Breast implant legislation neither "scientific" nor "fair"




As Reagan famously said to Carter in one of the 1979 presidential debates, "There you go again!"

Uber-liberal congresswoman, Rep. Rosa DeLauro (D-CT) (pictured at right), recently reintroduced her "FDA Scientific Fairness for Women Act" in the US Congress legislative docket. If you'll recall, last year Rep. DeLauro went out of her way (read here) to try and bully the FDA into ignoring both their own expert panels and unanimous international consensus when the final stages of FDA bureaucracy was being reached on reintroducing silicone breast implants (SBI) for cosmetic surgery indications in 2006. Now that Democrats have replaced Republicans as the crooks in charge and she has some actual political power, she apparently misses the irony when she claims her bill would take politics out of the FDA approval process?????

If passed, the bill would rescind the 2006 FDA approval for SBI's and create an impossible gordian knot standard for ever proving safety to her satisfaction. Keep in mind, the next generation of cohesive gel ("gummy bears") implants (which aren't even being debated about in this issue yet) are sitting poised for approval and would be even further from clinical use despite strong evidence of their superior performance and rupture rate data to currently used devices ("4th generation" implants).




Alexander cuts the Gordian Knot, by Jean-Simon Berthélemy (1743–1811)


Rep. DeLauro and the fringe cadre of anti-implant activists she associates with, live in a parallel bizarro-world universe in which SBI weren't (according to the FDA) the most extensively studied medical device in the history of the world. In contra-distinction to information contained in the text of the bill, we arguably know more and have more data about how SBI's (or silicone in any device for that matter) behave then any other implantable material in existence. Within the last few years, we have more then half a dozen studies (also here, here, here, here, & here) turning in outcome data on patients approaching two decades out in some cases from surgery with implants similar to what's currently manufactured.



In point of fact, there are already existing FDA clinical trials collection long-term outcome data on the issues Rep. DeLauro is demanding answers to. However, the activists she has allied herself with have no wish to actually let prospective information continue to accrue and be analyzed (We already have mountains of retrospective data on these issues which do not support their POV) . They are so convinced that SBI are toxic that they will use any means neccessary to achieve their political agenda.



There are legitimate issues still to be better characterized with SBI's

  1. What's the rupture rate in modern implants beyond a decade? (we have a good idea at around a decade it's ~ 6-8% with contemporary devices)


  2. How do you reduce reoperations relating to complications (not cosmetic issues)?


  3. Are there things we can do to reliably reduce capsular contracture (hardening of the implant)?


  4. What is an evidenced-based way to recommend MRI studies to screen for rupture? (Currently the FDA's "cover their ass" position of frequent MRI's is illogical)


  5. Is the superior performance of 5th generation cohesive gel SBI's compelling enough to abandon older device styles? (softer, round, & smooth surfaced)

Rob

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