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Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ms
Nasir
Nabila
+44 (0)161 795 4567
Nabila.nasir@mft.nhs.uk
Ms
Chrystelle
Barrier
+44 (0)1236780780
chrystellebarrier@gcaesthetics.com
Breast surgery: augmentation and reconstruction including revision for women
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
PERLE™ is a smooth round implant intended for breast augmentation or reconstruction and is approved for commercialisation. To assess the safety and performance of this implant the manufacturer Nagor is studying the rate of adverse events and satisfaction over a 10-year period.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Subjects undergoing implant augmentation with a BMI > 30 and undergoing reconstruction with a BMI >322. 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 involves chemical or drug study within 3 months prior to surgery, with the exception of subjects who are participating in breast cancer related clinical studies4. 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 muscle5. Subjects who have ADMs of synthetic origin6. 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 implant7. Subjects with a known previous history of a sensitivity to silicone who, in the opinion of the Investigator, are unsuitable for surgery8. Subjects with an active infection who are unsuitable for surgery unless, in the opinion of the investigator, they are treated and cleared by the investigator9. Subjects with a history of abscesses anywhere in the body who, in the opinion of the Investigator, are unsuitable for surgery10. Subjects with a known history of compromised wound healing11. Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study12. Women who are pregnant and/or current breastfeeders who do not stop breastfeeding within 3 months of getting breast implants 13. Patients who have local recurrence or metastatic carcinoma at the time of insertion of breast implant
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Ms
Nasir
Nabila
+44 (0)161 795 4567
Nabila.nasir@mft.nhs.uk
Ms
Chrystelle
Barrier
+44 (0)1236780780
chrystellebarrier@gcaesthetics.com
The study is sponsored by Nagor Ltd and funded by Nagor Ltd.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 58062
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
