Motiva - study of safety and effectiveness of Motiva implants
Research type
Research Study
Full title
Study of the Safety and Effectiveness of the Motiva Implants® Silicone Gel-Filled Breast Implants SmoothSilk®/SilkSurface® in Subjects Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, and Revision Surgery
IRAS ID
257495
Contact name
Marcos Sforza
Contact email
Sponsor organisation
Motiva USA LLC, Establishment Labs subsidiary
Clinicaltrials.gov Identifier
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
This study is a pre-market approval study in USA and Canada, but it a Post Market Clinical Follow-Up in the United Kingdom and EU where Motiva Implants® have a CE Mark certification based on equivalence. The objective of this study is to support the long-term profile for the safety and performance of the devices.
The objective of this study is to assess the safety and effectiveness of Motiva Implants® silicone gel-filled breast implants in women who are undergoing primary breast augmentation, primary breast reconstruction, or revision surgery to correct or improve the results of a primary breast augmentation or primary reconstruction surgery.
The safety of the implant will be assessed by collecting information on the incidence, severity, duration and method of resolution of all complications. The effectiveness will be measured primarily by assessing patient satisfaction with
the implant using a 5-point scale and 3 other questionnaires designed to ask patients about their quality of life.
The study will be conducted at only one private site in the UK and will be open to women over the age of 22 who are seeking primary breast augmentation, primary breast reconstruction, or revision surgery to correct or improve the results of a primary breast augmentation or primary reconstruction surgery, and who meet the other inclusion and exclusion criteria.
The study is expected to last 10 years and the participants will attend for post-surgery follow up visits after 3-6 weeks, 1 year and then annually up to 10 years after the procedure.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0674
Date of REC Opinion
8 Feb 2019
REC opinion
Further Information Favourable Opinion