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Thread: Women forced to have hysterectomies to remove Essure device

  1. #31
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    Quote Originally Posted by ptif219 View Post
    Using the Lords name in vain does not make you right it just shows you hate Christians and Jesus. We are not talking about Reagan or what happened 30 years ago
    We're talking about how you think Obama is responsible for the pot holes in your neighborhood while you gave Reagan a pass for something that took place right under his nose. In other words, you're a total hypocrite and the only reason why you are so hard on Obama is because he's a black guy in your WHITE House.

  2. #32
    Veteran Member Dr Sampson Simpson's Avatar
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    Quote Originally Posted by Kontrary View Post
    I do think this raises an issue, the FDA and the process for getting approval has been flawed for a long time...and most likely, its a purposeful flaw ie. corrupt. The studies are funded by the people who will BENEFIT from it being approved...the study does seem to have some issue as well and you have an under-funded and under-staffed FDA and considering the powerful strings that deep pharm pockets can afford...well its not hard to see there is a problem.

    I-Team: Clinical Trial Patient Criticizes Study That Led to FDA Approval of Essure | NBC New York



    Dr. Diana Zuckerman, who leads the National Research Center for Women and Families, a non-partisan FDA watchdog, said the survey questionnaires exhibit dubious research methods.

    “These studies are always done by the company that is selling the product so it is not exactly unbiased,” Zuckerman said.


    It also seems that some of these things have a protection...the company cant be SUED even if they cause damage. The reasoning behind it seems to be due to the concept that such devices would undergo such heavy scrutiny by the FDA that they would protected from being sued...the idea that the FDA is now really the responsible one since they approved it and provided additional scrutiny. Now this device seems to come under that protection BUT its apparent that extra scrutiny was not applied.

    I-Team: Clinical Trial Patient Criticizes Study That Led to FDA Approval of Essure | NBC New York

    I'm really sick of the "the company performs the study, so its biased and incorrect" type of comments

    It's called FDA preemption, which bars lawsuits against some approved devices.

    "They've given them a pass. That's exactly what they've done," said Robert Jenner, an attorney with Janet, Jenner and Suggs in Pikesville.

    Jenner has been fighting device and drug cases that involve the FDA for almost three decades. But he says law firms turn down preemption cases on a daily basis.

    Devices given pre-emption are generally ones you put inside your body, things like the Essure coils, a pacemaker or pump.

    Jenner says the idea behind preemption is that the companies that make approved devices get protection from the FDA and can't be sued because the agency so heavily scrutinizes their devices. But attorneys and patient advocates consider it a flawed concept.

    "This is a $100-billion industry. There's simply not enough money, not enough time and not enough people in the FDA to give it the oversight, the attention that it needs," Jenner told us.

    There is attention that comes during product development, during the approval process and in long-term testing. But even if a product or device turns out to be problematic or defective, Jenner says preemption means even if you tried to take the maker to court, your case would likely be thrown out.

    "Unless and until the law is changed, they're just out of luck," said Jenner.



    I see no benefit to offering such "immunity" to corps, especially in light of the fact that the FDA seems to allow companies to do their own research and we just "trust" them....I see no evidence this device got that "extra" scrutiny either, the whole rationale to grant them immunity. Apparently this extra scrutiny has no official tasks to perform to meet that standard...
    I'm kind of sick of the "the company does the research, so its biased" from people that are ignorant of how the process works.

    yes, companies design and execute the clinical trials, and they monitor the studies, which are actually performed by the doctors not associated with the company. yeah, they get paid for their service like anybody would. The FDA is also involved in this process

    The studies are double blinded, neither the doctor or patient knows who gets the placebo, who gets the drug. This gets rid of placebo effect and doctor knowing the patient got the drug from influencing the results. Only when all the data is in and compiled, are the codes broken.

    The studies have to be designed well, because human biology is complex. Everybody has different genetics, diets, preexisting conditions, environmental factors, lifestyles, on different drugs, supplements, etc. So its hard to tell how people react. Anything the patietn reports is put down, even if they get the shits unrelated to the drug, they have to put it down, and that gets included in the side effects (hence the long list). This is why studies need to be designed, well, this is why people who are too far gone, or don't fit criteria, cna't get the drug. If they die, that data is included in the study, regardless of the fact they were too far gone to be helped. This could kill the drug and prevent millions of people from benefiting from it.

    Every piece of data is reviewed by the FDA. Some trials can have truckloads of data. The majority of the cost of drug development are in these trials. The FDA is incredibly strict on their approval of drugs. Many drugs don't get approved,so that discredits the FDA being paid off, or that companies fudge data. there would be a better drug approval rate, because failures cost 100s of millions of dollars to a company.

    Oh, and anybody associated with fraud in data is punished severely by the law. CEOs, low people, doesn't matter, they get prosecuted strongly. Not like other industries where people get off when there is huge fraud. Then the fact the company would be destroyed if they were caught fudging data.

    And when drug goes to the market, they do what is called phase IV trials, to monitor for any side effects. BEcause now the population size is bigger, mixing medicatoins and other stuff that couldn't possibly be tested.

    There will always be side effects and patients not reacting well to a drug or procedures. Even with Vioxx,. multi millions of people benefited immensely from Viox. The percentage that had negative side effects leading to the drug being pulled was about 2%. Out of millions, tha'ts miniscule. But definitely if people are dying, can't take the risk, even though so many were benefitting.

    Genetics will play a huge part in the future, so that drugs can be tailored to a person specifically and you can know how one will respond to a drug or treatment
    Thanks from 1069

  3. #33
    Veteran Member ptif219's Avatar
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    Quote Originally Posted by TennesseeRain View Post
    I never accused mah main man Perry Weitz of being a shyster. Shark? yes. Shyster? Nope.
    That is the impression you gave me

  4. #34
    Veteran Member ptif219's Avatar
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    Quote Originally Posted by TennesseeRain View Post
    We're talking about how you think Obama is responsible for the pot holes in your neighborhood while you gave Reagan a pass for something that took place right under his nose. In other words, you're a total hypocrite and the only reason why you are so hard on Obama is because he's a black guy in your WHITE House.
    I was not concerned with politics when Reagan was president. You are the hypocrite that will never admit Obama does anything wrong.

    I don't have pot holes in my neighborhood.

  5. #35
    Veteran Member Kontrary's Avatar
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    Quote Originally Posted by Dr Sampson Simpson View Post
    I'm kind of sick of the "the company does the research, so its biased" from people that are ignorant of how the process works.

    yes, companies design and execute the clinical trials, and they monitor the studies, which are actually performed by the doctors not associated with the company. yeah, they get paid for their service like anybody would. The FDA is also involved in this process

    The studies are double blinded, neither the doctor or patient knows who gets the placebo, who gets the drug. This gets rid of placebo effect and doctor knowing the patient got the drug from influencing the results. Only when all the data is in and compiled, are the codes broken.

    The studies have to be designed well, because human biology is complex. Everybody has different genetics, diets, preexisting conditions, environmental factors, lifestyles, on different drugs, supplements, etc. So its hard to tell how people react. Anything the patietn reports is put down, even if they get the shits unrelated to the drug, they have to put it down, and that gets included in the side effects (hence the long list). This is why studies need to be designed, well, this is why people who are too far gone, or don't fit criteria, cna't get the drug. If they die, that data is included in the study, regardless of the fact they were too far gone to be helped. This could kill the drug and prevent millions of people from benefiting from it.

    Every piece of data is reviewed by the FDA. Some trials can have truckloads of data. The majority of the cost of drug development are in these trials. The FDA is incredibly strict on their approval of drugs. Many drugs don't get approved,so that discredits the FDA being paid off, or that companies fudge data. there would be a better drug approval rate, because failures cost 100s of millions of dollars to a company.

    Oh, and anybody associated with fraud in data is punished severely by the law. CEOs, low people, doesn't matter, they get prosecuted strongly. Not like other industries where people get off when there is huge fraud. Then the fact the company would be destroyed if they were caught fudging data.

    And when drug goes to the market, they do what is called phase IV trials, to monitor for any side effects. BEcause now the population size is bigger, mixing medicatoins and other stuff that couldn't possibly be tested.

    There will always be side effects and patients not reacting well to a drug or procedures. Even with Vioxx,. multi millions of people benefited immensely from Viox. The percentage that had negative side effects leading to the drug being pulled was about 2%. Out of millions, tha'ts miniscule. But definitely if people are dying, can't take the risk, even though so many were benefitting.

    Genetics will play a huge part in the future, so that drugs can be tailored to a person specifically and you can know how one will respond to a drug or treatment
    But the company DID falsify some reporting, a person who was IN the study has already said. She reported pain and problems, they checked "excellent" for her comfort level and didnt indicate her problems or pain.

    Thats a lot of "trust" to decide companies can do their own studies and we just trust them. The FDA did not observe anything. There werent truckloads of data either, it was ONE study and a flawed one at that.

    People who are involved in fraud are often NOT punished.

    You seem to think no corruption exists, thats naive.
    Thanks from bajisima and ptif219

  6. #36
    Veteran Member Kontrary's Avatar
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    Quote Originally Posted by Shelly View Post
    Hmmm.... where.do.I.start?
    The clinical trials I suppose. A biased five year study, nothing long term. A few of the participants have had a hysterectomy and some are still trying. Many implanted women were seeking birth control not necessarily permanent but we're talked into these implants by their doctors who stood to gain financially. 1 out of 10 people are allergic to nickel yet the word "nickel" was never mentioned to many of us. Thousands were never tested even before the warning was taken off the label. Nickel is not the only issue. The PET fibers in the coils are designed to cause inflammation which causes the buildup of scar tissue in the fallopian tube. This process uses the immune system and NEVER stops. This can cause numerous health problems over time. Many women do not develop symptoms right away and some do. Doctors are refusing to believe or even consider Essure as the cause and are REFUSING to give hysterectomies to the point of absurdity. Insurance companies will not pay for a hysterectomy for those who "want" one. A hysterectomy causes a woman to go into menopause even if the ovaries are left intact sometimes due to a lack of blood flow. Many of these women are in their twenties. 750,000 IS THE NUMBER OF KITS SOLD NOT THE NUMBER OF WOMEN IMPLANTED. We do not know how many have been implanted. Bayer's new warning covers chronic pain and migration. Chronic pain is one symptom. The list of symptoms is pages long. My symptoms started months later and progressively got worse with time. New symptoms each year. Doctor after doctor and test after test with no answers. The pain is EXCRUCIATING similar to labor pains only it's constant, relentless, day after day. If the pain does not debilitated me the weakness, fatigue and constant nausea will. I have been told time after time that this is all in my head. I am stressed, depressed, or hormonal. I can feel myself dying. I thank God for Erin Brockovich and her determination to raise awareness. Now I know. I have an appointment in a few weeks with an OB GYN. I am PRAYING she will listen to me. I have spent countless hours researching and joined the Essure Problems Facebook group with almost 4000 members. I plan to be armed with as many facts as possible. Your forum came up in a Google search. I came here seeking knowledge, or at least some insight. Instead I found a group of pathologically narcissistic asshats discussing a subject they know nothing about.
    I am definitely not very well versed about this particular product and its impact. On a fairly cursory research, I did see that there was too much "trust" and "self reporting" going on...there is also at least one complaint by a person who took part in the clinical trials and said that the answer they recorded for her did NOT reflect what she said. THEY determined her lower back pain was NOT related to the product so wrote that her comfort was "excellent" instead of recording her answer of having back pain (no matter what caused it...how can you see a pattern when you keep deciding that the symptoms have nothing to do with the product?).

    So without knowing much about this particular product to say its good or bad, I can see that the system is broken and asking for clinical trials from those who are definitely biased is a problem a BIG problem.

    Sorry to hear of what you are going through, I hope you can get it removed ASAP and you have no long term health impact *crosses fingers for you*

  7. #37
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    Quote Originally Posted by ptif219 View Post
    I was not concerned with politics when Reagan was president. You are the hypocrite that will never admit Obama does anything wrong.

    I don't have pot holes in my neighborhood.
    I admit it when Obama does stuff wrong. This isn't one of those times.

  8. #38
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    Quote Originally Posted by ptif219 View Post
    That is the impression you gave me
    You are prone to false impressions, so I'm not surprised.

  9. #39
    Veteran Member Dr Sampson Simpson's Avatar
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    Quote Originally Posted by Kontrary View Post
    I am definitely not very well versed about this particular product and its impact. On a fairly cursory research, I did see that there was too much "trust" and "self reporting" going on...there is also at least one complaint by a person who took part in the clinical trials and said that the answer they recorded for her did NOT reflect what she said. THEY determined her lower back pain was NOT related to the product so wrote that her comfort was "excellent" instead of recording her answer of having back pain (no matter what caused it...how can you see a pattern when you keep deciding that the symptoms have nothing to do with the product?).

    So without knowing much about this particular product to say its good or bad, I can see that the system is broken and asking for clinical trials from those who are definitely biased is a problem a BIG problem.

    Sorry to hear of what you are going through, I hope you can get it removed ASAP and you have no long term health impact *crosses fingers for you*
    How does the woman know what they recorded for her? How could she possibly know? Did she get access to all the data? And that is totally not how clinical trials are supposed to be, everything gets reported. They don't determine whether it was because of the product or not. They have to report everything. THis is why the list of side effects on drug labels a nd in the commerials are there, because everything has to be reported if the patient feels it.

    If a patient with cancer got the procedure, then died of cancer, that would have to go into the report, regardless of the fact it had nothing to do with the procedure. That's why someone with cancer would not be in the trial. That's why selection in the trial is important, and why for life saving diseases, people too far gone can't be given the drug, that would reflect poorly on the result if that person died anyway since they were too far gone. not sure about this study and if they did a placebo, and what that consisted of.

    So, if the data truly was lied about, that person is in some serious trouble, and the company as well. That's if its even true, I find it hard to believe a patient would know what was written down in the trial.

  10. #40
    Veteran Member Kontrary's Avatar
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    Quote Originally Posted by Dr Sampson Simpson View Post
    How does the woman know what they recorded for her? How could she possibly know? Did she get access to all the data? And that is totally not how clinical trials are supposed to be, everything gets reported. They don't determine whether it was because of the product or not. They have to report everything. THis is why the list of side effects on drug labels a nd in the commerials are there, because everything has to be reported if the patient feels it.

    If a patient with cancer got the procedure, then died of cancer, that would have to go into the report, regardless of the fact it had nothing to do with the procedure. That's why someone with cancer would not be in the trial. That's why selection in the trial is important, and why for life saving diseases, people too far gone can't be given the drug, that would reflect poorly on the result if that person died anyway since they were too far gone. not sure about this study and if they did a placebo, and what that consisted of.

    So, if the data truly was lied about, that person is in some serious trouble, and the company as well. That's if its even true, I find it hard to believe a patient would know what was written down in the trial.
    I posted the link, you can read it...thats why I offered it.

    Thats the point isnt it, the woman in the clinical trial reports lower back pain and when you look at her answer on the actual study, they have "excellent" checked for her level of comfort.....lower back pain is NOT comfort. That brings up another problem with the study, you get a choice of 5 answers.....3 would reflect positively on the product, 1 neutral and 1 negative. You say "lower back pain" and they checked "excellent", one of the more positive answers.

    This is a problem, you cant expect them to SELF POLICE. Tests should be done by UNBIASED parties and those studies should be peer-reviewed and public.

    Here is the link, her name is Kim Hudak

    http://www.nbcnewyork.com/investigat...tml?akmobile=o
    Last edited by Kontrary; 15th November 2013 at 07:06 AM.
    Thanks from ptif219

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