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.
Faculty of Medicine and Psychology, Sant'Andrea Hospital, Sapienza University of Rome, Via di Grottarossa 1035-1039, 00189, Rome, Italy.
Aesthetic Plast Surg. 2023 Apr;47(2):517-530. doi: 10.1007/s00266-022-03118-9. Epub 2022 Oct 13.
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.
Following FDA recommendations, this study aims at identifying potential risk factors by evaluating their effect on BI rupture cases.
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.
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).
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.
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乳房植入物(BI)在整形手术中被广泛应用,但它们不是终身设备。据报道,平均破裂前的使用寿命约为 10-15 年。目前尚无共识认为哪些因素与此有关。
根据 FDA 的建议,本研究旨在通过评估其对 BI 破裂病例的影响来确定潜在的危险因素。
在这项观察性研究中,2003 年至 2019 年间对 763 名 BI 患者进行了手术,平均植入物留置时间为 12.2 年。返回随访的患者接受了关于术后生活方式和习惯的问卷调查。BI 破裂率为 15.1%,而 BI 的寿命为 10.1 年。我们从 191 名乳房植入物患者(288 个植入物)中获得了完整的数据。评估了 23 个潜在的危险因素,并分为四类:患者相关、手术相关、术后并发症/症状和术后护理/生活习惯。计算了每个因素的优势比(OR)。对具有显著 OR 的因素进行线性回归分析。
我们报告了 120 名患者(195 个植入物)的 BI 完好无损,71 名患者(93 个植入物)的 BI 破裂。95.1%的 BI 为宏观纹理(86.8%为 Allergan BIOCELL)。使用带钢圈文胸(OR:2.708)、汽车安全带(OR:3.066)、乳房 X 光成像(OR:2.196)、举重(OR:0.407)和携带重物手提包和背包(OR:0.347)的 OR 具有显著性。
佩戴带钢圈文胸、安全带和进行乳房 X 光检查会增加破裂的风险。举重和携带重物不会增加这种风险。BI 破裂与留置时间直接相关。BI 患者的术后建议应考虑本研究的结果,但应鼓励开展更大规模的多中心研究。
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