MyBreast selected to participate in FDA-reviewed study for safety in breast implants
- The first UK clinic to be selected to take part in a US clinical trial –
- Study Sponsored by Motiva USA LLC –
In addition to participation from leading US plastic surgeons, the study will include top surgeons from outside the US, with countries set to participate including the UK, Sweden and Germany.
Professor Marcos Sforza, Expert Aesthetic Surgeon and Scientific Director at MyBreast, is the only UK surgeon enlisted by Motiva Implants® to represent the British research arm of the study.
This is a significant milestone for MyBreast, as it is the only UK clinic to date to be asked to participate in an FDA-regulated trial on breast implants. The clinic was selected because of its reputation as a centre of excellence due, in part, to its outstanding contribution to enhancing research, technology and safety across the UK cosmetic surgery industry.
The trial is a 10-year research study of breast implants and the purpose is to determine the safety and effectiveness of the investigational Motiva Implants®, SmoothSilk®, Round and Ergonomix®.
The global study began in April 2018 and includes approximately 40 study sites selected in the US, Canada, Sweden, Germany and the UK. Approximately 800 patients over the age of 22 years-old are estimated to enrol in the clinical trial.
The study includes women considering primary breast augmentation, primary breast reconstruction and revision surgery. They will need to accept participation in the study by the end of April, but a 6-month period has been set before surgery commences to give candidates ample time to decide whether a cosmetic procedure is the best option for them.
The MyBreast clinic will work with Motiva USA LLC to focus mainly on primary breast augmentation and candidates will be selected according to the protocol, in compliance with FDA regulations.
Professor Marcos Sforza, Expert Aesthetic Surgeon and Scientific Director at MyBreast commented on the announcement saying:
“It is an honour for MyBreast to be selected as a centre of excellence to conduct one of the most important global studies to take place on breast implant safety. It is hoped, upon completion, the findings and subsequent recommendations will inform future improvements to patient safety and clinical outcomes.
“This is a fantastic opportunity for MyBreast to join the global conversation on breast implant safety and a partnership which recognises all of the hard work of its team over the past ten years.”