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1st
appeared 28 June 1999
UCSF Faculty Played Major Role in Implant
Safety Report
 Two women's health experts from UCSF were members of the Institute
of Medicine committee that last week issued a report finding that silicone-based breast
implants do not cause life-threatening systemic diseases. Virginia Ernster, professor and
vice-chair of epidemiology and biostatistics in the School of Medicine, and Diana Taylor,
associate professor in the department of family health care nursing, brought their
expertise to this high-profile endeavor.
Although the committee could not find definitive evidence linking breast implants to
systemic diseases, such as cancer, rheumatoid arthritis, lupus and scleroderma, they did
find that silicone implants commonly cause specific local complications.
"I think that the bottom line of the report is a bit of a mixed message," says
Ernster, who served as vice-chair of the IOM committee. "We concluded that the
evidence did not indicate an increased risk for cancer and connective tissue diseases. On
the other hand, we were impressed with the relatively high frequency of local
complications."
Breast implants can cause the surrounding fibrous tissue to contract, which can distort
the appearance of the breast and cause pain, Ernster explains. Implants can also rupture
or deflate, causing cosmetic problems that may require an operation to correct.
"We feel it's very important that women who are contemplating having an implant
recognize that chances are it will not last a life time," says Ernster. "The
panelists estimate that up to a quarter of women might have to have re-operations within
three to five years of having a silicone gel implant."
The 13-member committee reviewed existing literature and did not conduct new research.
However, they held a three-day session last July which included testimony and
presentations from independent and industry scientists, as well as from women who
attributed their illnesses to breast implants. Although the committee heard this evidence,
their final report was overwhelmingly based on published peer-reviewed literature, Ernster
says.
The committee did urge that a national model of informed consent be developed for women
undergoing breast implantation that would include information on the likelihood of local
complications. They also suggested that the effectiveness of this model be monitored and
that the long- and short-term effects of implants be tracked.
The committee focused primarily on silicone breast implants because they had been
available from the 1960s through 1992, when the FDA issued a moratorium on silicone
models. Since that time, most implants have been filled with saline, with a silicone
exterior shell, Ernster says. The panel estimates that 1.5-1.8 million women in the US had
breast implants as of 1997.
"Because the experience with a large number of saline implants is so new, it will be
important to see whether our findings can be extrapolated to saline," Ernster says.
"There is no reason to expect the findings would be any worse because saline is a
harmless solution. However, there is probably a greater chance of deflation and, because
the shell of saline implants is made of silicone, there will probably be some of the same
issues of rupture and contracture."
Ernster and Taylor were appointed to the IOM committee in the Spring of 1998. The
committee had their first meeting in April of that year and met several more times --
including once at UCSF -- up until the committee's findings were made public on June 21.
"The IOM wanted to be sure that this committee was composed of individuals without
conflict of interest, people who hadn't worked for one side or the other of this issue,
and people who had methodological expertise in various fields," says Ernster, who was
selected for her expertise in epidemiology.
Ernster, who serves as associate director for epidemiology prevention and control of the
UCSF Cancer Center, also leads a large National Cancer Institute (NCI)-funded project to
establish a computerized population-based mammography registry for San Francisco that is
designed to increase knowledge of mammography practice and outcomes. She is also the
senior scientific editor of the upcoming Surgeon General Report on women and smoking.
Ernster has served on many NCI committees and currently serves on their Board of
Scientific Advisors.
Taylor, who was selected for the IOM committee for her expertise in women's health,
conducts research on the health of women across their lifespan. Taylor's research has
focused on perimenstrual (around periods) symptoms and how those symptoms can be dealt
with from a biopsychosocial approach. Taylor also serves as co-director of the Center for
Collaborative Innovation in Primary Care, and has been active on several national
organizations, such as the National Women's Health Network since 1979, the Society for
Menstrual Cycle Research since 1984, the NIH Menopause Research Agenda panel since 1992,
and the IOM National Research Council since 1993. Taylor has been on the nursing faculty
at UCSF since 1989.
Links:
IOM
press release on report
Summary "Safety of Silicone
Breast Implants" report
"Information for Women about the
Safety of Silicone Breast Implants" (IOM)
Ernster biosketch
UCSF School of Medicine
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