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Thread: Women forced to have hysterectomies to remove Essure device

  1. #11
    Veteran Member Kontrary's Avatar
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    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.

    http://www.nbcnewyork.com/investigat...tml?akmobile=o



    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

    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...
    Last edited by Kontrary; 13th November 2013 at 10:12 PM.
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  2. #12
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    Quote Originally Posted by ptif219 View Post
    If you're allergic to a medication, don't take it.
    But don't expect the fda to ban it.
    If you're allergic to nickel, don't have it implanted in your fallopian tube. Derr.
    Suing isn't going to do any good, because the patient no doubt signed all sorts of "cover your ass" forms beforehand, as every patient must do before any procedure.
    Maybe the dumbass should've sought medical attention before things got to the point where she was "having her husband wake her up in the night to make sure she hadn't died in her sleep." Any idiot knows it's not normal to feel like you're "dying" at twenty-five. I would've been camped out in the emergency room refusing to leave until they figured out what was wrong with me.
    A 25-year-old mother of three has that responsibility. You don't just lay at home morbidly begging others to check and make sure you're not dead. Other lives depend on you, and you must be proactive about your health. If she had been, things no doubt would not have gotten to this point. If you ignore pain and illness that is bad enough to make you feel you are "dying" and neglect to seek timely and appropriate medical attention... then you can consider yourself lucky if you don't actually die.
    Last edited by 1069; 13th November 2013 at 10:59 PM.
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  3. #13
    Conservatively Liberal NiteGuy's Avatar
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    Quote Originally Posted by ptif219 View Post
    So no deaths means it is okay? The FDA did one study by an outside group and that is it? Women having to get sick and having hysterectomy is nothing?
    And once again, @ptif219, you're putting words in my mouth and constructing strawmen to knock down. Pathetic. Try sticking to what I actually have said, okay?

    No deaths does not mean it's okay, and only one new study by the FDA is not enough. But, again, you want to convict them before all of the evidence has come in and been evaluated. And it is a shame that some women have had complications, but I find it extremely hard to believe that these women were not told of the possible side effects and risks of using this device.

    Quote Originally Posted by ptif219
    Kep trying but this is no small deal and it has the attention of local news all over the country as I have shown. This is not the end of this and the FDA should do it's job and find this unsafe. Part of the problem is the device is made from nickel which m,any women are having a reaction to
    So what? Do we now regulate businesses on the basis of how many local stations pick up a stringer's story to air?

    The FDA is doing it's job sport, and I'm telling you that a finding of an unsafe device, and ordering it pulled from the market is premature at this point, at best. If most of the problems can be found to be because of the nickel used in the product, there are options to taking Essure off the market. For example, they can mandate a test for allergy to nickel, since so many women don't know if they are allergic. After all, there is already a warning about it on the packaging, but women just tell the doc "no, I'm not allergic". Oops.

    So, mandate that they can use this device only if they are are tested and found to be non-allergic to nickel. Or, They can have the manufacturer try alternate formulations for the coils. Perhaps a different metal altogether, or perhaps a plastic or carbon fiber device would work as well.

    Your problem ptif219, is that you want something done, right here, and right now, and it must include the beheading of the FDA and preferably the President, too. Well, I'm here to tell you that that's never been the way it's been done, and it's not going to be done in this case, so I wouldn't hold my breath if I were you.
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  4. #14
    Veteran Member ptif219's Avatar
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    Quote Originally Posted by 1069 View Post
    If you're allergic to a medication, don't take it.
    But don't expect the fda to ban it.
    If you're allergic to nickel, don't have it implanted in your fallopian tube. Derr.
    Suing isn't going to do any good, because the patient no doubt signed all sorts of "cover your ass" forms beforehand, as every patient must do before any procedure.
    Maybe the dumbass should've sought medical attention before things got to the point where she was "having her husband wake her up in the night to make sure she hadn't died in her sleep." Any idiot knows it's not normal to feel like you're "dying" at twenty-five. I would've been camped out in the emergency room refusing to leave until they figured out what was wrong with me.
    A 25-year-old mother of three has that responsibility. You don't just lay at home morbidly begging others to check and make sure you're not dead. Other lives depend on you, and you must be proactive about your health. If she had been, things no doubt would not have gotten to this point. If you ignore pain and illness that is bad enough to make you feel you are "dying" and neglect to seek timely and appropriate medical attention... then you can consider yourself lucky if you don't actually die.
    Most people would not know they are allergic to nickel. The manufacturer denies this problem. The manufacturer says there is not enough nickle in the device to cause this

  5. #15
    Veteran Member ptif219's Avatar
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    Quote Originally Posted by NiteGuy View Post
    And once again, @ptif219, you're putting words in my mouth and constructing strawmen to knock down. Pathetic. Try sticking to what I actually have said, okay?

    No deaths does not mean it's okay, and only one new study by the FDA is not enough. But, again, you want to convict them before all of the evidence has come in and been evaluated. And it is a shame that some women have had complications, but I find it extremely hard to believe that these women were not told of the possible side effects and risks of using this device.


    So what? Do we now regulate businesses on the basis of how many local stations pick up a stringer's story to air?

    The FDA is doing it's job sport, and I'm telling you that a finding of an unsafe device, and ordering it pulled from the market is premature at this point, at best. If most of the problems can be found to be because of the nickel used in the product, there are options to taking Essure off the market. For example, they can mandate a test for allergy to nickel, since so many women don't know if they are allergic. After all, there is already a warning about it on the packaging, but women just tell the doc "no, I'm not allergic". Oops.

    So, mandate that they can use this device only if they are are tested and found to be non-allergic to nickel. Or, They can have the manufacturer try alternate formulations for the coils. Perhaps a different metal altogether, or perhaps a plastic or carbon fiber device would work as well.

    Your problem ptif219, is that you want something done, right here, and right now, and it must include the beheading of the FDA and preferably the President, too. Well, I'm here to tell you that that's never been the way it's been done, and it's not going to be done in this case, so I wouldn't hold my breath if I were you.
    Keep saying that but thousands of women that have gotten sick disagree with you

  6. #16
    Veteran Member Dr Sampson Simpson's Avatar
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    What does the article have to do with Obama? Nothing, holy ODS, give it a rest, its so pathetic.

    The cost of birth control is miniscule compared to the cost of a lifetime of medical care for a person, so it should be covered by insurance.
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  7. #17
    King Obama is a traitor! michaelr's Avatar
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    Quote Originally Posted by OldGaffer View Post
    This is why they have lawyers. I do not believe Obama is installing those devices or even knows about them.
    Really, is this actually the level that your brain works at?

    Obamacare is supposed to pay for this type of contraception. It must make some people happy, they added it to "his" law, but it is very dangerous, and Obamacare approves it.

    Learn something? Probably not.

  8. #18
    Veteran Member Dr Sampson Simpson's Avatar
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    I'm confused, she used birth control that basically blocked up her fallopian tubes, is the process reversible? It sounds like the substituted for having tubes tied, which would be more invasive. So why is she upset if she had to have a hysterectomy if she didn't plan on having kids?

    Unlike the OP, I'm going to do some actual research, not just read a biased article only presenting one side, and in fact, one woman's story.

    On edit, looks like NiteGuy did the research for me.
    Last edited by Dr Sampson Simpson; 14th November 2013 at 10:15 AM.
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  9. #19
    King Obama is a traitor! michaelr's Avatar
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    Quote Originally Posted by Dr Sampson Simpson View Post
    What does the article have to do with Obama? Nothing, holy ODS, give it a rest, its so pathetic.

    The cost of birth control is miniscule compared to the cost of a lifetime of medical care for a person, so it should be covered by insurance.
    Except it is approved and paid for by Obamacare, probably nothing.

  10. #20
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    Quote Originally Posted by ptif219 View Post
    So the FDA doesn't care if women have to have hysterectomies or if they die. I get it sounds like the FDA does not care or maybe they are paid off. I guess Erin Brockovich is also not credible in your eyes
    Erin Brockovich works for Weitz & Luxenberg, a plaintiffs personal injury law firm. She isn't investigating this necessarily because it's a worthy cause but because it's a potentially profitable one for her and her employers. This law firm, based in New York, specializes in asbestos litigation, but also makes a huge amount of money from defective medications and medical devices. Those commercials you see on late night tv? "Have you been injured by such & such?" That's often times them.

    Now, I know you will poo-poo this because I said it. But, I happen to be intimately familiar with this law firm and how they work.
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