SEBBIN INTEGRITY Round Implants

Prospective Observational Study About SEBBIN Silicone Gel-filled INTEGRITY Mammary Implants

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05642390

Enrollment

Registered

2022-12-08

Start date

2022-03-11

Completion date

2024-04-25

Last updated

2024-11-01

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

Conditions

Complication, Prosthesis Durability

Brief summary

This study is part of the clinical evaluation of SEBBIN silicone gel-filled INTEGRITY implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.

Interventions

DEVICEBreast implant

Patients operated for breast augmentation or reconstruction.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* The patient is at least 18-year-old. * The patient is a woman. * The patient was prescribed with a surgery for a breast augmentation or reconstruction, unilaterally or bilaterally with silicone gel-filled SEBBIN INTEGRITY mammary implants. * The patient has been informed of the study, has read the patient information letter and provided consent in writing.

Exclusion criteria

* The patient is pregnant or breastfeeding. * The patient has silicone implants somewhere else than in the breast. * The patient was diagnosed with one of the following pathologies: * Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease. * Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease. * Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease. * History of implant-associated anaplastic large cell lymphoma (BIA-ALCL). * Symptomatic autoimmune disease. * The patient has a pathology that could delay healing (does not apply to the reconstruction group). * The patient has cancer (does not apply to the reconstruction group). * The patient has anatomical or physiological conditions that could lead to postoperative complications.

Design outcomes

Primary

Measure	Time frame
Complication rate	At 10 years of follow-up

Countries

France

Outcome results

None listed

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