Lorraine Evans Highlights Global Problem of Mesh Mess

For Immediate Release:

Monday, February 13, 2012

End our ‘human guinea pig’ hell

A TIRELESS campaigner (from the UK) is calling on surgeons to stop treating incontinent women as medical guinea pigs.

Currently, medics aim to cure stress urinary incontinence (SUI) by inserting a device known as trans-vaginal tension free tape (TVT), or trans-vaginal tape obturator (TVT-O and TOT), but both have left thousands of women, partially disabled and struggling to rebuild shattered lives.

Lorraine Evans, founder of support group, TVT Mum, insists there ARE alternatives to surgery, and that surgeons are keeping sufferers in the dark when it comes to spelling out potential dangers.

The TVT is made from polypropylene which is a petroleum coated piece of plastic mesh with serrated edges, designed to embed itself in the vaginal tissues, and support the urethra. It’s a permanent implant, but mesh-related complications, such as erosion, are not uncommon.

Mesh can erode into the bladder, bowel, urethra and vaginal wall, and this can occur on day one, or years later down the line. The TVT implants also shrink and harden, with pieces of mesh breaking away and migrating into surrounding tissues and organs.

Lorraine said: “Too many urologists, gynaecologists and obstetricians offer the TVT/Mesh medical device implants as their first choice treatment for stress incontinence, and even mild incontinence.

“TVT Mum is of the mind that they should be offering non-surgical options in the first instance.

“Consultants make it sound like a Utopian solution for SUI by describing the TVT as a ‘piece of tape’ to hold up the urethra. It’s ‘sold’ as minimally invasive surgery with a day or overnight stay in hospital at worse.

“I can assure you this is far from an accurate description.”

Stress incontinence is an involuntary voiding of urine caused by coughing, sneezing, laughing, running or lifting, which can be sufficient to place enough stress on the bladder to cause leakage, since the sphincter muscle of the bladder has been weakened.

The treatment offered will depend on the scale of a patient’s incontinence and severity of symptoms. On the majority of occasions, surgical intervention is unnecessary.

Medical devices for (SUI) and flat graft surgical mesh for pelvic organ prolapse and hernias have caused insurmountable damage to the health and quality of life of so many women and men.

In 2005, Lorraine had mild stress incontinence and was offered TVT implant surgery. As a consequence, she suffered a pulmonary embolus and collapsed lung the following day and has been in and out of hospital ever since.

She said: “Women who have been affected by a TVT implant suffer on a daily basis and when problems arise they return to their surgeons for help. It's not unusual, for the surgeon to deny such a problem exists and refer patients onto another surgeon.

“Our health situation is critical, but it is so difficult to find a surgeon experienced in mesh-related complications within the NHS and many women have no choice but to seek help in private practice, which costs thousands of pounds for corrective surgery.”

Lorraine added: “If we had known the truth on the make-up, surgical procedure and complications associated with TVT vaginal tapes beforehand, we wouldn’t have gone ahead with this operation.

“In fact, we weren’t even aware that TVT resembled box strapping!”

Lorraine is calling on the medical authorities to ban these devices, and is also asking for a mandatory register, in which surgeons forced to remove defective mesh will be forced to submit an adverse event report to the Medicines and Healthcare Products Regulatory Agency (MHRA).

She said: “Currently, there is a severe under-reporting with skewed success and failure percentage rates. There is an urgent need for a ‘National TVT/Mesh Register’.

“We discovered that these devices had no long-term human randomized clinical trials (RCT). Our support group members are upset and disgusted that they have been used as human guinea pigs, without a fully-informed consent.

“The MHRA has now launched an investigation into better understanding the use of these devices and the complications associated with their use. “They should go one step further and have them banned until they can be 100 per cent sure that they are safe to use. It might be too late for thousands of people, but we must prevent a similar fate befalling others.

“These devices have left women permanently disfigured, while others are disabled, housebound and living in daily pain. Mesh has also destroyed marriages, and all because untried devices were forced upon us.”

For more information, log on to www.tvt-messed-up-mesh.org.uk

Notes to Editors

• TVT Messed up Mesh (TVT Mum) website: www.tvt-messed-up-mesh.org.uk was launched May 2009

• We can supply pictures of the TVT/Mesh medical devices and the TVT surgically removed plus if required other pictures to support the article. We have received thousands of enquires and hundreds of stories from women and also some from men. Members in our support group from all around the UK want to share their stories with the press and media.

• Medicines and Healthcare Products Regulatory Agencey (MHRA) Public Notice

September 2011 www.mhra.gov.uk/home/groups/clin/documents/websiteresources/con128943.pdf

• Food and Drugs Administration (FDA) Public Health Notice

July 2011 www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

• Food and Drugs Administration (FDA) Public Health Notice

October 2008

www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm

• Read some of the Stories showing on the online petition

www.thepetitionsite.com/1/an-urgent-review-is-required-on-the-medical-devices-tvt-tvto-tot-and-the-use-of-mesh-graft-for/

For more information, or images, contact Mrs Lorraine Evans (Mon–Fri 9am – 5pm, or 7pm – 9pm)

Telephone: 01179 658992 or 07754 499280

Email: lorraine@tvt-messed-up-mesh.org.uk