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Silicone on Trial– An Updated History

by Jack Dini

Twenty-five years ago from this coming December marks the anniversary of the famous Connie Chung diatribe against breast implants reports Dr. Jack D. Fisher, a surgeon and professor emeritus of surgery at UC San Diego, in his new book Silicone On Trial. (1)

He says,” What CBS and the Face to Face team achieved that night was a new low for one-sided fearmongering journalism. Millions of viewers, some of them with breast implants and many more with other silicone exposures, experienced a tsunami of terror. Ms. Chung and her producers had followed the lead of a single consumer activist, Sybil Goldrich, who had hand-picked the victims and the corroborating ‘experts.’ Chung’s report began with an unproven conclusion: breast implants are untested and therefore dangerous. The images and copy were assembled to support that position.”

Refuting this, the book provides a very detailed history—backed by many references—of a public health travesty that never should have happened in the first place. The books speaks to more than this one incident. It tells the story of a legal system that is badly broken and also provides an excellent discussion on the subject of chemophobia, the fear of chemicals and our concerns about chemicals and cancer.

Larry Schmidt observes, “The book is a tour de force of unfortunate events over more than two decades caused by unscientific minds in powerful positions. Those events led to profound, unnecessary and lasting damage to an industry and many individuals. The view was so distorted that most of us were profoundly misinformed. Many remain so.” (2)

The battle resulted in unnecessary high anxiety for women who already had the implants, loss of proper care for women needing or desiring implants and payment of outlandish financial settlements for baseless injury claims.

The scientific studies that demonstrated the safety of silicone in humans were many and available before and after the men in and around the FDA began the unscientific charges that silicone breast implants caused cancer and other diseases. They ignored the published science. The book reminds the reader how the media and people in power can profoundly mislead the public. (2)

Then by the time the Institute of Medicine granted its 1999 pardon to the embattled breast implant, a decade had passed since Public Citizen’s Sidney Wolfe issued his dire prophecy: an epidemic of cancer afflicting thousands of unsuspecting women harboring the devices. Allegations of more than two hundred silicone-induced symptoms or illnesses followed his unsubstantiated warning. During the years that followed, no such plague ensued nor was any illness linked to silicone exposure. In the meantime, more than eleven billion dollars (fifteen billion in today’s dollars) were spent by medical device makers to preserve their commercial viability and appease the fugitive demands of America’s litigation industry. Three manufacturers of breast implants had either declared bankruptcy or discontinued their medical products lines, while four major corporations with device subsidiaries terminated their engagement with silicone medical products. Implantable device innovation in America had nearly come to a standstill, and for the first time silicone product development gained traction in Europe and Asia.

In 2006 silicone gel breast devices received approval and request for implantation reached three hundred thousand a year. Demand for implants following the 1992 moratorium call had plunged 60 percent from one hundred and fifty thousand implanted during 1991. Remarkably, the 80:20 ration of cosmetic to reconstructive procedures has remained constant. For patients with breast cancer treated by mastectomy, reconstruction rates as high as 70 percent are reported.

As Fisher notes, however, “Less fortunate are the women who suffer genuine rheumatic illness and are still led to believe their symptoms evolve from silicone exposure. Not even thirty consecutive studies that disprove a causal link, nor thirty more, are likely to change their convictions.”

Researchers have shown the inability of facts to change people’s minds, how and why they cling to their beliefs despite evidence to the contrary, and how the unparalleled amount of information that we are now exposed to contributes to this. In other words, it’s never been easier for people to be wrong, and at the same time feel more certain that they’re right. This is only heightened by the information glut, which offers alongside an unprecedented amount of good information—endless rumors, misinformation, and questionable variations on the truth. (3) All of this applies in spades to the silicone issue.

In the end, after 328 pages and 431 references, Fisher says, “While I can hope this book might provide comfort for all prior recipients, I am more likely to inform and thus reassure those who seek implantable silicone devices for the first time.”

Josh Bloom sums this up well, “Mix the following in equal quantities: junk science and medicine, a misguided and politically-driven regulatory agency, a flawed legal system, predatory trial lawyers, a self-anointed know-nothing consumer ‘advocate’, greed, and a company with deep pockets, and voila: the perfect mix. This was done 30 years ago at the expense of Dow Corning, the largest maker of silicone breast implants. What happened to the company and its employees was nothing short of criminal. And, because of a mind boggling scenario that borders on something from The Twilight Zone, it is still going on—long after implants were not only declared safe, but were returned to the market.” (4)

Jack Dini

References

1. Jack C. Fisher, Silicone on Trial, (The Sager Group LLC, 2015)
2. Larry Schmidt, “Physician do no harm trampled,” amazon.com, March 7, 2015
3. Joe Keohane, “How facts backfire,” boston.com/bostonglobe, July 11, 2010
4. Josh Bloom, “Silicone on trial: bastardization of justice,” science2.0.com, February 20, 2015

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