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 "Owing to the flaws and inconsistencies among the studies reviewed,
further investigation is required to determine whether any true
associations exist between silicone gel implants and long-term
health outcomes," write the researchers, led by Dr. Ethan Balk of
the Brown University School of Public Health in Providence, Rhode
Island.
Breast enlargement was the most commonly performed cosmetic surgery
in the U.S. during 2014, with over 286,000 women having the
procedure, according to the American Society of Plastic Surgeons.
Silicone implants are used in about three quarters of those
surgeries.
Unlike implants that are filled with saline, silicone implants are
filled with gel to look and feel more like natural breasts. The U.S.
Food and Drug Administration (FDA) stopped the sale of silicone gel
implants in 1992 in response to public concern, but they were
reintroduced in 2006.
For the new analysis, the researchers reviewed more than 5,000
studies of health outcomes after breast implant surgery. Thirty-two
of the studies met their criteria for inclusion in the new report.
The studies, which came from North America, Europe and Australia,
reported on women who received breast implants between 1964 and
2003.
The researchers were interested in possible links between silicone
gel breast implants and several types of cancers, connective tissue
diseases, rheumatoid arthritis, immune system disorders, blood flow
problems, reproductive issues and mental health.
For most outcomes, however, "there was at most only a single
adequately (done) study," and the researchers could not find enough
evidence to link breast implants to any health conditions.
"Furthermore, because most studies analyzed all breast implants,
their findings are not specific to silicone gel implants," the
authors reported.
There was a suggestion that breast implants are linked to a
decreased risk of breast and endometrial cancers, and that implants
were tied to an increased risk of lung cancer, immune system
disorders and blood flow problems.
The researchers say larger studies may be able to overcome the gap
in evidence, if the authors of those studies could reanalyze their
results to tease out the data that are specific to silicone gel
implants and account for variables like family medical history,
hormone use, weight, depression and substance use.
The new analysis is meant to support the creation of a national
breast implant registry from the American Society of Plastic
Surgeons and the FDA that will track all breast implants, the
researchers write.
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The registry will track women's health from the time they receive
their implants until the time they get them replaced, said Dr. Rod
Rohrich, of the University of Texas Southwestern Medical Center in
Dallas.
"Hopefully it’ll show what the implants do in five, 10 or 15 years,
because that’s what’s lacking in the current data," said Rohrich,
who co-authored an editorial accompanying the new analysis.
He also told Reuters Health that women should be reassured that the
researchers did not find evidence linking major adverse events to
breast implants, "but we’re going to be tracking this because we
want to make sure we track them long term in case there are any
problems."
In another editorial, two Dutch doctors say women's reports of
health problems after receiving silicone gel implants deserve
further investigation.
"A logical next step would be to focus future studies on this group
with unexplained symptoms to identify the underlying role of the
immune system and how we might identify women at risk for
complications if they were to receive silicone implants," write Drs.
Prabath Nanayakkara and Christel de Blok of VU University Medical
Center in Amsterdam.
The researchers were unable to respond to questions before press
time.
SOURCE: http://bit.ly/SQRXAa Annals of Internal Medicine, online
November 9, 2015.
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