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Mesh Survivors UK- Contact Your GP, MP – Challenge the Information!

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Map of UK, WikiCommons

A mesh survivor from the UK suggests survivors contact their GP and MP with their mesh survivor stories. 

(GP is general practitioner and MP is Member of Parliament.

The reason – no one ever gets a letter to confirm it has been reported.

Finally, this writer got a report to confirm. It said:

 this event was considered to be reportable in accordance with the MEDDEV 2.12-1 Guidelines on a Medical Devices Vigilance System and a MDV report was submitted.

The Mesh News Desk reader writes, “Nobody has ever got this far, as they keep getting the Department of health letter and never get a letter to confirm it has been reported. All UK women need to put pressure on and start getting these ICO Information Rights concerns letters out – it is the only way to get a MDV report submitted here in the UK” she says. (She wishes to remain anonymous because of litigation).

She asks Netherlands and Belgium survivors to check if they have something the same they can do in FAGG as they have the same problem – and write about their mesh injuries.

Background

In the U.S. if you are mesh injured you must report the injury to the U.S. Food and Drug Administration (FDA). Not only is this difficult to maneuver (see how to do it here) but the number of actual “adverse events” is considered to be one to ten percent of actual real-world injures.

Similarly, in the UK, you must report to the MHRA, which is roughly equivalent to the FDA. MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency.

Our mesh survivor says: “If you are a fighter you quickly find out like USA that you have to self report, but you are not told you need to get the serial number, batch number and LOT number of the device before you leave hospital!

“Here in the UK everybody who has self reported has to agree that you give all your details, name, hospital, serial number of device etc to the manufacturers via the MHRA. Many campaigners said DON’T because it can be used against you in a legal case. So I tried just giving them the batch number. And that failed. In the end I gave the serial number too, which would have lead them to me.”

It takes from one to three months to get a reply from the Department of Health, a reply sometimes referred to as “standard rubbish that they take your concern seriously.” Generally it is the same template letter no matter who you address, whether the Health Minister, Prime Minister, Department of health or MHRA.

She found via the Information Commissioning Office website (ico.org) that you have a right and can challenge for information held about you.

After 28 days, she got the same Department of health letter!!! So she called the ICO and they told her to send the details = 24 hours later she got the more detailed reply with a promise of a report specifically to her device from the manufacturing unit in a week.

Anyone from the UK asking about self reporting to the MHRA is best advised to:

  1. After 15 days request a report. (no joy  we know of course)
  2. Write a letter in the format stated via the ICO website – raising a concern.
  3. Wait 28 days (to receive another department of health rubbish letter)
  4. Report via the raising a concern link on the ICO website.
  5. Hey surprise – get your letter promising a report.

The report then can be used to challenge the safety aspect (i.e. resin etc. and the process of reporting and corporation accountability. One can also challenge that the MHRA works for the pharma companies not the public, perhaps with a legal challenge.

“But if I find a way then everyone doing the above – can do the same = more pressure I hope!!”

 

Learn More:

TVT Messed Up UK Petition on Right Hand side

http://www.tvt-messed-up-mesh.org.uk/      

MHRA reporting here:

http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Product-specificinformationandadvice%E2%80%93M%E2%80%93T/Vaginalmeshforpelvicorganprolapse/

MHRA standard response letter here

Tell the FDA about your Adverse Event

http://meshmedicaldevicenewsdesk.com/fda-notices/how-to-post-an-adverse-event-with-the-fda/

11 Comments

  1. All Meshed Up says:

    It is with stories like this that you realize that the Agencies that should be helping those hurt by a Medical Device are actually set up to make it so difficult to get answers that you finally give up. Not that the FDA has been the champion to the Mesh Victims here in the U.S. but they at least send you a bull crap letter fairly quickly. Of course anything beyond that is quite difficult for them unless it concerns tainted doggie treats THEN you better watch out!!

    Now that Gynecological Mesh damage has become a world wide phenomena, do you think the FDA will be on the fore front of getting rid of these mesh products? Or do you think they will do everything to obfuscate the situation and continue letting more ‘New and Improved” mesh products through the 501(K) process? Follow the money…….

  2. heart broken says:

    I did report it to MHRA and they informed the Manufacturer! who got in touch and poopooed the report and nothing was done, by MHRA who said only a very tiny minority about 1%. of adverse reported, and said mesh was safe to use they believed the manufacturer above urologist’s reports!! they are a waste of time,and Andrew Lansley Health Minister at the time in David Camerons Government was sent an email with concerns raised about the mesh implants but chose to ignore it, and left defenceless people like me to suffer ,because they couldn’t care less and who cant get Legal Aid anymore or backing, but will remember them when they want our votes in 2015. this government should compensate all mesh sufferers because this mesh did not go through the rigorous testing it should have we have been guineapigs! for surgeons and the manufacturers.

    • Jane Akre says:

      Even if it were 1% (which it’s not) don’t those people deserve protection as well? In the U.S. if we have dogs dying from tainted dog food, they pull it off the shelves. Love dogs but don’t people deserve the same consideration?

      • heart broken says:

        yes jane you are right, but most of the mesh operations done here are done on the NHS, and it should be the duty of Drs, Surgeons, etc who take an oath towards there fellowship and human beings, who are trusted and believed by the majority of patients to do what is safely and painless as possible, they are the professionals. I would like to know how many surgeons have done mesh removals and covered for there colleagues botched ops. and don’t want to upset government statistics. the truth is out there but who has the guts to tell it.

  3. Many women have written to Members of Parliament in The United Kingdom and have received the same standard letter back from The Department of Health and MHRA UK via their Member of Parliament. It is a vicious circle that goes around and around. Many surgeons do cover up for their colleagues or say nothing as I have endured this treatment of lies for over 7 years before eventually receiving help. The years go by and you become more injured because time and time again it is repeated that you have nothing wrong with you and it is all in the head or you need pain management. Regarding General Practitioners they are at a loss and do not have time to digest what you are talking about regarding mesh when you have an appointment with them they need to be educated. I have sat outside Member of Parliaments offices on my own with a placard and a petition before today to highlight the serious nature of what women are going through and have been through with the serious injuries that they are left with. Try sitting on a bench outside an MP’s Surgery with serious mesh injuries and you will know what it is about, but I was prepared to do this for all mesh injured women and men. Surgeons who I have met at meetings still say that the benefits outweigh the risks.

  4. All Meshed Up says:

    Both Jane and Theresa said it perfectly, even if it was 1% of the total implants, that is still alot of people damaged by a supposed safe and benign medical device. Those of us that have suffered for so many years have come to relize that a Dog Food gone bad has more priority than we do. And the reason why? MONEY!

    • The MHRA UK are a toothless watchdog with an antiquated reporting system. The Department of Health and NHS England are also useless they have not listened to the sufferers of mesh injured women and men over the years of campaigning they still think it is the best thing since sliced bread.

      The word Mesh Survivor doe not apply to me as I am dying from the inside out. I will never recover from my mesh injuries inflicted upon me by a piece of mesh which was called a tape and never explained what it was made of and that it can become embedded in your own tissue to destroy and mutilate and change your quality of life forever.

      These transvaginal and prolapse mesh operations are barbaric and should be banned and should never have been allowed onto the Worldwide Market. Still they have women taking part in trials. I wonder do they tell them they are a Guinea Pig. Take a look at my injuries on my website because that’s what every woman should look at before contemplating having this quick fix mutilating operation. YOU TO COULD LOOK LIKE THIS! We live with an invisible illness and the powers that be couldn’t careless.

      http://www.meshiesunitedgroup.co.uk

      .

      • heart broken says:

        the 1% I was told about was back in 2010 from MHRA they said I was a very small minority, and there had been no need to investigate as the manufacturer had satisfied them it was perfectly safe !!!! of course they would, but I wonder how many women know how to report this, when you have GPs and Hospitals just doing gynaecological investigations after they have had the mesh implanted, not realising how serious and damaging it is. one surgeon even tried to cut the visible tape in clinic, the operation on youtube looks straightforward and this is how some surgeons are copying at weekend seminars, it is medieval and very dangerous ,the problems are when things go wrong they do not know how to remove the mesh, there are only a handful of surgeons in Britain who can achieve 90% mesh removal ,and not always on first operation. I know from personal experience and have had major surgery 3 times.and still in pain. until someone famous the likes of Angelina jolie etc etc. we will be ignored much to the pleasure of MHRA and world goverments who stick there head in the sands, I cannot understand how world media has this not been reported on a grand scale with hundred of thousand litigation cases going on , I suppose it doesn’t involve oil, Wars, weapons, etc etc.

        • heart broken says:

          Ps I think also Ann Dillon who works at MHRA should be sacked as her post is not fit for purpose . doesn’t she look stupid considering the hundreds if not thousands of mesh sufferers here in Britain, hope she has the indignity of having Incontinence, but then ( benefits outway the risks on mesh so were told) rubbish! its a cost cutting device. but is it? when so many have to seek further medical investigation, and treatment. the establishment should stop lying to us, and stop all mesh implants. NOW.

  5. msm says:

    Why is 1% considered acceptable when the direct cause is known? The risk of other complications of any surgery (infection, reaction to anesthesia, bleeding, etc) is 1%. But those causes are not known in advance. It cannot be predicted or eradicated in all cases so 1% is acceptable.

    But not so with mesh. The mesh itself is the KNOWN CAUSE of the 1%. Because it is the known cause, it can be eliminated. There are alternatives.

    One out of every 100 patients. Picture 10 rows of 10 people. That’s not many people. What if all surgeons implanting mesh had to look at a room of 100 people and pick out the person that they were going to injure? They could explain to that person that her injury is “acceptable” and the price women should pay for using mesh. I think some docs would stop using it. Unfortunately, many would not because they don’t look at patients as people.

  6. ToddDog says:

    Hi All

    The MDV report from the manufacturer is the only reporting the MHRA takes notice of, and since nobody seems to get this, it shows why there is so much under reporting. Pushing via the ICO.org our right to be informed about what happens to our data in the reporting process is very important.

    I just got the final report of the my incident from the MHRA/manufacturer and it still has holes in it, which I am planning to complain to the ICO about again to get more information – I have detailed this below and hope that it will help others to continue to fight to gain information about just how the MHRA and the manufacturing units are in fact using the data we provide to ensure the detect and act quickly…. please if anyone is at the same point as me – KEEP GOING – KEEP ASKING QUESTIONS via the ICO and push for answers.

    Keep the fight strong 😉

    While the MHRA/ Department of Health states in letters and on this report

    “Manufacturers of medical devices such as transvaginal mesh are legally required to report adverse incidents to the MHRA… etc”

    “ The General Medical Council guidance published in February 2013 MAKES IT CLEAR that clinicians should report medical device incidents to the MHRA and make information available to patients about how to report side effects to the MHRA”

    My operation was done on the September 2013 and I was not given information on how to report NOR did the final report say that the clinicians had filed a report for my device lot number or product. Therefore the report lacks substance because it has NOT investigated a clear breach of guidelines both for the clinicians and the manufacturing unit.

    This was not covered in the final report and is my right to know why.

    As far as my case goes, and the final report I am now going to further use this to complain again to the ICO on these grounds:

    “However, the batch number was requested and provided by the MHRA and a review of the batch manufacturing records was conducted, the batch met all finished goods release criteria for lot number and product ”

    I am writing again to the ICO case manager and to the MHRA because as this device is implanted in me, I have the right to know the following:

    a)What is the manufacturing criteria the device has to meet. Has this changed at any time since the release of the product? If so when and how?

    b) EXACTLY, what is the exact ingredients of the mesh for product ? Has the ratio or ingredients changed since the release of the product – I want to know the resin, plastic and chemicals used in the process of the lot number ?

    Is the mix changing or has it changed for the new “ Artisyn Y-shaped mesh due to come on the market?

    “As part of the complaint investigation this file was assessed by Ethicon’s Medical Director who stated that based on the information provided to date, there is not enough information to draw a conclusion.”

    NOT enough information to draw a conclusion – I am therefore going to ask

    WHAT INFORMATION EXACTLY IS NEEDED AND WHY, TO DRAW A CONCLUSION – WHAT factors do the MHRA and manufacturer use to make this statement, since underreporting is admitted in the letters and report and voluntary reporting is still in place?:

    “ The benefits of these tapes and meshes outweigh the risks.”

    I will therefore:

    a) Have my mesh analysed by a expert for chemical make up – the decay of the product since inside me – i.e. shrinkage etc.

    b) I intend to film my removal. I am seeking the best person to do this operation, having found out the surgeon due to do this operation also puts them in. I am seeking a international opinion – I want a report done for my case.

    c) I am going to ask for a new device from that batch be sent to me so the before and after can be independently analysed.

    Per Ethicon’s established complaint handling process, product evaluation and review of manufacturing records are performed when possible. In this case, the device remains implanted, therefore it has not been returned for evaluation.

    Nobody who is planted with this device, is given the info they need should they need to report.

    ie, I wasn’t even told what device I had, I was unaware I had a TVT-O. I did not leave the hospital with the serial number batch number, how to report, nor told that after removal it would need to be returned for evaluation. Therefore, it is my right since the device is implanted in me to know the following:

    Exactly what process did the manufacturing unit take to evaluate that the material used in my lot/batch mesh and other batches is fit for human use? Please provide me with the studies.

    Exactly what is the process that a manufacturing unit will under take to evaluate a returned mesh device after removal from a human being? What criteria will you base your evaluation?

    Is the chemical make up evaluated? If so how and what?

    Is the shrinkage assessed? If so how and what method?

    Is decay and break up of the material assessed? If so how and what method?

    How is the auto immune reaction evaluated, i.e. reaction from material to human body assessed? What needs procedure must be undertaken at the point of removal to assess whether or not the material causes an auto immune reaction.

    The anchors of the TVT-O are not able to be removed, and should the operation show this is the part pressing on my leg nerve – I therefore require the studies done to show the research done to determine the risks, and the reasoning for the decision to approve the TVT-O.

    “However as the serious health deterioration of a patient is reported in relation to the implanted device, this event was considered to be reportable in accordance with the MEDDEV 2.12-1 Guidelines on a Medical Devices Vigilance System and a MDV report was submitted.”

    “What we have seen, and continue to see, is that the greater proportion of the clinical community and patients support the use of these devices in the UK in the treatment of distressing conditions of incontinence and organ prolapse.”

    Please state how this statement can be made given that voluntary reporting is stated as under reported in the letter from the department of health and given that you did not investigate why my incident was not reported via the clinicians in line with the General Medical Council guidance in February 2013.

    “All surgical procedures carry a small element of risk and the MHRA continues to works in collaboration with patients, the NHS, professional bodies and international partners to ensure emerging issues are detected and acted upon quickly.”

    Please can you state why you have included this on my report, when my incident was not reported in line with the General Medical Council guidance in Feb 2013?

    Please also state why the mesh is still inside me and I am still having complications after over a year, if bodies detect and react quickly – Please state why at the 3 month check up, unable to walk without 2 crutches and at a slow , painful pace, I was considered a 100% success – Why I needed to seek private help to get confirmation that my symptoms were mesh related?

    Since, I could only find ONE professional experienced and trained to remove the TVT-O mesh – please state how the MHRA and manufacturing units ensure emerging issues are detected and acted upon quickly.

    Please give me details of the complication and removal training every surgeon is expected to undergo. Please state the protocol used in my case – the NHS, professional bodies and international partners did not detect or act quickly in my case.

    Therefore please in the final report Give further evidence as to why you include this statement.

    “We will continue to investigate all incident reports associated with these vaginal mesh and tape devices to build a better picture of the reported problems associated with them.”

    Please state how incidents can be investigated when they are being under reported. Information is not given to the patient on how to report and clinicians are not bound by law to report? – what law holds clinicians legally bound to report?

    Please also state under what law is the manufacturer of devices required to report and they break the law (Stated in the Department of Health letter)

    – under what legal action can a patient or the MHRA take legal action? – stated in letter from Department of health – Please state the MHRA process. from self report to MHRA, to MHRA reporting to Manufacturer to manufacturer reporting to MHRA.

    What does MHRA do after this point.

    Please add to this list if anyone can think of other things we need to work on. 😉

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