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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!

Articles - United States

Updated 3rd July 2011

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Please scroll down the webpage to view all articles. The date above will tell you when new ones have been added.

Advice on reading mesh
Sue kindly posted on the Topix forum the following information:
No, MRI will not show the TVT. MRIs are good for detecting tumor sizes. You need to have the Ultrasound done via labial, instead of the traditional abdominal or transvaginal. Only Labial US will show the location of the mesh. Unfortunately, most radiologist location are not trained to do it via labial only the other two. When I had the US done the tech said, they didn't know for a long time either until a German doctor said to try it via labial. The US machine is same just the technique is different. I used to work at a Radiologist place so I was familiar with the machines. Before having the test done, I actually had the test I just assumed UCLA had a special machine, since they are an University and sometimes get the newest technology for scientific data testings and what not but it turns are it's just an ordinary US machine; like the ones used for pregnant women as well. With the US Dr. Raz was able to locate exact location of the TVT but still wasn't able to remove all of the mesh, I still have a tiny piece left, am going to have it try to get it all out when I have the fascia sling surgery in July. Best of luck to you...Sue
Thank you Sue, your information is going to help many people!

Prolapse Surgery
How to Handle
Innovations
Polypropylene is not inert in the Human Body
By Donald R Ostergard MD
PDF format - Polypropylene is not inert in the Human Body >>>
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Professor Philippe E Zimmern Professor of Urology. I actually contacted Professor Zimmern back in August 2008 where he kindly helped me find someone to contact here in the UK, I asked him who can I contact for help on my mesh problems. He suggested I contact Dr Christopher Chapple in Sheffield or Dr Bill Turner in Cambridge. I visited Dr Christopher Chapple and he was extremely understanding and helpful. You can view Professor Zimmern's article here >>>> PDF file format. Article Title: Vaginal Mesh for incontinence and/or prolapse: caution required. "Even if the rates of these devasting complications are fairly low, they are life-changing for the patient, sometimes irreversible and often sources of litigation" >>>
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PDF Format
Title: Lessons from the past: directions for the future Do new marketed surgical procedures and grafts produce ethical, personal liability, and legal concerns for physicians? >>>>

By Donald R. Ostergard
International Urogynecology Journa Received: 6 February 2007 / Accepted: 6 February 2007 / Published online: 16 March 2007
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Abstract found from Obstetrics & Gynecology:
October 2010 - Volume 116 - Issue 4 - pp 962-966
doi: 10.1097/AOG.0b013e3181f39b20
Current Commentary
Polypropylene Vaginal Mesh Grafts in Gynecology
Ostergard, Donald R. MD

Abstract Basic concepts are presented for the use of polypropylene mesh in gynecology for prolapse and stress-incontinence repair. The vagina is a clean–contaminated environment, and it is not possible to insert polypropylene mesh devices without bacterial contamination, despite standard antibiotic usage. Once inserted, the host tissue immediately attaches to the polypropylene and attempts to defend it from bacterial invasion, but if the bacteria have already reached the surface of the device, then dislodgement is difficult. The devices with larger surface areas result in greater bacterial contamination, more polypropylene degradation, increased inflammatory response, fibrous tissue stimulation, and erosion. Noninert polypropylene degrades into potentially toxic compounds that would be expected to stimulate a greater inflammatory reaction leading to erosion. If the physician does not place the mesh below full-thickness vaginal epithelium, penetrates the epithelium during insertion, or if there is hematoma formation near the vaginal incision, then defective healing and erosion may result. Scar tissue causes contraction to less than 50% of the implanted size, which results in dyspareunia and tension on the pelvic mesh attachments. Such contraction may cause pelvic pain and subsequent erosion into adjacent organs. An individual response in fibrosis also exists, with some individuals being “high responders.” Manufacturers need encouragement to develop meshes that are inert and incorporate without contraction along with routine clinical tests to detect “high responders” to avoid complications. Polypropylene is not inert within the human body.
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Are new tools for correcting prolapse and incontinence better just because they’re new?
by Anne M. Weber, MD, MS
Abstract
Until we can provide our patients with answers that are supported by evidence, products that lack such evidence should be considered experimental, and patients should be counseled accordingly.
How-economics-intersects-with-the-management-of-urinary-incontinence >>>
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Articles for November 2010

PDF Format
Title: Vaginal mesh grafts and the Food and Drug Administration
Author: Ostergard, Donald R.
Publication Date: 2010 >>>

Open Source: http://www.escholarship.org/uc/item/3j89k81j
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Dr. Richard Miller is a Professor of Surgery, Medical Director, Trauma Intensive Care Unit, Division of Trauma and Surgical Critical Care at Vanderbilt University Medical Center inNashville, Tennessee.

He sees abdominal wall hernia repair patients after they've had complications with synthetic mesh, some made out of Gortex or Marlex.

"The problem with synthetic mesh is as a foreign body the body tries to reject it and encapsulate it. You can bathe it in antibiotics, but the bottom line is that has to be removed and start over again. Because it's a foreign body you have to be a lifelong risk" he tells IB News.

The key to minimizing that risk, Miller believes, is in patient selection.

"Smoking is the worst. I will not operate on a patient who continues to smoke. Diabetes, obesity, malnutrition, all increase the risk of wound infections. I don't use synthetic mesh in any of those patients," he says. Even prior infections increase the risk of a bad outcome.

"It never made sense to put a foreign body in a person to repair abdominal wall reconstructions. "Synthetic mesh, they never feel the same," he says noting that Ethicon worked hard to create a material that didn't have an inflammatory reaction.

For the patients who Miller rejects, a cadaver or pig skin mesh is a better alternative. But there's the cost. "Synthetic may cost $1,000 to $10,000 for biologic mesh. Hospitals decide what material to use based on cost efficiency," he says.

Dr. Miller says hernia repair complications can occur in up to 40 percent of patients, based on his experience that he admits is a "skewed group, obviously".

"They can erode into the bowel, that's a half million dollar problem. They can erode through the abdominal wall and into the skin. I've seen a couple of circumstances when you remove the synthetic mesh the symptoms resolve. And many do fine."

Miller too encourages the establishment of a national database to support his theory of patient selection. Over the next decade he predicts that biologic mesh material will be refined to form a scaffold that incorporates the body's own tissue and allows it to incorporate immediately.

"My goal is to help these patients and a lot have huge problems. I'm not here to bash synthetic mesh but in certain subgroups there is a better alternative. Certainly, absolutely, they should not be used."

Source - http://www.injuryboard.com/national-news/Sufferinig-In-Silence-From-A-Medical-Device-Surgical-Mesh-Part-3.aspx?googleid=261960 >>>
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PDF Format
Risk factors for mesh erosion 3 months following vaginal reconstructive surgery using commercial kits vs. fashioned mesh-augmented vaginal repairs >>>

The International Urogynecological Association Received: 29 April 2009 / Accepted: 29 August 2009 / Published online: 4 December 2009
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The following links are articles by Suzanne McClain
http://www.injuryboard.com/national-news/suffering-in-silence--medical-device-surgical-mesh.aspx?googleid=260038 >>>
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http://www.injuryboard.com/national-news/Suffering-in-Silence-From-A-Medical-Device---Surgical-Mesh-Part-2.aspx?googleid=260612 >>>
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http://www.injuryboard.com/national-news/Sufferinig-In-Silence-From-A-Medical-Device-Surgical-Mesh-Part-3.aspx?googleid=261960 >>>
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The following links are articles by Lana Keeton
http://www.injuryboard.com/national-news/Suffering-In-Silence-From-A-Medical-Device---Surgical-Mesh-Part-4.aspx?googleid=262334 >>>
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Vaginal Mesh Surgery Complication Risk High, Despite Effectiveness: Study
www.tvt-messed-up-mesh.org.uk/vaginal-mesh-surgery-complication-risk-high.html >>>
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Please view the FDA warning:
www.tvt-messed-up-mesh.org.uk/fda-warning-notice.html >>>
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Who is Responsible for Evaluating the Safety and Effectiveness of Medical Devices? The Role of Independent Technology Assessment
www.tvt-messed-up-mesh.org.uk/pdfs/who-is-responsible.pdf>>>
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Something Doesn't Mesh
www.tvt-messed-up-mesh.org.uk/pdfs/Something-Doesnt-Mesh.pdf>>>
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Vaginal Mesh Contraction
www.tvt-messed-up-mesh.org.uk/pdfs/Vaginal-Mesh-Contraction.pdf>>>
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Is New Always Better?
www.tvt-messed-up-mesh.org.uk/pdfs/Is-New-Always-Better.pdf>>>
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New Surgical Procedures: Should I or Shouldn't I? Read PAGE 6
www.tvt-messed-up-mesh.org.uk/pdfs/New-Surgical-Procedures.pdf>>>
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Watching over the medical device industry
Although all new drugs have to be tested to get regulatory approval, the same is not necessarily true for medical devices. Jeanne Lenzer reports on loopholes that leave patients at risk
www.tvt-messed-up-mesh.org.uk/pdfs/watching-over-the-medical-device-industry.pdf>>>
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More will be added shortly, thank you for your patience.



articles and research
www.tvt-messed-up-mesh.org.uk/research.html >>>

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




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