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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.
Market removal
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.
Increased risk
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.
'Shape and size'
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.