21st Century Essential Guide to Breast Implants, Silicone Gel Implants -Documents and References from the Food and Drug Administration (CD-ROM)

This electronic book on CD-ROM provides coverage of breast implants, silicone gel implants, along with a collection of documents, publications, and reference sources on other aspects of the Food and Drug Administration (FDA). Contents include: FDA's mission is to assure that the products that we approve are safe and effective, and that includes breast implants. Breast implants are medical devices that typically consist of a silicone elastomer shell filled with saline or silicone gel. They are intended for women who are seeking breast augmentation (cosmetic) or breast reconstruction. There is information related to both approved breast implants and investigational (under study for safety and effectiveness) breast implants. Consumer Breast Implant Questions and Answers * FDA Backgrounder on Platinum in Silicone Breast Implants * FDA Breast Implant Consumer Handbook * Brochure of Complications * Photographs of Complications * FDA Consumer - Making an Informed Decision About Breast Implants * FDA Studies / Articles - Study of Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women Study of Re-operations and Self-Reported Silicone-Gel Breast Implant Rupture * Study of Rupture of Silicone Gel-filled Breast Implants (MRI Component) * Breast Implant Adverse Events During Mammography * Making an Informed Decision About Breast Implants * Labeling for Approved Breast Implants * Labeling for Approved Breast Implants * Saline-Filled Breast Implants * Patient labeling for Mentor saline breast implants * Patient labeling for Inamed saline breast implants * Physician labeling for Mentor saline breast implants * Physician labeling for Inamed saline breast implants * Silicone Gel-Filled Breast Implants * Reconstruction Patient Labeling for Allergan (formerly Inamed) * Augmentation Patient Labeling for Allergan (formerly Inamed) * Physician Labeling for Allergan (formerly Inamed) * Reconstruction Patient Labeling for Mentor * Augmentation Patient Labeling for Mentor * Physician Labeling for Mentor FDA is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public. Some of the agency's specific responsibilities include: Biologics - product and manufacturing establishment licensing; safety of the nation's blood supply; research to establish product standards and develop improved testing methods; Cosmetics - safety; labeling; drugs; product approvals; OTC and prescription drug labeling; drug manufacturing standards; Foods - labeling; safety of all food products (except meat and poultry); bottled water; Medical Devices; premarket approval of new devices; manufacturing and performance standards; tracking reports of device malfunctioning and serious adverse reactions; Radiation-Emitting Electronic Products - radiation safety performance standards for microwave ovens, television receivers, diagnostic x-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser products, ultrasonic therapy equipment, mercury vapor lamps, and sunlamps accrediting and inspecting mammography facilities; Veterinary Products - livestock feeds; pet foods; veterinary drugs and devices.