FDA: Breast Implants Eventually Need To Be Removed Or Fixed
June 24, 2011 by Special To Personal Liberty
The Food and Drug Administration (FDA) issued an update Wednesday to its safety guidelines and recommendations regarding silicone breast implants.
“Based on the totality of the evidence, the FDA believes that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use,” the FDA said in a statement on its website.
However, the FDA also found that “the longer a woman has breast implants, the more likely she is to experience local complications or adverse outcomes. Women with breast implants will need to monitor their breasts for local complications for the rest of their lives… Recognize that breast implants are not lifetime devices. The longer you have your implants, the more likely it will be for you to have them removed.”
The FDA reached these conclusions after reviewing updated industry studies and literature.
The FDA recommended that women with breast implants receive regular checkups with their doctors to monitor the implants for damage, and to “notify your health care provider if you develop any unusual signs or symptoms including pain, asymmetry, hardness or swelling.”