Safely re-integrating silicone breast implants into the plastic surgery practice.
In the early 1990s, it was reported that silicone breast implants were possibly responsible for serious damage to women's health. In January 1992, the Food and Drug Administration issued a voluntary breast implant moratorium and, in April, issued a ban on the use of silicone gel-filled implants for cosmetic breast augmentation. Since that time, silicone gel-filled breast implants have been available to women only for select cases: women seeking breast reconstruction or revision of an existing breast implant, women who have had breast cancer surgery, a severe injury to the breast, a birth defect that affects the breast, or a medical condition causing a severe breast deformity. Since the ban on the use of silicone gel-filled breast implants for cosmetic breast augmentation, numerous scientific studies have been conducted. To ensure patient safety, the American Board of Plastic Surgery believes that these scientific studies and the Food and Drug Administration's scrutiny of silicone gel-filled breast implants have been appropriate and necessary.
Gladfelter
Joanne
J
INAMED Corporation, Santa Barbara, California, USA. jpglad@cox.net
D019928:Breast Implantation / Q000009:adverse effects* / Q000295:instrumentation / Q000706:statistics & numerical data; D018427:Breast Implants / Q000009:adverse effects* / Q000706:statistics & numerical data / Q000600:supply & distribution; D003257:Consumer Product Safety; D018795:Device Approval; D019317:Evidence-Based Medicine; D006801:Humans; D007258:Informed Consent; D018579:Patient Selection; D011358:Product Surveillance, Postmarketing; D017751:Safety Management / Q000458:organization & administration*; D012826:Silicone Elastomers / Q000009:adverse effects*; D020034:Silicone Gels / Q000009:adverse effects*; D014481:United States; D014486:United States Food and Drug Administration
D012826:Silicone Elastomers; D020034:Silicone Gels