new report<\/a>, the Food and Drug Administration said the risks were well enough understood that prospective patients could make informed decisions.<\/p>\nBut it found as many as one in five breast augmentation patients had the implants removed within 10 years.<\/p>\n
The US approved the implants in 2006 after a long absence from the market.<\/p>\n
Market removal<\/span><\/p>\nOn Wednesday, the FDA released a 63-page report on the safety of the silicone gel-filled implants that compiled studies performed by the two companies approved to manufacture the the products.<\/p>\n
Approximately five to 10 million women across the world have breast implants, the FDA said.<\/p>\n
In 2006, the FDA approved two brands of silicone gel implants for women over 22, Allergan’s Natrelle implants and MemoryGel implants from manufacturer Johnson and Johnson’s Mentor division.<\/p>\n
Silicone implants had been off the market since 1992, when the FDA removed them amid concerns about implant rupture and silicone leakage.<\/p>\n
The agency allowed saline-filled implants to remain on the market, and allowed limited distribution of silicone implants for mastectomy patients and other cases of medical necessity.<\/p>\n
Increased risk<\/span><\/p>\nAccording to the new report, as many as one in five breast augmentation patients and half of breast reconstruction patients had to have the implants removed within 10 years.<\/p>\n
Studies found no association between the silicone implants and connective tissue disease, breast cancer, or reproductive problems, the FDA reported.<\/p>\n
But they did find a “very small” increased risk of anaplastic large cell lymphoma.<\/p>\n
The most frequent complications from the implants included implant rupture, wrinkling, asymmetry, scarring, pain, and infection.<\/p>\n
‘Shape and size’<\/span><\/p>\nThe report found that the risk of those local complications increases with time.<\/p>\n
“Breast implants are not lifetime devices,” the FDA cautioned women. “The longer you have your implants, the more likely it will be for you to have them removed.”<\/p>\n
But the agency also found that most women who had breast implants “report high levels of satisfaction with their body image and the shape, feel and size of their implants”.<\/p>\n
“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 concluded.<\/p>\n<\/div>\n
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