||Is there a debate?
What is the debate?
ABSOLUTELY SAFE raises
questions about the quality of safety data that has been gathered
on breast implants. The Food and Drug Administration, the Institute
of Medicine (IOM), implant manufacturers, and the vast majority
of plastic surgeons believe that the data collected in numerous
studies on breast implants does not prove a link between implants
and systemic illness. However, some health experts believe that
studies conducted by manufacturers and used by the FDA are severely
flawed and misleading.
The data debate is complex and involves disputes over multiple
variables of research. Here are some essential questions to consider
when reviewing breast implant safety studies:
• Who paid for the studies on
• Can breast implant manufacturers
bring an objective eye to their studies?
• How long were the women in
the studies followed?
• Why have no long-term studies,
following women who’ve had breast implants for at
least 8 years, ever been conducted?
• How many women were included
in the studies done by manufactuerers?
• Why were women who removed their
implants dropped from many studies?
• Why have few studies on breastfeeding
women with breast implants and their
babies ever been conducted?
• Why have so few breast cancer
patients been included in the manufacturers’
• Are studies that are based on self-reporting
• Does a study that does not distinguish
among different types and brands of implants have
Short-Term vs. Long Term Research
One of the most important variables that affects breast implant
safety data is TIME: How long has
a woman in a study had her breast implants? For how long has this
woman been studied?
According to the IOM, the risks of local complications
such as capsular contracture, breast pain, rupture, and
deflation “accumulate over the lifetime of the implant.”
FDA has a comprehensive list of
Therefore, the number of years an implant has been in a woman’s
body is of utmost significance when analyzing risk, especially
rupture rate. Studies should cover long periods of time because
the chance of breast implant rupture increases with each year
the implant has been in the body, and some believe that the chance
of illness may increase with rupture.
However, over the years, manufacturers have presented
short-term research to the FDA to gain approval of both
saline and silicone breast implants. Typically, these studies
have only followed women who have had implants for 3 to 4 years.
Given that often it takes several years for the adverse effects
of implants to develop, a study that only follows women for 4
years, rather than 10 to 15 years, will draw more favorable conclusions
about safety—less time means fewer complications, lower
rupture rates, and less potential for illness.
Critics of the manufacturers’ data presented to the FDA
to gain approval maintain that the current short-term research
is misleading and incomplete. Rather, they say,
long-term research, research that follows women who have
had breast implants for longer periods of time, is essential in
evaluating breast implant safety.