logo tvt messed up mesh tvt mumtvt mum petition

The Voices Today on Messed up Mesh (TVT Mum)
Help and support to both men and woman who have had the medical device TVT Retropubic, TVT-Secur, TVTO and TOT, synthetic polypropylene mesh for hernias, prolapse, stress incontinence and bladder and bowel disorders. You're not alone!

Mesh Sling in an Era of Uncertainty: Lessons Learned and the Way Forward

Christopher R. Chapple, Shlomo Raz, Linda Brubaker and Philippe E. Zimmern
Published online 4 July 2013
European Association of Urology

For many years, synthetic mesh was avoided whenever possible for surgical treatment of stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP) because of the recognized complications of fibrosis and erosion seen with Mersilene [1] and Gore-Tex slings [2].

Petros and Ulmsten [3] in 1990 and Petros and Papadimitriou [4] more recently described a fairly simple procedure with tension-free vaginal tape (TVT), during which the surgeon placed a thin strap of polypropylene mesh in a midurethral position. Since the 1990s, the marketing and use of synthetic materials for SUI and POP indications have dramatically increased. This was particularly noticeable after the publication of a randomized controlled trial comparing TVT with colposuspension [5]. A number of similar procedures were subsequently granted marketing licenses with little clinical data from adequately powered randomized studies. This was followed by a series of modifications including transobturator tape (TOT) [6] and, recently, a wave of single-incision slings, or mini-slings, to prevent passage of trocars through the retropubic space or obturator fossa [7]. Concomitantly, the specialty of female pelvic medicine and reconstructive surgery has witnessed the very rapid growth of larger segments of synthetic material, referred to as mesh, being implanted beneath the vaginal wall to correct POP based on the early data supporting efficacy of TVT and TOT.

More than 40 implants are on the market [8] and [9] and are used with little evidence related to mid- and long-term safety and efficacy. Training to place these new implants has often comprised cadaver courses on weekends, review of video procedures, observing “experts” performing implants, and mentorship in institutions by a visiting surgeon. The use of these materials and the surgical techniques have not been limited to subspecialist practice. In 2008, following an escalation in complications reported to the Manufacturer and User Facility Device Experience (MAUDE) database, the US Food and Drug Administration (FDA) issued a first notification to inform the public [8] that these devices and “kits” had risks, should be used with caution, and might result in nonreversible outcomes [10]. A second FDA notification in 2011 sounded even more alarming [11] and provoked a chain reaction from patients, physicians, manufacturers, and lawyers. Similar initiatives were under way in the United Kingdom, with recognition of the problem by the Medicines and Healthcare Products Regulatory Agency (MHRA) [12] and [13]. As the Internet facilitated connection between desperate patients seeking help [14], television advertisements started to inform the public about issues related to “transvaginal meshes.” A number of Web sites inspired by patients’ experiences identified problems with mesh (eg, TVT Messed up Mesh [TVT Mum], http://www.tvt-messed-up-mesh.org.uk/).

During specialty meetings, many presentations and discussions have focused on mesh or tape complications and their management, specifically, obstruction, pain, dyspareunia, and erosion that may have irreversible consequences despite multiple interventions [10]. In daily practice, patients have begun to inquire more intensely about “mesh” or “tape,” and the regulatory authorities have provided information for patients on this subject. There is a lack of registries to establish the true incidence of the problems with the use of synthetic materials, as has been recognized with the underreporting of these complicated cases to the “optional” MAUDE database [15] and to the other regulatory bodies such as MHRA in the United Kingdom. Although voluntary registries have been established by professional groups, they do not provide accurate information because registration of all cases would be required and, invariably, existing voluntary registries are prone to selective reporting of cases. To read the full article please click on the links below.

Article information
PII: S0302-2838(13)00660-X
DOI: 10.1016/j.eururo.2013.06.045
Copyright 2013 European Association of Urology, Published by Elsevier B.V.
To read full article on the internet it's best viewed in Google Chrome Browser please click on the link below:
Source: http://www.europeanurology.com/article/S0302-2838(13)00660-X/pdf/Mesh+Sling+in+an+Era+of+Uncertainty%3A+Lessons+Learned+and+the+Way+Forward
To view the article in full text PDF please click on the link below:
Mesh-Sling-in-an-Era-of-Uncertainty-Lessons-Learned-and-the-Way- Forward.pdf


You will see and hear from people who decided not to go ahead with surgery after reading our website. They have been saved from harm!

For more information on our petition please visit here www.tvt-messed-up-mesh.org.uk/petitions.html >>>



Navigation links within the TVT Mum website

Hidden Disability Chronic TVT/Mesh Implant Inflammation |
Articles, Urology/Urogynaecology Conferences and Research from around the World |
Articles and Letters by TVT Mum

British Medical Journal | Dispatches Channel 4 Documentary 'The truth about going under the knife'

Advice and Help Guide on TVT, TVT-Secur,TVT-O and TOT Tape/Mesh Medical Devices | Alernative Treatments for Stress Urinary Incontinence (SUI) and Prolapse (POP) | Men's Health | Mesh Related Complications | Mesh Unexplained Symptoms | Mesh Surgery Experiences | Mesh Removal Stories | Synthetic Mesh Other Nasty Products | TVT, TVT-Secur, TVT-O and TOT, Medical Devices | TransObturator Tape (TvT-O and TOT) Medical Devices | TVT Medical Terminology

Medicine and Healthcare Products Regulatory Agency (MHRA) | Worldwide Medical Device Incident Reporting

Message Board and Forums | TVT Mum Volunteers | The History of TVT MUM| Latest News |
Frequently Asked Questions | Press and Media | Testimonials |
Privacy and Data Protection | Terms and Conditions | Website Map | Links

Translator




Follows us on

Twitter YouTube


information image
TVT Mum Search Engine

When you use the search box
the first results are google ads external links,
to view links within the TVT Mum website scroll down the page
a bit further and voila everthing you need to know!

When you have finished go back to
the green bar and click x icon to return
the search bar back to normal.

Very niffty tool to use!

Loading



Location: Stoke Gifford, Bristol, United Kingdom

disclaimer

copyright notice

Website Design by Lorraine Evans at TVT Messed up Mesh