FDA: Breast Implants Basically Safe, But Won't Last a
WEDNESDAY, June 22 (HealthDay News) -- Silicone-gel breast
implants don't last forever, with as many as half of women with the
devices requiring removal within 10 years of the initial surgery,
U.S. health officials said Wednesday.
And "the longer a woman has the implants, the more likely she is
to experience complications," Dr. Jeffrey Shuren, director for the
Center for Devices and Radiological Health at the U.S. Food and
Drug Administration, said during a press briefing.
The report released Wednesday said one in five women who
receives silicone-gel implants to increase the size of their
breasts will need to have these devices removed within 10 years of
implant due to complications. And as many as half of women who
receive implants for reconstruction after breast surgery will need
them removed within the same time frame.
The difference in rates has to do with how much healthy tissue
the woman has to support the implants, Shuren explained.
Common complications include: capsular contracture, which is
hardening of the area around the implant; the need for additional
surgeries; and implant removal. Other frequent problems include
implant rupture, wrinkling, breast asymmetry, scarring, pain and
infection, the FDA said.
These are basically the same complications noted when the two
silicone-gel implants available in the United States were returned
to the market in 2006, the FDA said.
Until 2006, silicone-gel implants had been banned by the FDA for
14 years because of concerns about possible links to several
diseases, including cancer and lupus.
On Wednesday, Shuren said, "Preliminary data doesn't show an
increased risk of breast cancer or connective tissue disease such
as rheumatoid arthritis. But to rule those out, we need studies
that are larger and longer than those conducted thus far."
The FDA had said recently that breast implants may be linked to
a higher risk of a rare form of lymphoma called anaplastic large
cell lymphoma, but Shuren noted that those risks are actually
The findings announced Wednesday were based on preliminary data
from six ongoing post-approval studies conducted by Allergan and
Mentor, the two companies that manufacture the silicone-gel breast
implants. The studies were mandated by the FDA as a condition of
approval back in 2006.
But the companies have acknowledged problems with poor patient
follow-up, to monitor their health. The situation is "improving,"
Shuren said, but wouldn't say what the rate of follow-up is at this
The new report concerned only silicone gel-filled implants, not
For now, the FDA recommends that women: follow-up regularly with
their doctor, which includes occasional MRIs to detect potential
ruptures; pay attention to any changes and notify their health-care
provider if they notice any unusual symptoms such as pain,
asymmetry or swelling; and educate themselves on the signs and
symptoms of complications.
Women who have agreed to participate in a study should stay
The implants are safe if "used for the right patient population
and the right circumstances, and that is that they are surgically
implanted properly and that women continue to have appropriate
follow-up," Shuren said.
"If women don't have any symptoms or signs, there's really nothing to do [except follow-up regularly with their doctor]," Shuren said. "At 10 years, most women won't have to take the implant out but, if you need to have it removed, you should have it removed."
According to Shuren, an estimated 5 million to 10 million women
worldwide have breast implants.
More FDA advisory panel meetings are planned on the
Dr. Sidney Wolfe, director of Public Citizen's Health Research
Group, said the FDA's position that "although silicone breast
implants have 'a reasonable assurance of safety . . . the longer a
woman has breast implants, the more likely she is to experience
local complications or adverse outcomes,' is unquestionably
shortsighted as well as contradictory."
"Public Citizen continues to oppose the FDA's 2006 decision to return silicone breast implants to the market for cosmetic use in women for augmentation," Wolfe said in a news release. "The agency's newer information about the risk of implant-associated lymphoma and the previously known risks are serious enough to warrant advising women against having these implanted."
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