Check Out Our New Forum!
The Your Turn Forum provides a space where people can post questions about mesh and medical device related issues and get advice and support from the Mesh News Desk community.
Join the Discussion!
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:
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:
MHRA standard response letter here
Tell the FDA about your Adverse Event
https://www.meshmedicaldevicenewsdesk.com/fda-notices/how-to-post-an-adverse-event-with-the-fda/
TVTInfo
http://tvtinfo.wordpress.com/category/medicines-and-healthcare-products-regulatory-agency-mhra/
