The FDA has put silicone breast implants back on the market. But journalists, who hyped the implants’ dangers more than a decade ago, have shown they’re not convinced.
“Given the history of this product, I think 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,” said NBC anchor Brian Williams on the Nov. 17, 2006, “Nightly News.”
Some will disagree with the FDA decision, especially if they listened solely to the biased media coverage of the implants during the early 1990s as fears first arose about their safety. But others have said science has finally won the debate on silicone breast implants.
In a recent article, Dr. Gilbert Ross, medical and executive director of the American Council on Science and Health, described the FDA’s decision as a “welcome development to those of us who believe that regulatory decisions should be based on science, rather than activist hype.”
Throughout the early 1990s, media hyped the unproven dangers of implants by including dramatic examples, not identifying activists, and excluding relevant opinions. In 1992, FDA banned the implants except in controlled studies so that their safety could be examined. Years later, multiple scientific studies would show no connection between cancer and autoimmune diseases and the implants.
Face to Face with Bias
One of the most memorable one-sided stories was a segment on CBS’s “Face to Face with Connie Chung,” which warned only of dangers during a Dec. 10, 1990, broadcast. “But what’s shocking,” Chung warned, “is that these devices have never been approved by the federal government. Only now is the government looking at the dangers. But for some women, it may be too late.”
The segment included four women who believed their medical problems stemmed from their silicone implants and one doctor who agreed with them.
“We have done a large-scale clinical experiment on an unproven, probably unsafe medical device which is placed inside the body where the body can react to it,” said Dr. Douglas Shanklin of the University of Tennessee Health Science Center during the show.
Chung’s story did not include anyone satisfied with silicone implants, despite the fact that 2 million women had breast implants at that time, including many who had reconstruction after a mastectomy. The story also left out any doctors who disagreed with Dr. Shanklin, or representatives of the implant manufacturers.
Other newsmagazine shows like CBS “Street Stories” on Dec. 10, 1992, and “48 Hours” on June 3, 1992, also offered tear-jerking stories of people dealing with real medical problems, but with little scientific balance.
In a 12-minute segment on “Street Stories” there was only one person, plastic surgeon Dr. Scott Spear, who disagreed that there was a cause-and-effect relationship between medical problems and silicone breast implants. But a woman with an implant concerned about her two children’s medical problems, Dr. Shanklin, an attorney, a pediatrician and several other women all supported the idea that silicone implants caused illness.
Occasionally, reports included a comment from someone happy with their implants.
“And it gives you such a sense of well-being that you’ve been able to defeat the cancer and continue to have the quality of life that you had before,” said implant recipient Rosemary Locke during CBS “This Morning” on March 20, 1992.
Others had them for cosmetic reasons like Lyn McCain. “I’m also one of those vain women who chose to have bilateral augmentation and I’m proud of it. There’s a huge boost on your self-image, your body image, your sexuality, your femininity,” she said on Nov. 13, 1991 CBS “This Morning.”
However, opinions like Locke’s and McCain’s weren’t always presented. Instead, multiple opponents of silicone breast implants were quoted without an alternate viewpoint.
This happened during a two-minute CBS “This Morning” segment on April 17, 1992, following the FDA’s decision to ban the implants. Correspondent Edie Magnus included quotes from two implant recipients who said implants are harmful. Magnus also left out any reaction from Dow Corning, the leading manufacturer of silicone implants, or from the other companies in the business.
Dow Corning, Bioplasty and Bristol-Myers Squibb left the silicone breast implant business in March of 1992. Legal settlements, which are still being paid, drove Dow Corning into bankruptcy in 1995.
Expert or Activist?
Beginning in the 1980s, Ralph Nader’s pro-regulatory group Public Citizen began warning that silicone breast implants could cause cancer and called for them to be taken off the market.
“There are probably a million and a half women in the country with these implants and hundreds of thousands of them have suffered significant injuries,” Dr. Sidney Wolfe of Public Citizen said on “World News Tonight with Peter Jennings” in 1991.
But instead of being identified as an activist, Wolfe was identified only as a member of a “consumer group” in that segment. Earlier, on Nov. 9, 1988, Wolfe was referred to as a “consumer advocate” on ABC’s “World News Tonight.”
Implants Unconnected to Diseases
As a result of fears about silicone implant safety and alleged connections to disease, the Food and Drug Administration banned the implants in April 1992, except in controlled studies for women in need of breast reconstruction. The FDA continued to investigate silicone implants and research their safety until Nov. 17, 2006, when it announced it was approving them for the market.
“The silicone breast implant is one of the most extensively studied medical devices. We now have a good understanding of what complications can occur and at what rates,” said Dr. Daniel Shultz, director of the FDA’s Center for Devices and Radiological Health, in the announcement.
Dr. Ross of the American Council on Science and Health said it’s about time the FDA listened to the science about silicone breast implants instead of bending to “accommodate political and media-driven pressures.”
“For most of us involved in public health, the scientific debate on SBI’s ended in 1995, when several large studies were published confirming the lack of association with systemic diseases, including auto-immune disease and cancer. Finally, the Institute of Medicine of the National Academy of Sciences issued a definitive report in 1999, absolving silicone implants entirely,” Ross wrote in a November 20 column published in the American Enterprise Institute’s new magazine, The American.
The FDA is requiring that manufacturers Allergan Corp. and Mentor Corp. each study 40,000 implant patients for a 10-year period. It has also set an age requirement of 22 for silicone implants.
The agency also cautioned that ruptures can still occur, that women should get regular MRIs to check on the implants, and that replacement implants may be required for some patients. Studies “have concluded there is no convincing evidence” that the implants are “associated with connective tissue disease or cancer,” said the FDA.
In his column, Ross said media pressure contributed to fears about silicone implants and helped lead to the 1992 ban from the marketplace.
It certainly contributed to fear among women. “Since all this has been coming through the media, it’s like every little cramp, every little pain, every little headache I have, I think, ‘Oh, my God, I wonder if it’s because of the silicone,’” said Susan Mann, a “Houston businesswoman” who had silicone implants for 10 years before appearing on ABC’s “Nightline” on Jan. 13, 1992.
2006, a little better, still not great
While silicone breast implant stories in 2006 immediately following the FDA reversal were significantly better than hyped coverage leading up to the 1992 ban, they still weren’t great.
On NBC, anchor Williams’ opinion marred an otherwise balanced and insightful report by Robert Bazell, which included relevant information generally missing from 1991-1992 segments.
“We have to remember that this is an elective procedure, and the FDA’s position is that women need to understand the risks and benefits to these products,” Bazell said. “They have to be closely monitored …That [ruptures] can be very unpleasant, but in the studies of these two products, it occurred in about 1 or 2 percent of the cases, Brian.”
In 1994, the Business & Media Institute newsletter MediaNomics analyzed network coverage of silicone breast implant coverage during January 1992 – after the FDA moratorium, but before the April 1992 ban. The analysis found that coverage of implants was significantly more balanced than news coverage of the 1989 Alar scare [when the media hyped the threat of a chemical used on apples] and that morning shows did interview experts and activists in favor of silicone breast implants at least as often as they interviewed the opposition.
Still, the report found that "there were many alarmist stories which graphically portrayed women with illnesses without pointing out that those could have been (and, as it turned out, were) isolated cases. Reporters also ravaged implant manufacturer Dow Corning." It included a June 15, 1994, quote from Peter Jennings that showed media coverage had been overly hyped: "today comes a serious study which says the earlier fears may have been exaggerated."