Tag Archives: TVT-O

Hazards of Laparoscopic Mesh Removal

Online message from Dr. Dionysios Veronkis (slightly edited for clarity) :

Vaginal mesh is placed extra peritoneally[1] (outside the body cavity and away from bowels). Although laparoscopy is touted as minimally invasive, [it is minimally invasive in] abdominal surgery. Vaginal surgery is less invasive than both laparoscopic and robotic surgery.

Robotic surgery is laparoscopic surgery aided by a computer to help the surgeon move robotic arms [which guide instruments].

When mesh is placed vaginally and removal is attempted laparoscopically, the surgeon must place small 5mm to 12mm incisions and ports in the abdomen, [adding] the risk of injury to the bowel blood vessels during trocar insertion. The peritoneum must then be cut and the bladder and vagina or rectum and vagina must be separated [by cutting through the connecting fascia].

Bear in mind that when instruments are inserted thru the abdomen, that port creates a fulcrum and a vertical angle thru the abdominal wall limits the movement of the instruments [while they operate on the horizontally-oriented] vagina.

While all this is going on you are tipped head down pelvis up so your bowels move out of harm’s way. The surgeon is operating while standing at your side with thin 5mm to 10mm instruments pushed thru your abdomen to reach your vagina—17 to 25 inches [away].

[Your alternative is to] find a vaginal surgeon who can forgo all that and go directly thru your vagina to the mesh. Remember, mesh was placed vaginally.

The thin laparoscopic instruments were never designed for the structural stiffness of the mesh. Laparoscopic instruments were designed to be thin and delicate since bowel is always present. Due to the nonspecific delicate instruments used in laparoscopic and robotic surgery, in order to remove mesh in laparoscopic surgery, robotic energy must be used. Laparoscopic surgery uses electricity to cut tissue and stop bleeding which generates heat.

Mesh is plastic. Heat melts plastic.[2] Removals done with the use of electricity will look blackened or burned with no clear edges or ends and small blood vessels need to be cauterized.

Liberal use of energy will melt the mesh, create a thermal injury that will kill tissue days later (and may result in a hole in the rectum or the bladder) or, in order to avoid melting the mesh, more tissue will be removed [than necessary], increasing the risk of a hole or a fistula.

Mesh in both groins from a TOT and mesh under the skin and muscles from a TVT can NOT be accessed by laparoscopy. They [require] an incision.

Finally, you can do all that or have the mesh removed vaginally with sharp dissection using more durable instruments designed specifically for vaginal surgery.

– D. K. Veronikis M.D. of St Louis, MO

[1] Peritoneum: the serous membrane that lines the walls of the abdominal cavity and folds inward to enclose the viscera. Normally, it is separate from the pelvic viscera.

[2] When polypropylene melts, depending on the particular material, it releases plasticizers, stabilizers, and biocides. Most of these materials will have a very low vapor pressure, so they will probably form aerosols (white smoke) and should be taken care of with a little fresh air
Burned polypropylene (black smoke, and/or flames) can form a large number of organic compounds (oxidation and/or decomposition products) including some formaldehyde, an eye and respiratory irritant, as well as related compounds.

 

 

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Peggy Day is working on a book to combine all these stories. This is an excerpt from Pelvis in Flames: Your Pelvic Mesh Owner’s Guide. Your input is welcome to help make Pelvis in Flames the book you need to read.

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, join my group, Surgical Mesh or check the list of support groups here.

Subscribe to 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 [email protected]..

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10 Facts of Life for the Pelvic Mesh Newbie

  1. Mesh injuries and illness rates are much higher than medical studies show. Most published research favorable to mesh is funded by the manufacturer.
  2. Mesh is mesh. There is no “old mesh.” It is all that same thing with minor changes in shape or route. Polypropylene is just plain damaging to human tissue.
  3. The pelvis is a perilous place to conduct surgery. Even human or pig mesh or simple suture repairs can cause problems–but not as frequently as pelvic mesh.
  4. Your new pelvic problem is very likely caused by the mesh itself. Fearing litigation and believing the manufacturer’s advertising, doctors are reluctant to blame the device.
  5. Some pain and infection get better with removal–but not all.

    KIM Mesh

  6. Very few surgeons know how to take mesh out, so they fake it with partial revision surgeries that lead to new complications and more surgeries. More surgeries = more scar tissue.
  7. There is no justice. There are almost no medical malpractice lawsuits anymore. There is no money in malpractice litigation for the lawyers since “Tort Reform” was enacted in all 50 states. Doctors and the AMA lobbied and paid for Tort Reform.
  8. About class actions, there is no money for a lawyer who represents a patient with pain, infection, nerve damage, etc. because recent settlements are based on the number of surgeries you’ve had and not how sick or injured you are.
  9. Don’t wait for legal recourse before finding a competent surgeon. Consider crowd-funding to get well.
  10. You shouldn’t have to do this alone. Join a mesh support group but keep a critical mind and don’t accept advice just because another person is adamant in their post Be careful. Be sure to double check any answers you receive. A good internet search can provide your best education.

 


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Peggy Day is working on a book to combine all these stories. This is an excerpt from Pelvis in Flames: Your Pelvic Mesh Owner’s Guide. Your input is welcome to help make Pelvis in Flames the book you need to read.

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.

Subscribe to 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 [email protected]

    • 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

[email protected]

    .

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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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Peggy Day is working on a book to combine all these stories. This is an excerpt from Pelvis in Flames: Your Pelvic Mesh Owner’s Guide. Your input is welcome to help make Pelvis in Flames the book you need to read.

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, join my group, Surgical Mesh or check the list of support groups here.

Subscribe to 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 [email protected]..

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Pelvic Mesh: Your Device is Tracked Unless You Opt-Out

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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Peggy Day is working on a book to combine all these stories. This is an excerpt from Pelvis in Flames: Your Pelvic Mesh Owner’s Guide. Your input is welcome to help make Pelvis in Flames the book you need to read.

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, join my group, Surgical Mesh or check the list of support groups here.

Subscribe to 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 [email protected]..

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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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Peggy Day is working on a book to combine all these stories. This is an excerpt from Pelvis in Flames: Your Pelvic Mesh Owner’s Guide. Your input is welcome to help make Pelvis in Flames the book you need to read.

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, join my group, Surgical Mesh or check the list of support groups here.

Subscribe to 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 [email protected]..

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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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Peggy Day is working on a book to combine all these stories. This is an excerpt from Pelvis in Flames: Your Pelvic Mesh Owner’s Guide. Your input is welcome to help make Pelvis in Flames the book you need to read.

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, join my group, Surgical Mesh or check the list of support groups here.

Subscribe to 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 [email protected]..

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UPDATE: Australian Pelvic Mesh – Carolyn Chisholm

UPDATE: Carolyn (Caz) Chisholm, of Perth Australia, started a search three years ago to find a surgeon and a hospital to sponsor a visit by Dr. Dionysios Veronikis (St. Louis, Missouri) to Australia because is skilled in the removal of pelvic mesh devices from women that no Australian surgeon can. Today, women must travel to the United States to have pelvic mesh removed in its entirety. Veronikis invented equipment to reach deep into the pelvis to retrieve mesh that no Aussie surgeons can reach. He’s removed more than 2000 meshes.

Larger prolapse meshes are very complicated and dangerous to remove, and it takes a special surgeon to remove them. Dr. Veronikis designed and patented specialized pelvic mesh removal equipment and instruments, which no other surgeon in the world has.

Recently, Caz left her leadership role in the Australian pelvic support group to devote her time and efforts to finding a surgeon and a hospital to sponsor a visit from Dr. Veronikis in the hopes that he would teach Aussie surgeons safe mesh removal techniques.

Like anti-mesh advocates across the globe, Aussie’s leaders do not like mesh or support mesh. They do not believe in partial removals and encourage full removal wherever possible to minimize the trauma to women. They want Australia to have the same removal possibilities that the U.S. does.

“This is a huge undertaking, and it involves a hell of a lot of work from numerous people including mesh-injured women themselves. Unfortunately, the RANZCOG (Royal Australian and New Zealand College of Obstetricians and Gynaecologists) stand by their statement that a partial removal is an acceptable form of treatment. They refuse to get on board with full removal procedures  [even though] when pain occurs the only way is to remove all of the mesh,” wrote Chisholm.

Aussie injured women do not agree with RANZCOG’s and Professor Vancaille’s position about partial removal because “every single woman who has had this procedure ends up with more complications, [goes] back into hospital for more surgery, and often ends up with infections that don’t go away and [long-term] antibiotics.”

Aussie activists also try to help mesh injured women find pain specialists, accurate diagnoses, psychological help, and referrals to competent mesh removal surgeons—even if it means traveling half-way across the world.

Caz distinguishes between mesh used to treat prolapse and that used to treat urinary incontinence. Prolapse mesh is considered “high risk” by FDA officials but the SUI meshes are treated as the “gold standard.” There are no long-term studies proving the use of mesh is safe or efficacious. “RANZCOG states the clinical trials still need to be done for the SUI meshes; so this means that women are still guinea pigs,” wrote Chisholm.

She says women are being implanted with mesh unnecessarily and afterward, their GP’s don’t know how to treat them, and gynecologists deny care by saying their new problems are not related to mesh (duplicating the actions of doctors in the U.S. and all other countries). “These surgeons don’t want to know anything about the complications that their implants have caused women. In fact, I have read stories 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 we need 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,” the determined activist added.

Caz Chisholm won two awards for her advocacy work.

 

Caz Chisholm winning two awards for her advocacy work.

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Peggy Day is working on a book to combine all these stories. This is an excerpt from Pelvis in Flames: Your Pelvic Mesh Owner’s Guide. Your input is welcome to help make Pelvis in Flames the book you need to read.

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, join my group, Surgical Mesh or check the list of support groups here.

Subscribe to 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 [email protected]..

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FDA Ups Enforcement After 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 the 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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Peggy Day is working on a book to combine all these stories. This is an excerpt from Pelvis in Flames: Your Pelvic Mesh Owner’s Guide. Your input is welcome to help make Pelvis in Flames the book you need to read.

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, join my group, Surgical Mesh or check the list of support groups here.

Subscribe to 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 [email protected]..

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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.

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

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
  • Generic Mesh Device Company

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Peggy Day is working on a book to combine all these stories. This is an excerpt from Pelvis in Flames: Your Pelvic Mesh Owner’s Guide. Your input is welcome to help make Pelvis in Flames the book you need to read.

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, join my group, Surgical Mesh or check the list of support groups here.

Subscribe to 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 [email protected]..

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Adverse Events Statistics Misleading – Transvaginal Mesh is Dangerous

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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Peggy Day is working on a book to combine all these stories. This is an excerpt from Pelvis in Flames: Your Pelvic Mesh Owner’s Guide. Your input is welcome to help make Pelvis in Flames the book you need to read.

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, join my group, Surgical Mesh or check the list of support groups here.

Subscribe to 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 [email protected]..

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