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Thread: Women forced to have hysterectomies to remove Essure device

  1. #41
    Veteran Member Dr Sampson Simpson's Avatar
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    Based on the FDA, they are aware of reported complications, all of which were a known possibility based on the initial studies and the post marketing approval follow up. So this isn't a case about data being fudged. Post market data is not solely gathered by the company, so can't claim bias in those.

    FDA Response to Essure Complaints | NBC4 Washington

    It sounds like if there is this much complaints, they should re-evaluate the procedure. I would imagine there would be discomfort of having an inflammatory response in your body and forming scar tissue, at least in the beginning when that happens. Once the scar tissue forms, your body no longer recognizes the foreign object because the scar tissue is blocking it. so its not permanent immune response going on.

  2. #42
    Veteran Member Dr Sampson Simpson's Avatar
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    Quote Originally Posted by Kontrary View Post
    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

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


    Hudak says Dr. Linda Bradley, one of the lead medical investigators for the clinical trial, insisted pain symptoms were unrelated to the Essure implants, so Hudak went along with the characterization that her comfort was “excellent.”

    “I honestly didn’t feel like she was listening to what I was saying and I thought it was important. I was a clinical trial participant. I thought that whatever I was saying, even if it didn’t seem related, should be taken seriously,” Hudak said.
    That doctor can be in serious trouble for this, very unethical.

    The claims that FDA doesn't review it thoroughly is just false, the people have no clue. They most certainly review the data thoroughly, and post marketing.

    And the doctors that perform the stuides, they are supposed to be unbiased. They get paid for doing the job, they don't get paid for giving positive results or not. They don't work for the company, the perform and report the trials for them since they are the doctors.

    I don't think a company is going to open themselves up for being destroyed by bribing doctors for positive results. I would love to hear the doctors explanation on this. Maybe the doctor was influenced by knowing the people got the procedure. That's why studies are blinded, that avoids any doctor bias and should in this case. BUt with med devices, not quite sure how they work the placebo thing.


    And a non scientist knowing nothing about science and medicine, and the entire process, has no right claiming they don't think they have enough data.
    Last edited by Dr Sampson Simpson; 15th November 2013 at 07:19 AM.

  3. #43
    Veteran Member Kontrary's Avatar
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    Quote Originally Posted by Dr Sampson Simpson View Post
    Based on the FDA, they are aware of reported complications, all of which were a known possibility based on the initial studies and the post marketing approval follow up. So this isn't a case about data being fudged. Post market data is not solely gathered by the company, so can't claim bias in those.

    FDA Response to Essure Complaints | NBC4 Washington

    It sounds like if there is this much complaints, they should re-evaluate the procedure. I would imagine there would be discomfort of having an inflammatory response in your body and forming scar tissue, at least in the beginning when that happens. Once the scar tissue forms, your body no longer recognizes the foreign object because the scar tissue is blocking it. so its not permanent immune response going on.
    Data was fudged, the woman complained of lower back pain...how is that EXCELLENT comfort? It was fudged when a participant claims the lead researcher is pressuring and even deciding that symptoms have nothing to do with the device and therefore should not be noted. The study itself was a problem with the choices that were given...it was slanted to favor the product.

    The procedure should be better, it BEGS for corruption the way it is now. You dont trust the people selling you the stuff, you trust a peer reviewed un-biased public study! Biased studies are not what the FDA should be using to approve or disapprove a drug and they certainly shouldnt be giving companies immunity from being sued based on such a biased study.

    I give you an example of a problem we have here ...when you purchase a house here, you go see it on the "showing days" and then bidding starts. You call the realtor to place your bid. When you are outbid by another person, you are notified and given a chance to up your own bid. NOW the person who takes these bids is the real estate agent..the one who gets a percentage of the sale price. They have a bias and you could see how some might FAKE bids to get people to bid higher than they would have. This might also work out for the seller...but the buyer ends up screwed. Now so far, there arent any complaints about this and no one complaining this happened BUT then again, it may happen and no one is the wiser. It needs to be changed because you dont put the St Bernard in charge of the doggie treats!
    Thanks from ptif219

  4. #44
    Veteran Member Kontrary's Avatar
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    Quote Originally Posted by Dr Sampson Simpson View Post
    That doctor can be in serious trouble for this, very unethical.

    The claims that FDA doesn't review it thoroughly is just false, the people have no clue. They most certainly review the data thoroughly, and post marketing.

    And sorry, a non scientist knowing nothing about science and medicine, and the entire process, has no right claiming they don't think they have enough data.
    If the FDA has followed this up and reviewed it properly they would have seen it was NOT a good clinical trial! The lady doesnt have to be a scientist to know that a researcher is telling her the pain she is reporting has nothing to do with the product so we can go ahead and say "excellent" for comfort! It doesnt take a scientist to know that one biased study isnt enough.

    If the FDA reviewed this as they should have, this would have been caught first and more trials would have had to have been done to satisfy the FDA to give this approval.

  5. #45
    Veteran Member Dr Sampson Simpson's Avatar
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    Quote Originally Posted by Kontrary View Post
    If the FDA has followed this up and reviewed it properly they would have seen it was NOT a good clinical trial! The lady doesnt have to be a scientist to know that a researcher is telling her the pain she is reporting has nothing to do with the product so we can go ahead and say "excellent" for comfort! It doesnt take a scientist to know that one biased study isnt enough.

    If the FDA reviewed this as they should have, this would have been caught first and more trials would have had to have been done to satisfy the FDA to give this approval.
    they followed up for more than 5 years post marketing, which they do. And not just data collected from the company, but from doctors reports from their patients. And nothing stood out as to what was already known and put on the label for complications.

  6. #46
    Veteran Member Kontrary's Avatar
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    Quote Originally Posted by Dr Sampson Simpson View Post
    they followed up for more than 5 years post marketing, which they do. And not just data collected from the company, but from doctors reports from their patients. And nothing stood out as to what was already known and put on the label for complications.
    Funny you should mention doctors...one doctor who says he did hundreds and had only a few problems ALSO admitted that he hadnt reported ANY of the problems he did have to the FDA because he worries about getting sued. So again, you seem to rely on how things SHOULD be rather than how they actually are. There is too much trust in this system...which means too much temptation to be dishonest and become corrupt...there is also obviously discouragement of other checks and balances (like doctors reporting) as you can see from a doctor who DOES support the product, he has NEVER reported an adverse affect to the FDA....you think he is the only one?

    FDA reviewing complaints with Essure after public outcry and ABC15 Investigation

    At the same time, Dr. Falk defends Essure, he recognizes many medical issues are underreported to the FDA. Dr. Falk said he’s never reported an adverse event to the FDA.

    “If the system were different, and we could report complications without fear of being sued,” said Dr. Falk, “Then, I think doctors would be more comfortable with reporting complications.”

  7. #47
    Veteran Member Kontrary's Avatar
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    Quote Originally Posted by Shelly View Post
    Thank you, I agree that there was too much trust at least in my case anyway. I try to remember that hindsight is 20/20 and blaming myself is unproductive but that's easier said than done. There were so few adverse event reports then and no widespread media attention. All the research I did was favorable. I'm not sure what I could have done other than use my common sense and that's where I failed. I am determined to not make the same mistake twice. I cannot afford to. I look and feel like death. I have fought this every step of the way but I continue to lose. I have no control and that's a hard pill to swallow.
    The woman who participated in the clinical trials that you are talking about is in our group. She claims she reported "severe pain" seven times and was ignored. She has her records as proof. Hopefully something will come of this.
    There are so many things I do not understand. How can a five year study done by the manufacturer be approved by the FDA? AND be given FDA preemption? Am I the only one who thinks this is wrong? And what kind of financial gain are these doctors getting? Each new member that comes into our group seems to have the same story. These doctors pushed this. Some say they were bullied. We have new members coming in daily who do not yet have the coils asking for advice on how to handle this. And why are they so adamantly denying the coils are the cause even with women who are developing symptoms immediately? I feel like I'm trapped in the twilight zone. They are refusing to do tests that will prove it is the coils! Instead they are prescribing other forms of birth control to manage the hormones including Mirena! How many women are out there suffering and don't know the cause? Bayer puts out a warning NOW that these things can cause chronic pelvic pain but that's only ONE symptom. We currently have over 90 women in our group who are pregnant with "e-babies" because these things MIGRATE so Bayer warns us now? I've heard story after story from women who say their coils are broken or missing. Doctors are finding them in their bowels, attached to the appendix etc after numerous complaints of severe pain. These women come to our group to get advice on how to get their doctors to listen and do the appropriate tests. WHY is this a fight? These women are already suffering! What the HELL is going on here?
    You definitely arent the only one who thinks something is wrong. Its all about the money. You have an under-funded and under-staffed FDA and then you have deep pockets that can use them to get a product to market that will give them an even bigger windfall of profits, stocks will rise, people will get bonuses etc. As you can see from one of the links I provided, a doctor who is SUPPORTIVE AND making money from this product even admits he has reported NO ADVERSE events (not just this product, but on ANY) due to worries about being sued.....because those pharm companies with those deep pockets can BURY a doctor who speaks up and makes them lose money.

    Its a very corrupted system and this corruption started decades ago and has been getting worse every year.

    There has also been one death now attributed to this device.

    10News - New report filed with FDA on Essure birth control, woman's death investigated - 10News.com - News

    A DEATH REPORTED

    In an Adverse Event Report filed with the FDA on September 19, 2013, a physician describes a patient who had the Essure coils implanted this year going to the “emergency room with abdominal pain.” There, a different doctor “performed a pelvic exam [and] found the patient’s cervix, fallopian tubes and uterus were necrotic.”

    The report goes on to describe the patient as testing positive for a type of strep infection. Then, the “patient went into renal failure ... and patient passed away,” the report said.

    The doctor “believes the cause of death was related to necrotizing group a streptococcus infection (streptococcal toxic shock syndrome),” the report said.



    I think its actually the women who suffer who got this to go public...it wasnt the FDA, not Bayer, not the doctors... it was the patients and thats why its taken too long to be heard.
    Thanks from ptif219

  8. #48
    Veteran Member Dr Sampson Simpson's Avatar
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    Quote Originally Posted by Kontrary View Post
    Funny you should mention doctors...one doctor who says he did hundreds and had only a few problems ALSO admitted that he hadnt reported ANY of the problems he did have to the FDA because he worries about getting sued. So again, you seem to rely on how things SHOULD be rather than how they actually are. There is too much trust in this system...which means too much temptation to be dishonest and become corrupt...there is also obviously discouragement of other checks and balances (like doctors reporting) as you can see from a doctor who DOES support the product, he has NEVER reported an adverse affect to the FDA....you think he is the only one?

    FDA reviewing complaints with Essure after public outcry and ABC15 Investigation

    At the same time, Dr. Falk defends Essure, he recognizes many medical issues are underreported to the FDA. Dr. Falk said he’s never reported an adverse event to the FDA.

    “If the system were different, and we could report complications without fear of being sued,” said Dr. Falk, “Then, I think doctors would be more comfortable with reporting complications.”

    Fear of being sued? that is the biggest crock of shit I've ever heard of. Why would a doctor get sued for doing what they are legally obligated to do, and that is report results of the clinical trial. Please find me an instance where that is supported, where pharma companies sued doctors for reporting negatively? Just because this guys say so, that means it must be true? That is a complete load, in fact, he should get sued for not reporting the data if what he says is indeed true and he failed to report any negative symptoms or experiences. Why would a company that would be sued for billions and billions, have its name tarnished, sue doctors for doing what they are supposed to do? As much as companies want their drug or device to get approval and be good, they want to know these things, because it will come out, and if they kill people, that will get them sued. If its known the intentionally influenced doctors, people are going to jail and they will be sued even more.

    As usual, all these links just present one side, the side of the woman who have had issues, the one doctor. Where is the other side? not presented. WHere is the mention of the others in the 750K who had great results? Where are the actual data? The actual facts about how clinical trials are performed?

    The comment about fear of being sued is the biggest load of crap I ever heard. THis guy should have his license revoked.

  9. #49
    Veteran Member Kontrary's Avatar
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    Quote Originally Posted by Dr Sampson Simpson View Post
    Fear of being sued? that is the biggest crock of shit I've ever heard of. Why would a doctor get sued for doing what they are legally obligated to do, and that is report results of the clinical trial. Please find me an instance where that is supported, where pharma companies sued doctors for reporting negatively? Just because this guys say so, that means it must be true? That is a complete load, in fact, he should get sued for not reporting the data if what he says is indeed true and he failed to report any negative symptoms or experiences. Why would a company that would be sued for billions and billions, have its name tarnished, sue doctors for doing what they are supposed to do? As much as companies want their drug or device to get approval and be good, they want to know these things, because it will come out, and if they kill people, that will get them sued. If its known the intentionally influenced doctors, people are going to jail and they will be sued even more.

    As usual, all these links just present one side, the side of the woman who have had issues, the one doctor. Where is the other side? not presented. WHere is the mention of the others in the 750K who had great results? Where are the actual data? The actual facts about how clinical trials are performed?

    The comment about fear of being sued is the biggest load of crap I ever heard. THis guy should have his license revoked.
    You can definitely be sued by a pharm company, they can claim you have no basis to say it was due to the product and you filed an adverse event INACCURATELY. Some struggling doctor who has loans and an office to support is no match for a pharm company...plus if you EVER want to get those 100 grand gigs (the ones where you show up and talk as an "expert" about how great a new product is) you better NEVER cross the pharm industry.

    I dont buy you really have such a naive polly-anna view.

    Funny how you think he should have license revoked for even expressing his fear of being sued.

    Of course what you still seem to be not understanding is that all your claims that all was working as it should be is WRONG.....the trials arent nearly as good as you claimed, the doctors cant be trusted to report adverse events...the FDA does not give proper scrutinization.....and I bet you think Bayer is just completely innocent in all this, the biggest benefactors of getting this to market and not having to do more years of clinical trials.

  10. #50
    Veteran Member Dr Sampson Simpson's Avatar
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    As usual, this discussion turns to conspiracies based on ignorance of the process.

    OK, people who claim its bad, explain the alternative? Do you realize how much a clinical trial costs? The doctors don't work for the companies, they don't use their big pockets to bribe the FDA, because if the drug is not safe, they pay big time when sued. Doctors don't get paid for their results. Also, most studies are double blinded, how can a doctor, who has no idea which patient got placebo, which got the real drug, influence a clinical trial?

    and as I mentioned, the FDA has big role in aiding in the design of the studies. They direct what type of data they require for approval. What would be the alternative? You don't think if there was independent organizations that did the studies, that there would not be the chance for corruptiona nd mistakes? For a company that has no stake in the game could make a huge mistake in the design of the trial that can kill the drug.

    I really think people need to research this thing more, not finding FDA bashing, biased, one sided internet articles, but from sources that actually hhave done the trial.

    And the rate of approval would be far greater by the FDA, and you would not have companies complaining about the high standards set by the FDA, if corruption was involved. There would be far more drugs, because an unapproved drug costs a company millions and millions.

    And a drug which is unsafe put on the marking knowingly by the company would cost them billions.

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