The Volokh Conspiracy - Silicone Breast Implants Back on the Market:

On Friday, the FDA lifted most restrictions on the sale of silicone breast implants, almost fourteen years after FDA chairman David Kessler ordered the implants off the markets, in a decision motivated by politics, not evidence.

Indeed, the end of the FDA ban marks the conclusion of what amounted to a massive scams. Political activists, politicians, trial lawyers, and media sensationalists joined forces to promote the view, wholly lacking in scientific support, that implants caused systemic disease. First, they claimed it caused cancer; when studies rejected that assertion, they claimed it caused immune system diseases; when that was debunked, they moved on to the claim that it caused "atypical" immune system diseases. The latter claim had the advantage of being very difficult to disprove, because no ever ever defined what these "atypical" diseases were. Nevertheless, the best evidence available rejects that claim, as well. It should be emphasized that there was never any sound scientific evidence supporting any of these claims; that didn't stop plaintiffs and their attorneys from collecting $10 billion or so in damages.

The victims of the scam included implant manufacturers (which, admittedly, were not exactly poster children for corporate responsibility) and their shareholders, such as the Dow Corning Corporation, which went bankrupt; women who, frightened by media reports about "dangerous" implants, had unnecessary surgery to explant their implants, or avoided pregnancy to prevent injury to their unborn children from "toxic" silicone; biomedical research, which for a time seemed in danger of collapse due to the phony claims against silicone implants--who would test and market any product to be used inside the body, much less one involving silicone, if invented claims with no scientific basis could result in billions of dollars of liability for breast implant manufacturers?; and public trust in the American legal system, which quite properly suffered severe criticism for doling out billions for no good reason.

Perhaps not surprisingly, I have seen no sign of contrition from any of the actors who were most responsible for the breast implant fiasco. For example, the Times reports that "Dr. Sidney Wolfe, chief of Public Citizen's Health Research Group, which claimed in the 1980s that breast implants cause cancer, called the implants "the most defective medical device ever approved by the F.D.A. The approval makes a mockery of the legal standard that requires 'reasonable assurance of safety.'"

You can read my review of the whole mess, including substantiation of what I wrote in the first three paragraphs of this post, in "The Breast Implant Fiasco," 87 California Law Review 457 (1999). An earlier version is posted at SSRN.

	[David Bernstein, November 20, 2006 at 1:56pm] Trackbacks Silicone Breast Implants Back on the Market: On Friday, the FDA lifted most restrictions on the sale of silicone breast implants, almost fourteen years after FDA chairman David Kessler ordered the implants off the markets, in a decision motivated by politics, not evidence. Indeed, the end of the FDA ban marks the conclusion of what amounted to a massive scams. Political activists, politicians, trial lawyers, and media sensationalists joined forces to promote the view, wholly lacking in scientific support, that implants caused systemic disease. First, they claimed it caused cancer; when studies rejected that assertion, they claimed it caused immune system diseases; when that was debunked, they moved on to the claim that it caused "atypical" immune system diseases. The latter claim had the advantage of being very difficult to disprove, because no ever ever defined what these "atypical" diseases were. Nevertheless, the best evidence available rejects that claim, as well. It should be emphasized that there was never any sound scientific evidence supporting any of these claims; that didn't stop plaintiffs and their attorneys from collecting $10 billion or so in damages. The victims of the scam included implant manufacturers (which, admittedly, were not exactly poster children for corporate responsibility) and their shareholders, such as the Dow Corning Corporation, which went bankrupt; women who, frightened by media reports about "dangerous" implants, had unnecessary surgery to explant their implants, or avoided pregnancy to prevent injury to their unborn children from "toxic" silicone; biomedical research, which for a time seemed in danger of collapse due to the phony claims against silicone implants--who would test and market any product to be used inside the body, much less one involving silicone, if invented claims with no scientific basis could result in billions of dollars of liability for breast implant manufacturers?; and public trust in the American legal system, which quite properly suffered severe criticism for doling out billions for no good reason. Perhaps not surprisingly, I have seen no sign of contrition from any of the actors who were most responsible for the breast implant fiasco. For example, the Times reports that "Dr. Sidney Wolfe, chief of Public Citizen's Health Research Group, which claimed in the 1980s that breast implants cause cancer, called the implants "the most defective medical device ever approved by the F.D.A. The approval makes a mockery of the legal standard that requires 'reasonable assurance of safety.'" You can read my review of the whole mess, including substantiation of what I wrote in the first three paragraphs of this post, in "The Breast Implant Fiasco," 87 California Law Review 457 (1999). An earlier version is posted at SSRN.