2006P-0151
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC6
  



  

  
Submitter : 
  

  
Ms. Ruby Rahn
  

  
Date & Time: 
  

  
06/29/2006 02:06:00
  



  

  
Organization : 
  

  
MDRC
  



  

  
Category : 
  

  
Device Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I would like the FDA to stay the current approval letter and all Premarket Application for silicone gel-filled breast implants (SGFBI) until studies on platinum levels in women who have had SGFBI are conducted. 



The lack of research on platinum is an example of the unknown risks of breast implants. Many  consumer groups have repeatedly insisted that the FDA require comprehensive long-term studies before approving these products. I would like to add my voice to this request especially since recent studies have shown significant levels of platinum and platinum salts in the bodily fluids of women with SGFBI including breast milk. 



I would like to urge further studies to investigate this issue through either the National Institute of Environmental Health Study (NIEHS) or CDC. It should include a significantly large number of women, who have had SGFBI for 10 years or longer and include women with leaking and ruptured SGFBI. It is imperative to determine if platinum and platinum salts are found in women with SGFBI.



So far, the FDA has relied on implant makers and their paid consultants to examine this essential questions regarding SGFBI. Implant makers and their consultants claim that the platinum in implants is safe, but have failed to study the platinum in the bodies of women with SGFBI.



With hundreds of thousands of women having already reported serious health problems, as a result of their SGFBI-it would be unconscionable to decide upon approval without further investigating this grave and unknown risk to American women.



Sincerely,

Ruby Rahn

MDRC

1350 NW 82nd Street

Kansas City, MO  64118

rubyrm@yahoo.com