Breast implants are medical devices that are surgically implanted into a woman’s body to:
• Enhance and enlarge breast size and shape in breast augmentation
• Create the substance of a breast mound for breast reconstruction following mastectomy or other surgery to treat breast cancer
• Restore a more normal appearance to a woman’s body that is lacking a breast due to congenital anomaly or birth defect Breast implants were introduced in the United States in the early 1960s, mainly for augmentation purposes.
It was not until 1976 that breast implants became subject to U.S. Food and Drug Administration (FDA) regulation under the U.S. FDA’s Center for Devices and Radiological Health. All breast implants currently in use in the United States are reviewed by the U.S. FDA Center for Devices and Radiological Health and are approved by the U.S. FDA. All approved breast implants have an outer shell of medical- grade, biocompatible solid silicone rubber.
• Implants approved strictly for enlargement or augmentation purposes are filled with sterile saline solution.
• Implants approved strictly for reconstructive purposes are saline or silicone filled. In addition, silicone-filled implants are currently in clinical trails and pending U.S. FDA approval for augmentation. These implants were last reviewed for approval in April 2005. Breast implants are surgically placed through incision patterns in a woman’s body, either:
• Underneath existing breast tissue and on top of the chest muscles
• Beneath the chest muscles
• Beneath a muscle flap repositioned to the chest wall
There are several factors you must understand about all breast implants, and about all cases in which breast implants are placed into a woman’s body. First, know who is recommending and placing your breast implants. The only medical specialty with accredited training in breast cosmetic surgery and the placement of breast implants is cosmetic surgery, and physicians who are certified by the American Board of Cosmetic Surgery. No other medical specialty has core training in breast surgery specific to the placement of breast implants. Next, know that despite the fact that only boardcertified cosmetic surgeons have the appropriate training to surgically place implants into your body, in the United States any licensed physician can purchase these medical devices and surgically implant them with your consent. It seems odd, but unfortunately medical manufacturers cannot deny selling these devices to a licensed physician. It would be a restraint of trade. Therefore, you must take it upon yourself to know exactly the qualifications and training of the physician who you will consult with and who will perform surgery to place breast implants into your body. You have the right and the responsibility to make certain of the surgeon’s qualifications and expertise. Equally vital to your health and safety as knowing who will surgically place your implants is knowing what type of implants are being placed. Specific questions to ask include:
• The name of the manufacturer
• The type, model, and serial number
There are only two manufacturers of breast implants that are approved for use by the U.S. FDA in the United States: Inamed Corporation (who acquired McGahn Medical) and Mentor Corporation. If the breast implants recommended for your surgery are not manufactured by either of these two companies, you must ask some very serious questions of your surgeon. Either the implants being used are part of an U.S. FDA-qualified clinical trial and so you will be a research subject or, more likely, the implants being used are an imported device and not subject to U.S. FDA regulation. Be cautious. Imported devices may be cheaper, but they have no proven track record for safety or outcomes in the United States. Therefore, you should not agree to the use of any implant that is not manufactured by Inamed or Mentor, or that is not part of a qualified U.S. FDA trial. The American Society of Cosmetic Surgeons and the American Society for Aesthetic Cosmetic Surgery have made statements advising their members against the use of imported medical devices and substances. However, no public policy exists that prohibits or makes it unlawful to use imported medical devices with a patient’s consent. Both Inamed Corporation and Mentor Corporation have Web sites specific to breast implants and breast implant surgery. In addition, the American Society of Cosmetic Surgeons and the American Society for Aesthetic Cosmetic Surgery have online information about all breast implants and their use in women.
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Note: This article was sent to us by: Cynthia H. Bailey at 01212010
1. Breast cosmetic surgery and its results on the appearance of the breast
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