Motiva Flora Tissue Expander PMCF

Exclusion Criteria

• •The participant is pregnant or planning a pregnancy during the first year after surgery or is currently breastfeeding.
• •Participants with implanted devices that may be affected by magnetic fields (pacemakers, drug infusion devices).
• •Participants with abnormal haematological and biochemical values after chemotherapy.
• •Participants with tumour residues in or near the area where tissue expansion is to be performed.
• •Participants who do not have adequate tissue at the intended site for expansion, at the surgeon's discretion, due to previous radiotherapy, ulceration, vascular involvement, history of impaired wound healing or scar deformity.
• •Participants with current or previous infection in the area where the expansion will take place.
• •Presence of autoimmune diseases such as lupus or scleroderma, or immunocompromised participants due to immunosuppressive or steroid therapy.
• •Inadequate chest wall tissue due to damage caused by radiotherapy, tight skin grafts or radical resection of the pectoralis major muscle.
• •Participant who is included in another pharmacological or device research study.
• •Participants with a previous history of failure of attempted tissue expansion or breast implant placement at the site of intended expansion.
• •Participant with a history of silicone sensitivity.
• •Employees of Establishment Labs or any of its divisions or sites; Researchers or anyone who collaborates on the study or is directly related to a person working for Establishment Labs, sites or commissioned Researchers.