Post-market Prospective Clinical Study of Nagor Perle Mammary Implants

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 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