Tag Archives: incontinence

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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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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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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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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Forty Percent Failure Rate and Erosion Rate! Polypropylene is Not Fit For Humans

“For the want of a nail the shoe was lost,
For the want of a shoe the horse was lost,
For the want of a horse the rider was lost,
For the want of a rider the battle was lost,
For the want of a battle the kingdom was lost,
And all for the want of a horseshoe-nail.” Benjamin Franklin

Polypropylene has been found to be responsible for more deaths than just mesh patients as a recent examination of MAUDE reports to the FDA reveals. Meanwhile the plastic surgical mesh continues to be sold to patients.

The FDA’s recent announcement that it would reclassify only one application for pelvic mesh is a disaster for anyone wanting to do no harm because in its statement the agency promoted the use of synthetic surgical mesh for other pelvic applications. The only way to protect women from harm and avoid severe and devastating complications is to pressure the FDA to take all synthetic surgical mesh off the market—for good. A failure rate of forty percent (between 37.8 and 44.2%) and an erosion rate of 41.5% percent (see Figure 1. Lee, SY) represents an unacceptable iatrogenic mass casualty no matter how you toss the dice. It’s not the application (vaginal vs abdominal) or the surgical technique that’s harming many thousands of patients, it’s the material itself: the polypropylene.

Screen Shot 2016-01-15 at 8.44.26 AM

Polypropylene begins its life as crude oil, like any plastic product. Polypropylene is made up of a combination of ingredients combined to produce a product that will resist temperature change and keep its tensile strength when shaped into strands. Microscopically, polypropylene is a polymer—a large molecule composed of many repeating subunits. When polypropylene is stretched into a fiber, its strength is dependent on the quality of ingredients, the width of the strand, and the shape the strand.

438px-Polypropylene_tacticity.svg

Polypropylene Chain

Polypropylene is a favorite child of plastics scientists for containers, automobile parts, rugs, and countless other applications often illustrated on this blog. Patients are told the device is inert, completely safe, does not react with the body yet, it is the same material that is used to make thousands of household 81YYBL4yzwL._SY355_products, like scouring pads. Imagine taking Scotch-Brite Scrub pad and stuffing it into your most private spot.

Polypropylene reactions: Although marketers call mesh inert, when polypropylene materials come in contact with human tissue, both sides of the interchange suffer in very dramatic ways. Plastic mesh reacts, degrades, shrinks, curls, rolls, or migrates in a woman’s body. The human host is vulnerable to allergic reactions, foreign body responses, organ injury and migration of the material. If a patient reacts badly, she is in an alarming predicament: it is nearly impossible to take pelvic mesh out.

Allergic reactions to polypropylene are said to be rare and it is nearly impossible to predict who will react. Allergists disagree on what testing method to use to diagnose an allergy to polypropylene. Foreign body responses are much more common. A few pathologists took a look at hernia mesh and all of the samples they examined demonstrated rejection responses.

POLY IS FOR COAXIAL CABLESAlthough allergists believe that polypropylene carried a low allergic response, they say the longer it is left in the body, the more likely a reaction will occur. The skin is said to spit out a suture sometimes but it is nearly impossible for a body to spit out pelvic mesh.

The same material used in transvaginal mesh was once declared unfit for the human body. In 2013, lawyers uncovered emails showing that CRBard, tried to deny the company knew it was unfit until prosecution lawyers forced them to divulge secret company emails. On Thursday this week, Mostlyn Law filed an injunction against Boston Scientific alleging the corporation smuggled a resin which it added to pelvic mesh products between 2011 and 2012.

•∞•

Recently, I looked at who died from mesh and tripped onto a little known fact–one polypropylene suture, Prolene, was involved in one tenth of the deaths from Ethicon Corporation products—a quarter of all suture-related deaths reported to MedWatch. Over the past decade, Prolene failures were found in 39 of 417 Ethicon product deaths yet the FDA never warned the public about the suture and there is no evidence that the agency is even aware of the problem. MAUDE event descriptions characterized failures leading to deaths from breaks in the suture or knots which unraveled. Reading the stories, I could only imagine the surgeon’s umbrage. After many hours of high-risk surgery where he carefully applied his many years of training and masterful skills to save his patient’s life, he lost his patient—through no fault of his own. A piece of polypropylene suture broke or failed. “All for the want of a nail.”

Prolene maude deaths

Until polypropylene is removed from all medical devices, sadly, women and men will continue to suffer and die.

•∞•

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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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26 Pelvic Mesh Complications Your Doc Never Mentioned

Welcome to the Pelvic Mesh Owner’s Guide! This page is like a Table of Contents.

Over 4.2 million women have the implants and a quarter to a third of them suffer debilitating complications while doctors say, “It’s not the mesh.” The FDA warned in both 2008 and 2011 that complications are serious. Too many women are finding out they were right all along, it is the mesh. 

If you’re having trouble with mesh, here is a list of 26 complications in the Pelvic Mesh Owner’s Guide. Sign up for updates to learn more and take the first step on your healing journey.

POLY IS FOR CABLES copy

26 Mesh Complications Your Doctor Never Warned You About:

1) Intractable Pain (pain that doesn’t go away) – Some people wake up from implant surgery knowing something is wrong. It is too tight or the pain is beyond measuring. Part 1 talks about the post operative pain from pelvic mesh & Part 2 is one woman’s journey with pelvic mesh pain.

2) Excessive BleedingBleeding happens but when is it too much? When to call the doctor? How to regain strength after heavy bleeding

3) Urinary tract infection, Kidney infection – Urinary tract infections are serious health-risks and can involve the bladder and kidney. When mesh is stuck in the bladder it continually irritates the bladder until it is removed surgically. Learn how to prevent UTIs and test yourself at home and to distinguish a bladder infection from a kidney infection.

     4) Wound infectionsA bladder sling can act like a petri dish harboring and incubating strong, sometimes drug-resistant bacteria. Left undiagnosed, they can lead to a delay in wound healing, even open up wide and deep surgical wounds and putting your life at risk.

5) Bladder injuryA slip of the knife, a puncture from an ice-pick like trocar, sling pulled so tight that it cuts the bladder. A bladder injury is one of the most difficult to repair. One study says it happens 10% of the time, another say 75%!

6) Bowel InjuryWhen a part of the bowel is nicked, fecal matter seeps into the interior of the body, when it the diagnosis is delayed or completely missed, patients become extremely ill.

7) Fistula (a hole between two organs) – Imagine your urine draining out of your vagina or your stool coming out. Fistula is all to common and deeply embarrassing for women.

8) Wound Opening Up After Stitches(also called dehiscence) – You think your surgery is healing and you are trying to get back on your feet and back to normal. Then your wound starts to open up. Dehiscence delays healing for a very long time.

9) Erosion – (also called exposure, extrusion or protrusion) As many as one patient in three experiences erosion from mesh. Would you agree to mesh if you were told the odds that you wouldn’t enjoy sex ever again were one in three?

10) Incontinence “I sneeze, I pee.”The odds that mesh surgery won’t cure your incontinence is the same as other surgical repairs: one in three.

11) Urinary Retention “I can’t pee right.”A mesh that is implanted too tight can slow down or stop your urine stream for about four percent of patients. Why does your surgeons “handedness” (right- or left-handed) affect your outcome?

12) Dyspareunia – pain during sexual intercourse One study found 26% of women found sex too painful after mesh surgery.

13) Multiple surgeriesWhen things go wrong, often the solution is another surgery and another. Some women have had over a dozen surgeries to correct mesh complications. More surgery = more scarring.

14) Vaginal scarring/shrinkage – Vaginal scarring: one of the most emotionally and physically difficult problems to heal.

15) Emotional DamageNaturally, an injury to a woman’s re-creative center causes emotional pain but can we allow doctors to blame the women?

16) Neuro-muscular problems – nerve damageStinging, burning, pins-and-needles, numbness all are signs of nerve damage. Even the way your body was positioned during surgery can cause nerve damage.

17) Obturator Nerve – Symptoms in your mid-thighs (saddle region).

18) Ilioinguinal/iliohypogastric Nerve – Symptoms in your pubic region.

19) Genitofemoral Nerve – Symptoms in your inner groin.

20) Femoral Nerve – Symptoms in your outer thighs

21) Pudendal Nerve Entrapment – Symptoms in your “sit spot.”

22) Fibular Neuropathy – Symptoms on the outside lower legs

23) Saphenous Nerve – Symptoms on your inner lower legs

24) Piriformis Syndrome – Symptoms across your buttocks.

25) Sciatica – Symptoms all the way down your leg.

26) Peripheral Neuropathy – Symptoms from the bottom of your feet and up your legs, even your hands can be involved.

MESH IS NOT FOR BODIES 2


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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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Multiple Surgeries: Signing Up For Just One Surgery With Pelvic Mesh?

Imagine this: Two women had tree branches fall across their homes causing major damage. Both trees did the most damage to the kitchen. Cindy Lu hires the guys who promises to get the job done the fastest for the least money. Her contractor comes in one day, and chops out the middle of the branch and cleans up the mess on her kitchen floor and replaces her kitchen faucet so it will run. He gets the job done in less than a day. Karen hires a more experienced contractor who takes out the entire branch and repairs all her plumbing, appliances and replaces her furniture and cleans up every tiny piece of bark or wood chip. It takes several days. He comes back later on and fixes the broken walls, windows and doors and returns her home to as close to pre-storm conditions as possible.

Which contractor would you hire?

This is an analogy to what happens when pelvic mesh goes bad. The surgeon who chips away at pelvic mesh, one eroded bit at a time, sets up a patient for multiple surgeries— today’s mesh problem. Recently, Linda Gross won over 11 million dollars at trial after 18 surgeries to repair erosion, scarring, and tissue damage from a Gynecare Prolift pelvic sling. Surgeries performed after the pelvic mesh implant correct erosion, new or continued incontinence, difficulty urinating, infections, scar tissue, pain, deheisance, or fistulae. Women experiencing generalized symptoms they attribute to mesh opt for removals as well and report an improvement in their symptoms.

Did you know one study found 41% of mesh implant patients had to have at least one other surgery?

Synthetic surgical pelvic mesh was first thought to be faster, easier and better than traditional repairs like culpopexy and porcine and native tissue sling repairs. Newer research says it  just wasn’t true.  In a 2013 review, authors concluded that, even though sacral colpopexy had a longer operation time: “the sacral colpopexy had a higher success rate on examination and lower reoperation rate than high vaginal uterosacral suspension and transvaginal polypropylene mesh.”

Mesh removal is risky business due its faulty design. Absent-minded scientists have been accused of not stepping back and looking at the “big picture” ever since Thales, the Greek mathematician, looked up at the stars so often that he fell down a well. Designers of pelvic mesh imagined they found the best thing since the flat turret lathe or bifocal eyeglasses. It was so perfect, they must have thought, nobody would ever want to remove it.

It is an interesting observation that more doctors are prone to diagnose only what they can see—on your body, an x-ray, in a lab report then by the patient’s description of her problems. Headaches, backaches and now pelvic pain are the least recognized and treated medical complaints today. Until the “BLUE sh*t” (as Johnson & Johnson execs called Gynecare mesh in a secret email) could actually be seen by the doctors, women’s complaints were ignored. If they got an answer from their doctors, they were advised to have it snipped, dissected, ligated, trimmed or revised. When the mesh kept sneaking back, surgeons removed more little bits.

It takes a highly skilled surgeon like Veronikis, Una Lee in Seattle, and Shlomo Raz at UCLA to remove all of the mesh, including the anchors (secured ends).  The few surgeons who do remove the mesh in its entirety complain that removing all of shards of mesh from healthy human flesh is like getting bubblegum out of hair.

Dr. Dionysios Veronikis of St. Louis, MO invented a surgical instrument that dissects the mesh away from the healthy tissue without cutting surrounding structures. He finds one end of the mesh and then carefully cuts, moving his instrument forward until it frees up the entire sling in one piece. It is hours and hours of painstaking work and healing from the procedure takes a long time.

Once mesh is removed, more surgeries are often needed to revise the damage left behind and fix structural problems. Complications, like bleeding, infection, and nerve damage, from mesh removal surgery are common. After finally going through removal surgery, 87% said they would never have had the artificial mesh implant in the first place, if they had only known. If you’ve not yet had an implant, you are one of the lucky ones because, now that there is more research and information is available on the net–mesh does not appear to be easier or better. Many, if not most, doctors are reverting to traditional fixes. You can save yourself a boatload of trouble by finding a surgeon who can repair your problem without 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 daywriter1@gmail.com..

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“I’m (Still) Incontinent:” Forty Percent Mesh Surgery Failures

Doctors are saying that the nearly 100,000 mesh trouble lawsuits don’t mean the mesh is bad–it’s just that lawyers are greedy and “everybody is out for a buck,” and you need to believe them that synthetic surgical mesh is the gold standard. Women report that, as well as causing new mesh-related problems, more than up to forty percent of mesh surgeries fails to cure incontinence. Knowing that–a woman might choose not to have plastic mesh implant surgery.

Mesh is for Butterflies

“I had bladder sling surgery about a month ago and am actually having worse incontinence than I had before the surgery. I was diagnosed with stress incontinence before the surgery and had to wear a pad for leakage when I coughed or sneezed. Now I am wearing adult diapers because when I move from a sitting to a standing position,  all of the urine leaks out.”

“I had a hysterectomy and bladder sling surgery for a prolapse… I never leaked before having the surgery. Now I void every few minutes and leak constantly. The surgery was done robotically. If I knew this was going to happen I never would have had my bladder done.”

“All I can do is stand there with my bladder as tight as I can while I wet myself like a 2-year-old.”

“We found the solution by going to a urologist at Mayo Clinic in Scottsdale, AZ. I found that going to a clinic/Doctor that actually works in a team environment … was the answer. After the second surgery I am now at least back to where I was before all of this started. I do wear a diaper at night but during the day just a pantyliner. Try a different doctor and see what their assessment for your situation is.” For more read here.

Numbers: I know statistics are boring but bear with me here for just a bit. 565 women where asked if they were continent a year after they had slings put in, “How satisfied or dissatisfied are you with the result of bladder surgery related to urine leakage?”  their answers were from 55.8 to 62.2 percent “yes.”  That means or 37.8% to 44.2%  said “no.” In this study, only 15 women “required” new surgery although approximately 231, (4o%) women were still leaking. That just doesn’t seem like success to me. But then, I imagine the researchers were not crossing their legs tightly, avoiding standing up, changing poise very two hours, or trying to hide their Depends under bulky clothing as they questioned those women.
Here, I created a pie chart if you hate reading numbers in a paragraph as much as I do:

: graph
If we look at the same study more carefully, it calls into question whether urodynamic testing is a good measure of incontinence. When the machines were used to measure stress urinary incontinence, between 77.7 and 80.8 percent of women were fine yet when they themselves were asked, many more women said they were not. Here is another pie chart. If surgeons rely on the higher number for a “success” rate, more slings get sold. What the women actually experienced may be a better number to help guide you in making your decision about whether a mesh sling is worth the trouble.

Uro vs women

Handling incontinence is an major problem for anyone who would rather stay home than walk around smelling like a latrine. If your incontinence is so bad that changing position makes you gush, you’ll be paying close attention to how long it takes a drink of water or a cup of tea to make its way through your system and lowering your intake before going out in public. You’ll be taking baby wipes or cleaning cloths everywhere you go (in your over-sized purse), limiting your time out and avoiding social events. Be careful if you are drinking less because of the leaking because when your urine gets more concentrated, you are more vulnerable to urinary tract infections and your urine smells stronger.

Some women have had success with an injection of collagen for incontinence after sling surgery. Some end up with repeat surgeries—some even say they have three slings inside them. Before you have another surgery, think about finding another surgeon who may be more skilled in handling your problem and who does not implant mesh. While very few in number, there are surgeons who make repairs without using plastic surgical mesh and this blog will be publishing the names soon.

If you’d like to compare incontinence products, try this site.

In the study above, there were many complications found, especially nerve pain going down one leg and an inability to urinate normally.

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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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Fistula: A Most Embarrassing Mesh Complication

Among the new words mesh-affected folks must learn is “fistula.” Before  mesh implant surgery most people have never heard of it, yet fistula is one of the most devastating mesh injuries. Fistula is a connection between two organs that are not normally connected. For example, between the rectum and the vagina. The fistula gets there because something happened to the normally healthy tissue that separates the two organs—a sharp injury (such as a surgical cut), blunt force injury (such as childbirth or violent rape), inflammation or infection. Other known causes are inflammation due to Crohn’s disease, cancer, radiation treatment, diverticulitis or ulcerative colitis.

Mesh-related fistulas are caused by a surgical mistakes (e.g. puncturing an organ with a trocar or a scalpel), erosion of the mesh into one or more organs, inflammation or infections.

When fistulas develop in the vagina, they create an abnormal opening between the vagina and bladder or rectum. Fistula is an grave emotional injury as well—imagine how it would feel to sit on the potty and urine or stool is passing through your vagina. Vaginal fistulas play on a woman’s feeling of shame, a situation that surgeons often ignore. A women harbors primitive and deep feelings about her vagina that should be honored. She places special emotional, spiritual, and tribal values on her most private and sacred organ and, while her surgeon can label those feelings as “embarrassing,” her feelings go much deeper than that. Surgeons should be aware of the effect of the callous treatment women say they experience, both in the examining room and in the operating room. Pelvic surgeons need to take a long, hard look at their own behavior and remember why they became a doctor in the first place.

 

Types of vaginal fistulae:
• Vesicovaginal fistula—Vagina and the urinary tract
                                                    • Enterovaginal fistula—Vagina and the small bowel                                                    
• Rectovaginal fistula—Vagina and the rectum                                                                
• Colovaginal fistula—Vagina and the colon

Complications, or mesh troubles, with fistulas:
Fistulas can lead to serious medical conditions like an infection in the genital area, and unusual discharge, urinary incontinence and pain in the vagina.

Treatment of vaginal fistulas: How you decide to have your fistula treated, is your decision once you know more about the size and placement of your fistula and take into consideration your overall health and your financial MESH IS FOR OIL FILTERSand emotional support system. Treatment often requires surgery to close the unwanted opening but attempts to use a transvaginal mesh patch to keep the organs separated ignore recent research about foreign body reactions  and infections common to vaginal mesh. There are other ways to regain strength in the surrounding muscles that might help a woman avoid a(nother) dangerous and defective implant.

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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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Bladder Injury: The Surgeon Cut My Bladder, All Too-Common Pelvic Mesh Injury

In order to understand bladder injuries, it is important to understand why pelvic mesh is a misguided and faulty idea and a defective device in the first place.The device is so dangerous that over 100,000 women sued the manufacturers and many won millions of dollars. The collective financial hit to the manufacturers is in the billions. Many have had their lives substantially changed for the worse, losing health, jobs, marriages, etc.—yet the makers continue to sell the device and gynecologists and urologists continue to situate pelvic mesh inside the most vulnerable area of a woman’s body–at a rate of 300,000 a year.
Pelvic mesh is really a plastic woven or knitted hammock that holds up sagging organs in the pelvis; the bladder, uterus, and  large bowel or is placed to control a leaky bladder.

In order to insert a sling, special surgical tools were invented: a trocar that looks like a giant sewing needle that was caught in the blender, or staples, screws, and large non absorbable sutures. With transobturator tapes (TOT’s), the trocars puncture through sensitive areas in the lower pelvis, grab hold of one end of the sling or tape and pull it under the bladder where it meets another trocar from the other side. The procedure is done “blind,” meaning the surgeon can’t see what he/she is doing but try to  “feel” the resistance to the trocar in order to mentally identify pelvic structures ias they go. If the guess is wrong, the trocar can go right through the delicate bladder structures (as well as nerves, blood vessels, and the bowel).
The most common complication during mesh implantation is perforation of the bladder. If this is not discovered and fixed during the original operation, it can lead to frequent urinary tract infections, pain while urinating, persistent leakage, hematuria (blood in the urine), chronic pain and voiding difficulties and cause the development of a hole between the vagina and the bladder known as a vesicovaginal fistula.
Sometimes normal movement after surgery turns the “hammock” into a hacksaw cutting its way into the bladder. This process eventually perforates the bladder and is know as erosion.
Diagnosing erosion should be done by a careful interview with the patient, listening to complaints of worsening pain as the bladder fills with an easing after emptying, a feeling like a razor blade is cutting them or that they are sitting on knives. Most MRI’s and CT scans cannot identify the placement of mesh. A specialized ultrasound known as a translabial ultrasound can but few radiologists know how to perform them or read them. A cystoscopic exam (a narrow tube with a camera on the end that is inserted inside the bladder) can only identify mesh after mesh enters the inside surface of the bladder but mesh can be embedded on the outside, cause great pain and yet not be seen. Most urologists seem not to know that cystoscopy cannot be used to rule out erosion by itself. Many women have been told the problem they are experiencing is not due to the mesh only to discover during removal surgery that the mesh had become embedded inside their bladders, vaginas, blood vessels, muscles or rectum.

Interestingly, women complain that their pain is worse on one side or the other. Studies mention the experience of the surgeon , whether he is right-handed or left-handed, or whether the patient was vulnerable to injury yet there has been no focus on the design of the instrumentation or studies that measure the subjective feelings of patients with injuries as to whether the risk for injury outweighed the problem that took them to the doctor in the first place. With studies showing wildly different estimates of the numbers of complications between ten and 75%, aMESH IS FOR TEA BAGSnd many injuries that go unreported to the FDA, the real risk remains uncertain. It is clear the use of pelvic mesh has not risen to the level of “Gold Standard,” yet  patients continue to report to each other that they are hearing that  comment from their physicians.

On October 8, 2008 the FDA issued this warning about the mesh and trocars to all surgeons:

Physicians should:

  • Obtain specialized training for each mesh placement technique, and be aware of its risks
  • Be vigilant for potential adverse events from the mesh, especially erosion and infection
  • Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations
  • Inform patients that implantation of surgical mesh is permanent, and that some complications
  • associated with the implanted mesh may require additional surgery that may or may not correct the complication
  • Inform patients about the potential for serious complications and their effect on quality of life
  • including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair)
  • Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available

Despite the warning, patients receive pelvic mesh implants in unprecedented numbers and many come to support groups saying they were never warned and do not have a written copy of the patient label.

The newer mini-tapes are still polypropylene based and mesh affected women continue to report higher than normal rates of foreign body reactions and autoimmune disorders.

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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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