SEBBIN INTEGRITY Round Implants

Sebbin

Status: Terminated

Conditions: Prosthesis Durability; Complication

Treatments: Device: Breast implant

Study type: Observational

Funder types: Industry

Identifiers

NCT05642390

PEC 20-08-001

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.