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Medical and Dental Device Safety Urgent Reform (MEDDSURGE)

Public Comments (586)
  • Nov 10th, 2015
    Someone from Houston, TX signed.
  • Nov 5th, 2015
    Someone from Dallas, TX signed.
  • Nov 3rd, 2015
    Someone from Menomonie, WI signed.
  • Nov 1st, 2015
    Someone from Cincinnati, OH signed.
  • Oct 30th, 2015
    Someone from Abbeville, LA signed.
  • Oct 30th, 2015
    Someone from Atlantic Highlands, NJ writes:
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    So many devices pass through on an antiquated loophole called the 510K. Devices that have been declared unfit for the human body have been called "The Gold Standard", a phrase often used by pharmeceutical representatives, and coincidentally many surgeons. Many of these devices would never have passed through if the FDA actually looked and tested them. For example the medical, vaginal meshes used today are, as evidenced by the thousands of litigants, and harmed patients, used without thought, nor informed consent. Had I known that a material akin to the backing of a rug, was to be implanted inside me, I never would have allowed this...Who would? The oil companies that the mesh material is derived, warned big pharmeceutical companies, to never put this inside a human being, yet greed outweighed clear, rational thinking. It clearly states that Polypropylene mesh degrades at anything over 75*. Our bodies are at a constant 98.7, so what does this tell you? It doesn't take a genius to figure that out...But, because it's predicate device was safe, it went on to market with absolutely no testing. Now you have to really ask yourself, who is the FDA protecting! Not the US consumers, no. The pharmeceutical companies have gained, and gained quite a lot. Please, stop catering to pharmeceutical influence, and begin to care for the public, their health and well being.
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  • Oct 29th, 2015
    Someone from Chesapeake, VA writes:
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    Myself and many women have been suffering because of the lack of clinical testing and the lack of education to these surgeons from the big pharmaceutical companies, it needs to stop now!
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  • Oct 29th, 2015
    Someone from Bolingbrook, IL signed.
  • Oct 29th, 2015
    Someone from Spring Hill, FL signed.
  • Oct 29th, 2015
    Someone from Point Reyes Station, CA signed.
  • Oct 28th, 2015
    Someone from Groveland, FL writes:
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    Bile duct and pancreas stents are a biohazard to the human body.I have contracted klebsiella pneumoniae from these stents .Doctors had to call me back to the hospital, once released after doing an ERCP (how they put the stents in ) because blood cultures came back Positive for klebsiella pneumoniae. I am still infected but doctors have already scrambled and have red flagged me to hide and falsify reports.I have many referrals from doctors stating that I need surgery to remove the stents but no doctors want to be Black Balled for Whistle Blowing. Code of Federal Regulations Section 803 Title 21 States that the FDA is bound Mandate and Self Report by Users Facility (Hospitals) Manufacturer Practitioner Any and all adverse events of medical devices. They are NOT reporting. They are injuring and killing American people by the THOUSANDS every year. THIS MUST STOP NOW!!!!!!!!!!
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  • Oct 23rd, 2015
    Someone from Broomfield, CO writes:
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    The sole responsibility of the FDA is to protect the public health. For the sake of the American people, the FDA needs to require product manufacturers to inform us of the materials used and the necessary compatibility testing to be done. If I had known that the Essure implants contained nickel, PET (and who knows what else) and that women were having adverse reactions, I would not have had the Essure implants! In 2011, Essure was presented to me as the safe alternative to tubal ligation and vasectomy. It was stated that it was non-surgical (which was a lie) and that side-effects were very rare. As it turns out, complications were covered up by the device manufacturer and it took the American population to come forth in numbers stating the devastation the Essure device has caused to bring awareness. Furthermore, Essure is an elective procedure - not a lifesaving procedure. Most women I talked to have never heard of the Maude database (so many cases have not even been reported).The result of this is that women who were young and healthy(prior to Essure implants) are now having hysterectomies in record numbers. And the sad thing is that corporate greed still reigns and Essure is still on the marked with no warning flag to the American people from the FDA!!!
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  • Oct 23rd, 2015
    Someone from Virginia Beach, VA signed.
  • Oct 21st, 2015
    Someone from Pacoima, CA signed.
  • Oct 20th, 2015
    Someone from Grand Rivers, KY signed.
  • Oct 20th, 2015
    Someone from Elizabethtown, KY writes:
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    DNA analysis should be done before any medical devices are implanted in a patient. It's cheap compared to the long term cost of someone, like me, has MTHFR mutation, as well as other gene defects.
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  • Oct 16th, 2015
    Someone from Cumming, GA writes:
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    Please take this off the market and make Bayer pay for all costs associated with removal and damages caused to the thousands of women who have this device. It has ruined my life and the lives of countless others
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  • Oct 16th, 2015
    Someone from Lake City, FL writes:
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    Please take Essure off the market and revoke the pma I have got Essure in2012 I have horrible back and admin pain and heavily bleeding y'all are there to protect the people of America not companies
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  • Oct 16th, 2015
    Someone from Redford, MI signed.
  • Oct 16th, 2015
    Someone from Jamaica, NY writes:
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    Please Recall essure!!!! It has damaged so many women's lives and their families as Well. This device is not helpful it is very damaging to a woman's body please revoke PMA 4 Essure. I have been a victim of this device since seven and a half years ago it has been a nightmare! I am in so much pain, I'm 36 i feel like I'm 95. Help us get this off the market! Essure problems shows 23,000 women hurt by the device. HELP!
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  • Oct 15th, 2015
    Someone from San Jose, CA signed.
  • Oct 14th, 2015
    Someone from Santa Cruz, CA signed.
  • Oct 13th, 2015
    Someone from Tacoma, WA signed.
  • Oct 9th, 2015
    Someone from Little Suamico, WI writes:
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    Please take Essure off of the market it is not safe. And help all of the women to have it removed.
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  • Oct 9th, 2015
    Someone from Racine, WI writes:
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    I have been permanently injured and suffered chronic metal poisoning which almost killed me thanks to Essure. Something needs to be done to protect us from harmful devices and from greed and power over safety.
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  • Oct 7th, 2015
    Someone from Rancho Palos Verdes, CA writes:
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    After 9 years the Essure coil on my left side doubled over to resemble a fish hook which caused me severe bone throbbing pain on the left side of my body for 7 months. Finally surgery to remove my coils in tubes left fragments. Another surgery 3 months later to remove my uterus and cervix. Now I have Raynauds syndrome, chronic tailbone pain and other strange symptoms that come and go and come again daily and/or weekly. Doctor bills are piling up. I wish I would've just gotten my tubes tied!!!
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  • Oct 7th, 2015
    Someone from Huxley, IA writes:
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    Frequent trips to the ER uncontrollable pain, took my healthy gallbladder out, greatly effected my ability to run my business, huge financial burden to my family and emotional burden. Hours and hours of wasted time running auto immune tests, blood tests, and being useless on pain killers. Essure is ruining my life!
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  • Oct 7th, 2015
    Someone from Hollywood, FL writes:
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    People over PROFITS. I am an Essure victim!!
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  • Oct 7th, 2015
    Someone from Cumming, GA writes:
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    Please take this off the market, it is poisoning women and causing irreversible damage
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  • Oct 7th, 2015
    Someone from Omaha, NE writes:
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    Seriously, the time has come for you to do your job...and do the right thing.
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  • Oct 7th, 2015
    Someone from Carson City, NV writes:
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    Please get the Essure off the market and pay for those who have it to get it removed.!!
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  • Oct 7th, 2015
    Someone from Arnold, MO signed.
  • Oct 7th, 2015
    Someone from Sherman, TX writes:
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    I have had the ESSURE implanted in 2013. Since then have pelvic pain, terrible migraines, and no energy. Having my coils/tubes removed and D&C done this Friday in hopes to provide relief back to my body. I would have never had the ESSURE placed if I would have know the horrible side effects that were to follow. My insurance would not pay for me to have a full hysterectomy or I would have went down that route to totally free of the ESSURE.
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  • Oct 7th, 2015
    Someone from Las Vegas, NV signed.
  • Oct 7th, 2015
    Someone from Weidman, MI signed.
  • Oct 7th, 2015
    Someone from Syracuse, UT signed.
  • Oct 7th, 2015
    Someone from Baldwin, MI signed.
  • Oct 7th, 2015
    Someone from Lyons, NY writes:
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    The fact that Medicaid won't pay to replace amalgam fillings with something less toxic is proof that Medicaid works primarily to boost profits of the for-profit medical industry, and any considerations of health come in a distant second.
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  • Oct 7th, 2015
    Someone from Cape Coral, FL writes:
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    essusr is hell to live with i wont it recalled and out of me
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  • Oct 7th, 2015
    Someone from Corbin, KY writes:
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    I have something for sale, if you want it, I'm currently still using it, but I'm sure like a fine wine, it just adds with time. I bought brand new, I wasn't told all it could do. In fact there just one thing it could so I was told, convincing me it's worth more then it's weight in gold. For me it did what it said it would do, no new additions here. But before you buy the same that I had bought, just a thought, what do you think of its improvements over time? Frequent urination, insomnia extreme tiredness exhaustion mass of mood swings low to no sex drive painful sex hurt days afterward Constant cramping sharp shooting pain's pre-labor contractions nausea lack of appetite weight gain extreme bloating consistent feeling of fullness on and off rashes Small sores rashes that will not heal ridges on nails and toenails random tingling in hands and arms Rush of electricity through legs and feet almost daily extreme brain fog short-term memory loss mouth health changes receding gum line debilitating migraines at least twice a week That being said if you still wanna buy, do you think you add any "improvements" on top of mine? #essureeducation #essureproblems
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