Breast Cancer Survivors Who Have Been Battling Traumatizing And Damaging Things, Such As Mastectomies

If approved, breast cancer survivors who have been battling traumatizing and damaging things, such as mastectomies, rounds of radiation and chemotherapy, will face additional complications and risks because of these devices.  In fact, data reviewed by this very committee in 2003 show the reconstruction population experience far more complications and repeat surgeries, and nearly half the women had at least one additional surgery in the first few years.  If approved, healthy young women are at risk of a lifetime of repeat surgeries, pain, and other complications.  The standard for approval of this medical device should not be based on a level of perceived demand or allow a choice in breast implants.  They should only be approved if they are proven safe for all women, which is not the case. The second issue, to me, and quite compelling to the breast cancer community, is silicone breast implants obscure mammograms.  Two recent studies, one in the "Journal of the American Medical Association" in January of 2004 and another conducted by the FDA's Office of Surveillance and Biometrics, also in 2004, clearly, clearly demonstrate breast implants result in missed and delayed diagnosis of cancer.  According to the FDA's study, because silicone is radiodense, it has been shown to obscure between 22 to 83 percent of breast tissue. While studies of this nature have not yet been able to definitely clarify difference in mortality, the FDA's study outlines research showing that there is, and I quote, "a difference in and possible limitation of treatment options."  Women with breast implants more often had to undergo a total mastectomy instead of breast preserving procedures because of delayed diagnosis of cancer.  According to the FDA, even under ideal conditions, alternative mammography techniques are limited and pose risks, and it still may be difficult to find cancer because the scar tissue develops around implants and can further obscure mammography.  The additional images necessary during screening may subject women with breast implants to at least double the radiation dose per mammogram than normal.  The FDA's study also found that at least some portion of the breast implant population would stop having mammograms altogether because of severe pain and the fear of implant rupture during the mammogram.  My mom is here today because of early detection, and it is widely medically accepted that the earlier breast cancer is detected, the greater the likelihood of successful treatment.  Complications from mammography are a real risk and should be considered as heavily and seriously as other complications.  This fact alone strongly argues against approval of these devices at this time. There is life after breast cancer and that should be of the highest quality because the best care available was given and received.  No one should have to look back and wonder if they made a choice for choice sake that could cost them their health and vitality.  My last area of concern, which was made clear from your 2003 panel meeting, are the many unknowns and concerns about the long-term safety of silicone breast implants, why the reconstruction population experiences significantly more complications and re-operations than the augmentation population.  What are the long-term effects and complications of the real problems of silent or asymptomatic rupture, gel bleed, and silicone migration?  If silent rupture and gel migration pose a risk, how is this risk addressed since the device does not fail in a manner that alerts women, such as with saline breast implants?