Duffy M J, Woods J E
Department of Plastic and Reconstructive Surgery, Mayo Clinic, Rochester, Minn.
Plast Reconstr Surg. 1994 Aug;94(2):295-9. doi: 10.1097/00006534-199408000-00012.
The purpose of this paper is an assessment of clinically evident systemic health problems associated with failed silicone gel breast implants. A computer search of the medical records of 2033 patients receiving implants in the years 1962-1992 revealed that between 1970 and 1992, 200 women 14 to 75 years of age underwent secondary silicone gel breast implant procedures by a single surgeon. This allowed determination of the exact integrity status of 681 implants collectively placed in these 200 patients between 1962 and 1992 and followed clinically for a median of 49 months. The common indications for surgical reexploration in these 200 patients were capsulectomy, open capsulotomy, or implant exchange/removal. All patients had a minimum clinical follow-up of 6 months. Surgical findings revealed that 577 (85 percent) implants were intact in 135 (67.5 percent) patients and that in 65 (32.5 percent) patients, 104 (15 percent) implant failures were found. The patients' medical records were reviewed with specific attention to diagnoses suggesting immune-related disorders, siliconoma, acquired non-breast malignancies, metachronous breast cancer, and recurrent breast carcinomas. In this very select subgroup of 65 patients with silicone gel breast implants which had failed or were deteriorating, no excess of expected immune-related disorders or malignancies was identified. Our 30-year clinical experience with silicone gel breast implants for augmentation mammaplasty or breast reconstruction failed to demonstrate that clinically evident adverse health problems are incurred by those women who subsequently experience a silicone gel breast implant failure.
本文旨在评估与硅胶乳房植入物失败相关的临床明显的全身健康问题。对1962年至1992年间接受植入手术的2033例患者的病历进行计算机检索发现，在1970年至1992年间，有200名年龄在14至75岁之间的女性由同一位外科医生进行了二次硅胶乳房植入手术。这使得能够确定在1962年至1992年间共同植入这200例患者体内的681个植入物的确切完整性状况，并进行了中位时间为49个月的临床随访。这200例患者进行手术再次探查的常见指征是包膜切除术、开放性包膜切开术或植入物更换/取出。所有患者的临床随访时间至少为6个月。手术结果显示，577个（85%）植入物在135名（67.5%）患者体内完好无损，而在65名（32.5%）患者体内发现了104个（15%）植入物失败。对患者的病历进行了审查，特别关注提示免疫相关疾病、硅瘤、获得性非乳腺恶性肿瘤、异时性乳腺癌和复发性乳腺癌的诊断。在这一非常特定的65例硅胶乳房植入物失败或恶化的患者亚组中，未发现预期的免疫相关疾病或恶性肿瘤过多。我们对用于隆乳或乳房重建的硅胶乳房植入物30年的临床经验未能证明，那些随后经历硅胶乳房植入物失败的女性会出现临床明显的不良健康问题。
