Guest guest Posted October 16, 2003 Report Share Posted October 16, 2003 Patty, You are absolutely right when you say we are going to see a significant increase of exchanging saline for silicone. The sad part is NOW that they are legal, the forms that they will be filling out( I am not sure but I am guessing), will be much more detailed on what could happen. WHEN THESE WOMEN GET SICK, because it is a matter of time, they can't go back to their doctors for not informing them or SIGNING a consent form because they will be fully informed UNLIKE MOST OF US. There are going to be alot of sick women in the future but I think the attitude is going to be totally different for these women because THEY DID KNOW. I think it is going to be really sad. Teri ----- Original Message ----- From: *~Patty~* Sent: Wednesday, October 15, 2003 8:25 PM Subject: Re: Fw: Corporate greed & deception wins ... Women and their health lose ... You are so right on this one. Thousands of women will be getting silicone gel, and will completely ignore the risks...and will be in denial even when they do get sick. This decision will bolster the idea that implants are safe in the minds of anyone who has not investigated the controversy. I believe we will also be seeing women going to their plastic surgeons in droves to exchange their saline for silicone gel, with the emphasis on how much more natural the silicone gel are supposed to feel. There may be one saving grace in this....(can we dare to have hope?) From the article: "All implant recipients also must be enrolled in a registry to track their health." If this registry is done right, with ALL recipients followed, monitored and scientifically validated, we may see the beginnings of some real science regarding breast implants and their long term safety...gosh, do you think this is expecting too much? I'm afraid to even let myself think that the FDA could REALLY want to know the truth. As Ilena said, they have proven themselves to be unworthy of our respect. Patty ----- Original Message ----- From: me lee Sent: Wednesday, October 15, 2003 5:45 PM Subject: Re: Fw: Corporate greed & deception wins ... Women and their health lose ... Unfortunately vanity will also win. Most women will choose to ignore the risks involved with silicone and get implants. I just wish society didn't pressure women to do this.*~Patty~* <fdp@...> wrote: What else is there to say? God help us...----- Original Message -----From: "ilena rose" <ilena2000@...><ilena@...>Sent: Wednesday, October 15, 2003 3:12 PMSubject: Corporate greed & deception wins ... Women and their health lose...> ~~~ This is a very sad day in history. The FDA has proven itself to be> unworthy of respect and the abililty to make sound decisions. ~~~~>>>>>> http://www.guardian.co.uk/uslatest/story/0,1282,-3268127,00.html>> FDA Panel Recommends Lifting Silicone Ban>> Wednesday October 15, 2003 10:16 PM>>> By LAURAN NEERGAARD>> AP Medical Writer>> WASHINGTON (AP) - Eleven years after most silicone-gel breast implants> were prohibited, government advisers recommended on Wednesday that the> ban be lifted despite lingering questions about safety and durability.>> But the Food and Drug Administration's advisers urged that Inamed> Corp.'s sales be allowed only under certain conditions, including> ensuring that all users get detailed brochures explaining the devices'> known risks - such as a need for frequent reoperations for pain or> breakage.>> Women will need annual exams to be sure their implants haven't> silently begun leaking, the panel stressed. That will be expensive and> hard to ensure, the scientists acknowledged, but crucial because> implants can break without immediate symptoms and should be removed> when that happens.>> ``This is as important as your annual mammogram,'' said FDA adviser> Barbara Manno, a Louisiana State University toxicologist.>> All implant recipients also must be enrolled in a registry to track> their health.>> The vote was 9-6.>> The panel also said Inamed must do more research tracking women's> health for 10 years after implants, a time when many say their devices> begin breaking and causing painful disorders. So far, Inamed's> research tracks women's health for three years.>> Still, after two days of debate, the panel ultimately agreed with> Inamed's argument that it is not fair to restrict women's access to> silicone implants when research suggests they break and cause other> problems no more frequently than today's main alternative - implants> filled with salt water.>> The decision came after emotional testimony pitting woman against> woman: those who say implants broke inside their bodies to leave them> permanently damaged and those who wa nt implants they say feel more> natural to repair cancer-ravaged breasts or make their breasts bigger.>> If women keep their implants long enough, they all may break> eventually, panelists said.>> The question is how to tell: Saline-filled implants deflate so fast> that women know they've broken, but silicone leaks slowly and may not> cause immediate symptoms. Because women may not be able to get all the> leaking silicone out of their bodies, ``we have to hold this to a> different standard,'' argued adviser Dr. Amy Newburger, a New York> dermatologist.>> The FDA ended routine sales of silicone breast implants in 1992,> restricting them to breast cancer patients in strictly controlled> clinical trials.>> Seeking to restart broader sales, Inamed Corp. argued that the> implants have been exonerated.>> Indeed, studies to date show little eviden ce the implants cause major> diseases such as cancer.>> But the FDA worries that rare disease issues aren't settled, and that> subsets of women - especially the small proportion who have silicone> leaking through scar tissue into the breast or beyond - might be more> vulnerable to painful conditions like fibromyalgia.>> ``I wanted to be more beautiful. Instead, my breasts became hard,> scarred and ugly,'' -Miles, of Michigan, told the FDA> panel. She as one of more than 100 women, plastic surgeons and> consumer advocates who spoke over the two days.>> Schambeck pleaded for women to have a choice. ``I didn't like> the feeling of wrinkled water bags in my body,'' she said, explaining> why she exchanged salt-water implants for those filled with silicone> gel.>> ``It is not a perfect device,'' said Dr. Wells, president of the> Ame rican Society of Plastic Surgeons. But, he said, ``the procedure> significantly improves the quality of life for many patients.''>>>> Guardian Unlimited © Guardian Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 16, 2003 Report Share Posted October 16, 2003 I really do not know what to say, I have just read the emails regarding the decisions of the FDA, I am so sorry in fact I am devastated for all the women who have worked so hard for this and for all the women like myself who are ill.As you are probally aware England is years behind America so I was hoping that if these rotten implants were banned we (THE English ) MAY FOLLOW , well in a few years time when we catch up. My own doctor has a son who is a doctor in America she keeps telling me silicone is safe and that I have no problems, only problems with my mind , as her son in America tells her they would be banned if they were not safe, what will she say now. Thank you for all your input with the FDA I did do my small bit I signed the form, for what it was worth.I just hope that you all keep going to get us justice, so oneday over here we may get it too. Sue. England. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 16, 2003 Report Share Posted October 16, 2003 Hi there, I read your email and thank you so much for the support. It is much appreciated! I could not make it to Washington DC because I have been sick but my mother and her friends(the chickettes)HA! were there supporting all of us here on this website. They protested with signs and my story along with other stories from women on this website. My mother and her friends are devastated for they heard even more horror stories than I have and could not believe what happened yesterday. I had gotten a message on my mobile from my mother and then got home to my emails and just cried for all of us. I talked to my mother until early this morning and she filled me in on things that occurred and I am deeply disappointed in our government but we all here on this website will keep supporting and fighting! Thank you for your kind words. Teri ----- Original Message ----- From: gibbense@... Sent: Thursday, October 16, 2003 11:42 AM Subject: Re: Patty--To all I really do not know what to say, I have just read the emails regarding the decisions of the FDA, I am so sorry in fact I am devastated for all the women who have worked so hard for this and for all the women like myself who are ill.As you are probally aware England is years behind America so I was hoping that if these rotten implants were banned we (THE English ) MAY FOLLOW , well in a few years time when we catch up. My own doctor has a son who is a doctor in America she keeps telling me silicone is safe and that I have no problems, only problems with my mind , as her son in America tells her they would be banned if they were not safe, what will she say now. Thank you for all your input with the FDA I did do my small bit I signed the form, for what it was worth.I just hope that you all keep going to get us justice, so oneday over here we may get it too. Sue. England. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 20, 2003 Report Share Posted October 20, 2003 Sue, Yes, I am quite appalled at what the very poor decision of our FDA "experts" (NOT!) will do to squelch the work of those who are struggling for justice in other countries too. I can only feel frustration, as I am certain there are women all over this world, sick from implants, and have absolutely no clue. This will only serve to keep them in the dark about their pain and suffering...it is a travesty that will reverberate the world over. Let's hope that this is not the end yet...and that the FDA will not follow the panel's recommendation. I am praying...and writing letters! I urge all of you to keep writing as well. Thanks for hanging in there with us Sue. Patty ----- Original Message ----- From: gibbense@... Sent: Thursday, October 16, 2003 9:42 AM Subject: Re: Patty--To all I really do not know what to say, I have just read the emails regarding the decisions of the FDA, I am so sorry in fact I am devastated for all the women who have worked so hard for this and for all the women like myself who are ill.As you are probally aware England is years behind America so I was hoping that if these rotten implants were banned we (THE English ) MAY FOLLOW , well in a few years time when we catch up. My own doctor has a son who is a doctor in America she keeps telling me silicone is safe and that I have no problems, only problems with my mind , as her son in America tells her they would be banned if they were not safe, what will she say now. Thank you for all your input with the FDA I did do my small bit I signed the form, for what it was worth.I just hope that you all keep going to get us justice, so oneday over here we may get it too. Sue. England. Quote Link to comment Share on other sites More sharing options...
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