2006P-0151
  

  
 Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC2
  



  

  
Submitter : 
  

  
Ms. Sybil Goldrich
  

  
Date & Time: 
  

  
06/27/2006 11:06:57
  



  

  
Organization : 
  

  
Command Trust Network
  



  

  
Category : 
  

  
Consumer Group
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 With the recent studies on platinum in silicone breast implants it is premature to approve breast implants.  No studies have been conducted to see whether or not silicone gel can pass through the placental barrier.  Criminal investigations of the manufacturers should be completed before any consideration of approval.  There should be another scientific panel with independent scientists to evaluate the data before approval is considered. The current "approvable" letter should be rescinded.  Manufactures should be required to present better follow-up data (currently they have a 90% loss to follow-up) before their products are considered.