Audrey tells the 2003 FDA Advisory Panel that she did not have an informed choice about her implants.

“There was no negative information given to me at the time to say that they could affect my health in any way.”
– Audrey Ciancutti



Breast cancer survivor Anne Stansell testifies at the 2005 FDA Advisory safety hearings. She tells the panel that she did not make an informed choice about her implants because she didn’t know breast cancer patients with implants had never been fully studied.

“The part that angers me the most is that we weren’t given all the facts. Had I known all the facts, I would have made an intelligent decision.”
– Anne Stansell

 

INFORMED CONSENT-A 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 safety information?

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?