Warning Notice: Concerning Activities from the MHRA and the Manufacturers

DATED: 30th November 2011

Unbelievable and shocking behaviour. To those who have submitted their adverse report into the Medicines and Healthcare Regulatory Agency (MHRA) Do not give permission or allow the manufacturers to contact your surgeon to allow them access to your medical records!

I have heard through the grapevine the Medicines and Healthcare Products Regulatory Agency (MHRA) are sending out requests asking patients to give permission for the manufacturers to contact their surgeons. Can we trust the MHRA after hearing this? This is another serious concern.

The people who are submitting their adverse report are in ill health and most are in a vulnerable state of mind and not thinking straight. We have put our trust in the MHRA to do the decent thing by doing their own investigation helping the patients and not backing the manufacturers.

The main purpose of adverse reporting is to show the MHRA how many people are harmed and to collate data on all the TVTs/Meshes medical devices also to show the MHRA there is a real serious growing health problem in the UK. It is the MHRA who should be asking the manufacturers WHY is this happening and to give answers on their faulty medical devices, specifications, RCTs etc etc directly to them only and not to allow the manufacturers to approach ill people who are in a vulnerable state of health plus for putting the surgeons in a very awkward sitution after receiving permission to disclose private and confidential medical information between patient and surgeon, this is breaking patient confidentiality and also putting vulnerable people under pressure.

It is the MHRA duty to protect us and not to give a helping hand to the manufacturers who we believe are to blame for this despicable health situation we are all facing today. We have trusted the MHRA has the Data Protection Act 1998 in place, for the MHRA to allow the Manufacturers or whoever to access very private and confidential records is not protecting us.

The MHRA have already admitted there are significant numbers of people who have submitted their adverse reports and admit they do not know how many have been harmed or how many TVTs/Meshes have been surgically implanted. This has been going on since the early 1990’s with TVT’s and other related TVT products and since the early 1950’s with Meshes for hernias and other surgeries. Still to this day the MHRA have not issued a public health notice, the only thing they have done is to issue a small notice on their website (see link below) and all of us are reading this notice as a health notice considering they admit they have launched an investigation, significant numbers, multiple manufacturers and products. So why haven’t they issued a significant public health notice? The Food and Drugs Administration (FDA) website in the USA has issued 2 public health notices details as below:

FDA: First Public Health Notice
U.S. FOOD AND DRUG ADMINISTRATION Archived Safety Alerts, Public Health Advisories and Notices - FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence Issued: October 20, 2008 direct link to view:
www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm

FDA: Second Public Health Notice
FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
Date Issued: July 13, 2011
www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm >>>

Date: September 2011
Recent Public Health Alert issued from the MHRA
Advice from the MHRA:
Synthetic vaginal tapes for stress incontinence
The MHRA has seen a recent increase in numbers of adverse event reports in comparison to numbers received in previous years, increasingly from patients. As a result, the MHRA has launched an investigation to better understand the use of these devices and the complications associated with their use. Please click on the following links to read more:
MHRA-PUBLIC-NOTICE.pdf >>>

To those who have submitted their adverse report into the MHRA on their faulty medical device DO NOT allow anyone else outside of the MHRA especially the manufacturers to access your private medical information plus it could affect your negligence claim if you allow them to access your data. We believe the manufacturers are trying to blame the surgeon for inadequate surgical skills (implantation of your medical device into your body) when in fact we believe the medical device is FAULTY, the evidence is clear in peer articles on TVT’s and other Mesh related products these types of medical devices are NOT inert for the human body plus there are thousands of people harmed going back years and years. We believe it is not surgical skills at fault it is the manufacturer’s products. We have to stop 'Medical Marketing overtaking Medical Science'.

It should be the Surgeons approaching the MHRA to sort this out because at this moment in time it appears the manufacturers are blaming the surgeons for this massive negligence concerning their products and growing serious health problem. We say to the surgeons "Go out there, join an investigative team and support and help your patients who have life changing and devastating consequences both to their health and quality of life." The TVTs/Meshes should NEVER have come onto the market without long term Randomized controlled trials (RCTs) no clinical trials were performed before marketing these medical devices. This has been going on for years and years, we all want 'action now' to have the TVT’s/Meshes taken off the market or at least stop implanting anymore until the investigation run by the MHRA, the Lawyers, the BMJ and other appropriate investigative teams is finished.

Unfortunately for us who are harmed by these faulty medical devices were not given a fully informed consent or choice of treatments and most of us only had mild stress urinary incontinence (SUI) we have heard from an Obstetrician/Gynaecologist 'surgical intervention is totally unnecessary in most cases for SUI' also we were not told of any mesh related complications before having the TVT/Mesh surgery and unfortunately this scenario is still happening today.

This notice is just a brief warning to be very careful. I hope this notice has helped you to make your own mind up on who has permission and access to your private medical information data and an insight into other raised concerns. Keep strong.

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