Post-Marketing Clinical Follow-Up Study to Confirm the Safety and Effectiveness/Performance of Motiva Flora® Tissue Expander in Staged Breast Reconstruction Surgery
The Motiva Flora® Tissue Expander clinical study (hereafter Motiva Flora® TE study) is a 6-month, open-label, prospective, multicentre post-marketing follow-up study designed to confirm the Safety and Effectiveness/Performance of Motiva Flora® TE in breast reconstruction surgery. The study will include 136 women, planned for staged breast reconstruction, in 6 countries (Spain, Belgium, France, Costa Rica, Chile and Panama). Breast tissue expansion and the final breast implant will be performed using devices from the Motiva Flora® TE catalogue.
• The participant gives written informed consent.
• The participant is genetically female, aged 18 years or older.
• The participant needs tissue expansion as part of breast reconstruction treatment following mastectomy, which may include immediate reconstruction.
• The participant is in a suitable clinical condition to allow breast implant placement after tissue expander placement, at the discretion of the investigator.
• The participant has the physical and cognitive capacity to understand and follow the surgeon's recommendations.
• Complete radiotherapy at least 1 year before surgery.
• Partial or total decrease in tumour volume after radiotherapy.
• The participant is able and willing to comply with all study requirements including attending follow-up appointments.
• Participant with reasonable surgical risk.
• Participant with a history of non-metastatic breast cancer.
• Participant willing to undergo an MRI, CT scan and any other studies if required at surgeon discretion.
⁃ For substudy - MRI / CT - the following additional criteria apply:
⁃ \- Patient is willing to undergo one MRI and one CT anytime during the follow up