast Implants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-28

Study Completion Date

2025-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Breast implants, like all implantable medical devices, are subject to wear and tear as they age in the body. In addition to this wear and tear, they are subject to external trauma, whether accidental during daily life, during insertion or during mammography.

The kinetics and mechanisms of aging are poorly studied and the phenomenon of implant rupture is not elucidated. However, studies of older generation implants have shown that implant rupture is correlated with the duration of implantation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sonication of Explanted Breast Implants for Detection of Subclinical Infection

NCT01138891

Implants, Breast

COMPLETED

Impact of Buccal Bone Thickness on Pathological Peri-implant Bone Loss: A 3-year Prospective Cohort Study

NCT02939222

Periimplantitis Oral Surgery

WITHDRAWN NA

Molecular Mechanisms Associated With Breast Implant Complications

NCT05736354

Breast Implant; Complications Infection or Inflammation

RECRUITING

The Role of Bleeding at Implant Placement

NCT03705247

Bleeding Angiogenesis Peri-Implantitis

COMPLETED

3D-printed Biodegradable Breast Implants for Breast Restoration

NCT06993714

Breast Cancer Breast Reconstruction

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aging of Breast Implants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female adult (≥18 years old)
* operated on at the HUS for a change of breast prosthesis, aesthetic or reconstruction, between 2022 and 2024
* having not expressed, after information, her opposition to participate in this research.

Exclusion Criteria

* Women who have expressed their opposition to participating in the study
* ruptured prosthesis, associated with a LAGC-AIM, excessive perspiration
* interfering treatments and associated diseases, history

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No