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Understanding the Phenomena of Aging and Rupture of Breast Implants (CRIMA)

U

University Hospital, Strasbourg, France

Status

Enrolling

Conditions

Aging of Breast Implants

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

laetitia RUFFENACH, MD

Data sourced from clinicaltrials.gov

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