Post-market prospective clinical study of nagor perle mammary implants
Research type
Research Study
Full title
A prospective, multi-center, observational, non comparative, post-marketing surveillance study to obtain clinical outcome data on the Nagor PERLE range of silicone breast implants when used in breast implantation
IRAS ID
331001
Contact name
Chrystelle Barrier
Contact email
Sponsor organisation
Nagor Ltd
Duration of Study in the UK
12 years, 3 months, 21 days
Research 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.REC name
West of Scotland REC 4
REC reference
23/WS/0130
Date of REC Opinion
9 Oct 2023
REC opinion
Further Information Favourable Opinion