Kern K A, Flannery J T, Kuehn P G
Department of Surgery, Hartford Hospital, Connecticut, USA.
Plast Reconstr Surg. 1997 Sep;100(3):737-47; discussion 748-9. doi: 10.1097/00006534-199709000-00032.
To clarify the carcinogenic potential of silicone breast implants, 680 implant procedures performed on women in Connecticut with no prior history of cancer were correlated with the subsequent development of primary breast and nonbreast cancers. Neoplastic events after the placement of silicone breast implants during the 13-year interval from October 1, 1980, through September 30, 1993, were quantified using a retrospective, linked-registry method. ICD-9-CM discharge codes contained in the Uni formed Hospital Discharge Data Sets (UHDDS) from 34 hospitals across Connecticut were linked to procedure codes for unilateral and bilateral implants, and to medical histories for new malignancies after the implant procedures. Data were cross-linked to the Connecticut Tumor Registry to confirm the clinical history of each cancer. The rates of breast and nonbreast cancers in patients with silicone breast implants were compared with those of a control population drawn from the UHDDS of 1022 women undergoing sterilization by tubal ligation between 1981 to 1985. Ages (mean +/- SD) were similar in the implant group (34 +/- 10 years) and in the sterilization group (32 +/- 6 years). The mean follow-up in the implant group (4.6 years) was also similar to that of the control group (5.4 years). Compared with the control group, the implant group demonstrated lower rates of breast cancer (0.59 versus 0.88 percent, p = 0.35) and nonbreast cancer (0.59 versus 2.7 percent, p = 0.001). Correspondingly, the implant group had a lower relative risk of breast cancer (relative risk = 0.67, 95 percent, confidence interval = 0.20 to 2.17) and nonbreast cancer (relative risk = 0.21, 95 percent, confidence interval = 0.07 to 0.60). Based on these data, it was concluded that silicone breast implants are not carcinogenic, because they are not associated with increased rates of either breast or nonbreast cancers. The validity and threats to the conclusions are discussed, and the results are placed into context with similar findings from other studies.
为明确硅胶乳房植入物的致癌潜力，对康涅狄格州680例无癌症病史女性的植入手术与随后原发性乳腺癌和非乳腺癌的发生情况进行了相关性研究。采用回顾性关联登记法，对1980年10月1日至1993年9月30日这13年间植入硅胶乳房植入物后的肿瘤事件进行了量化。康涅狄格州34家医院统一医院出院数据集（UHDDS）中包含的国际疾病分类第九版临床修订本（ICD-9-CM）出院编码，与单侧和双侧植入物的手术编码以及植入手术后新恶性肿瘤的病史相关联。数据与康涅狄格肿瘤登记处进行交叉核对，以确认每种癌症的临床病史。将植入硅胶乳房植入物患者的乳腺癌和非乳腺癌发病率与从1981年至1985年接受输卵管结扎绝育的1022名女性的UHDDS中抽取的对照人群的发病率进行比较。植入组（34±10岁）和绝育组（32±6岁）的年龄（均值±标准差）相似。植入组的平均随访时间（4.6年）也与对照组（5.4年）相似。与对照组相比，植入组的乳腺癌发病率较低（0.59%对0.88%，p = 0.35），非乳腺癌发病率较低（0.59%对2.7%，p = 0.001）。相应地，植入组患乳腺癌的相对风险较低（相对风险 = 0.67，95%置信区间 = 0.20至2.17），患非乳腺癌的相对风险较低（相对风险 = 0.21，95%置信区间 = 0.07至0.60）。基于这些数据，得出结论：硅胶乳房植入物不具有致癌性，因为它们与乳腺癌或非乳腺癌发病率的增加无关。讨论了结论的有效性和面临的威胁，并将结果与其他研究的类似发现放在一起进行了分析。
