SEBBIN INTEGRITY Round Implants

Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05642390
• Other study ID #: PEC 20-08-001
• Status: Recruiting
• Start date: March 11, 2022
• Est. completion date: March 2032

Study information

• Verified date: March 2024
• Source: Groupe SEBBIN
• Contact: SEBBIN
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2032
• Est. primary completion date: March 2032
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Complication
• Prosthesis Durability
• Prosthesis Failure

Intervention

Device:
• Breast implant
Patients operated for breast augmentation or reconstruction.

Locations

Country	Name	City	State
France	SEBBIN	Saint-Ouen-l'Aumône

Sponsors (1)

Lead Sponsor	Collaborator
Groupe SEBBIN

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate		At 10 years of follow-up