Long-term follow-up of Nagor Perle smooth gel mammary implants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, non-comparative post-market observational follow-up collecting safety and performance data on Nagor Perle smooth gel mammary implants. Participants include adult genetic females receiving implants for primary augmentation, reconstruction after mastectomy (one- or two-stage, including prior radiotherapy and use of ADMs), or revision procedures. The protocol records complications with a focus on capsular contracture and implant rupture, plus other adverse events, with visits pre-operatively and at 12 months, then 3, 5, 8 and 10 years. Data will inform long-term device performance and regulatory post-market surveillance requirements.

Why it matters

Who can join: the full rules

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

Where it's running

• NHS Manchester
  Manchester, United Kingdom Recruiting

Study contacts

• Study coordinator: Nabila Nasir, Dr
• Email: pals@mft.nhs.uk
• Phone: (0)161 276 868

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.