2006P-0151 Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
FDA Comment Number : EC1
Submitter : Mrs. Dina Pastor Date & Time: 05/09/2006 04:05:49
Organization : Mrs. Dina Pastor
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
This issue I am facing while waiting for approval on the larger size implants for reconstructive surgery (I don't know if this is the appropriate docket but it is the only one that comes up regarding breast implants)is the implants given to me for reconstruction from breast cancer are large enough for small woman but I am a larger built woman and have swallowed up the largest size I can get in silicone implants. Mentor told me we were waiting for FDA Approval for the larger implants so I can get my reconstruction redone and completed. For my body type there is no way that the sizes allowed currently is enough. It looks absolutely unproportionate and ridiculous to say the least. I have some pictures to back this up if you would like but I do not see the use of reconstruction if they don't allow the right size for every size woman not just the small ones. If this doesn't pertain to this particular docket,please forward to the correct area. Thank you.