Media Myth: Nine Worst Business Stories
(of the Last 50 Years)

5. Silicone Breast Implants
 

     “Most of us know little about breast implants. We’ve seen the ads. We’ve heard the rumors about which celebrities have them and which don’t. But we don’t know anything about the dangers,” Chung said in the introduction for her segment.

     On her CBS show “Face to Face” Dec. 10, 1990, Chung featured five women who claimed to be victims of faulty silicone implants. According to the women, their implants had leaked into their body tissue, causing what one woman called “silicone-associated disease.”

     Chung noted that one of the women, Karen Bollea, suffered from achy joints, extreme fatigue, hair loss and skin rashes, among other symptoms. Chung also noted that Bollea would later be diagnosed with Lupus, a disease with symptoms including achy joints, extreme fatigue, hair loss and skin rashes. Chung implied that that symptoms were caused by Bollea’s implants.

     “We have done a large-scale clinical experiment on an unproven, probably unsafe medical device,” Dr. Douglas Shanklin of the University of Tennessee said in the report. Chung displayed graphic images of “mangled and infected” breasts, the result of multiple surgeries to replace and remove implants.

     The segment featured five women and two doctors who alleged that silicone was connected to tissue disease. She noted that Surgitek, the maker of a silicone implant, and the Food and Drug Administration both declined to comment. About 26 seconds of the more than 12-minute segment focused on their side of the story.

     The Food and Drug Administration was already investigating complaints about silicone implants, according to Chung. But her report led to increased attention to the research as well as congressional investigations.

     The FDA banned silicone implants in April 1992 when it said manufacturers couldn’t come up with enough proof that they were safe. But the ban applied only to cosmetic implants. Women who had undergone mastectomies could still obtain them. The decision implied that the FDA didn’t consider silicone so dangerous that it warranted a full ban.

     On Nov. 17, 2006, the FDA lifted the partial ban on silicone, calling the implants “safe and effective.” The agency reported that some complications existed in studies of the implants but that “the majority of women in these studies reported being satisfied.”

     “In the past decade, a number of independent studies have examined whether silicone gel-filled breast implants are associated with connective tissue disease or cancer,” the agency said. “The studies, including a report by the Institute of Medicine, have concluded there is no convincing evidence that breast implants are associated with either of these diseases.”

     In the time between Chung’s “Face to Face” report and the FDA deeming the implants safe, however, businesses were on the chopping block. A “flood” of lawsuits followed the ban, according to a June 1996 article in the New England Journal of Medicine. One Texas woman received a $25-million settlement. NBC later reported that “thousands of women won billions of dollars in lawsuits.”

     Dow Corning, a major manufacturer of silicone implants, filed for bankruptcy in 1995 as a result of the overwhelming number of lawsuits. It didn’t come out of bankruptcy until nine years later, in June 2004.

     And while women who had lost breasts to mastectomies were allowed the implants during the FDA’s 14-year testing period, women who wanted the products for cosmetic reasons faced tough restrictions, despite FDA surveys showing a majority of women wanted them on the market with knowledge of potential risks.

     Even after the FDA exonerated silicone, the media couldn’t let go of the myth that it was widely dangerous. NBC anchor Brian Williams reported on Nov. 17, 2006, that “a lot of people are going to have a hard time with the government blessing for this particular product, being a foreign substance being sewn inside the bodies of women.” He didn’t mention other “foreign substances” sewn into patients’ bodies routinely, like pacemakers.

     While the FDA statement clearly said there was “no convincing evidence” that implants were dangerous, Katie Couric declared in a Nov. 17, 2006, “CBS Evening News” report that “there are still safety concerns.”

     The Washington Post led its November 18 story saying the ban was lifted “despite lingering safety concerns from some health advocates.” The “health advocates” were Diana Zuckerman, president of the National Research Center for Women and Families, and Susan Wood, a former FDA official who, ironically enough, quit in 2005 because the agency took too long to approve the “Plan B” morning-after pill. It appeared that to Wood, 14 years of study weren’t enough to prove silicone was safe, but Wood was willing to quit her job because the FDA wanted more than two years to study Plan B’s safety.

     The New York Times at the same time quoted Dr. Sidney Wolfe of the anti-business, pro-regulation Public Citizen, who insisted that implants were “the most defective medical device ever approved by the FDA.”

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