Corporate Interests Outweigh Women's Health
Posted by Parita Shah November 22, 2006
Biopolitical Times
The Food and Drug Administration (FDA) appears to have caved into corporate lobbying in its decision to lift a 14-year ban on using silicone gel breast implants for cosmetic purposes. The approval comes despite lack of safety data that the FDA itself had previously requested. The FDA decision has been strongly criticized by women's health advocates Amy Allina of the National Women's Health Network and Diana Zuckerman of the National Research Center for Women and Families, and by public health advocate Dr. Sidney Wolfe of the Public Citizen's Health Research Group.
In the New York Times, Dr. Sidney Wolfe 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.’ “
The FDA is allowing clearly unsafe procedures to move forward. The companies themselves warn women of the possibility of leaks & ruptures and the need to have regular MRIs to check for problems. MRIs are not cheap, and many insurance companies won’t pay for them because the breast implants are cosmetic. That makes it likely that many women who should be monitored won’t be.
Despite their call for MRIs, the companies that manufacture the implants reject the critics’ arguments that proper studies have not been done. The companies are calling for post-approval studies to ensure safety. Defending the decision to lift the ban, the director of the FDA's center for devices and radiological health, Dr. Daniel Schultz said: “We have been looking at this data continuously for the last 10 years. We have been watching as data had been collected, we have been watching as data has accumulated. We believe that from a scientific standpoint, the decision that we’re making tonight is, in fact, in the best interest of American women.”
Allina of the National Women’s Health Network said: “The F.D.A. has no credibility to assert post-approval studies will be any betterâ.... Once again, the F.D.A. is putting the interests of this administration’s allies, the economic interests of the industry, over public health.”
What’s more, the proponents are touting this victory as a triumph over ideology when in fact it’s quite the opposite. Dr. Richard A. D’Amico, president-elect of the American Society of Plastic Surgeons said: “For us, it’s a triumph of science.”
In the New York Times, Dr. Sidney Wolfe 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.’ “
The FDA is allowing clearly unsafe procedures to move forward. The companies themselves warn women of the possibility of leaks & ruptures and the need to have regular MRIs to check for problems. MRIs are not cheap, and many insurance companies won’t pay for them because the breast implants are cosmetic. That makes it likely that many women who should be monitored won’t be.
Despite their call for MRIs, the companies that manufacture the implants reject the critics’ arguments that proper studies have not been done. The companies are calling for post-approval studies to ensure safety. Defending the decision to lift the ban, the director of the FDA's center for devices and radiological health, Dr. Daniel Schultz said: “We have been looking at this data continuously for the last 10 years. We have been watching as data had been collected, we have been watching as data has accumulated. We believe that from a scientific standpoint, the decision that we’re making tonight is, in fact, in the best interest of American women.”
Allina of the National Women’s Health Network said: “The F.D.A. has no credibility to assert post-approval studies will be any betterâ.... Once again, the F.D.A. is putting the interests of this administration’s allies, the economic interests of the industry, over public health.”
What’s more, the proponents are touting this victory as a triumph over ideology when in fact it’s quite the opposite. Dr. Richard A. D’Amico, president-elect of the American Society of Plastic Surgeons said: “For us, it’s a triumph of science.”