2006P-0151
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC15
  



  

  
Submitter : 
  

  
Ms. brianna smith
  

  
Date & Time: 
  

  
06/29/2006 02:06:19
  



  

  
Organization : 
  

  
Ms. brianna smith
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Suggested Talking Points for Comments:



If the FDA approves silicone breast implants, many young women will get them. Studies have found higher than expected levels of platinum salts in breast milk and urine of women with implants. If they breast feed, their babies could potentially be permanently damaged or chronically ill from exposure to toxic platinum salts. 





Platinum salts also could be especially dangerous for breast cancer survivors. Chemotherapy often includes platinum. If a breast cancer patient decides to get breast implants, she potentially would already be exposed to platinum, and then get additional exposure from her implants. Breast cancer patients already are more susceptible than other patients to implant ruptures and other complications. Unfortunately, the companies that are seeking FDA approval for silicone gel breast implants have conducted research on relatively few breast cancer patients. 





So far, the FDA has relied on implant makers and their paid consultants to examine this essential question. 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 implants, or their breast milk, to determine if it is platinum salt. Platinum salt is a toxic form of platinum. These questions are too important to wait until after the FDA makes implants more available. 

WHAT WE WANT: 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.