SEBBIN INTEGRITY Round Implants

Terminated

• Conditions: Complication; Prosthesis Durability

• Registration Number: NCT05642390
• Lead Sponsor: Groupe SEBBIN

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-11
• Study First Submitted: 2022-11-30
• Study First Submitted QC: 2022-11-30
• Study First Posted: 2022-12-08
• Primary Completion: 2024-04-25
• Study Completion: 2024-04-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complication rate	At 10 years of follow-up

Trial Locations

Locations (1)

SEBBIN; 🇫🇷 Saint-Ouen-l'Aumône, France