Guest guest Posted November 17, 2006 Report Share Posted November 17, 2006 • Long-Term Effects – Allergan’s Core Study will continue to evaluate the long-term (10 years) safety and effectiveness of these products In addition, Allergan has initiated a separate large 10-year postapproval study to address specific issues for which the Allergan Core Study was not designed to fully answer, as well as to provide a real-world assessment of some endpoints. The endpoints in the large postapproval study include long-term local complications, connective tissue disease (CTD), CTD signs and symptoms, neurological disease, neurological signs and symptoms, offspring issues, reproductive issues, lactation issues, cancer, suicide, mammography issues, and MRI compliance and results. Allergan will update their labeling on a regular basis with the results of these two studies. See page 13: http://www.inamedlabeling.com/pdf/us_aesthetics/L034-02_Silicone_DFU.pdf As if the FDA REALLY expected doctors to report problems!!!! - Rogene Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 17, 2006 Report Share Posted November 17, 2006 You know that this is horse hockey. The adjunct study was a joke before implants were approved. What incentive is there now for them to find anything but glowing reports? > > • Long-Term Effects – Allergan's Core Study will continue to evaluate the long-term (10 years) safety and effectiveness of these products In addition, Allergan has initiated a separate large 10-year postapproval study to address specific issues for which the Allergan Core Study was not designed to fully answer, as well as to provide a real-world assessment of some endpoints. The endpoints in the large postapproval study include long-term local complications, connective tissue disease (CTD), CTD signs and symptoms, neurological disease, neurological signs and symptoms, offspring issues, reproductive issues, lactation issues, cancer, suicide, mammography issues, and MRI compliance and results. Allergan will update their labeling on a regular basis with the results of these two studies. > > See page 13: > > http://www.inamedlabeling.com/pdf/us_aesthetics/L034-02_Silicone_DFU.pdf > > > > As if the FDA REALLY expected doctors to report problems!!!! - Rogene > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 17, 2006 Report Share Posted November 17, 2006 I'm hoping one of the bigger organization will initiate a law suit against the FDA for their actions! . . . Can the FDA be sued? . . . How about the decison makers? Rogene Molly Bloom <mollyb54@...> wrote: You know that this is horse hockey. The adjunct study was a joke before implants were approved. What incentive is there now for them to find anything but glowing reports?>> • Long-Term Effects – Allergan's Core Study will continue to evaluate the long-term (10 years) safety and effectiveness of these products In addition, Allergan has initiated a separate large 10-year postapproval study to address specific issues for which the Allergan Core Study was not designed to fully answer, as well as to provide a real-world assessment of some endpoints. The endpoints in the large postapproval study include long-term local complications, connective tissue disease (CTD), CTD signs and symptoms, neurological disease, neurological signs and symptoms, offspring issues, reproductive issues, lactation issues, cancer, suicide, mammography issues, and MRI compliance and results. Allergan will update their labeling on a regular basis with the results of these two studies.> > See page 13:> > http://www.inamedlabeling.com/pdf/us_aesthetics/L034-02_Silicone_DFU.pdf> > > > As if the FDA REALLY expected doctors to report problems!!!! - Rogene> Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 17, 2006 Report Share Posted November 17, 2006 I didn't go to medical school but just looking through this, I can't imagine how supposedly educated people can look at this report and not find it a joke. It just completely dances around all of the controversial subjects and totally blows them off. It is written in such passive language. Well, we're not saying they make you sick, and we're not saying they don't, we're just saying we never looked into it - that's enough, right? I just love the one that refers to the study that claims more women who get implants smoke as compared to women who have other plastic surgeries. Oh my gosh. I've never been a smoker, and I got sick immediately from the implants. Sis > > > > • Long-Term Effects – Allergan's Core Study will continue to evaluate the long-term (10 > years) safety and effectiveness of these products In addition, Allergan has initiated a > separate large 10-year postapproval study to address specific issues for which the > Allergan Core Study was not designed to fully answer, as well as to provide a real-world > assessment of some endpoints. The endpoints in the large postapproval study include > long-term local complications, connective tissue disease (CTD), CTD signs and symptoms, > neurological disease, neurological signs and symptoms, offspring issues, reproductive > issues, lactation issues, cancer, suicide, mammography issues, and MRI compliance and > results. Allergan will update their labeling on a regular basis with the results of these two > studies. > > > > See page 13: > > > > http://www.inamedlabeling.com/pdf/us_aesthetics/L034- 02_Silicone_DFU.pdf > > > > > > > > As if the FDA REALLY expected doctors to report problems!!!! - Rogene > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 17, 2006 Report Share Posted November 17, 2006 Did you read the startling information on page 37???? Please look at CTD Signs and Symptoms: "In Allergan's core study, numerous signs and symptoms were collected.....statistically significant increases were found for the symptom categories of Gastrointestinal (which includes constipation, diarrhea, gastrointestinal pain, heartburn, loss of appetite, nausea, stomach pain or cramps and vomiting) and Fibromyalgia symptoms (including fatigue, non-specific pain, back pain, chest pain and neck pain)." They KNOW, they KNOW, they KNOW. They just don't care! At the very least, if implants are going to be approved, these doctors damn well better stop telling us that implants are not making us sick with these symptoms! Patty Long Term Effects • Long-Term Effects – Allergan’s Core Study will continue to evaluate the long-term (10 years) safety and effectiveness of these products In addition, Allergan has initiated a separate large 10-year postapproval study to address specific issues for which the Allergan Core Study was not designed to fully answer, as well as to provide a real-world assessment of some endpoints. The endpoints in the large postapproval study include long-term local complications, connective tissue disease (CTD), CTD signs and symptoms, neurological disease, neurological signs and symptoms, offspring issues, reproductive issues, lactation issues, cancer, suicide, mammography issues, and MRI compliance and results. Allergan will update their labeling on a regular basis with the results of these two studies. See page 13: http://www.inamedla beling.com/ pdf/us_aesthetic s/L034-02_ Silicone_ DFU.pdf As if the FDA REALLY expected doctors to report problems!!!! - Rogene Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 18, 2006 Report Share Posted November 18, 2006 I'm so angry I've given it all up. Can anyone tell me what the benefits from being implanted with silicone implants are? They keep talking about that. That's crazy making talk for someone in my position. I give it up because I can't avoid to be as wild as I would feel if I let myself experience the anger. > > Did you read the startling information on page 37???? > > Please look at CTD Signs and Symptoms: > > " In Allergan's core study, numerous signs and symptoms were collected.....statistically significant increases were found for the symptom categories of Gastrointestinal (which includes constipation, diarrhea, gastrointestinal pain, heartburn, loss of appetite, nausea, stomach pain or cramps and vomiting) and Fibromyalgia symptoms (including fatigue, non-specific pain, back pain, chest pain and neck pain). " > > They KNOW, they KNOW, they KNOW. > > They just don't care! > > At the very least, if implants are going to be approved, these doctors damn well better stop telling us that implants are not making us sick with these symptoms! > Patty > > > > Long Term Effects > > • Long-Term Effects > – Allergan's Core Study will continue to evaluate the long-term (10 years) safety and effectiveness of these products In addition, Allergan has initiated a separate large 10-year postapproval study to address specific issues for which the Allergan Core Study was not designed to fully answer, as well as to provide a real-world assessment of some endpoints. The endpoints in the large postapproval study include long-term local complications, connective tissue disease (CTD), CTD signs and symptoms, neurological disease, neurological signs and symptoms, offspring issues, reproductive issues, lactation issues, cancer, suicide, mammography issues, and MRI compliance and results. Allergan will update their labeling on a regular basis with the results of these two studies. > > See page 13: > > http://www.inamedla beling.com/ pdf/us_aesthetic s/L034-02_ Silicone_ DFU.pdf > > > > As if the FDA REALLY expected doctors to report problems!!!! - Rogene > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 18, 2006 Report Share Posted November 18, 2006 There will be no independent study. Allergan will put up a smokescreen, as has happened in the past with Dow-funded 'studies'. If the adjunct study was a joke (which even the FDA acknowledges it was), you know that now implants are approved there will be no real study. Also, 10 years is a rather short time, don't you think? Or are they going to tell women to now replace their implants every 10 years, since they are not going to study women for longer than that? I don't think it ultimately m atters, since I don't believe there will be any real study anyway. > > > > Did you read the startling information on page 37???? > > > > Please look at CTD Signs and Symptoms: > > > > " In Allergan's core study, numerous signs and symptoms were > collected.....statistically significant increases were found for the > symptom categories of Gastrointestinal (which includes constipation, > diarrhea, gastrointestinal pain, heartburn, loss of appetite, nausea, > stomach pain or cramps and vomiting) and Fibromyalgia symptoms > (including fatigue, non-specific pain, back pain, chest pain and neck > pain). " > > > > They KNOW, they KNOW, they KNOW. > > > > They just don't care! > > > > At the very least, if implants are going to be approved, these > doctors damn well better stop telling us that implants are not making > us sick with these symptoms! > > Patty > > > > > > > > Long Term Effects > > > > • Long-Term Effects > > – Allergan's Core Study will continue to evaluate the long-term (10 > years) safety and effectiveness of these products In addition, > Allergan has initiated a separate large 10-year postapproval study to > address specific issues for which the Allergan Core Study was not > designed to fully answer, as well as to provide a real-world > assessment of some endpoints. The endpoints in the large postapproval > study include long-term local complications, connective tissue disease > (CTD), CTD signs and symptoms, neurological disease, neurological > signs and symptoms, offspring issues, reproductive issues, lactation > issues, cancer, suicide, mammography issues, and MRI compliance and > results. Allergan will update their labeling on a regular basis with > the results of these two studies. > > > > See page 13: > > > > http://www.inamedla beling.com/ pdf/us_aesthetic s/L034-02_ > Silicone_ DFU.pdf > > > > > > > > As if the FDA REALLY expected doctors to report problems!!!! - Rogene > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 3, 2009 Report Share Posted March 3, 2009 This is Tom in NJ... I had two botox and two dilatations in the first 6 years.......I have NOT had anything, but an annual precautionary endoscopy for the last 10 years. I was diagnosed 16 years ago, and my diagnosis has been late-stage achalasia for the last 10 years.My esophagus is greatly distended and is always full of food! When I get my annual scoping I am on a liquid diet for 5 days and even then is doesn't fully empty. . My doctor Dr. Katzka at U-Penn hispital in Phila, has suggested an esophagetomy for the last 5 years, while I am still young (I am 52) and healthy. BUT I have been almost symtpom free for these last 5 years. I exercise strenously regularly and even have to diet so I don't get fat........Everyone is different but these last 10 years I have feel really good.Good Luck to All Re: Long term effectsachalasia > > wrote: > > > On another note I have been doing a lot of reading about the > differentprocedures and each of your own personal experiences > that I have read> and it all seems to lead to a lifetime of multiple dialations and> surgeries> > , while this is a lifetime disease, not everyone has > constant or > multiple dilations and surgeries. Please note as you read, > this group has over > 1800 members. Many of these have had successful treatment and > have not been > back to the group. There is only a handful who post to let you > know how > successful their treatment has been. Many don't ever come back > unless they have > repeated problems. It would be nice and would be so helpful, > if everyone > who'd posted on this site would report their success every few > months. We'd get > a better view of how successful treatments can be.> > I'm glad you've decided to go to Boston. Just don't put > treatment off. > Remember > early intervention could play a major role in how successful > your treatment > is.> > Maggie> Alabama> > **************A Good Credit Score is 700 or Above. See yours in > just 2 easy > steps! > (http://pr.atwola.com/promoclk/100126575x1219957551x1201325337/aol?redir=http:%2\ F%2Fwww.freecreditreport.com%2Fpm%2Fdefault.aspx%3Fsc%3D668072%26hmpgID> %3D62%26bcd%3DfebemailfooterNO62)> > > [Non-text portions of this message have been removed]> > Quote Link to comment Share on other sites More sharing options...
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