2006P-0151
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC14
  



  

  
Submitter : 
  

  
Ms. Connie Schaefer
  

  
Date & Time: 
  

  
06/29/2006 02:06:07
  



  

  
Organization : 
  

  
Ms. Connie Schaefer
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 FDA should ask a government agency such as the CDC or the National Institute of Environmental Health Study (NIEHS) to conduct a study of a large number of women who have had silicone gel breast implants for at least 10 years. The study should focus on women with leaking silicone implants, and evaluate the amounts of platinum salts in their blood, urine, hair, nails, and breast milk. The women's sensitivity to platinum should also be studied, as well as their health. The FDA should not consider approving silicone gel breast implants until this study is completed.