BACKGROUND: The demand for bilateral mastectomy and immediate breast reconstruction has increased in recent years, primarily due to the development of genetic testing. The aim of this study was to evaluate if there was a difference between anatomically shaped and round permanent expandable implants in one-stage bilateral breast reconstruction after bilateral prophylactic mastectomy. METHODS: The anatomically shaped permanent expander implant McGhan Style 150 (Inamed, Santa Barbara, Calif.) was compared with the round permanent expander implant Siltex Becker 25 (Mentor, Santa Barbara, Calif.). Thirty-six women who opted for bilateral prophylactic mastectomy and immediate reconstruction with implants from 2004 to 2006 were included and randomly assigned to each group [18 women (36 breasts) per group]. Time to follow-up was a minimum of 2 years after the bilateral prophylactic mastectomy. Implant-related complications, breast symmetry, aesthetic outcome, and patient satisfaction were evaluated. Aesthetic outcome was evaluated by an expert panel that also tried to recognize if the breasts were reconstructed with anatomically shaped or round implants. Patient satisfaction was evaluated by a questionnaire. RESULTS: Average time to follow-up was 30 months (range, 24 to 49 months). There was no statistical difference between the two implant groups in terms of complications, breast symmetry, or outcome scores from the expert panel and patient assessment. The expert panel guessed the right implant shape in 42 percent of the anatomically shaped implants and 66 percent of the round implants. CONCLUSION: In immediate one-stage breast reconstruction after bilateral prophylactic skin-sparing mastectomy, anatomically shaped and round permanent expander implants had comparable complication rates, aesthetic outcomes, and patient satisfaction after 2 years of follow-up.
RCT Entities:
BACKGROUND: The demand for bilateral mastectomy and immediate breast reconstruction has increased in recent years, primarily due to the development of genetic testing. The aim of this study was to evaluate if there was a difference between anatomically shaped and round permanent expandable implants in one-stage bilateral breast reconstruction after bilateral prophylactic mastectomy. METHODS: The anatomically shaped permanent expander implant McGhan Style 150 (Inamed, Santa Barbara, Calif.) was compared with the round permanent expander implant Siltex Becker 25 (Mentor, Santa Barbara, Calif.). Thirty-six women who opted for bilateral prophylactic mastectomy and immediate reconstruction with implants from 2004 to 2006 were included and randomly assigned to each group [18 women (36 breasts) per group]. Time to follow-up was a minimum of 2 years after the bilateral prophylactic mastectomy. Implant-related complications, breast symmetry, aesthetic outcome, and patient satisfaction were evaluated. Aesthetic outcome was evaluated by an expert panel that also tried to recognize if the breasts were reconstructed with anatomically shaped or round implants. Patient satisfaction was evaluated by a questionnaire. RESULTS: Average time to follow-up was 30 months (range, 24 to 49 months). There was no statistical difference between the two implant groups in terms of complications, breast symmetry, or outcome scores from the expert panel and patient assessment. The expert panel guessed the right implant shape in 42 percent of the anatomically shaped implants and 66 percent of the round implants. CONCLUSION: In immediate one-stage breast reconstruction after bilateral prophylactic skin-sparing mastectomy, anatomically shaped and round permanent expander implants had comparable complication rates, aesthetic outcomes, and patient satisfaction after 2 years of follow-up.
Authors: Marco Gardani; Nicolò Bertozzi; Michele Pio Grieco; Marianna Pesce; Francesco Simonacci; PierLuigi Santi; Edoardo Raposio Journal: Ann Med Surg (Lond) Date: 2017-07-20
Authors: Nicola Rocco; Corrado Rispoli; Lorenzo Moja; Bruno Amato; Loredana Iannone; Serena Testa; Andrea Spano; Giuseppe Catanuto; Antonello Accurso; Maurizio B Nava Journal: Cochrane Database Syst Rev Date: 2016-05-16