Post-market Prospective Clinical Study of Nagor Perle Mammary Implants

Last updated: July 8, 2025
Sponsor: GC Aesthetics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Implants

Breast Reconstruction

Treatment

PERLE Sterile Smooth Opaque gel filled mammary implants

Clinical Study ID

NCT06013514
DM6 640 0101
  • Ages 18-65
  • Female

Study Summary

Patients can undergo breast implant surgery for multiple reasons; cosmetic and reconstructive being the primary indications. In order to confidently state safety and due to strict regulation on medical devices it is important to maintain a record of safety and performance with all medical implants.

This study is designed to collect data on a new generation of smooth mammary implants to assess the long term performance and safety data on this type of gel-filled mammary breast implant.

The two main complications of breast implants are capsular contracture and rupture; these complications can take years to develop. The study is designed to evaluate the occurrence of these two primary complication as well as other secondary complications over a period of 10 years. Patient follow up will be carried out pre-operatively and post operatively at 12 months and then 3, 5, 8 and 10 years thereafter.

The study will be carried out over 10 years to adequately assess complications which may only occur over the lifetime of the device such as systemic complications

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Genetic female subjects aged ≥18 and ≤65

  2. Subjects who underwent single or bilateral breast implantation with the study devicefor 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

Exclusion Criteria:

  1. Subjects undergoing implant augmentation with a BMI > 30 and undergoingreconstruction with a BMI >32.

  2. Subjects with autoimmune disease, lung fibrocystic disease, conditions thatinterfere with wound healing and blood clotting, a weakened immune system, reducedblood supply to the breast tissue or any other condition for which breast implantsare contraindicated.

  3. Subjects who have participated in a clinical study which involve chemical or drugstudy within 3 months prior to surgery, with the exception of subjects who areparticipating in breast cancer related clinical studies.

  4. Subjects with insufficient tissue covering due to either radiation damage on thechest wall, tight thoracic skin grafts or radical resection of the pectoralis majormuscle.

  5. Subjects who have ADMs of synthetic origin.

  6. Subjects who, in the Investigator's clinical opinion, have existing local ormetastatic carcinoma of the breast that is unlikely to be fully excised at the timeof insertion of the breast implant.

  7. Subjects with known previous history of a sensitivity to silicone who, in theopinion of the Investigator, are unsuitable for surgery.

  8. Subjects with an active infection who are unsuitable for surgery unless, in theopinion 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 theInvestigator, 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 thatwould compromise their participation and follow-up in this study.

  12. Women who are pregnant and/or current breast feeders who do not stop breast feedingwithin 3 months of getting breast implants

  13. Patients who have local recurrence or metastatic carcinoma at the time of insertionof breast implant

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: PERLE Sterile Smooth Opaque gel filled mammary implants
Phase:
Study Start date:
June 01, 2024
Estimated Completion Date:
September 30, 2038

Connect with a study center

  • NHS Manchester

    Manchester, M13 9WL
    United Kingdom

    Active - Recruiting

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