medical doctrine based on the notion that every patient has a
right to decide what's going to be done to his or her body.
It requires doctors to inform patients of all the risks and benefits
connected with an operation or procedure. Patients must not only
be informed of such risks, they also must fully understand them.
–John Byrne, Author of Informed Consent
Do women make informed choices when they choose to get breast
implants? Years ago, when women like ABSOLUTLEY
SAFE character Audrey
Ciancutti, got breast implants the answer was clear—No,
Audrey and thousands of other women were not informed about implant
risks. For years, Dow Corning Corporation told women their implants
would “last a lifetime.” Today, however, manufacturers
have adjusted their marketing campaigns and openly acknowledge
risks, including potential rupture. But, does offering information
in ads mean there is informed consent? What is the responsibility
of physicians to explain risk? Does the information burden rest
solely on the shoulders of the consumer? In an age of pharmaceutical
mass media, questions about informed choices are not so clear
and the discussion is not so simple.
Every night on television, we see images of happy people who
feel “healthier and happier” from various wonder drugs.
At the end of the commercial, a soothing voice gives a laundry
list of potential risks and complications—diarrhea, cramping,
headaches, nausea, and insomnia have emerged as risks that almost
sound common and expected. The age of pharmaceutical advertising
campaigns in mass media has made people more familiar with medical
symptoms and ultimately desensitized people to the very idea of
medical risk. We have become anesthetized to risk.
After years of safety controversy, breast implant manufacturers
now include information about medical risks in all breast implant
advertising. While the safety information is often in fine print
on the opposite side of a magazine ad, the information about risk
is present. Implant manufacturers no longer hide the fact that
implants rupture and do not last a lifetime. Phrases like “the
health consequences of a ruptured silicone gel-filled implant
have not been fully established…Safety and effectiveness
have not been established in patients” are present.
Some breast implant ads even provide charts and graphs about
complications of asymmetry
and capsular contracture, providing numerous statistics
based on short-term
research. Troubling phrases, scary sounding conditions,
and unsettling numbers—this is all present in advertising.
Are women paying attention to this
In response to the safety controversy in the 1990s, the FDA created
a handbook on breast implant safety in 2004 called Breast
Implant Consumer Handbook. The handbook was created
by the Office of Women’s Health at the FDA and was written
as a response to the growing number of women filing “adverse
event” reports to the FDA about the failure of their implants.
Numerous groups of women were also requesting that the FDA require
more studies form breast implant manufacturers.
The Breast Implant Consumer Handbook reads like
a “cautionary tale,” listing pages and pages of potential
risks regarding breast implants. Although the handbook is available
online, many women do not even know about the handbook’s
existence. Doctors are not required to provide or even tell their
patients about the handbook. In a telephone interview with ABSOLUTLEY
SAFE director Carol Ciancutti-Leyva, an FDA representative
said that the FDA has no jurisdiction over what is said in a plastic
surgeon’s office and cannot mandate that doctors provide
a handbook to patients.
If the handbook were available to implant patients at doctor’s
offices, would women make the same choice? Would their level of
informed consent change?
In today’s medical marketplace, patients have become consumers.
The burden of informed consent rests on the shoulders of the patients
who, while shopping for their new look, may or may not choose
to research breast implant safety. Uncomfortable questions emerge
in this model—who is responsible for fully explaining and
discussing the risks with patients? Do plastic surgeons fully
explain the risks along with the benefits? When does risk outweigh
benefit? Who are the sources of the measured risks? How is data
being gathered and how is it presented? Do patients understand
the fine print manufacturers provide?