MyBreast is the sole UK clinic selected for a landmark global study on breast implant safety
Posted on March 8, 2019
As the need for more real-world data into the safety and effectiveness of breast implants becomes apparent, MyBreast has been selected to take part in a global clinical trial in partnership with Motiva USA.
Notably, MyBreast is the only UK clinic to be asked to participate in the international study which includes 40 different study sites. This also marks the first time the FDA has permitted clinics from outside the US to participate in their trials.
In addition, Professor Marcos Sforza, Expert Aesthetic Surgeon and Scientific Director at MyBreast, is the sole UK surgeon chosen by Motiva Implants to represent the British research arm of the trial.
The decision to enlist MyBreast for this FDA-regulated landmark study underlines our commitment to enhancing research, technology and safety across the cosmetic surgery industry in both the UK and internationally.
The 10-year trial will help to determine the safety and effectiveness of Motiva SmoothSilk, Round and Ergonomix implants. Approximately 800 patients over the age of 22 years-old are expected to enrol in this first-of-a-kind study.
To qualify as viable candidates, women will need to be considering primary breast augmentation, reconstruction and revision surgery. In addition, they will also need to confirm their participation by the end of April 2019.
Importantly, however, there is a 6-month period before surgery is set to commence where a candidate can decide to opt out.
The MyBreast clinic will work alongside Motiva to provide the highest quality implants for primary breast augmentation and candidates who are chosen will have been selected due to their likelihood to adhere to regular check-ups and other strict guidelines directed by the FDA.
Reflecting on this momentous achievement for the MyBreast team, Professor Marcos Sforza commented: “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.”
The rigorousness of this decade-long study and the selection of MyBreast as the UK’s only clinic highlights our belief in upholding the safety and ethics of cosmetic surgery.
We believe in establishing an open and transparent dialogue with patients and ensuring they are aware of not only the physical toll of surgery, but the emotional and mental implications too.
We advocate for important measures such as detailed consultations which explain to candidates the realities of what surgery will entail and the potential aftermath a patient can expect.
MyBreast’s adherence to strict codes of conduct and ethics makes our partnership with Motiva USA all the more significant, as it reinforces our position as expert practitioners of safety and transparency in the cosmetic surgery field.
As Professor Marcos Sforza explains: ‘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.”