by Fred Facker, staff writer
The 1960 Sun, March 7, 2001
Women suffering from breast implant-related illnesses or trying to determine
what treatment to seek for breast reconstruction or augmentation have a
wealth of information and advice available to them through a support group
formed by women from the northwest Houston area who have gone through the
Meeting the second Thursday of every month, the United Silicone Survivors of
the World breast implant support group, led by Marlene Keeling, works to
find independent information and studies on the true effects of breast
implants, and helps women who believe they have illnesses caused by implants
to stay informed of new treatments.
"Surgeons downplay the risks of breast implants when women are considering
them for augmentation or reconstruction. They only show pictures of the
positive outcomes, never of the complications they may arise," Keeling said.
"A lot of people don't know that even though silicone gel implants were
classified as a class III device by the FDA in 1988 due to reports of
adverse events, the manufacturers have never proven them to be safe. After
a brief moratorium in 1992, the FDA declared gel-implants a 'public health
need', and put them back on the market without FDA approval as
'investigational' devices. And saline-filled implants, despite a 95 percent
complication rate (occurring) at five years, were approved because after
three years a significant percentage of the women studied reported
satisfaction with the product."
According to Keeling, the most common side-effects of breast implants that
she's encountered through the support group are chronic fatigue and
"Fatigue sets in slowly, so it's hard to link it to the implants. But it's
showing up in a lot of women (with implants)," she said. Keeling also said
that children born to mothers who had implants are now being studied for
high levels of toxic and hypersensitizing platinum which may explain many
unusual symptoms being reported in these children.
After research, initially by Baylor College of Medicine and ultimately by
ExperTox, Inc., has shown that silicone implants leak reactive and possibly
toxic platinum, Keeling has submitted Citizen Petition 00P-1607/CP1 to the
U.S. Food and Drug Administration (FDA) in an effort to stop the use of
silicone gel in breast implants. She is also working with United States
Congressman Gene Green to introduce legislation titled "The Silicone Breast
Implant Research and Information Act" asking for independent research on
this women's health issue.
The petition as written, requests that the commissioner of FDA revoke the
implantation of silicone gel-filled breast implants for any reason, in light
of new research documenting the significant release of platinum in a
reactive valence from intact implants.
"Platinum was used as a catalyst to change the silicone oil into silicone
gel. Although the manufacturers claimed all platinum was removed or
remained in its purely elemental form, test have shown that forms of
platinum from platinum 1 to platinum 6 leak from the implants (into the
body)," Keeling said.
The research from Baylor College of Medicine discovered that leakage
greatest in a lipid-rich environment, and that, in such an environment could
potentially lead to significant platinum accumulation within lipid-rich
tissues such as the breasts, brain and reproductive organs.
"While women can remove their implants, there is no way for them to end the
experiment and remove the platinum-cyclosiloxane complexes when it spreads
to all parts of their bodies," Keeling wrote in her petition.
"A lot of women also don't realize that some insurance companies won't carry
you or will charge higher rates, if you have breast implants. Some
insurance companies might carry you, but not pay for medical treatments
stemming from the implants. Women should know to check into these things,"
Women interested in finding out more about the risks and diseases related to
breast implants or the surgical methods used with implants can visit the
FDA's home page at www.fda.gov/cdrh/breastimplants or can call 281/350-9278
for more information on the United Silicone Survivors of the World breast
implant support group.