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Despite improvements in surgical techniques, approximately 30% of mastectomies are still performed. Definitively or temporarily, one of the alternatives to restore a volume in the bra is the external breast prosthesis. The main objective is to evaluate whether the "custom-made" MEAVANTI prosthesis improves the quality of life of patients who have had a mastectomy compared to the external standard prosthesis.
In France, breast cancer is a public health issue with around 59,000 new cases per year. Despite improved surgical techniques, there is still around 30% mastectomy performed every year. Definitively or temporarily, one of the alternatives to restore a volume in the bra is the use of external breast prosthesis. Currently, there are 3 silicone brands that are marketed and refunded. These standard prostheses take into account only the curve of the patients and not the weight of the remaining breast making adaptation difficult to all body types. The difference in breast weights can cause several disorders: postural, pain, discomfort, psychological impact on quality of life as well as medico-economic impact. MEAVANTI is an external breast prosthesis for custom calibration and personalization, which can prevent postural compensation and provide greater comfort.
The main objective of this study is therefore to evaluate whether the MEAVANTI prosthesis improves the quality of life of patients who have undergone a mastectomy compared to the standard prosthesis (through the EORTC questionnaires - European Organization for Research and Treatment of Cancer). This study will be monocentric, cross-over (2 periods), prospective, open with a wash-out period of 15 days. The period of the study will be conducted over 13 months.
The expected benefits can be major. The main benefit expected is the improvement of quality of life of the patients carrying the MEAVANTI breast prosthesis compared to those carrying the so-called standard prosthesis. A reduction in back and neck pain could also reduce the costs of patient management. In addition, this will demand referencing by the HAS of the custom-made prosthesis so that it is reimbursed in the same way as existing ones.
MEAVANTI prothesis, Standard prothesis
Not yet recruiting
University Hospital, Toulouse
Published on BioPortfolio: 2019-06-17T03:02:44-0400
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