US regulators: Silicone breast implants relatively safe
25 June BBC
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 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 Memory Gel 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.
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