Breast Implants: Closed Filling System Guards Against Saline Contamination
New York, NY (November 17, 2000) — There are no scientifically substantiated reports of harmful health effects associated with the rupture of saline-filled breast implants. Nevertheless, a recent consumer magazine article raised the issue of possible fungus or bacteria growth in saline solution. Published studies show that microbial growth within saline-filled implants is a rare occurrence and is generally avoided by the use of sterile techniques for filling breast implants, according to the American Society for Aesthetic Plastic Surgery (ASAPS), the leading organization of board-certified plastic surgeons who specialize in cosmetic plastic surgery.
Since the early 1990s, a "closed" system for filling breast implants has been available. Using this method, sterile intravenous (IV) saline solution is transferred directly into the implant. In this way, the saline solution is never exposed to air or environmental contaminants.
Implants might appear "black" if certain types of antibacterial, antiseptic or cleansing agents were added to the saline solution at the time of insertion. Implant manufacturers discourage this practice. Any implant being evaluated for possible contamination must be handled and stored properly to avoid exposure to microorganisms after its removal from the body. Such exposure may invalidate further scientific analysis.
The Food and Drug Administration (FDA) approved saline-filled breast implants in May 2000. The FDA ruled the implants are safe and effective for breast augmentation in women age 18 and older as well as for breast reconstruction.
The American Society for Aesthetic Plastic Surgery (ASAPS), is recognized as the world’s leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body. ASAPS is comprised of over 2,600 Plastic Surgeons; active members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and non-surgical aesthetic procedures. International active members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.
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