Multicenter Post-marketing Survey of SEBBIN Group Silicone Gel-filled Breast Implants

Breast Implant; Complications Clinical Trial

— IM02  

Official title:

Multicenter Post-marketing Survey of SEBBIN Group Silicone Gel-filled Breast Implants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04968457
• Other study ID #: PEC 15-10-001
• Status: Active, not recruiting
• Start date: January 2014
• Est. completion date: January 2027

Study information

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

Clinical Trial Summary

The aim of the study is to allow Groupe SEBBIN to communicate to competent authorities and to the scientific community data relative to the safety and effectiveness of SEBBIN silicone gel-filled breast implants.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 908
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient is at least 18-year-old.

• The patient is genetically a woman.

• The patient is candidate to a breast augmentation or breast reconstruction with silicone gel-filled breast implants.

• The patient gets all information regarding the study and signs the informed consent relative to the use of her personal data.

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.

• 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

• Breast Implant; Complications

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Groupe SEBBIN

Outcome

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