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 The U.S. Food and Drug Administration (FDA) banned silicone breast
implants in 1992 over concerns about an increased risk of cancer,
connective tissue diseases and autoimmune disorders that were
disproved by subsequent research. As a condition of approving a new
generation of silicone implants in 2006, the FDA required
manufacturers to gather long-term safety information.
For the current analysis, researchers examined data from almost
100,000 women who had breast augmentation or reconstruction with
either the new generation of silicone implants or with saline
alternatives. Women were followed from two to seven years, although
most were studied for no more than three years.
"Breast implants were found to have common complications such as
infection, scar development, rupture, and the need for
re-operation," said senior author Dr. Mark Clemens of the University
of Texas MD Anderson Cancer Center in Houston.
"We also found that silicone implants were very rarely associated
with some diseases, and these findings were confirmatory and in line
with previous smaller studies on breast implants," Clemens said by
email.
Over the short term, women had a higher likelihood of an implant
rupturing with the saline versions. This happened in 2.5 percent of
women with saline implants and in 0.5 percent of women with
silicone, researchers report in the Annals of Surgery.
Compared to women without implants, however, women with silicone
implants had an eight times higher risk of Sjogren's syndrome, a
rare immune system disorder characterized by dryness in the eyes and
mouth that is often accompanied by other immune problems like
arthritis or lupus.
With silicone implants, women also had seven times the risk of
scleroderma, a different rare immune system disorder that leads to
hardening and tightening of the skin and connective tissue.
Silicone implants were also associated with almost six times the
risk of rheumatoid arthritis, an inflammatory joint disorder.
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The study did not find comparable risk increases for saline implants
but did not directly compare silicone and saline implants.
While the data were gathered to detect safety issues with
new-generation silicone implants, the current study was not a
controlled experiment designed to compare various silicone implants
to one another, the authors note. The researchers also lacked
detailed data on individual patients and could only assess results
for large groups of women.
Previous research has found an increased risk of certain cancers
associated with textured breast implants, but the current analysis
lacked data on this aspect of implants and could not examine how
other aspects of the implants or procedures to place them might have
influenced safety outcomes for women.
"Given the study design's limitations, it would not be appropriate
to warn patients about a higher risk of connective tissue or
autoimmune disorders," with silicone implants, said Dr. Michael
Alperovich of Yale University School of Medicine in New Haven,
Connecticut.
"The study does support performing a more rigorous, methodologically
sound analysis to better explore the identified associations,"
Aperovich, who wasn't involved in the study, said by email.
Based on the currently available data, both silicone and saline
appear safe, said Dr. Tomer Avraham, also of Yale.
"This issue, however, is not settled with 100 percent certainty, and
all types of surgery is associated with risks," Avraham, who wasn't
involved in the study, said by email. "Therefore, vigilance is
warranted."
SOURCE: https://bit.ly/2DKhfm7 Annals of Surgery, online September
14, 2018.
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