Post-market Prospective Clinical Study of Nagor Perle Mammary Implants

Launched by GC AESTHETICS · Aug 22, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on studying a new type of breast implant called the Nagor Perle Mammary Implant. It's designed for women who need breast surgery for various reasons, including cosmetic enhancement, reconstruction after a mastectomy, or revising previous breast surgeries. The goal of the study is to gather information about the long-term safety and performance of these implants, specifically looking at possible complications like capsular contracture (where the tissue around the implant tightens) and ruptures. Participants will be followed for up to 10 years after their surgery to monitor any issues that might arise.

To join the study, women between the ages of 18 and 65 who have received a Nagor Perle implant for reasons like breast reconstruction or augmentation can apply. However, there are some exclusions, such as individuals with certain medical conditions or those who have undergone recent clinical studies involving drugs. Participants will have check-ups before and after their surgery at specific intervals to ensure their health and the implants' performance over time. This research is important as it helps ensure breast implants are safe and effective for women who choose to have them.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Genetic female subjects aged ≥18 and ≤65
• • 2. Subjects who underwent single or bilateral breast implantation with the study device for one of the following reasons:-
• • i) Primary breast reconstruction following mastectomy (both for one-stage or two-stage surgeries, including patients with previous radiotherapy and who have ADMs of animal origin (bovine, porcine)). ii) Primary breast augmentation (cosmetic surgery) with or without mastopexy iii) Breast revision surgery with or without mastopexy c) Subjects who have received a Nagor PERLE implant. d) Subjects who have provided informed consent and can adhere to the requirements of follow up appointments as per the study protocol.
• Exclusion Criteria:
• • 1. Subjects undergoing implant augmentation with a BMI \> 30 and undergoing reconstruction with a BMI \>32.
• • 2. Subjects with autoimmune disease, lung fibrocystic disease, conditions that interfere with wound healing and blood clotting, a weakened immune system, reduced blood supply to the breast tissue or any other condition for which breast implants are contraindicated.
• • 3. Subjects who have participated in a clinical study which involve chemical or drug study within 3 months prior to surgery, with the exception of subjects who are participating in breast cancer related clinical studies.
• • 4. Subjects with insufficient tissue covering due to either radiation damage on the chest wall, tight thoracic skin grafts or radical resection of the pectoralis major muscle.
• • 5. Subjects who have ADMs of synthetic origin.
• • 6. Subjects who, in the Investigator's clinical opinion, have existing local or metastatic carcinoma of the breast that is unlikely to be fully excised at the time of insertion of the breast implant.
• • 7. Subjects with known previous history of a sensitivity to silicone who, in the opinion of the Investigator, are unsuitable for surgery.
• • 8. Subjects with an active infection who are unsuitable for surgery unless, in the opinion of the investigator, they are treated and cleared by the investigator.
• • 9. Subjects with a history of abscesses anywhere in the body who, in the opinion of the Investigator, are unsuitable for surgery.
• • 10. Subjects with a known history of compromised wound healing.
• • 11. Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
• • 12. Women who are pregnant and/or current breast feeders who do not stop breast feeding within 3 months of getting breast implants
• • 13. Patients who have local recurrence or metastatic carcinoma at the time of insertion of breast implant