Risks of saline filled breast implants
There is a perception that saline-filled implants are less
risky than silicone implants. This may be due to the fact that if a saline implant
leaks, only saline or salt water would be leaked into the body, as opposed to silicone
gel, a "foreign" substance. Studies are being conducted; however, to determine
what risks may be associated with even saline-filled implants. More information about this
study is available at the FDA site (http://www.fda.gov/cdrh/breastimplants).
Much attention has been focused, by those apparently against
implants, on reports about the possibility of saline allowing the growth of bacteria
inside implants. On an episode of the Jenny Jones show in 1998 (Jones had recently
had her implants removed), and in a Fall 2000 Glamour Magazine article, slimy breast
implants with brackish material in them were highlighted as examples of the danger of
fungus growing inside of saline implants. The issue apparently arose after an article
entitled "Microbial Growth Inside Saline-filled Breast Implants" by V. Leroy
Young, M.D., and others, appeared in the Journal of Plastic and Reconstructive Surgery in
July of 1997 (Vol. 100, Number 1, Page 182).
According to the study, if bacteria are allowed into the implant,
otherwise sterile saline could potentially support the growth of such bacteria as staph,
e-coli and others. The in vitro study found that sterile saline in flasks, when injected
with bacteria, could support the growth of those bacteria in a flask. In the in vivo
study, they implanted 61 white rabbits with two implants each, one with sterile saline
only and one, which also had a test organism, inoculated into the saline of the implant,
such as staph, e-coli, etc.
Not surprisingly, the sterile saline implants did not show any
bacteria after 1, 3 or 6-month intervals whereas the inoculated implants did. In other
words, where there were no bacteria to begin with; there was none after six months.
Bacteria, which they purposely put in, could survive. Short story: Make sure you go to a
reputable doctor and find out how they take steps to insure that you receive a sterile
implant with sterile saline and that no contamination can take place.
Another study by Young found bacteria in a woman's implant that had
severe contracture and was removed after 14 months. He concluded that bacteria can survive
in the implant but no one seems to know how bacteria would be introduced unless
contamination occurred while filling the implant by the doctor, or there was a fault in
the implant valve. Based on the lack of many studies or findings, this seems to be a long
shot risk but one worth discussing.
In July of 1999, the Institute of Medicine of the National Academy
of Sciences, reported that, after exhaustive review of all of the studies that have been
conducted to date, they found no correlation between having breast implants, including
silicone, and the myriad diseases claimed to be caused by implants during the scare since
1990. These include autoimmune disorders, breast cancer, lupus, scleroderma, chronic
fatigue syndrome and others. The IOM report is about 455 pages long but well worth
reading. A condensed version is also available.
Due to concerns about the safety of even saline-filled implants
(which also have a silicone elastomer shell), manufacturers of saline-filled implants
conducted studies as requested by the FDA. In March of 2000 the FDA convened an
advisory panel to hold a public hearing at which time the PMA (pre market approval) filing
of the manufacturers was formally reviewed and considered by the panel. I spoke at
the panel on behalf of myself and all women who wanted breast implants. The FDA gave
approval to two manufacturers of saline implants - Mentor and McGhan - in May of 2000 to
continue marketing saline implants in the U.S. Both manufacturers now provide all of
the study results in a condensed format, on the inserts that come with each set of
implants. Read them online at the FDA website but also ask your doctor for a copy of
yours.
Anti-silicone groups have found fault even with the above studies,
apparently adding The National Academy of Sciences' Institute of Medicine and the FDA to
the list of what anti-silicone groups claim is a huge conspiracy to make money through
breast implants at any cost, including the lives of women. A little far-fetched, it
would appear. The National Academy was created by the federal government to be an
adviser on scientific and technological matters. Studies undertaken for the
government by the Academy complex usually are funded out of appropriations made available
to federal agencies. Most of the studies carried out by the Academy complex are at the
request of government agencies. The IOM's implant report was commissioned by
Congress through the U.S. Department of Health and Human Services.
