Tag Archives: Transobturator Tape

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.

 


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.

Polypropylene – “Not for use in human body”

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

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

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

Phillips Sumika Polypropylene Company Material Product Safety Sheet (undated)

 

Here is an early warning about polypropylene predating pelvic mesh

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Pelvic Mesh: Your Device is Tracked. So Are You

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

Tracking Devices vs. Device Tracking

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

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

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

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

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

Polypropylene creates cripples when placed inside the pelvis.

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

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

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

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

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FDA Publishes 50 Known Pelvic Mesh Device Problems – Approves Anyway

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

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

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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 slings or sutures after surgeries). 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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FDA Responds to Pelvic Mesh Counterfeit Resin Allegations

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


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

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Comprehensive List of Pelvic Mesh Products

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

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

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

American Medical System

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

Boston Scientific

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

Covidian

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

C.R. Bard

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

Coloplast (out of business)

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

Cook Medical System (out of business)

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

Ethicon Division (Johnson & Johnson)

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

Mentor Corporation

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

Other companies:

  • Caldera
  • Sofradim
  • Neomedic Sling

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

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Specialized MRI and 3D Ultrasound See Mesh – CT Can’t

Too many surgeons are sending patients to have a CT (Cat Scan) and,  when the radiologist says he/she can’t see mesh, tell the patient the mesh must have disappeared or dissolved when a CT cannot identify mesh. Plastic mesh does not dissolve. Sadly too many patients have their pain disrespected or disregarded when the problem is the doctor’s. Only specialized 3D Ultrasound with the right technician and radiologist (more on this coming in another blog soon) and specialized MRI’s with the skills to see it and read it can identify mesh.
Here is a graphic, courtesy of www.scbtmr.org that you can print out an take to your doctor.

MRI to find mesh

How to see mesh with an MRI

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Why So Many Doctors are Bad Doctors – Mesh Trouble

To those who have been participating in surgical mesh discussions, it comes as no surprise that the practice of medicine in 2016 has completely broken down. It is not safe to become a patient these days yet, by the very nature of living in this world of fast cars and eating unhealthy food, it is inevitable that most people will need to enter the Healthcare System someday and take their chances that they professionals will do right by them.

Discussions abound about how surgical mesh was cleared for implantation inside human bodies by corrupt Food and Drug Administration officials — insiders from the pharmaceutical industry. The number of deaths that occur from medical mistakes is over 300,000, and is considered the third leading cause of death in the U.S. Many other discussion participants report cruel, dismissive, even dangerous treatment by doctors in office and hospital settings; yet most of us are unaware of two things that should be — but are not — changing the game in favor of the patient.

prison mesh welded wire copy

In 1986 Congress passed legislation that bad doctors must be reported to a national database called the National Practitioner Data Base [PD2] in order to protect the consumer (The Healthcare Quality Improvement Act). That is you. But you have no access to the database either to report bad doctors or to find out if your doctor is bad. Usually, the only way to discover you have chosen a bad doctor is to find out the hard way, by being exposed to rude, aggressive, dismissive, or harmful treatment yourself. You may get lucky and be part of an private discussion group between patients and hear about some of the bad ones and avoid trouble, even disaster, for yourself. Websites like Vitals.com, etc. submit to pressure from lawyers and doctors to remove feedback that would have negative consequences to the doctors and are not reliable if you are trying to protect yourself from harm.

Every battle has its heroes and for patients and we found two: Bob Wachter and an anonymous emergency doctor (Shadowfax) who runs a fittingly named blog, “Moving Meat.” Both of them acknowledge that today’s medicine puts the priority of the patient well below the protection of the doctor’s career and reputation. Both say the NPDB is not doing its job.

What do you think? What is your experience in today’s medical world? Do you feel safe? Protected? How is the Healthcare Improvement Act working for you?

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    http://community.the-hospitalist.org/2009/06/01/is-hospital-peer-review-a-sham-well-mostly-yes/

    http://allbleedingstops.blogspot.com/2009/06/review-of-peer-review.html

    [PD1]https://www.npdb.hrsa.gov/resources/titleIv.jsp

    [PD2]https://www.npdb.hrsa.gov/topNavigation/aboutUs.jsp