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Understanding the Phenomena of Aging and Rupture of Breast Implants

Understanding the Phenomena of Aging and Rupture of Breast Implants

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05527132
Acronym
CRIMA
Enrollment
50
Registered
2022-09-02
Start date
2022-02-28
Completion date
2025-01-31
Last updated
2023-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging of Breast Implants

Keywords

Breast Prosthesis Implantation, Aging of breast implants, Rupture of breast implants

Brief summary

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.

Interventions

None listed

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frame
The mechanical properties of breast implants will be evaluated by uniaxial tensile testsAfter extraction of breast implants

Countries

France

Contacts

Primary Contactlaetitia RUFFENACH, MD
laetitia.ruffenach@chru-strasbourg.fr33 3 68 76 51 67

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026