Silverman B G, Brown S L, Bright R A, Kaczmarek R G, Arrowsmith-Lowe J B, Kessler D A
U.S. Food and Drug Administration, Rockville, Maryland, USA.
Ann Intern Med. 1996 Apr 15;124(8):744-56. doi: 10.7326/0003-4819-124-8-199604150-00008.
To review the range of local and systemic complications attributed to silicone breast implants and to evaluate the epidemiologic literature on these complications.
Epidemiologic studies of the potential risks of silicone breast implants identified by MEDLINE search and literature review.
Epidemiologic studies with cohort, case-control, and cross-sectional designs. When epidemiologic studies were unavailable (as for estimates of local complications), case series were reviewed.
Epidemiologic studies evaluated for methodologic quality, including such characteristics as study design, sample size and selection, determination of silicone exposure and outcome variables, and duration of follow-up.
The epidemiologic literature on the potential complications of silicone breast implants has concentrated primarily on connective tissue disorders and cancer. Estimated of the true incidence of local complications, such as rupture, capsular contracture, and breast pain, are unavailable. Studies of scleroderma and other defined connective tissue diseases suggest that implant recipients have no substantially increased risk for these disorders; however, the epidemiologic literature is insufficient to rule out an association between breast implants and connective tissue disease-like syndromes. Overall, the rate of breast cancer does not seem to be increased in women with silicone breast implants. However, the risk to women as they reach the postmenopausal years in not yet known.
Information is insufficient to adequately advise women who currently have or are seeking to obtain breast implants about the overall risk of these devices. No epidemiologic study has indicated that the rate of well-defined connective tissue disease or breast cancer has greatly increased in women with silicone breast implants, but no studies have ruled out a moderately increased risk for these diseases. No studies have adequately addressed the crucial issue of local complications such as rupture and capsular contracture, although evidence increasingly points to a higher risk for rupture as implants age.
回顾归因于硅胶乳房植入物的局部和全身并发症范围，并评估关于这些并发症的流行病学文献。
通过医学文献数据库检索和文献综述确定的硅胶乳房植入物潜在风险的流行病学研究。
采用队列研究、病例对照研究和横断面设计的流行病学研究。当无法获得流行病学研究时（如对于局部并发症的估计），则回顾病例系列。
对流行病学研究进行方法学质量评估，包括研究设计、样本量和选择、硅胶暴露和结局变量的确定以及随访持续时间等特征。
关于硅胶乳房植入物潜在并发症的流行病学文献主要集中在结缔组织疾病和癌症方面。无法获得局部并发症（如破裂、包膜挛缩和乳房疼痛）真实发病率的估计值。对硬皮病和其他明确的结缔组织疾病的研究表明，植入物接受者患这些疾病的风险没有大幅增加；然而，流行病学文献不足以排除乳房植入物与结缔组织病样综合征之间的关联。总体而言，硅胶乳房植入物女性的乳腺癌发病率似乎没有增加。然而，绝经后女性的风险尚不清楚。
信息不足，无法就这些装置的总体风险向目前已有或正寻求获得乳房植入物的女性提供充分建议。没有流行病学研究表明，硅胶乳房植入物女性中明确的结缔组织疾病或乳腺癌发病率大幅增加，但也没有研究排除这些疾病风险适度增加的可能性。没有研究充分解决破裂和包膜挛缩等局部并发症的关键问题，尽管越来越多的证据表明，随着植入物使用年限增加，破裂风险更高。
