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FDA Steps Up Medical Device Monitoring – It’s About Time

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Bar Code

Could the entire mesh mesh have been averted much sooner before perhaps one million women were implanted with controversial transvaginal mesh?

Yes, if the U.S. tracked medical devices the way it’s done elsewhere.

The Food and Drug Administration (FDA) is finally taking a step in that direction.

The FDA has just announced a final rule for the Unique Device Identification System (UDI).  This will allow a device to be tracked once it is approved to see how it fares in real-life conditions.

Here is how it will work. Each device will be assigned a number that identifies the version or model, production lot or batch, the date it was manufactured and if applicable, the expiration date. This will appear in the form of a barcode also known as AIDC or Automatic Identification and Data Capture.

The FDA had originally wanted to imprint each implantable device with this bar code, but in a concession to industry, it will appear on the label and packaging only. Better hope one does not become separated from the package. Some external devices that undergo repeated use will have the data marked directly on the device in the form of a readable barcode.

This is a reflection of the FDA’s “least burdensome” standard for the $100 billion-a-year medical device industry, which had an influence in crafting the UDI system.

And since this information is no good without a corresponding database, the FDA will create a Global Unique Device Identification Database (GUDID), which is searchable by the public. The device identification will be entered minus any specific patient information.

Head-In-the-Sand Approach Post Approval

Up until this time, the U.S. did not monitor medical devices after they were approved. Since the bulk of medical devices, as many as 3,000 of the 4,000 approved each year did not have to prove safety and efficacy, we’ve seen the real-life clinical trials in the unfortunate patients who’ve received  defective devices.

This is particularly true in implantable hip and knee prosthesis, metal-on-metal hips, defibrillators, transvaginal mesh and stents, some of which were later recalled or have caused havoc in patients and likely should be recalled.

Since the U.S. is not watching such things, it did not notice, for example, that the DePuy hip implants were failing far short of their 15-year performance promises.

It took Australia, with its National Joint Replacement Registry, a post-approval monitoring program, to notice the higher than expected revision rates of metal-on-metal hips and initiate a recall far in advance of the U.S. saving many people from a lifetime of complications.

New, Improved System

When there is a problematic device, companies, doctors and patients will know sooner allowing any recall to be faster and more effective, says the FDA’s medical device director, Jeff Shuren, MD.

High-risk medical devices such as heart valves, hip prostheses and pacemakers will be introduced to the system first. Manufacturers will have one year to phase in the UDI on the label and packaging. Moderate risk or Class II devices will have three years and Class I, the least dangerous, will either be exempt or have five years to enter the information.

Mesh will be phased in under Class II. According to the FDA’s Morgan Liscinsky:

“Here is a link to the UDI information: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm

“There is a chart that outlines the compliance dates for the UDI final rule. According to the chart, 3 years after publication of the final rule the labels and packages of class II medical devices must bear a UDI; dates on the labels of these devices must be formatted as required by § 801.18; class II stand-alone software must provide its UDI as required by § 801.50(b); and data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database.”

The plan is for this UDI system to go global since many U.S.-made devices are exported. Manufacturers also hope it cuts down on counterfeit medical devices.

Here is a fictitious medical device as an example of what the code will look like:

Fictitious company with UDI label, Courtesy FDA

Fictitious company with UDI label, Courtesy FDA

Learn More:

MDND, Sept 4, 2012, How to Follow Medical Devices

http://meshmedicaldevicenewsdesk.com/fda-notices/fda-how-to-follow-medical-devices/

Fierce Medical Devices

http://www.fiercemedicaldevices.com/press-releases/fda-finalizes-new-system-identify-medical-devices#ixzz2fSNDdYnH

FDA on UDI

http://blogs.fda.gov/fdavoice/index.php/2013/09/identifying-medical-devices-will-strengthen-safety/?source=govdelivery&utm_medium=email&utm_source=govdelivery

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm

Science World:

http://www.scienceworldreport.com/articles/9611/20130920/new-tracking-codes-medical-implants-save-lives.htm

 

 

 

13 Comments

  1. pj says:

    Sounds like another shit job to me, so the fda is going to track the next damn guinea pigs for mesh! while dam,n courts are bogged down purposely so that some women cannot get the medical help funds to get to the almighty damn doctor gods mentioned . so many damn cases filed so that some women never get help with infections and are treated like animals while some have links with those in power of doctors and more to get heard in courts , while some women will not even be shown on internet where their cases are?>?????? answer that one. BELIVE ME I KNOW HOW EVIL THOSE IN POWER AND RICH ARE, this was and is a criminal act on human beings that some ungodly people abuse their positions of power , to choose who will be chosen to die and who will not.

    I KNOW, THIS IS NOT THE FIRST TIME i HAVE BEEN PUT THROUGH PURE HELL BY THOSE EVIL IN MEDICAL AND IN COURTS  AND NOT EVEN SORRY LEADERS OF STATES WILL GO AGAINST THEIR EVIL COLLEAGUES TO DO SOMETHING. NICE FOR THE FDA TO SAY THEY WILL TRACK BETTER THEIR NEXT GUINEA PIGS FOR LIFE AS THOSE WOMEN LIKE ME, GET NOTHING.

    i HAVE CALLED AND GOT NO WHERE WITH FDA, IN PAST YEARS ONLY FOR THE PHONE TO BE SLAMMED DOWN ON ME ,AS THOSE IN LEADERSHIP IN TENNESSEE, THEY HAVE TO HELP[ THE COMPANIES GET OUT FROM CRIMINAL PRISON FOR LIFE , AND LOSE ALL TO WE THE PEOPLE THEY LIED TO.

    some people need to know how to grow up to be good people, inside , the bogged down courts with women not damaged is hurting those from getting needed funds to also find out if there is hope, that they will get strength back, so many have suffered for so many years , and could not get any info. from evil in medical, docs, attorneys and looks lke the sorry damn courts are going to patty cake with the companies and medical to get them out of what I call treason to humanbeings, so many say there is no god, and those in power are gods over the souls of men and women and children. no one that had or has a conscious could do what they have done to another human being. but I guess they sleep like most evil do on dope and alcohol, like most in power.

    They still will go before god almighty with blood on their hands , of doing the kind of evil they do, I AM SURE THIS IS NOT THE FIRST TIME THEY HAVE DONE THIS KIND OF EVIL WHY HASN’T MORE MEDIA EXPOSED THIS EVIL CRIMINAL ACT OF THOSE IN POWER , CHEMICAL COMPANIES , THOSE THAT COVER FOR THEM.

    WHAT DOCTOR OR NURSE WOULD NOT ASK, HOW THE SELLERS OF THIS ESH AND MORE WAS TESTED

    BEFORE THEY LIED TO THEIR PATIENTS , AND FOR WHAT FAVORS DID THEY GET? FOR PUSHING THE MESH, EVEN DRUGS ON TV THEY SHOW GIVEN TO MOTHERS ATI DEPRESSANTS THAT CAUSE DEFORMITIES IN THEIR BABIES, DON’T YOU KNOW WHAT THESE DRUGS TO PEOPLE’S MINDS TAKING THEM, HOW WERE THEY TESTED ALSO, AND DID THOSE IN LEADERSHIP AND IN POWER GET PAID OFF, PEOPLE GOT RICH, PUSHING THESE KIND OF DRUGS AND IMPLANTS, NOW THEY ARE GOING TO IMPLANT LIKE SEA ANIMALS DEVICES TO KNOW WHERE THEIR NEXT GUINEA PIG HUMANS ARE. DAMN THEM AND THEIR EVIL MINDS AND HEARTS AND SOULS. YEAH LINDA I AM DFAMN MAD TOO, BUT i am deprived because I show my anger, DO YOU AND SOME OF YOUR BUDDIES/

  2. Betty says:

    I must be missing something. I fail to see how this is going to help. They already have barcodes on the products they sell – I have a barcode on my copy of the implant records. Putting a barcode on the product that is implanted wouldn’t necessarily help much either – as records can be “lost or changed”. Of course industry does not want to be regulated – it costs $$$$$$$$$. Why is it up to them? Independent auditing should always be the norm. If caught in buy offs they should go to jail – period. I see drug reps wherever I go these days. I want to grab them and shake them and ask them “how much do you really know about this?” “Do you know the side effects?” “Have you – yourself searched the internet for this product you’re peddling?” “Have you checked the FDA website?” Of course, I do not do this. I heard one Dr. tell the drug rep that visited his office that if they wanted to tell him about their product they had to take him out to lunch for a lobster dinner. He hates drug reps, and often gets rid of the products they give him. What about the fact that transvaginal mesh was being sold on ebay? The barcode intact. What patient would be happy knowing their Dr. bought a reduced price product??? The answer is not in barcodes, tracking systems, and a new database alone. The MAUDE DATABASE is a joke. The posts are mostly from patients, and they are not specific enough to get a clear picture of what is happening. In my opinion the real need is in enforcing some of the mandates that have already been put in place. In 2011 the FDA asked all the Dr.’s who saw any kind of a complication to inform the FDA. This did not happen. There should be a huge fine involved in not reporting any complication. There should be a hotline that allows patients to be injured to check if the Dr. reported their complication. This should be put on TV, in newspapers, spread by the media. Not by lawyers who are looking for clients. It gives pause to the Dr.’s who say, “that’s the old product, this is a new one”. The FDA should be required to fax every single registered Dr. about the products they’re dealing with about any announcement they make – so no Dr. has an excuse for not knowing the FDA put out a warning. Or send out a certified letter, or other way to have some kind of accountability. We’ve heard about “plausible deniability” and I do not see where any of this is going to help that. There should be criminal charges pending because of the all the severe injuries we are seeing. Civil court does not give us justice no matter the amount that we are “compensated with”. There is no compensation for the losses that we have sustained. We regulate the automobile industry, the utility industry, and others. I’d be fine with the system if they were accountable on their own – the issue is they’re not. They are allowing money to rule their own consciences. They rationalize why they are doing what they are – with things like “it’s the Dr. not the product”. Nice convenient way to let their conscience off the hook. The truth is – there is no solid agreement across the board on what is really happening with mesh and other products. Until there is – it should be stopped, prosecuted and send a message that harming of any human being is unacceptable.

  3. PJ says:

    Betty, I DO OT SEE WHERE THE FDA TRACKING IS GOING TO HELP EITHER, i CALL THIS A FRONT, FOR THE COMPANIES.

    THIS IS A CRIMINAL ACT THAT SHOULD ALSO BE PROSECUTED WITH CRIMES, but in america it is the rich companies and organizations that pay off our leaders also, and I mean all, from politics, to medical to courts, for the almighty vote and money. 2 million for suffering at what even state leaders knew of people being used as guinea pigs, mind boggling.

    2 million and after every one gets their part, first attorneys, then state gets theirs , the guinea pigs are just laughed at because they made the rich , richer, doctors and medical research. I have seen to many times, trying to expose these evils that take place in america, as one state law agent told me a couple f years ago, there is no truth and justice in america . why? I DID NOT KNOW SO MANY PEOPLE IN POWER AND RICH LIKE THOSE THAT BUY OFF POLITICIANS, DOCTORS, AND LAW OFFIICERS , GREW UP , TO BE EVIL ADULTS, IN THEIR PROFESSION THAT THEY >CANi DID NOT DESERVE THAT FROM GROWN MEN THAT i TRUSTED IN MEDICAL AT ALL. NOR THE CRUELTY OF >SOME < OF THEIR COLLEAGUES THAT COVERED FOR THEM. NEITHER AM i ALLOWED TO SUE, TRUELY, THEY CAN BLOCK ANY CITIZEN THAT

    NEEDS TO SEE JUSTICE FROM GETTING ATTORNEY IN STATES, AS WE ALL KNOW SO MANY IN MEDICAL AND ATTORNEYS RUN FOR POLITICAL OFFICE TO PUT INTO LAWS , AS i WAS TOLD BY A WOMAN SO EVILLY THAT WORKED CLOSE IN COURTS WITH ATTORNEYS AND JUDGES AND LAW OFFICERS, THAT A JUDGE TODAY CAN DO ANYTHING HE WANTS TO TO ANYONE WITH LAWS AND AMENDMENTS ND MORE PUT IN BY COLLEAGUES , TRUTH AND JUSTICE, IT ALL WHO WILL PAY OFF THOSE IN POWER TODAY. AS i WAS TOLD, A COUPLE OF MILLION FOR LIFE DESTROYED AND NEVER TO GET BACK STRENGTH FIGHTING INFECTIONS , BLEEDING AND PAIN, IS NOTHING TO THE BILLIONS AND BILLIONS THESE COMPANY MADE MAKING ANIMALS OUT OF HUMANS TESTING PRODUCTS AND CHEMICALS AND MORE.

    WE TRULY GET NOTHING FOR BILLIONS THEY MADE OFF OF US, AND EVERY STATE LEADER, GOV, CONG , REPS, SEN. AND MORE KNOW IT. SOME EVEN CALL THEIR SELF GOOD PEOPLE AND GOOD CHRISTIANS, LIKE HITLER .

    IT'S TRUTH OF WHAT THEY DID, WITHOUT COVER UP AND PROPAGANDA., IT IS HARD TO SMILE KNOWING , WHEN THEY LIE AND COVER UP, KNOW SOMEONE IS BEING PAYED UNDER TABLE AND FAVORS, i HAVE SEEN IT TOO MANY TIMES AND EVEN READ LIES THEY WRITE IN REPORTS TO COVER UP FOR EVIL IN POWER IN EVERY ASPECT IN AMERICA TODAY . WHAT THEY DID IS A CRIME, AND IT IS A CRIME THAT THE COURTS THINK SO LITTLE OF HUMAN LIVES THEY DESTROYED, THEY KNOW THE WOMEN EVERYTIME THEY GO INTO A DOCTORS OFFICE FOR ANTI BIOTICS AND WHAT THEY NEED , THEY WILL BE THEIR GUINEA PIGS FOR TYE REST OF THEIR LIFE. i AM LIKE LINDA, i am in severe pain at times, but have not took pain prescrioption, knowing they are addictions,

    THE WOMEN IN OTHER NATIONS HURT TO, THINKING WOMEN AND PEOPLE ARE NOT GOING THROUGH HELL IN AMERICA TOO, SOME OF THOSE IN MEDICAL ARE CRUELEST. i HAVE HAD TO BEG FOR ANTI BIOTICS THAT i NEEDED AT TIMES. SOMETHING FOR INFECTIONS, KNOWING THE CARELESS OF WHAT WE SUFFER. LOOKS LIKE THE COURTS AND LAW , WANT GREEDY MONEY FROM THEM, LIKE THE DOCTORS THAT LIED TO THE PATIENTS.

    i want to cuss, but this time, I won't. THE STATES WILL GET ITY AND THE COURTS AND EVERYONE INVOLVED KNOW THE PEOPLE USED AS ANIMALS GET NOTHING. JUST COVER THE TRUTH OF WHAT THEY DID UP. AS THEY LAUGH ALL THE WAY TO THE BANK. AHND SETTING UP THE NEXT GUINEA PIGS. KEEPING TRACK???????

  4. The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20. Dates on the labels of these devices must be formatted as required by § 801.18. Data for these devices must be submitted to the GUDID database. § 830.300.A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014.Class III stand-alone software must provide its UDI as required by § 801.50(b).

  5. Jane Akre says:

    From one of our readers who asked the FDA is there was a federal regulation requiring hospitals to keep tags or actual physical records of an implanted medical device. Here is the answer:

    “There is no FDA requirement to retain, in patient files, labeling (which is what I believe you mean by “tags”) for all devices implanted in humans.

    “For devices specifically identified as tracked devices, (see link below), both the device manufacturer and the user facility have obligations intended to assure that patients can be contacted in the event of a device problem. Many tracked devices are implanted, but not all implanted devices require tracking.

    “The current list of tracked devices can be found at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/MedicalDeviceTracking/default.htm#link_2

    “I hope this is helpful,

    “Deb Yoder

    Senior Regulatory Analyst

    Center for Devices and Radiological Health”

  6. Bejah Notrettu says:

    What we have to remember is that the FDA is not and probably never has been a protector of the people. So, yes, this news is rendered meaningless because of that fact. This nation, its government, its corporations all are controlled by an international banking elite.

  7. Bejah Notrettu says:

    This may sound like science fiction but there is a powerful force in government that wants all American citizens to have bar codes also (like products!) and rather like our pets sometimes have chips implanted in them. It would make it easier then for them to track us. It is hard to believe, sounds more than a little Biblical, and today would not go over very well but watch for the campaign to convince the population that this is a good thing…rather like getting a flu shot.

    Look to Homeland Security and the FDA to be involved. BTW The Department of Homeland Security may not be what you think it is. Encourage all to investigate these assertions and come to your own conclusions.

    Finally there is talk that another financial catastrophe is coming soon. Make sure your assets are as safe as possible. If you thought it was over…sadly it may be far from over. Please investigate this and think carefully about spending, especially this time of year.

    My son and his wife volunteer at a homeless shelter on Christmas and Thanksgiving serving the homeless. My grandchildren gather up their “old” toys and donate them to needy children. This is what we need to do to create a better world…teach our children the value and importance of service, volunteering, helping others,

    Do you know that 70% of the US economy is based on consumer spending!!!! That is way too high and I think it is much higher than it was 20 years ago. That is a very bad sign and IMHO a foolish way to operate an economy unless perhaps you care more about the corporations well being than your nations well being or her peoples well being. We need to send a message that 70% is way too high and stop excessive spending. We need to save and invest to protect ourselves. Our government is NOT protecting us.

    For those of you who have an argument with Johnson & Johnson you may wish to consider this. I have been doing deep research into this corporation and I believe it is in serious trouble. It will be interesting to see if it turns out that they are. Then watch for them to be bailed out (too big to fail!) and reorganize. If that happens those of us with actions against JNJ may be out of luck. This is just my opinion based on some big stock sell offs recently, and downsizing, and a raft of bad products and recalls. These are strange days, indeed. In our house we are going to have a simple, quiet holiday season.

  8. Betty says:

    Bejah,

    Sounds good to me. We live in a spoiled country and I agree we are about to lose many of our privileges. And some of our rights. We do not need to be afraid, just smart. You have given some good advice. God is still in control and doing more underneath than we can see on the surface.

  9. Bejah Notrettu says:

    I was thinking today that it seems unconstitional to me that a surgeon can do what they determine is best for a patient without the patients consent even when that patient has made it very clear what is not acceptable. How is it that this is allowed..it is that the AMA, the Health insurers, the medical products corporations, the drug companies…all of them are responsible for this. It is a GOD given right that no one is allowed to do anything to my body without my permission and yet they do with the blessing of the government and the medical community and government agencies. Nor do I want some slimy salesperson from Ethicon in my surgery theater at the time of my surgery. No one who is not a part of the medical team has any business being there and violating my right to privacy.

    What eles is there that we are unaware of and need to find out?

    I know only that I live my life trying always to treat others with respect, honor and remembering that I am my brothers keeper. I see increasing treacery and greed everywhere I turn in this world and when called I will be happy to go to my true home knowing that it is, as you say, all in HIS hands. That is a great comfort for those who have faith. Thank you for reminding me of this.

  10. g guest says:

    Who did these chemical companies pay off to keep the truth about what doctors and chemical companies and fda, and even politicians would not get involved. WHY , didn’t someone demand that these chemical companies and doctors and nurses that lied to patients so long knowing the mesh was going to move into other body parts and do more damage , and some women never got a chance , because doctors and nurses kept the truth and would not tell women. THIS GETS DEEPER , LIKE IN ALL COURTS AND ATTORNEYS LIKE MINE DROPPED ME, i didn’t cuss until they kept provoking me, with not answering my calls , and when I even tried to get funding from my case , I was told they rejected me, so they knew they were going to drop me so chemical companies and doctors and all that lied to women were covered, paid off. I have seen it before, and I know what those so evil in law can do to anyone that tries to expose them. THIS IS NOT THE FIRST TIME. I HAVE BEEN PUT THROUGH HELL BY COURTS AND MORE POLITICIANS WHEN THEY COVER FOR THOSE THAT BUY THEM OFF AND LIE.

    i KNEW IN THE BEGINNING THAT THOSE THAT i TOLD THE TRUTH ON IN TENNESSEE WOULD STOP MY CASE , all I could do was to try to expose them. I know you don’t see the link but I know how dirty they are in law and those in politics and big business that gave money to campaigns to get favors back. I WAS TOLD i COULD NOT GET ON INTERNET. AND TALK THAT i WAS TO CLOSE ALL FACEBOOK , TWITTER, AND MORE , i WAS NOT SUPPOSE TO FIND OUT WHAT OTHER WOMEN WERE SUFFERING LIKE ME, i told them I did nothing wrong, what doctors and nurses were lying to me about or not telling me , what are women suppose to do. When I did get through, I told them this, and they said we are not after the doctors , so what are women to do, trying to find out what happened ,

    mary even said her son and husband went with her , I had noone, and she said her son wanted to throw the lying doctor out the window, don’t you know I wanted to tear some exam rooms all apart, when I told doctors they were hurting me in exams and they kept saying I am not hurting you, but after exam blood was very appaent, and I told them , why was there blood if they were not hurting me. I am so sick of this mess attorneys betraying women with mesh cases , these need to be found out and prosecuted for doing this and the judges need to do it if they are not corrupt with them, , THE 11 MILLION SHOULD BE GIVEN BY CHEMICAL COMPANIES AND DOCTORS AND NURSES THAT LIED TO THE WOMEN FOR SO LONG KNOWING THE MESH WAS MOVING TO DO MORE DAMAGE. NOT THE 1 MILLION AND 2 MILLION, WHAT THEY DID DESERVES DEATH OR LIFE IN PRISON. AND NO MORE PROCRATINATING IN COURTS, PUT SOME MORE JUDGES ON THE CASES THAT WILL NOT ALLOW ATTORNEYS TO CORRUPT THIS FOR PAY OFFS THESE COMPANIES MADE TO EVEN THOSE POLITICIANS AND MORE. TREASON, AND TRAITORS TO AMERICA , AND CITIZENS OF THIS COUNTRY IS WHAT THEY SHOULD BE CHARGED WITH AND THE CROOKED ATTORNEYS TOO.

    WHAT HAPPENED TO TRUTH AND WHOLE TRUTH AND NOTHING BUT THE TRUTH TOLD, INSTEAD OF HIDING ALL THE PAIN AND SUFFERING WOMEN HAVE GONE THROUGH. NOT THE ONES THE ATTORNEYS FILED CASES OF WOMEN THAT WERE NOT DAMAGED AND HAVE NOT SUFFERED BUT THESE ARE THE ONES THAT THEY WILL GET MORE MONEY FOR, TELL THE TRUTH LIKE IT IS , ENOUGH LIES AND JUDGES AND ATTORNEYS COVERING FOR BIG BUSINESS AND BETRAYING AMERICAN CITIZENS FOR PAY OFF AND COVER UP. THE MEDIA WON’T GET INVOLVED THEY COVER FOR THOSE TOO i mentioned..

  11. g guest says:

    THEY DO NOT NEED TO WAIT ANY LONGER FOR SOME WOMEN TO GET TO THE DOCTORS WITH HOPE OF BEING TREATED LIKE HUMANS AGAIN, THAT WILL EXPLAIN WHAT THEY ARE FACING, LONG TERM, TOO LONG, NOONE DOING ANYTHING TO HELP SOME WOMEN EXCEPT LYING TO THEM. THE SHAME OF THOSE THAT ARE SUPPOSE TO SAVE LIVES AND DO THIS TO HUMANS. TELL THEM THEY ARE CRAZY AND LIE LIKE THE EVIL GREEDY GUTTED PEOPLE THEY ARE.

  12. g guest says:

    THE JUDGES IN W. VIRGINIA, R.I., MASS, AND ALL STATES NEED TO KNOW WHAT MORE SOME WOMEN ARE GOING THROUGH. AND WHAT SOME ATTORNEYS AND MEDICAL ARE DOING TO WOMEN , THEY NEED TO DEMAND FUNDS SET UP FAST SO WOMEN CAN GET TO DOCTORS TO HELP THEM , THAT SHOULD HAVE BEEN DONE YEARS AGO, THEY KNOW 4 AND 5 YEARS IS TOO LONG, BUT LOOK AT THE WOMEN THAT SUFFERED EVEN LONGER, AND SOME DIED. GOVERNORS AND MORE OF STATES COVER IT UP TOO. PAYED OFF NOT TO SAY ANYTHING ABOUT WHAT THEY GET MONEY FROM FOR CAMPAIGNS AND MORE.

  13. All Meshed Up says:

    The MAUDE data base was designed to track problems with drugs and medical devices so as to determine if investigation is warranted and a Warning or Recall is justified. In the case of Mesh (Gyno or Hernia), the one factor missing in the equation is the”Product” that is being blamed for damage or pain. The “Product” being the removed Mesh. Until there is a “Requirement” or “Mandate” that any and all Mesh that has to be removed be sent to the FDA and the Manufacturer for analysis, the MAUDE data base is useless. By reading through the MAUDE data base, referencing which ever make, model,lot# or manufacturer, the lack of the “Product” is the main reason that the majority of submissions are “Inconclusive”. If we as Mesh victims and the FDA, as our Governmental protector are trying to “discover” why so many patients are having (Clearly) the same symptoms, then a Law requiring said “Product” to be sent to the FDA/Manufacturer has to be made. Now, I know I’m just a disgruntled, old nobody with no medical training and not an expert in the intricate dance that the FDA plays with consumers and the Manufacturers, but it seems to me that when you have THOUSANDS of complaints about a “Product” you would do what was necessary to get to the facts. Well, the fact is that the FDA apparently, by it’s lack of action, does not want to do that when it comes to Mesh. If indeed it did, my Mesh, your Mesh would be under a microscope and not in the incinerator! Both Bruce Rosenberg and myself have had conversations with and have given documents and medical records to the FDA’s Office of Criminal Investigation concerning product failure and misleading advertising/statements. Among the 30 or so documents that I sent them was their own FDA letter, acknowledging my MAUDE submission. In that letter it states unequivocally “If we get 2 or 3 documented complaints about a product, we will issue a Warning about that product”. Anybody else get that same letter? I have 3 of them myself. So the FDA issues letters assuring victims of their tenacity for getting to the bottom of your particular complaint but actually do little if anything at all when it concerns Mesh. There can be no doubt about that then or now. Bruce has presented Video evidence via an Ethicon DVD that clearly shows that they were aware of and were trying to get away from the “heavy” Mesh and replace it with a lighter more pliant material. The Doctor in the video was very succinct when he said Ethicon/J&J will have a problem in the next few years because of the product Ethicon has made to be put into many patients. That evidence was and is ignored. Combine that with what you can read into the MAUDE data base and only one conclusion can be garnered, the FDA wants to keep the Status Quo to the detriment of Mesh Victim’s. Until the FDA requires the Mesh Product be sent to them AND testimony(honest) from the Doctor as to the condition of the Mesh, WHILE STILL IN THE BODY, our plight as Mesh Victims will continue. We, as Mesh Victims, will continue to be abused and lied to by the Medical community because there is no clear consequence to them until the FDA requires, by Law, to have removed mesh sent to them to be analyzed. There will be little or no consequences for the Manufacturers either, other than a small slap on the wrist and a little money to the lucky victim. And the longer they can put that off, the more of us will lose our chance at a lawsuit and the more of us will die in pain and poverty. I have little Hope that the Staus Quo will change.

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