The FDA removed silicone implants from the market from 1992-2006 over safety concerns Silicone breast implants are relatively safe despite frequent complications and a small increased risk of the disease lymphoma, US drug regulators have said.
In a new report, the Food and Drug Administration said the risks were well enough understood that prospective patients could make informed decisions.
But it found as many as one in five breast augmentation patients had the implants removed within 10 years.
The US approved the implants in 2006 after a long absence from the market.
On 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.
Approximately five to 10 million women across the world have breast implants, the FDA said.
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.
Silicone implants had been off the market since 1992, when the FDA removed them amid concerns about implant rupture and silicone leakage.
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.
According 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.
Studies found no association between the silicone implants and connective tissue disease, breast cancer, or reproductive problems, the FDA reported.
But they did find a “very small” increased risk of anaplastic large cell lymphoma.
The most frequent complications from the implants included implant rupture, wrinkling, asymmetry, scarring, pain, and infection.
The report found that the risk of those local complications increases with time.
“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.”
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”.
“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.
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