Guido Paolini1, Guido Firmani2, Francesca Briganti2, Mattia Macino3, Simone Nigrelli2, Michail Sorotos4, Fabio Santanelli di Pompeo5. 1. NESMOS (Neurosciences, Mental Health, and Sensory Organs) Department, Faculty of Medicine and Psychology, Azienda Ospedaliera Sant'Andrea - U.O.D. Chirurgia Plastica, Sapienza University of Rome, Via di Grottarossa 1035-1039, 00189, Rome, Italy. guido.paolini@uniroma1.it. 2. Faculty of Medicine and Psychology, Sant'Andrea Hospital, Sapienza University of Rome, Via di Grottarossa 1035-1039, 00189, Rome, Italy. 3. Department of Biomedicine and Prevention, Tor Vergata University, Via Montpellier, 1, 00133, Rome, Italy. 4. NESMOS (Neurosciences, Mental Health, and Sensory Organs) Department, Faculty of Medicine and Psychology, Azienda Ospedaliera Sant'Andrea - U.O.D. Chirurgia Plastica, Sapienza University of Rome, Via di Grottarossa 1035-1039, 00189, Rome, Italy. 5. NESMOS Department, Faculty of Medicine and Psychology, Chair of Plastic Surgery - Sant'Andrea Hospital, Sapienza University of Rome, Via di Grottarossa 1035-1039, 00189, Rome, Italy.
Abstract
BACKGROUND: Breast implants (BI) are widely used in plastic surgery, though they are not lifetime devices. Average life before rupture is reported to be around 10-15 years. No consensus exists regarding which factors are involved. OBJECTIVES: Following FDA recommendations, this study aims at identifying potential risk factors by evaluating their effect on BI rupture cases. METHODS: In this observational study, 763 BI patients were operated between 2003 and 2019, with a mean implant indwelling of 12.2 years. Patients that returned for follow-up were administered a questionnaire regarding postoperative lifestyle and habits. Implant rupture rate was 15.1%, while BI lifespan was 10.1 years. We obtained complete data from 191 breast implant patients (288 implants). Twenty-three potential risk factors were evaluated and divided in four categories: patient-related, surgery-related, postoperative complications/symptoms, and postoperative care/lifestyle habits. Odds Ratio (OR) for each factor was calculated. Linear regression analysis was calculated for those with a significant OR. RESULTS: We report 120 patients (195 implants) with intact and 71 (93 implants) with ruptured devices. BIs were macrotextured in 95.1% of cases (86.8% Allergan BIOCELL). OR was significant for underwire bra use (OR: 2.708), car seat belts (OR: 3.066), mammographic imaging (OR: 2.196), weightlifting (OR: 0.407) and carry-on heavy purses and backpacks (OR: 0.347). CONCLUSION: Wearing underwire bras, seat belts and undergoing mammography increases the risk of rupture. Weightlifting and carry heavy bags do not increase that risk. Implant rupture is directly linked with time of indwelling. Postoperative recommendations in BI patients should consider findings from our study, though larger multicenter studies should be encouraged. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
BACKGROUND: Breast implants (BI) are widely used in plastic surgery, though they are not lifetime devices. Average life before rupture is reported to be around 10-15 years. No consensus exists regarding which factors are involved. OBJECTIVES: Following FDA recommendations, this study aims at identifying potential risk factors by evaluating their effect on BI rupture cases. METHODS: In this observational study, 763 BI patients were operated between 2003 and 2019, with a mean implant indwelling of 12.2 years. Patients that returned for follow-up were administered a questionnaire regarding postoperative lifestyle and habits. Implant rupture rate was 15.1%, while BI lifespan was 10.1 years. We obtained complete data from 191 breast implant patients (288 implants). Twenty-three potential risk factors were evaluated and divided in four categories: patient-related, surgery-related, postoperative complications/symptoms, and postoperative care/lifestyle habits. Odds Ratio (OR) for each factor was calculated. Linear regression analysis was calculated for those with a significant OR. RESULTS: We report 120 patients (195 implants) with intact and 71 (93 implants) with ruptured devices. BIs were macrotextured in 95.1% of cases (86.8% Allergan BIOCELL). OR was significant for underwire bra use (OR: 2.708), car seat belts (OR: 3.066), mammographic imaging (OR: 2.196), weightlifting (OR: 0.407) and carry-on heavy purses and backpacks (OR: 0.347). CONCLUSION: Wearing underwire bras, seat belts and undergoing mammography increases the risk of rupture. Weightlifting and carry heavy bags do not increase that risk. Implant rupture is directly linked with time of indwelling. Postoperative recommendations in BI patients should consider findings from our study, though larger multicenter studies should be encouraged. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
Authors: Mintsje de Boer; Michele van Middelkoop; Michael Hauptmann; Noortje van der Bijl; Jorn A W Bosmans; Narda Hendriks-Brouwer; Sijmen J Schop; Jan Paul de Boer; Nathalie J Hijmering; Lucy I H Overbeek; Marc B I Lobbes; Caroline A H Klazen; Daphne de Jong; Hinne A Rakhorst; René R W J van der Hulst; Flora E van Leeuwen Journal: Aesthet Surg J Date: 2020-01-29 Impact factor: 4.283