Tag Archives: TVT-O

Polypropylene – “Not for use in human body”

“Do not use this Phillips Sumika material in medical applications involving permanent implantation in the human body or permanent contact with body fluids or tissues.

Do not use Phillips Sumika Polypropylene Company material in medical applications involving brief or temporary implantation in the human body or contact with human body fluids or tissue unless the material is provided by Phillips Sumika Polypropylene Company under an agreement which expressly acknowledges the contemplated use.

Phillips Sumika Polypropylene Company makes no representation, promise, express warranty or implied warranty concerning the suitability of this material for use in implantation in the human body or in contact with internal body fluids or tissues.”

Phillips Sumika Polypropylene Company Material Product Safety Sheet (undated)

 

Here is an early warning about polypropylene predating pelvic mesh

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Pelvic Mesh: Your Device is Tracked. So Are You

The FDA requires Medical Device distributors to track your device up until and including your death—including your name, address, phone number and social security number. Title 21 of the FDA regulations require the device distributor, final distributor, or multiple distributors (devices that move from patient to patient), promptly upon purchase, provide the manufacturer the name and addresses of all distributors along its journey to you, including the lot number, the date the device was received, and the person from whom it was received.

Tracking Devices vs. Device Tracking

The last distributor before your implant must also provide the manufacturer with their own name and address, the unique device identifier (e.g. lot or serial number), your name, address, phone number and social security number—unless you refuse to release that information under 821.55(a).* They must also record the date of your implant, name, address, and phone of both implanting surgeon and regular physician, and the date the device was explanted.

If a patient dies, the end point distributor must provide the date of death, name, address, and phone of treating physician, date of any explant with contact information for explanting physician, and, where applicable, and the date the device was returned to the manufacturer, retired from use or disposed of in any other way.

* Any patient receiving a device subject to tracking may refuse permission to release their name, address, phone and social security number or any other identifying information but, the hundreds of pelvic mesh implantees who were not told they had an implant or that a tracking system exists, would have no way to refuse permission. Title 21 can override a patient’s right to privacy if the “health or safety of the patient requires that such persons have access to the information.”

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Pudendal Nerve Injury Caused by Improper Insertion of TOT Obturator Tape – Pelvic Pain

The two main nerve complications TOT-injured women report in support groups are 1) pudendal and 2) obturator in that order. Because most studies do not evaluate for nerve injuries past 3-12 months, there is no scientific estimate of how common the injury is. Our experience is that it is extremely common. Pudendal injury causes persistent pain localized around the urethra and around the clitoris, irradiating to the one labia majora (maximum at the lower edge of symphysis) or both.

Polypropylene creates cripples when placed inside the pelvis.

The pudendal nerve is nowhere near the pathway of an obturator tape so how did the women get injured? The mystery may have been solved by three Czech investigators.

In 2011, Jaromir Masata & Petr Hubka & Alois Martan decided to look into why their patient, a 48 years old female obtained a pudendal nerve injury. After receiving a TVT-O, the woman experienced what the authors saw as an “atypical” postoperative pain that continued without relief for three years. While the authors treated her with injections and replaced her sling with yet another dubious tape, the work they did to track down the cause of her injury is valuable.

Authors circled scar and placed a “+” pointing to correct placement location.

The woman’s insertion scar (see Figure 1) was in the wrong place. By using a cadaver to trace the aberrant passage of her sling, the researchers found it intersected with the pudendal nerve. How many others were injured this way? Are you one of them? Was your transobturator tape placed incorrectly? If the manufacturer provided short videos and an instruction sheet, was that adequate training for your surgeon?

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FDA Publishes 50 Known Pelvic Mesh Device Problems – Approves Anyway

The FDA received nearly 9,000 complaints about predicate devices before approving a new TOT. Here is a list from the January 2007 application for FDA clearance for the Align Urethral Support. This list does not include many device-related problems like bleeding, infection, pain, dyspareunia (inability to have sex) or those on the list in the right hand column on this page.

The Align (Bard Avaulta) was approved anyway on March 21, 2007.

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Australian Pelvic Mesh Survivor Group Position Statement – Carolyn Chisholm

By Carolyn Chisholm
June 5, 2017, Perth

I started the Australian Pelvic Mesh Support Group 2.5 years ago to find an empathetic and ethical surgeon who would invite Dr. Dionysios Veronikis to Australia to remove the mesh devices from women that no other surgeons in Australia are able to remove. Veronikis can remove more prolapse mesh from the pelvis and legs than any surgeon here because he has invented equipment to reach deep into the pelvis that other surgeons can not reach. He has also removed more than 2000 meshes.

It is important that you know what the group is about. It is about Dr Veronikis; about him coming here. It is about empathy and support for women who are suffering. We do not like mesh or support mesh. We are anti mesh. We do not believe in partial removals. We believe in full removal wherever possible.

We have found a surgeon in Sydney who is a gynecology pain specialist and pudendal nerve specialist. The pudendal nerve is the area around the groin that so many women are having complications with who have mesh; when this nerve is damaged it is extremely painful and affects the groin and legs, the vulva, the vagina, the rectum, and lower back. It really is a specialised area that implanting surgeons seem to know very little about and yet it is the main problem with mesh-injured women. Proving that [to other gynecologists] though is another issue.

This surgeon has agreed to invite Dr. Veronikis to Australia to remove the large prolaspe meshes from women that other surgeons in Australia refuse to or cannot do. Dr. Veronikis is the surgeon I flew to St Louis to see to have my stress incontinence tape fully removed. This is a momentous step for mesh injured women having Veronikis come here because we have been searching for 2.5 years to find a surgeon who will agree to do this. The surgeon here has already flown to America recently to meet Dr. Veronikis and receive training in mesh removal of the smaller tapes/meshes for incontinence. However, the larger prolapse meshes are very complicated and dangerous to remove and it takes a special surgeon to remove these.
Dr. Veronikis designed his own removal equipment and instruments and patented them himself so he can get deep into the pelvis to remove the mesh. No other surgeon in the world has this equipment. However, now Australia will have it because there are two hospitals in Sydney who are paying for the equipment. The Sydney surgeon is flying back to the USA in a few weeks time to have more discussions with Veronikis about equipment and training nurses in theatre.

This is the beginning of a massive breakthrough for mesh injured women and now we have some hope. It is a huge undertaking and it has involved a hell of a lot of work from numerous people including mesh injured women and we have some fantastic, highly qualified and highly regarded medical staff backing us.

Women from all over Australia are booking in to have removal surgery with Dr. Veronikis in Sydney when he comes. Unfortunately the RANZCOG (Royal Australian and New Zealand College of Obstetricians and Gynaecologists)
stand by their statement that partial removal is an acceptable form of treatment. They refuse to get on board with full removal procedures, even though Dr. Veronikis has removed more than 2000 mesh devices and travels around the world speaking about the pain associated with mesh and that when pain occurs the only way is to remove all of the mesh. The women in the Austrailian support group do not agree with the RANZCOG about partial removal because every single woman who has had this procedure ends up with more complications and ends up going back into hospital for more surgery and they often end up with infections that don’t go away and they live on antibiotics.

The Australian Pelvic Mesh Support Group is in the process of becoming a not for profit organisation so we can apply for funding to help mesh injured women Australia wide who need pain specialists, the correct diagnosis of mesh complications, psychological help and referrals to mesh removal surgeons which, at the moment, are very few and far between. The plan is to set up clinics in each city in Australia.

Caz Chisholm winning two awards for her advocacy work.

What is really important to distinguish is the prolapse meshes and the stress incontinence meshes. The prolapse meshes are in the high risk category whereas the stress incontinence meshes are still considered the gold standard even though there are no long term studies to prove it and RANZCOG state the clinical trials still need to be done for the SUI meshes, So this means that women are still guinea pigs otherwise why would they need the trials? I do know from a poll in our group that there are more women injured from stress incontinence meshes than prolapse meshes, possibly because more surgeons are implanting them these days since they have the “all clear” from RANZCOG.

I feel that the gynaecological associations have lost control of their gynaecologists and women are being implanted with mesh unnecessarily. Most GP’s know nothing about mesh complications and most gynae surgeons are sending women out the door telling them that their pain has nothing to do with the mesh. These surgeons don’t want to know anything about the complications that their implants have caused women. In fact I have read stories in the group about surgeons being rude to the women, some shout at them, some get angry with them, simply because the woman is presenting with pain and complications. They are turning their backs on the women. It is diabolical what is happening. This is why the Australian Pelvic Mesh Support Group needs to set up clinics Australia wide and find ethical and empathetic surgeons who want to be trained in full removal and to find the right medical professionals that really want to listen to these women, to believe them and not turn them away.

It is a very specialised issue and needs to be addressed immediately.
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FDA Responds to Pelvic Mesh Counterfeit Resin Allegations

Mostlyn Law alleged that Boston Scientific smuggled counterfeit resin containing toxic selenium and used it in mesh products after 2010. The FDA responded  January 5, 2017 by requiring BSC to prove that the material is safe for human use and to analyze the contents of their own mesh.
In its response, FDA doesn’t recommend removal of the suspected counterfeit material claiming the removal surgery is more risky than keeping selenium in your body.


Counterfeit Class Actions:
“In addition to the mass tort docket, Boston Scientific said it also faces two class action lawsuits by plaintiffs who allege that the company used counterfeit or adulterated resin from China to make the mesh in its pelvic mesh devices and not brand-name, American-made mesh as specified in regulatory approval for the devices. It said one case was stayed to allow the Food and Drug Administration to issue a determination about the counterfeit allegations.The company said the U.S. Attorney’s Office for the Southern District of West Virginia has also requested information about resin used in the company’s pelvic mesh devices.” — Lexis Legal News Boston Scientific Has Pacts To Settle About 37

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Comprehensive List of Pelvic Mesh Products

Since the 1950’s, surgical mesh has been used for all types of internal repairs, particularly hernia repairs to strengthen the abdominal wall. In the 1970’s, gynecologist and urogynecologists began to develop and patent products which used surgical mesh to treat urinary incontinence (most often due to early bladder sagging) and later more pronounced pelvic organ prolapse. Gynecologists began to cut small pieces of hernia surgical mesh into precise shapes.

A company by the name of Versica Medical introduced a product called the “Vesica Bone Anchoring System”, which used sutures attached to small screws to urinary incontinence. Vesica’s system was one of the precursors to transvaginal mesh devices that followed, beginning with the ProteGen. 

Below is a comprehensive list of transvaginal (pelvic) mesh products. Expect this list to be updated with more information like dates of use soon.

American Medical System

  • Apogee
  • BioArc
  • Elevate
  • In-Fast Ultra Transvaginal Sling
  • MiniArc Precise Single Incision Sling
  • Monarc Subfascial Hammock
  • Perigee
  • SPARC Self-Fixating Sling System
  • Straight-In

Boston Scientific

  • Advantage Fit System
  • Advantage Sling System
  • Arise
  • Lynx Suprapubic Mid-Urethral Sling System
  • Obtryx Curved Single
  • Obtryx Mesh Sling
  • Pinnacle Pelvic Floor Repair Kit
  • Pinnacle Pelvic Floor Repair Kit II
  • Polyform Synthetic Mesh
  • Prefyx Mid U Mesh Sling System
  • Prefyx PPS System
  • Solyx SIS System
  • Uphold Vaginal Support System

Covidian

  • Duo
  • IVS Tunneler Intra-Vaginal Sling
  • IVS Tunneler Placement Device
  • Parietene Polypropylene Mesh
  • Surgipro Polyproylene Surgical Mesh

C.R. Bard

  • Align
  • Avaulta BioSynthetic Support System
  • Avaulta Plus BioSynthetic Support System
  • Avaulta Solo Support System
  • Avaulta Solo Synthetic Support System
  • CollaMend Implant
  • Faslata Allograft
  • Pelvicol Tissue
  • Pelvilace
  • PelviSoft Biomesh
  • Pelvitex Polypropylene Mesh
  • Ugytex
  • Ugytex Dual Knit Mesh
  • Uretex
  • Uretex TO
  • Uretex TOO2
  • Uretex TOO3

Coloplast (out of business)

  • Minitape
  • Omnisure
  • Smartmesh
  • Restorelle
  • T-Sling-Universal Polypropylene Sling System
  • Aris-Transobturator Sling System
  • Supris-Suprapubic Sling System

Cook Medical System (out of business)

  • Surgiss Biodesign Tension-Free Urethral Sling
  • Surgiss Biodesign Anterior Pelvic Floor Graft
  • Surgiss Biodesign Posterior Pelvic Floor Graft
  • Cook Urological Stratasis Tension-Free Urethral Sling.

Ethicon Division (Johnson & Johnson)

  • Prosima
  • Gynemesh PS
  • Prolene Polypropylene Mesh Patch Secur
  • Prolift
  • Prolift+M
  • Prosima
  • TVT
  • TVT Abbrevo
  • TVT Exact
  • TVT Obturator (TVT-0)
  • TVT Retropubic System
  • TVT Secur

Mentor Corporation

  • Obtape (recalled – was implanted between 2003 and 2006)

Other companies:

  • Caldera
  • Sofradim
  • Neomedic Sling

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Early device, Perigee, with insertion tools. Note frayed ends of mesh.

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Adverse Events Statistics Misleading – Transvaginal Mesh

Today’s press release from the Lawfirm Newswire stresses the importance of reporting injuries from TVM.

“Former FDA Program Manager, Madris Tomes, now the founder of Device Events, firmly believes all TVM kits are dangerous. Additionally, although many of the adverse event reports deal with ongoing symptoms, a question arises whether TVMs could cause deaths.

Due to the nature of the reporting system, death may be reported as malfunctions and injuries. Based on current information in the FDA reporting system it is allegedly not clear how many deaths may be related to TVM kits. However, according to Medscape, an FDA review of records for all urogynecologic mesh products spanning the years 2005 to 2010, there were 3,979 reports of malfunctions, injuries and deaths.

“It was not until 2011 that the FDA announced that the serious complications with the TVM kits everyone was reading about in the news were not rare — a reversal of its original stance on the product issued in 2008,” said Austin TVM attorney, Bobby Lee. After the FDA released its revised position on TVM kits, it was revealed they had been sent over 4,000 complaints involving TVM malfunctions, injuries and/or deaths over a five-year period.”

Here are easy to follow instructions for reporting your own mesh injury. If you have new injuries? File a new report!

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Partial Pelvic Mesh Removal — Wrong Solution to Permanent Problem

Your surgeon says he or she can snip the part of the mesh sling they can see, a quick operation and you’ll be better. Or says he can cut it to release it because it was put in too tight. Or, he promises a full removal but the operation takes less than an hour and, if the parts go to pathology, most of the mesh is still not accounted for.

Women who knowingly or unknowingly have partial removal surgery come to regret it. They issue strong warnings for the lucky women who read or search for answers online before signing up for a partial removal. Thousands of Urogynecologists and Urologists do partial removals. The very people who profit from mesh tell those specialists how to handle complaints: just cut a little out. Some heartless doctors cut it right there in the office with no anesthesia whatsoever.

The woman who have been through this tell newcomers not to allow a surgeon to cut bits and pieces of mesh but to leave it whole for a qualified surgeon with the skills to necessary to remove the entire device in one operation. They warn that doctors are not telling the truth about those partial surgeries.

Frayed rope is like sliced mesh

Partial removal can be a temporary solution to a permanent problem. Nearly everyone gets temporary relief after a partial surgery. When a rope breaks, the ends fray. That’s what happens with partials. All the ends leak toxic chemicals, stirring up a immune storm inside your body and spring back, eventually attaching to other parts of your vagina, bladder, intestines, bones, nerves, and blood vessels. After a year or two, you develop new symptoms and go looking for a doctor who can help. More than 99% of board certified surgeons will do another partial. Some women have dozens of surgeries before finding help from advocacy groups.

Be very careful. Get the whole thing out in any way you can because you are in the best possible shape to have a good outcome when your surgeon goes after the whole thing and it’s still intact! When mesh is cut, the next surgeon must go searching for shreds of it. They compare that surgery to trying to get bubble gum out of hair or searching for shrapnel.

POLY IS FOR CUTTERS

If your surgery took less than four hours, consider that it may not be a complete removal, get your medical and surgical records and your pathology report. Learn the dimensions of your implant and ask for an accounting for every piece of it. Before your explant surgery, demand a micro and macro pathology be done. Afterward, get those reports!

We’ve found only five surgeons in the U.S. who consistently prove they removed complete pelvic mesh including arms or anchors (fixation devices):

  • Shlomo Raz, UCLA
  • Dionysis Veronikis, St. Louis, MO
  • Una Lee, Seattle WA
  • Dmitriy Nikolavsky, Syracuse, NY
  • Michael Hibner, Phoenix, AZ

The surgery is very risky but research has shown that is in no more risky that partial removals.

Beware of sugeons loan companies Beware of Mesh News
If you’d like to join an online support group and learn about erosion, partial removals, surgeons, or just find out that you are not alone, check the list of support groups here.
PelvicMeshOwnersGuide.com to learn more about pelvic mesh. I’d like to hear from you if you are helped by what you read here or if you need to know more about any particular topic. Comment below or email me privately at daywriter1@gmail.com.





4 Kinds of Pelvic Mesh and 4 Properties

Four Types of Transvaginal Mesh

     Transvaginal full-length or patch slings are implanted through both abdominal and vaginal incisions and secured with either absorbable sutures or anchors (miniature screws). The full-length sling is roughly two by seven-inches long. A patch is about one by two inches. Examples include: the Gynecare Prolift and the Gynecare Prolift+M.

     Tension-free transvaginal tape is mainly used to treat SUI. The mesh is inserted through your vagina and two small incisions in your lower abdomen near your pelvic bone. To pull the mesh inside, using his finger to identify anatomical markers, the surgeon passes a specialized needle through the area above your pubic bone called the retropublic space, which contains highly vascular tissues and is close to your bowel and bladder. Sutures and bone anchors are not required because it relies on your own tissues to hold it in place. Example: Gynecare Exact.

The transobturator tape procedure eliminates the need for a needle to go into your retropublic space. One or two needles are placed blindly through your groin area. Your surgeon then uses a vaginal incision to help guide the tape under your bladder. Example: Boston Scientific Obtryx.

The mini sling procedure uses only one incision in the vaginal area under the urethra. The mesh is secured with two “self-retaining tips” which are punched into your obturator foramen, the site of many permanent nerve injuries. Some doctors say this reduces the risk for injuries but recent scientific literature reports an equal number of complications. Example: AMS MiniArc Single Incision Sling.

POlypropylene IS FOR VEGIES NetsOnRolls

Properties of Synthetic Surgical Mesh

Synthetic materials are categorized according physical properties: composition (mono-filament or multi-filament), pore size, flexibility, and architecture (knitted or woven). Mesh used in pelvic reconstruction is different from hernia mesh in order to provide ease of use and the capability for the host tissue to grow into it while reducing your risk for erosion, infection, extrusion, and cancer.

     Type I monofilament macroporous polypropylene mesh (preferred synthetic material) has a large pore size, greater than 75 micrometers, facilitates the infiltration of the mesh by macrophages, fibroblast and blood vessels (your body’s wound healing defenses). It is believed to cause less infection as your tissue grows into it. Lightweight Type I mesh has a lower density of polypropylene and is believed to cause less foreign-body response.

     Type II monofilament microporous mesh – allows bacterial infiltration and it is harder for blood vessels and fibers to grow into because of the small pore size (smaller than 10 micrometers) resulting in a higher risk of recalcitrant infections.

     Type III multifilament mesh – has small interstices, (less than 10 micrometers) and bacteria that is less than one micrometer can replicate within its interstices. It is less than optimal because it allows access to macrophages and limits your ability to fight bacterial colonization within the spaces. There is also an increased risk of bacteria adherence due to increased surface area of the mesh (biofilm).

     Type IV meshes – are sub-microporous coated biomaterials with pores of less than one micrometer. They are generally avoided in pelvic reconstructive surgery.