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New* Fridays with the FDA: One Lovely Lady's Plea

Anonymous woman, WikiCommons

Anonymous woman, WikiCommons

A lovely woman called me this afternoon. Her suggestion for a Friday effort and beyond!!

She can’t be identified but she says:

“The FDA is giving us an opportunity to speak and get mesh reclassified so  more women will be less likely to innocently have it done to them. Doctors would be forced to give more information and companies would be forced to do testing for safety.”

“My friends and family see what mesh has done to me. They ask ‘Is there anything I can do for you?’ and I tell them YES!

“You do not have to be mesh-injured, you can be my friend, co-worker, church friend, relative, anyone who sees what has happened to others can weigh in….Please ask them to do so. That’s what you can do for me!”

Tell the FDA it should consider mesh for pelvic organ prolapse (POP) AND stress urinary incontinence (SUI) AND hernia mesh- it’s ALL POLYPROPYLENE. Tell the FDA to make it Class III- HIGH RISK, and tell them why. Tell them what you’ve seen in your friends and family.   They see my life, they know what’s been done by this product” she says.

This lovely woman has encouraged at least 50 others to sign on.

Have you asked your friends and family and associates to DO SOMETHING FOR YOU?  Have you entered you concerns to the FDA?  It’s the only way they know.  The door is opened- please walk through.  The comment period ends July 30.

Without enough comments, it will not happen.  Thank you for the Friday reminder lovely lady….

Click on the Reclassification Entry here:

Here is the proposal.

Here is the Mesh News Desk story:

http://meshmedicaldevicenewsdesk.com/fda-notices/fda-announced-proposal-to-reclassify-pelvic-mesh/

 

25 Comments

  1. pam says:

    I read in texas , how they are telling about state medicaid paying for mesh surgery and more. I KNOW THAT THE TIME THAT i was married and had children, bladder fell, and bladder leakage started years before mesh implant, I was married , I worked hard with my then husband, now ex, WE PAID FOR INS, >>NOT MEDICAID AND MEDICARE. ,<< AS BEFORE DIVORCE, THEY SAID HIS MONEY AND MY MONEY WAS BOTH OF OURS, (SOMEONE DIDN'T TELL HIM THAT) I worked hard in and out of home on jobs paying SS and taxes, plus, but as soon as divorce happened , they would not consider our work together as both with ss and taxes and more. IT WAS NOT MEDICAID THAT PAID FOR CHILD BIRTHS AT ALL, BUT INS WE PAID AT WORK TO COVER OUR FAMILY HEALTH NEEDS, NOR WAS IT MEDICARE. i AM OFFENDED AT ANYONE SAYING THOSE THAT MESH IMPLANT WAS PAID BY STATE INS. WHEN WE HAD NO CHOICE TO WANT BLADDER LEAKAGE TO STOP, TO GET BACK TO NORMAL LIFE, NOT ALL WERE STATE MEDICAID WHEN BLADDER INJURIES HAPPENED BY WAS WORKING TAX PAYERS AND ALSO PAID OUR INS THROUGH OUR WORK PLACES OF EMPLOYMENT, NOT FREE LOADERS AS SOME CALL MEDICAID STATE , INS. IT HAPPENED JUST AS WE WANTED THE MIRACLE BLADDER MESH AS WE WERE TOLD TO STOP LEAKAGE AND MORE FROM BLADDER Falling during child birth years. as when bladder mesh implant was done, when surgery to remove mesh came, immediately we were taken off of state medicaid, even the day before mesh to remove surgery. STATE LEADERS HAD TO BACK REMOVING MESH IMPLANT PATIENTS FROM GETTING STATE HELP, TELL THE TRUTH! IF ANY WITH MESH WEB SITES ARE PUSHING DEMOCRAT OR REPUBLICAN ISSUES AND STANDS FOR EVIL , IT IS BOTH PARTIES THAT DID NOTHING TO STOP MESH BECAUSE BOTH PARTIES BENEFITED COVERING UP MESH ALL THE WAY TO THE SORRY FDA. WHEN PEOPLE COME ACROSS AS ANGELIC PEOPLE NOT SPEAKING STERN BACK UP, NOT ALL ARE FLYING HIGH IN COVER UP AND LIES TO PIUSH EVIL WAYS. BUT SPEAK OUT FOR TRUTH, AS SOME WILL NOT SPEAK OUT, BECAUSE THEY LIKE MESH COMPANIES NOT SUFFERING AS SOME HAVE SUFFERED HAVE GREEDY WAYS TO THINK THEY HAVE A RIGHT TO CHOOSE, i SAY ANYONE FALSELY SAYING THEY HAVE A CASE NOT DAMAGED BE THEY, WOMEN, MEN, ATTORNEY, DOCS , NURSES, , POLITICIANS AND MORE DESERVE NO REWARD AT ALL BY THOSE THAT WON'T POWER AND MONEY SAME AS SORRY MESH COMPANIES. i have suffered enough , has some other women damaged not mildly , but very severely by mesh, not funny or entertainment at all,

    • Kitty says:

      First off–Jane thanks for getting this out again regarding the FDA. Hopefully others will enter their comments

      and Pam—its interesting what you write. ——-I am thinking of this.—Medicare and Medicaid and Private insurance companies can sue to get paid back for explanting mesh—- Do they also want the money back for implanting the mesh?

      • Jane Akre says:

        Kitty= Can we get the premiums we paid them back also? Only seems fair.

        • msm says:

          Jane, I hadn’t even thought about that. It should be 100% recoverable if the only bills paid during that period are for mesh related treatment (just my opinion as always)

        • Kitty says:

          Hello Jane That is what am waiting for in my law suit if it ever comes to fruition—I believe that would come under personal injury.

      • pam says:

        kitty, I want to know why no one has done nothing about what doctors and nurses, (and I know you are a nurse) that has been so inhumane, mind games , lying to women over and over, that they know and attorney’s know that would break a person mentally for years of hell and lies they tell, and they get paid for every office visit and do nothing at all to help women just more lies, THE PROOF OF ANTI BIOTICS RECORDS OF YEARS HAVING TO TAKE THEM FOR ON GOING INFECTIONS, AS ONE DOCTOR SAID, NO MESH, NO SIGNS OF INFECTIONS, SO WHY DID SHE GIVE ME A CREAM FOR OUT SIDE INFECTION OF FISTULAS AND ANTI BIOTIC, LIKE THOSE THAT SAID NO INFECTION , IN RECORDS THEN IS IT IN THEIR EVIL LIES THEY PUT IN RECORDS THAT THEY CALLED DAYS LATER STRESSING INFECTION AND TO GET IT BECAUSE OF INFECTION. COVERING FOR THE SORRY SCUM DOCTORS THAT LIED TO US AND YES THEIR SORRY LYING NURSES THAT LAUGHED EVEN IN OUR FACES OVER PHONE. ATTITUDES FROM MOST VILE IN MEDICAL THAT WAS PLANNED TO CHOOSE GUINEA PIGS WHY? i am not the only 1 that has told they have been through similar cruelty of docs and nurses, so why can’t these be exposed like the sorry chemical companies . why is ins and more saying women have to pay back what lying docs and nurses lied to us and got paid millions , (billions) robbing ins companies also, not women as they put bladder mesh women on their evil merry go round, calling us even ignorant as the woman said the doc said to her at wal greens, I am sick of the damn mind games , and lies and everyone wants the lying doctors and nurses to slide and get by with assisted murder as was told on this web site some women have died , comitted suicide, because of sorry scum in medical too.

        I am sure as some investigators with medicare in this state that also was cruel, said they saw nothing wrong with what sorry doctors and their nurses did to me, using words that some have used in other med offices since they too read medical news desk, well bless your heart, sarcastically, not nice at all, I TOLD A WOMAN, NOT A LADY THAT USED THE WORDS AGAIN SARCASTICALLY, i said do not use those words to me, the way they are said makes me sick. THEY NEED TO GET THEIR MONEY BACK FROM LYING DOCTORS AND NURSES. TRYING TO BEREAK WOMEN MENTALLY , WHEN THEY HAVE TRIED TO BE STRONG AND ATTORNEYS DO NOTHING BUT ADD MORE STRESS ALSO TO CLIENTS REALLY NEEDS TO BE INVESTIGATED. INHUMANE, THOSE WE TRUST IN MEDICAL. WHEN i told an evil doctor , I was nice about drawing up my hand and arm, I HAD MENTIONED IT TO HIM BEFORE, HE RESPONDED SO EVIL, WHY YOU MUST HAVE HIT YOUR FUNNY BONE, i have done nothing to deserve what I HAVE HAD TO TAKE. NOT UNTIL THEY PROVOKE ME TO ANGER. BUT MY MESH GOES DEEPER, IF EVER ANYONE SAYS THAT i AM NOT CRAZY AS THOSE IN POWER AND LAW HERE, THAT LIED , THAT SHINES LIGHT ON TRUTH OF THOSE THAT DO THE DIRTY WORK FOR THOSE IN POWER AND COURTS AND LAW LIKE THEY DO HERE TO COVER UP , JANE LIKE YOU FOUND OUT, THAT MEDIA ALSO DOES, THEY ALL HAVE ALL COVERED, they tried to buy you off jane, not with me, they even get those in medical to do their dirty work, to say I AM CRAZY AND CANNOT BE BELIEVED , i did not know some children taught to lie is good, and to grow up doing evil in lies destroying people’s lives , is what adults do to get ahead, You could not do that jane, but to tell the truth and expose those so evil especially in news and power and law, > medical too. if all we have are liars, america is in worse that deep mesh meshed up s—-.

  2. stopmeshimplants says:

    Excellent suggestion. Thank you.

  3. Mary pat says:

    Let’s consider this. Many of the treatments needed to repair or treat damage and pain caused by mesh are deemed “experimental” by insurance companies so they will not pay for them (out of state surgery by Mesh removal experts, botox injections, hyperbaric oxygen treatments….). Yet, mesh that was NEVER tested was implanted and paid for wothout question by insurance companies. Go figure?

    • Kitty says:

      I am starting to see the picture. Do the states have the Chutzpah to go after the federal. —And didn’t I read somewhere that President Obama and wife Michelle may have some ties to J&J?

      • Jane Akre says:

        Hi Kitty-

        Many mutual funds are invested in J&J since it is considered a reliable stock and usually a “buy” by investors….Raising the profile may raise some questions among those investors… don’t know about the president.

    • Jane Akre says:

      And why do insurance companies suggest this as a first line defense if it is experimental? Remember the story on Dr. Lucente in the WSJ where that was revealed?
      http://online.barrons.com/article/SB10001424052702303546204579435162509926916.html?mod=rss_law&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+wsj%2Fxml%2Frss%2F3_7091+%28WSJ.com%3A+Law%29

      • Kitty says:

        Hi Jane The following letter was sent to you some time ago and I cut and pasted it. —But I think it is worth looking at again—especially in light of the the AMS 40K settlement. See below:

        August 21, 2013 at 6:35 pm

        Jane, Thanks as always for your reporting…always waiting with baited breath for your reports. Love the backstories and side stories as well.

        If I may digress a bit…I really take offense at calling the women victims “meshies”. I find it offensive and self-denigrating. It is not cute…nothing about any of this is cute and I wish women would not refer to themselves in this way. I do not wish to be critical of our British sisters, but please lets find some more respectable term.

        I have advised my counsel that I am not happy with the Cisson award because of the 75% her state of residence (or where surgery was done) is taking of the punitive award. I have stated that if that is going to be allowed then the punitive award must be increased retroactively to reflect that and/or the “law” should not apply where plantiffs were not aware of it. We must not put up with this. How much are we going to allow our governments to take from us before we protest in earnest? What are they doing with these monies. Are we holding them accountable. Where is the reporting. I want to know.

        Also with regard to awards being based on lifetime value as earners….I protest that as well. My guess is that a large percentage of the victims are older women…baby boomers and older. Already they are a disadvantaged group because they are women and because they are older. Now they tell us that because they are older their award will be less because the remainder of their work (productive) lives has passed….meaning they are of less value to the state (Lets tell it like it is)? This is how we value human life? How many great statesmen, poets, musicians. teachers, religious leaders, and philosphers do you know of who did their best work in their “golden” years? Do we value human life based on only how much one produces for the corporation? If that is the case there is little hope for a bright future for the America we knew and loved. And how many of these older women, these victims, might go on to serve as the matenal and female figures that knit their communities together, through their participation in womens clubs, grass roots politics, school boards, church choirs and volunteers in hospitals and in after school programs giving more than they are nourished by these activities. If they do not even have enough money for future medical care, if they get the message that they are not valuable and their nation cares more about corporations than its people, they are likely to be brokenhearted and die much sooner. Mrs. Cisson may not have the money to even cover the long term costs of her medical care, costs incurred because of corporate greed. What will happen to her when she runs out of money and hits her lifetime maximum with her insurance company? Her husband will probably pass away before she does unless the toxic mesh kills her first and then what will she do? Will she need to depend on Medicaid at some point or will she not even qualify for that eventually and end up dying alone before her time in some obscure third rate Nursing Home run by another corporation in some obscure corner of the state that took her money, another forgotten victim, while Johnson & Johnson continue producing products that make them billions of dollars. If they have to pay off a few old ladies to the tune of $2M a pop that is just part of the cost of doing business, it is nothing to them, such losses are built into their business plans. Then lets force that state to support her for the rest of her life!

        So what are we going to do about it? Are we going to retreat each into our own little lives or are we going to use our legislative power and organizational power to change laws, to draw attention to injustices, and monitor our governments and their actions. Democracy is like a marriage….it requires constant work, attention, modification, understanding. We can not just go shopping and let someone else handle it. If we are not vigilant we will lose our Democracy, it will evolve into something dark and menacing and folks, it has already started to happen.

        • pam says:

          Thanks kitty, true, I AM NOT GOD AT USING WORDS I NEED, to post, I know. I HATE THIS MERRY GO ROUND, THAT I HAVE NO CHOICE SINCE MESH IMPLANT AND NOT 1 DAMN THING I CAN DO TO GET OFF OF IT, NO matter what is going on with me getting older as a senior citizen, When I see a doctor, nothing to resolve what mesh has done, IT IS BECAUSE I AM NOW 65, BUT, I KNOW, that before mesh, you bounce back, and get strength back, to carry on as before. after 1st attempt to remove, I NEVER GOT BACK STRENGTH AT ALL, LAST 2 YEARS, HAS GOT WORSE. I SEE WOMEN OLDER THAN ME, WALKING, AND DOING THINGS i did, even 2 years ago , WHAT HAPPENED? IN 2012, TO TRIM MESH, , ON GOING THAT MESH STILL PROTRUDING OUT CANNOT BE REMOVED, so I will die with on going infections, and mesh moving, NO STOPPPING, i believe some women were chosen for exactly what I am going through, before mesh implant, some not. some could be removed , some not. we are the ones that have been through pure hell, since mesh implants, every where we go, with medical and more. my memory serves me right, all that was going on with medical doctors before mesh. no questions allowed, as I was told before mesh by a doctor I asked to many questions. red flags, no talking. I and they knew too, I was 1 that showed anger when I GOT ATTITUDE AND NO ANSWERS. i want to know, <<< WORDS NO PERMITTED.

  4. pam says:

    KITTY, > DATA INFLUENCE EXPLORER, SHOWS CHEMICAL COMPANIES AND MONEY GIVEN FROM THESE COMPANIES , OBAMA , ROMNEY AND MORE IN EVERY STATE. JUST TYPE IN CR BARD, BOSTON SCIENTIFIC, AND OTHER IT SHOWS WHO AND AMOUNT THEY GAVE TO BOTH POLITICAL PARTIES, WHY THIS IS HARD TO MAKE A STAND WHEN SO MANY LEADERS IN AMERICA PAID BY CHEMICAL COMPANIES, , IT IS STILL THERE NOW ON THAT WEB SITE. ANOTHER WEB SITE WAS TAKEN OFF , i had

  5. pam says:

    look at the amounts political parties get, from chemical companies, at influence explorer data, type in organization , chemical company name, dates and it pulls it up. sure that is not all they give, and they want to settle for pennies to women they damaged for life. NO WONDER JUDGE GOODWIN WANTS TO WASH HIS HANDS OF MESH MESS. LOOK AT THE STATES COURTS THAT HAVE CASES WHERE THE CHEMICAL COMPANIES ARE BASED.

  6. pam says:

    on the web site influence explorer , click on contractor> settlements> years see what settlements were made with companies, some were even drug companies in trials like mesh is. year by year different politicians, lobbist and names, amount given, for favors. I know I saw more names familiar in this state , but now are not there , I CALLED THEM AND ASKED THEM A COUPLE OF MONTHS BACK HOW MUCH MONEY DID THEY GET, AND GOT THE OLD SLAMMER DOWN ON THE PHONE, THEY DO NOT WANT IT TO BE TOLD HOW MUCH THEY GET FROM CHEMICAL COMPANIES.THAT WE ARE HAVING PROBLEMS WITH.

  7. karen says:

    Well its about time . It nice to see everyone is awake. The real truth. Take a good look. This has been going on for decades. Lies, murder, ginny pigs, poisons, cheating, you name it . But the bad thing is what took us so long too see it. Political parties are nothing but investors. Their money is invested in ever thing out here you name it their money is in it. We are Trained to believe what you think is the truth 70% of it is a Lie. Slow down a minute , what did you see , broke it down. All day go back and redirect your day. See what you can figure out , how much did you gain in your everyday life. Then you will understand how they (political parties) gain from you. The doctors, department store, gas prices. We the people hold the keys too all these situations. But we go on in Life as if theirs a human with superman powers is going too Help Us. Not true no super power just Super Money. Money is and will always be the root of Greed and Evil. Unless it a unselfish Human that takes there own money and say Enough. We are on our own. We have to come to reality. No more delusion, No more pretend. This is a game and Whom ever finish first is the winner. Put your fighting gear on and get ready for battle. Learn to stay ahead of the game . If you don’t need it don’t buy it , buy the stock and the share. Play the game . In time the things you buy are the things they invest in. The doctors that inplanted these’s mesh should come to our homes and become our servants. We have too stay aware keep our eyes open and understand it all about the money. Every single thing on this earth is all about the money. So ask yourself would you ever invest in polypropylene for 33.00 a share and and 3 months you had a half a million sitting in the bank. This is what we are up against. Until all heavy investors start pulling out then it will change . So let get ready to rumble. Who can we trust ????? Thats the Trillion dollar question. Never know .

  8. Dan Hooper says:

    Our attorney says do not sign anything or add or name to any public forum. How can we help? Dan

    • Kitty says:

      Dan—is your attorney saying not to sign comment on regulations.gov?

      • msm says:

        My attorney says not to write anything anywhere. Don’t say anything to anybody even a friend unless I want them to possibly be subpoenaed. No letters, protests, or anything anywhere identifying me as a mesh victim represented in the lawsuit. I may lose their representation and have to pay their fees. Over a barrel and I’m sure AMS and others know this.

        • Jane Akre says:

          Quick question- Has anyone been subpoenaed for speaking out? or for going on social media? I’ve not heard of it but a genuine question….. Thank you!

          • msm says:

            For me it is just my attorney saying he will no longer represent me. The only thing I heard about social media was a man’s daughter posted about his settlement and he lost it. What a way to live always looking over your shoulder.

  9. Kitty says:

    I see no harm in signing regulations.gov. I would suppose that one does not want to mention their attorney’s name or their company or what they asking for in damages. . If one does not have the integrity to ask for an FDA study on what they believe harmed them–they probably won’t get anything DAN—are you afraid?

  10. kristine says:

    My attorney warned me not to speak to anyone because you cannot trust. I do talk privately in emails with Jane.

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