Understanding how breast implants age and rupture
Understanding the Phenomena of Aging and Rupture of Breast Implants
This study looks at how breast implants wear out and break over time to help women who have had breast surgery understand what affects their implants from 2022 to 2024.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT05527132 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the aging process of breast implants and the factors contributing to their rupture. It focuses on women who have undergone breast prosthesis changes at the University Hospital of Strasbourg between 2022 and 2024. The study seeks to gather data on the wear and tear of implants over time and the impact of external trauma on their integrity. By analyzing these factors, the research hopes to shed light on the mechanisms behind implant rupture, which remains poorly understood.
Who should consider this trial
Good fit: Ideal candidates are adult women aged 18 and older who have had breast prosthesis changes at the University Hospital of Strasbourg.
Not a fit: Patients with ruptured prostheses or those who have expressed opposition to participating in the study may not benefit.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and longevity of breast implants for patients.
How similar studies have performed: While the aging and rupture of breast implants have been studied in older generations, this specific observational approach is novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Strasbourg
- Service de Chirurgie Plastique Esthétique et Reconstructrice - CHU de Strasbourg - France — Strasbourg, France (Recruiting)
Study contacts
- Principal investigator: laetitia RUFFENACH, MD — Service de Chirurgie Plastique Esthétique et Reconstructrice - CHU de Strasbourg - France
- Study coordinator: laetitia RUFFENACH, MD
- Email: laetitia.ruffenach@chru-strasbourg.fr
- Phone: 33 3 68 76 51 67
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.