FDA Imposes One-Size-Fits-All Ban on Breast Implants

FDA Imposes One-Size-Fits-All Ban on Breast Implants

Agency’s “Pathway for Approval” is in Fact a Roadblock
January 08, 2004

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Jody Clarke, 202.331.2252



<?xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" />Washington, D.C., January 9, 2004—The Food and Drug Administration’s decision to continue its ban on silicone breast implants demonstrates one thing—for all its talk about empowering patients, FDA hasn’t changed its heavy-handed “we-know-best” approach to practicing medicine.  In denying Inamed’s breast implant application, FDA rejected not only the findings of its own expert panel, but the conclusions of numerous studies, such as the Institute of Medicine’s 2000 breast implant report.


“FDA characterizes its issuance of new guidelines as a ‘pathway for sponsors seeking approval’.  In fact, the new guidelines are a roadblock,” said Sam Kazman, general counsel at the Competitive Enterprise Institute.  “Whether any sponsor ever succeeds in satisfying them is questionable; what’s unquestionable is that, for now, patients continue to be barred from seeking implants that they and their physicians judge best.  The fact that FDA is still issuing guidelines more than a decade after its original ban shows that it’s still spinning its wheels.”


In CEI’s view, any concerns that the agency has concerning silicone implants could be better addressed through mandated warnings and disclaimers, rather than an outright ban.  Such an approach would allow patients and doctors to make their own decisions, rather than be subjected to an across-the-board veto by an agency that knows nothing of individual patient needs and circumstances.


A series of CEI medical specialist polls show that most doctors view FDA as being too slow to approve new drugs and devices.  FDA’s latest decision indicates that the agency hasn’t changed its ways.