Tag Archives: Mini-Tape

Vesica Procedure Gives Birth to Pelvic Mesh – Pre 1996

[Trigger warning: This story contains graphic surgical details.]
If you have a retropubic bladder sling, you may want to get familiar with the procedure that paved the way for yours and all pelvic meshes. The Vesica technique was used to implant the ProteGen, the evil grandmother of all transvaginal mesh.

The story below was pieced together from historical patent applications, MAUDE reports, and donated personal stories in order to create a composite patient with the pseudonym Abbey Nordell. On the day of her operation for a little bladder leak, her surgeon, Brian Malikoff (also a pseudonym), asked the young woman who peed when she sneezed to sign a consent for a “Vesica Procedure” before he headed off to “scrub in.”

A short while later, Nordell was flat on the table, covered with a sheet,  ankles in stirrups when Malikoff swept into the operating room.. After saying hello, Malikoff watched his sedated patient drift off to sleep. Pushing his foot on a floor pedal, he tilted the table backward until his patient’s head was lower than her hips. The circulating nurse adjusted a powerful light behind his head until the young doctor could visualize the area of Abbey’s body she normally kept very private.
With a gloved hand, Malikoff unfalteringly inserted a sixteen-millimeter diameter Foley catheter, pushed a tablespoon of water through it and inflated her bladder just enough to feel her urethra through the front wall of her vagina with the other. Next, he took a pair of sharp tipped scissors and cut open a hatch-door-shaped flap at the top front of her vagina. He Exchanged the sharp scissors for blunt-tipped ones and, keeping them closed, swept the tips back and forth through the space outside of her vaginal canal, the periurethral fascia (periurethral fascia includes the obturator fascia, covers the pelvic walls formed primarily by muscles that pass from the interior of the pelvis to the thigh), until he separated her bladder from her vagina.

Illustration from Vesica Patent

The fascia around Nordell’s urethra is part of an uninterrupted head-to-toe system that surrounds and permeates every tissue in her body: organ, bone, muscle, skin, nerve, artery or vein. Fascial structures are made of collagenous tissue which is pre-loaded with tension and can stretch or compress in many directions without losing strength. They act as a lubricant to the surrounding surfaces. Cuts to Nordell’s fascia will heal, but will become scarred, more rigid, and change shape. To Malikoff, this was a reasonable trade-off with an acceptable risk-benefit ratio (a complex decision that balances the degree of illness or injury, the patient’s age and health, especially circulatory health, how well the patient is responding to non-surgical treatments, the patient’s feelings about surgery, and how much risk there is for surgical complications).
On each side of Nordell’s incision, Malikoff separated further using both sharp and blunt tools, cutting sideways as far as possible to avoid injuring her bladder and urethra. He then punctured her endopelvic fascia (Endopelvic fascia includes the obturator fascia, covers the pelvic walls formed primarily by muscles that pass from the interior of the pelvis to the thigh) behind her pubic bone and cut a path wide enough to pass a large darning needle-shaped instrument known as a “Stamey needle.” (Stamey needle: used for pulling sutures from a vaginal incision into the suprapubic area during bladder suspension surgery. This needle is reusable.) He then made a half-inch long incision deep enough to reach the next fascial area rectus fascia (thin but very tough layer that covers the abdominal muscles) above her pubic bone where he would soon anchor a suture. The circulating nurse opened a sterile package containing a Vesica kit and carefully dropped the contents onto the Mayo Stand (metal table that holds surgical instruments): two screws with sutures attached and a tube-shaped drill guide.

Two examples of anchor fixation devices

Still gloved, Malikoff grasped a tube-shaped drill guide and used it to insert a tiny anchor. He located specific internal landmarks at the back of Nordell’s pubic bone with his fingertip and aimed the head of the guide into the bone’s periosteum (dense fibrous membrane covering the surface of bones) and twisted the first tiny screw until it was securely seated. The second screw was not so easy. When he realized he accidentally twisted it into a ligament, his heart stopped. Unable to back it out, he cut the errant suture lose with a tiny saw Boston Scientific provided for this kind of mishap and requested a second Vesica kit to access a third screw. (The misplaced screw remained inside her body for years to come. She discovered it many years later.)*

Pubic bone

Malikoff then pulled the two properly secured sutures around her urethra and up through the incision above her pubis. After placing two fingers through her vagina and between the sutures and her urethra he estimated the amount of tension and then tied the ends above with a square knot “I’ll tie eight knots just to be sure. We don’t want this unraveling,” he said to no one in particular.
To make sure there was no injury to Nordell’s urethra and that the sutures were not to tight, Malikoff passed a cyctoscope (slender, cylindrical camera for examining the interior of the urinary bladder) into her bladder to look for signs of perforation. Happy there were none, he closed her vaginal and suprapubic incisions with absorbable sutures, inserted a Foley catheter and vaginal packing and signaled the anesthesiologist to wake her up.
* * *
Nordell’s procedure never worked to stop her leakage but put her into a world of pain. She began to suffer from UTI’s and the sutures cut her husband making love-making an ordeal.
The F.D.A. provides a place to report disasters like Nordell’s but the vast majority of tragic outcomes never make it there. Doctors are not required to report complications and company representatives rarely follow the reporting mandate. Medical personnel, lawyers, and patients themselves can report negative experiences to M.A.U.D.E. (Manufacturer and User Facility Device Experience), however. That’s how we know that, before pelvic mesh caused a slew of problems, patients were already suffering.
Look for more stories about other mesh inventions as I attempt to cover each different type of pelvic mesh.

* * *

*When the circulating nurse cleaned up after the surgery, she threw away a small folded paper that dropped out of the Vesica Kit package called the “instructions for use” (IFU). Those instructions recommended surgeons prepare for Vesica procedure surgery by planning in advance a way to replace “dropped, contaminated, mal-positioned or non-working screws” and by having extra supplies and extraction tools on hand—as Malikoff had done.

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Peggy Day is working on a book to combine all these stories. This is an excerpt from . Your input is welcome to help make Pelvic Mesh Owner Guide 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 daywriter1@gmail.com.

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How to Find What Mesh Product is Inside of You

You have a right to your medical records. Here’s what to do if you need to find out which product was implanted inside of you. It should be on your medical record, but when you simply ask for medical records, it’s often excluded, especially if you have an electronic record.

In this photo of an unopened bladder sling, there are 4 sticky labels to peel off and put on the medical record and other documents.

Not every hospital organizes medical records the same way and most made the transition from paper to electronics in the past 2 decades. You may have to do some investigating to see where your label is.

All implants come with a label (or sticker or log) with a unique tracking number and an expiration date and the country where it was made. Your hospital is required to let the manufacturer know who got which product and a record is supposed to be kept with the manufacturer. (Incidentally, I’ve never heard of a manufacturer contacting a mesh patient about a recalled defective device like car makers do).

  1. Ask your medical records department at the hospital where the surgery occurred for your complete “Operative Report” including any product labels. Tell them it might be on a separate piece of paper and may be only in your paper file.
  2. Search your operative report for it or for a notation by the circulating nurse that would name the product and include a serial number, usually preceded by a “#” symbol and, hopefully with an expiration date. (The date only refers to how long the sterilization process will last, not the device.) In an electronic record, look for a typed notation with a serial number. With that number, you can do an online search for your product name.
  3. If you do not find it, go personally to your hospital and speak with the director of Medical Records. Describe what you’re after and don’t take no for an answer.
  4. Failing all that, and if you have a copy of the note your surgeon dictated after your surgery, you are welcome to send it to me and I can narrow down to a few possibilities for what kind of mesh yours is.
  5. As a last (and expensive) resort, hire a lawyer to get it for you.

Notes: Click here for a list of how long hospitals must keep records by state.

Note: You may have to pay a reasonable fee for your paperwork.

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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 daywriter1@gmail.com.

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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 daywriter1@gmail.com.

    • 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

    .

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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 daywriter1@gmail.com..

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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 t

Caz Chisholm winning two awards for her advocacy work.

o 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.

 

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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 daywriter1@gmail.com..

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What Does a Bladder Really Look Like? Pelvic Mesh Implants

The bladder and urethra play a key role in pelvic organ prolapse and stress urinary incontinence. The most frequent cause of SUI is early bladder prolapse.

Figure 1. Illustration from patent application 2004. “u” is called a urethra. “B” is called a bladder.

As we age, the bladder loses support from neighboring fascia, muscles, ligaments and tendons and drops down, folding itself over supporting structures underneath (and over any slings or sutures in the pelvis). The folding narrows the outlet or urethra. Imagine you are holding a rolled up throw rug under one arm to carry it, it folds over and the hole inside it narrows and flattens.

Figure 2. Offset oil funnel.

Mesh illustrations in journal articles, public information handouts, and patent applications are inaccurately show the urethra as a straw-shaped tube through which urine flows. See example in Figure 1. It is really a sideways funnel — “offset” like the photo of the oil funnel in Figure 2. Figure 3. is a healthy bladder.

Figure 3. Healthy non-prolapsing bladder.

How in the world did the patent office and the FDA clear this product, a mesh tape with wing-like extensions for treating female urinary incontinence US 8047982 B2, when the illustration clearly shows a tube and the device is designed to fit a straight tube?

It is no wonder patients become confused.

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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 daywriter1@gmail.com..

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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 daywriter1@gmail.com..

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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 daywriter1@gmail.com..

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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 daywriter1@gmail.com..

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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.

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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 daywriter1@gmail.com..

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