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Breast implants were previously approved for use in the USA on the basis that they had been on the market prior to implementation of regulations in 1976. In April 1992 the FDA restricted the use of silicone gel breast implants to clinical trials with, initially, a limited number of indications (i.e. reconstruction, congenital abnormality and replacement of ruptured implants). Silicone gel breast implants were invented by the plastic surgeons Cronin and Gerow in the early 1960s. Objective information about breast implants is plentiful on the net but scattered.
Your surgeon should also send information about your operation to the National Breast Implant Registry so that information about breast implants can be collected. In January 1992 the FDA called for a moratorium on the use of silicone gel breast implants while the advisory panel reviewed new information from case reports of connective tissue disease and data on silicone bleed in some early models. This forum is devoted to positive discussions about breast implants between women who have had a saline or silicone breast augmentation or are looking to do so.
Although one series of patients examined showed a significantly higher prevalence of the disease than expected, overall there is no indication that the incidence of systemic sclerosis in women with breast implants is any higher than in the general population. In 1990, the Food and Drug Administration (FDA) in the USA requested technical data from breast implants manufacturers to support continued marketing approval. This is a place for women to share experiences, opinions and information on breast implants, breast augmentation, breast enlargement, plastic surgery and recovery.
It was envisaged that this would be extended to augmentation in later studies. In late 1991 an FDA advisory panel reviewed the data submitted and recommended that manufacturers needed to collect additional data on silicone gel breast implants before approval could be given, but that the products should remain on the market whilst these data were collected. They were developed into a commercial product by Dow Corning in 1962. Ask questions and get opinions about breast implants and breast augmentation in our live chat room or on our dynamic discussion forums and get real answers from real women who have had breast augmentation and plastic surgery.
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