Custom-made prostheses are a clinically meaningful choice for aesthetically driven patients post-mastectomy.A study presented at ESMO Breast Cancer 2026 shows that a custom-made external breast prosthesis has a slight advantage over a standard prosthesis among breast cancer patients who have undergone mastectomy.
A monocentric, open-label, crossover study conducted at CHU Toulouse, France, evaluated 64 post-mastectomy patients and compared a custom silicone prosthesis against a standard external breast prosthesis. The participants were randomly assigned to two sequential periods separated by a 15-day washout.
The primary endpoint was quality of life (QoL) evaluated using the European Organisation for Research and Treatment of Cancer QLQ-C30, QLQ-BR23, and QLQ BRECON14 scales. The five dimensions evaluated were emotional, social, body image, sexual, and cosmetic satisfaction. The secondary endpoints were visual satisfaction (self-evaluation and hetero-evaluation), pain assessment, comparative evaluation, and adverse events. [ESMO Breast Cancer 2026, abstract 188P]
In the intention-to-treat analysis, there were no significant differences observed between the custom-made prosthesis and the standard prosthesis across the five dimensions evaluated: emotional (+3.2 percent; p=0.30), social (+1.9 percent; p=0.53), body image (–2.7 percent; p=0.42), sexual (–0.5 percent; p=0.90), and cosmetic satisfaction (+7.5 percent; p=0.17).
However, in the per-protocol sensitivity analysis, the custom-made prosthesis was superior to the standard prosthesis in terms of cosmetic benefit (+16.3 percent; p=0.046) and visual outcomes verified by independent hetero-evaluation (adjusted difference, –0.7, 95 percent confidence interval, –1.0 to –0.4; p<0.01).
In the patient-perceived superiority analysis, patients also favoured the custom-made prosthesis over the standard prosthesis in terms of areola-nipple appearance (63.2 percent; p<0.01), colour matching (50.9 percent; p=0.02), and symmetry (51.6 percent; p=0.01).
The results align with evidence showing the positive effect of external breast prostheses on women’s lives after undergoing mastectomy. [Breast J 2009;15:385-393; Text Res J 2025;95:1757-1768]
There were no serious adverse events (AEs) attributed to prosthesis type, nor were there any prosthesis-related withdrawals reported. AE rates were not statistically different between the custom-made and standard prosthesis groups (27.6 percent vs 34.9 percent).
Aesthetic advantage
External breast prostheses have been shown to provide psychological and emotional benefits, as these restore body image, reduce the feeling of disfigurement, and provide a sense of femininity and wholeness following a mastectomy. [Asian Pacific J Cancer Prev 2014;15:9631-9634; Curr Oncol 2012;19:e43-e52; Breast Dis 2023;42:375-382]
Standard prostheses primarily address shape, but individualization is limited; custom-made prostheses provide personalized weight calibration (±5 g), morphological detailing, and colour-matched areola-nipple reconstruction.
No randomized controlled trial has evaluated the impact of custom-made prostheses on patient-reported QoL, noted study investigator Dr Caroline Bouche from the Department of Surgical Oncology, CHU Toulouse, France, and colleagues.
“[In this study,] a custom-made prosthesis demonstrated overall QoL equivalence to a standard prosthesis,” said Bouche and colleagues. “[However,] sensitivity analyses suggested aesthetic advantages with the custom-made prosthesis in terms of cosmetic satisfaction, visual symmetry, and areola-nipple appearance.”
“[As such,] custom-made prostheses are a clinically meaningful choice for aesthetically driven patients post-mastectomy,” they added.