Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh

Tuesday, July 24, 2018

BAYER Essure sterilization device: FAILED globally.

Bayer to phase out Essure birth control device in U.S.



NEW YORK (Reuters) - Life sciences company Bayer AG said on Friday it would discontinue the sale of its birth control product Essure in the United States, citing a decline in sales of the implantable device that made the business no longer sustainable.

The decision followed an announcement by the company in September 2017 that it would discontinue the sale of the contentious sterilization device in all countries outside the United States.
Bayer said in a statement that the decision was not related to safety concerns. The company, based in Leverkusen, Germany, is facing some 16,000 U.S. lawsuits over Essure, and it said it was expecting more.
“The benefit-risk profile of Essure has not changed, and we continue to stand behind the product’s safety and efficacy, which are demonstrated by an extensive body of research,” Bayer said.
It said it had informed the U.S. Food and Drug Administration of its decision and would update healthcare providers.

Essure will be gradually phased out and U.S. sales halted by the end of this year. Doctors will be able to perform Essure procedures until the end of next year when they will be asked to return unused devices.
FDA Commissioner Scott Gottlieb said in a statement that the agency would continue to monitor Essure’s safety, and added, “We expect Bayer to meet its postmarket obligations concerning this device.”
Early in 2016, the FDA put its strongest safety warning label on the device after thousands of complaints and asked the drugmaker to conduct a post-market study.
The agency said it received nearly 12,000 reports in 2017 related to Essure.
Bayer said extensive research by the company and independent medical researchers showed Essure was safe.
Women have claimed in lawsuits that Essure, which is implanted in a woman’s fallopian tubes to permanently block the passage of eggs to the uterus, could pierce the tubes, and that metal parts of the device could become dislodged and migrate to other parts of the body, causing pain, injuries and severe bleeding.

They also claimed that the device failed to prevent unwanted pregnancies and led to nickel allergies and depression.
Bayer has been accused in lawsuits of knowing the risks associated with Essure and failing to warn sellers, doctors and regulators.
Marcus Susen, a Florida-based lawyer representing a number of women who have sued the company, called its decision long overdue, and said it would be up to a jury to decide if Bayer stopped the sale of Essure for commercial or safety reasons.
Bayer spokesman Steven Immergut said the company had sold roughly one million Essure devices worldwide since the product came on the market in 2002.
The majority of those sales were in the United States, he said, where the company has seen an average 40 percent annual sales decline in the device since its introduction.
In April, the FDA said some women were not being properly informed of the risks associated with Essure before getting implanted and it limited its sale to healthcare facilities providing full information about its risks and benefits.

Bayer said in a statement that the decline in sales was due to an overall decrease of permanent contraception in the United States, a growing reliance on other birth control methods and “inaccurate and misleading publicity about the device.”

Reporting by Tina Bellon; Editing by Clive McKeef, Toni Reinhold

15 comments:

  1. I will recommend anyone looking for Business loan to Le_Meridian they helped me with Four Million USD loan to startup my Quilting business and it's was fast When obtaining a loan from them it was surprising at how easy they were to work with. They can finance up to the amount of $900,000,000.000 (Nine Hundred Million Dollars) in any region of the world as long as there 1.9% ROI can be guaranteed on the projects.The process was fast and secure. It was definitely a positive experience.Avoid scammers on here and contact Le_Meridian Funding Service On. lfdsloans@lemeridianfds.com if you looking for business loan,Thanks.
    Leslie,

    ReplyDelete



  2. Do you know you can withdraw free cash from any ATM machine with a hacked ATM card?

    introducing our newly designed super intelligent specially programmed blank ATM cards that can be use to hack ATM machines and cause them to spill out cash, the ATM cards can be used to withdraw at the ATM or swipe at stores and POS. We sell this cards to all our customers and interested buyers worldwide please beware of scams selling counterfeit cards we sell the original cards with documents to validate our transactions, the card has a maximum daily withdrawal limit of $5000 on ATM machines and also if you are in need of any other cyber hacking services, we are here for you anytime any day.
    Here is our price lists and withdrawal limits of each of our cards:

    limit of $1000 perday cost $200
    limit of $2000 perday cost $300.
    limit of $3000 perday cost $400.
    limit of $4000 perday cost $500.
    limit of $5000 perday cost $600.

    make up your mind before applying, straight deal no biting round the bush this is 100% legit its a one time payment the above prices includes the shipping fee and activation cost we base in USA!

    contact our via email at blankatm156@gmail.com

    ReplyDelete
  3. His never a good thing to be divorced but my ex cheated on me so i had to call it quit with her. I'm willing to remarry if am able to find the right one. Tell me about your family background i.e your parents and siblings?

    ReplyDelete

  4. CLASSIC CYBER NOTCH
    How well are you prepared for a Cyber incident or Breach?, Is your Data safe?
    Strengthen your Cybersecurity stance by contacting CLASSIC CYBER NOTCH @ GMAIL DOT COM for a Perfect, Unique, Classic and Professional Job in Securing your Network against all sort of breaches and from scammers as well.
    For we are Specially equipped with the Best hands to getting your Cyber Hack needs met as your jobs will be handled with utmost professionalism.

    We do All type of cyber Jobs such as:
    ☑ TRACKING of GPS location, cars, Computers, Phones (Apple, windows and Android), e.t.c.
    We also Track
    E-MAIL account,(G-mail, Yahoo mail, AOL, Proton mail, etc.)
    SOCIAL MEDIA account, (Facebook, Twitter, Skype, Whatsapp, e.t.c.)

    ☑ RECOVERY of Passwords for E-mail address, Phones, Computers, Social media Accounts, Documents e.t.c

    ☑ INSTALLATION of Spy ware so as to spy into someone else's computer, phone or E-mail address and also Installation of Spy ware software on your individual O.S to know if your Gadget is being hacked into..
    We also Create and Install VIRUS into any desired computer gadget.

    ☑ CRACKING Websites, any desired gadget it computers or phones, CCTV Survelance camera, Data base (of both Private and Govt organization, such as Schools, Hospitals, Court houses, The FBI, NSA) e.t.c....

    NOTE:
    Other Jobs we do are:
    ☑ We provide Private Investigator service
    ☑ Clearing Criminal records of diverse type
    ☑ Binary Options fraud Recovery
    ☑ Bitcoin Mining
    ☑ Issuing of Blank ATM cards
    ☑ And many more... etc.

    We assure you that your Job will be attended to with care and efficiency as it will be handled by the Best professional hands in Cyber literacy.
    We also have a forum where you can get yourself equipped with Advanced hacking Knowledge..

    CLASSIC CYBER NOTCH gives you the Best service in the Hacking world.

    Be sure to 📱 💻 us @

    Classic cyber notch at gmail dot com

    any time, any day to get the Best Professional hands involved in putting a smile on your face.
    We're Classic Notch

    Signed,
    Collins .A.

    ReplyDelete
  5. I was hurt and heart broken when my husband left me with two kids for one year, All effort to bring him back failed I thought I'm not going to see him again not until I met a lady called Jesse who told me about a spell caster called Dr.Oku, She gave me his email address and mobile number and I contacted him and he assured me that within 28 hours my husband will come back to me, In no less than 28hours my husband came back started begging for forgiveness saying it is the devils work, so I'm still surprise till now about this miracle,i couldn't conceive but as soon as the spell was cast,i became pregnant and gave birth to my third child(Michelle) if you need any assistance from him you can contact him via:email; okutemple@gmail.com , you can also call him or add him on Whats-app: +2347053113465 and tell him I referred you to him

    ReplyDelete
  6. I was hurt and heart broken when my husband left me with two kids for one year, All effort to bring him back failed I thought I'm not going to see him again not until I met a lady called Jesse who told me about a spell caster called Dr.Oku, She gave me his email address and mobile number and I contacted him and he assured me that within 28 hours my husband will come back to me, In no less than 28hours my husband came back started begging for forgiveness saying it is the devils work, so I'm still surprise till now about this miracle,i couldn't conceive but as soon as the spell was cast,i became pregnant and gave birth to my third child(Michelle) if you need any assistance from him you can contact him via:email; okutemple@gmail.com , you can also call him or add him on Whats-app: +2347053113465 and tell him I referred you to him

    ReplyDelete
  7. I find something in herbal medicine good to share on here with anyone suffering from the disease such as HIV, Herpes, Hepatitis or Chronic Lyme Disease, Lupus as well.Dr Itua herbal made cure my HIV and gave me hope that he can cure all types of diseases I believed him) I do the best of myself that I can do, I went for a program in west Africa about fashion on another side I was HIV positive. I walk through a nearby village for our program schedule then I found a signage notice that says Dr Itua Herbal Center then I asked my colleagues what all about this very man called Dr Itua, She told me that he's a herbal doctor and he can cure all kind of disease i walked to him and explain myself to him as I'm a strangler out there he prepared me herbal medicine and told me how to drink it for two weeks, when I get to my hotel room I take a look at it then says a prayer before I drank it not knowing after two weeks I went to test and I found out I was negative I ran to him to pay him more but he refuses and says I should share his works for me around the globe so sick people can see as well. I'm writing a lot about him this season so that is how I was cured by drinking Dr Itua herbal medicine, He's A caring man with godly heart. Well - everything I decided all go through for me well and how you're going to treat this new aspect to your life. You don't have to suffer alone, and it's okay to ask for help. It also doesn't have to be a constant demon, as you'll get to know your body and yourself in a much deeper way than most people. Take advantage of this, as it will help you appreciate Africa Herbal Made.
    Dr Itua Contact Information.
    Email...drituaherbalcenter@gmail.com
    Whatsapp Number....+2348149277967

    ReplyDelete
  8. INSTEAD OF GETTING A LOAN,,  I GOT SOMETHING NEW
    Get $5,500 USD every day, for six months!

    See how it works
    Do you know you can hack into any ATM machine with a hacked ATM card??
    Make up you mind before applying, straight deal...

    Order for a blank ATM card now and get millions within a week!: contact us
    via email address::{Automatictellers@gmail.com}

    We have specially programmed ATM cards that  can be use to hack ATM
    machines, the ATM cards can be used to withdraw at the ATM or swipe, at
    stores and POS. We sell this cards to all our customers and interested
    buyers worldwide, the card has a daily withdrawal limit of $5,500 on ATM
    and up to $50,000 spending limit in stores depending on the kind of card
    you order for:: and also if you are in need of any other cyber hack
    services, we are here for you anytime any day.

    Here is our price lists for the ATM CARDS:

    Cards that withdraw $5,500 per day costs $200 USD
    Cards that withdraw $10,000 per day costs $850 USD
    Cards that withdraw $35,000 per day costs $2,200 USD
    Cards that withdraw $50,000 per day costs $5,500 USD
    Cards that withdraw $100,000 per day costs $8,500 USD

    make up your mind before applying, straight deal!!!

    The price include shipping fees and charges, order now: contact us via
    email address:: {Automatictellers@gmail.com}

    Visit our Website for more Info: automatictellers.webs.com
    ®

    ReplyDelete
  9. PLEASE READ!!!Hello Guys!!! I am Sharon I live in Ohio USA I’m 37 Years old, am so happy I got my blank ATM card from Adriano. My blank ATM card can withdraw $4,000 daily. I got it from Him last week and now I have withdrawn about $10,000 for free. The blank ATM withdraws money from any ATM machines and there is no name on it because it is blank just your PIN will be on it, it is not traceable and now I have money for business, shopping and enough money for me and my family to live on.I am really glad and happy i met Adriano because I met Five persons before him and they could not help me. But am happy now Adriano sent the card through DHL and I got it in two days. Get your own card from him right now, he is giving it out for small fee to help people even if it is illegal but it helps a lot and no one ever gets caught or traced. I’m happy and grateful to Adriano because he changed my story all of a sudden. The card works in all countries that is the good news Adriano's email address is adrianohackers01@gmail.com

    ReplyDelete
  10. PLEASE READ!!!Hello Guys!!! I am Sharon I live in Ohio USA I’m 37 Years old, am so happy I got my blank ATM card from Adriano. My blank ATM card can withdraw $4,000 daily. I got it from Him last week and now I have withdrawn about $10,000 for free. The blank ATM withdraws money from any ATM machines and there is no name on it because it is blank just your PIN will be on it, it is not traceable and now I have money for business, shopping and enough money for me and my family to live on.I am really glad and happy i met Adriano because I met Five persons before him and they could not help me. But am happy now Adriano sent the card through DHL and I got it in two days. Get your own card from him right now, he is giving it out for small fee to help people even if it is illegal but it helps a lot and no one ever gets caught or traced. I’m happy and grateful to Adriano because he changed my story all of a sudden. The card works in all countries that is the good news Adriano's email address is adrianohackers01@gmail.com

    ReplyDelete
  11. Are you interested in any kinds of hacking services?
    Feel free to contact TECHNECHHACKS.

    For years now we’ve helped so many organizations and companies in hacking services.
    TECHNECHHACKS is a team of certified hackers that has their own specialty and they are five star rated hackers.

    We give out jobs to hackers (gurus only) to those willing to work, with or without a degree, to speed up the availability of time given to jobs!!

    Thus an online binary decoding exam will be set for those who needs employment under the teams establishment.


    we deal with the total functioning of sites like,


    • SOCIAL MEDIA (Facebook, Twitter, Instagram, Snapchat, google hangout etc.)

    • SCHOOL GRADES

    • IOS/OS

    • CREDIT SCORES

    • BANK ACCOUNTS

    • SPOUSES PHONE

    Our special agents are five star rated agents that specializes in the following, and will specially be assigned to you for a special job well DONE.

    • WESTERN UNION TRANSFER

    • CREDIT CARDS INSTALLATION

    • MONEY FLIPPING

    • CRIMINAL RECORDS

    • BTC RECOVERY

    • BTC MINING

    • BTC INVESTMENT

    Thus bewere of scammers because most persons are been scammed and they ended up getting all solutions to their cyber bullies and attacks by US.

    I am Jason williams one of the leading hack agent.

    PURPOSE IS TO GET YOUR JOBS DONE AT EXACTLY NEEDED TIME REQUESTED!!!



    And our WORK SUCCESS IS 100%!!!



    We’re always available for you when you need help.

    Contact or write us on:

    Technechhacks@gmail.com

    SIGNED....!

    Jason. W

    TECHNECHHACKS
    2021©️All Right Reserved

    ReplyDelete
  12. Are you interested in any kinds of hacking services?
    Feel free to contact TECHNECHHACKS.

    For years now we’ve helped so many organizations and companies in hacking services.
    TECHNECHHACKS is a team of certified hackers that has their own specialty and they are five star rated hackers.

    We give out jobs to hackers (gurus only) to those willing to work, with or without a degree, to speed up the availability of time given to jobs!!

    Thus an online binary decoding exam will be set for those who needs employment under the teams establishment.


    we deal with the total functioning of sites like,


    • SOCIAL MEDIA (Facebook, Twitter, Instagram, Snapchat, google hangout etc.)

    • SCHOOL GRADES

    • IOS/OS

    • CREDIT SCORES

    • BANK ACCOUNTS

    • SPOUSES PHONE

    Our special agents are five star rated agents that specializes in the following, and will specially be assigned to you for a special job well DONE.

    • WESTERN UNION TRANSFER

    • CREDIT CARDS INSTALLATION

    • MONEY FLIPPING

    • CRIMINAL RECORDS

    • BTC RECOVERY

    • BTC MINING

    • BTC INVESTMENT

    Thus bewere of scammers because most persons are been scammed and they ended up getting all solutions to their cyber bullies and attacks by US.

    I am Jason williams one of the leading hack agent.

    PURPOSE IS TO GET YOUR JOBS DONE AT EXACTLY NEEDED TIME REQUESTED!!!



    And our WORK SUCCESS IS 100%!!!



    We’re always available for you when you need help.

    Contact or write us on:

    Technechhacks@gmail.com

    SIGNED....!

    Jason. W

    TECHNECHHACKS
    2021©️All Right Reserved

    ReplyDelete