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 breast implants?

• 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’
studies?

• Are studies that are based on self-reporting accurate?

• Does a study that does not distinguish among different types and brands of implants have merit?

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.” The FDA has a comprehensive list of these complications.

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.

What the Professionals Have to Say

“This is a safe bio-material that reputable, ethical, board certified plastic surgeons are placing
into individuals who want a well performed operation. Every scientific study that’s done by
Mayo, by Harvard, by the plaintiff’s attorney own judge shows it’s a safe implant.”
– Dr. Franklin Rose

“I think that the science on the implants has been so discouraged from actually being undertaken
in a coherent and realistic fashion that we really don’t know much about these advices at all.”
–Dr. Michael Harbut

“There were only about seven studies done on women prior to 1999. Virtually all of them
were funded by Dow Corning, as is the Mayo Clinic study and the Harvard study, funded by
Dow Corning. Generously funded, I might add. Those studies and other studies done by
Dow Corning have certain fundamental scientific flaws. They look at small numbers of
women, who’ve had breast implants for short periods of time…’
–Diana Zuckerman, National Research Center for Women & Families

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