Pelvic Mesh: Your Device is Tracked. So Are You

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

Tracking Devices vs. Device Tracking

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

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

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

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

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

Polypropylene creates cripples when placed inside the pelvis.

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

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

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

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

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FDA Publishes 50 Known Pelvic Mesh Device Problems – Approves Anyway

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

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

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Australian Pelvic Mesh Survivor Group Position Statement – Carolyn Chisholm

By Carolyn Chisholm
June 5, 2017, Perth

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

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

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

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

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

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

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

Caz Chisholm winning two awards for her advocacy work.

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

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

It is a very specialised issue and needs to be addressed immediately.
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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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Adverse Events Statistics Misleading – Transvaginal Mesh

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

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

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

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

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

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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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RECIPE for Mesh Victims: Pasta Prima Vera

(A little comic relief after so much pain)

Pudendal Pasta Primavera Recipe

  • Prep time: Between 20 minutes and 5 hours
  • Cook time: 10 minutes
  • Yield: Serves 4

Ingredients

  • 2 regular strength Tylenol (you may substitute your choice of pain killer as needed)
  • 1/2 pound vermicelli pasta or spaghetti
  • 1 small bunch precut broccoli
  • 1 small zucchini, diced
  • 1/2 cup plus one unopened bag of frozen peas
  • 1/2 cup snow peas
  • 2 tsp. garlic powder
  • 1 8 ounce can seeded and diced tomatoes
  • 12 basil leaves, 3 tbsp. chopped or pre-packaged pesto
  • 4 Tbsp. butter
  • 1/4 cup chicken broth (use vegetable broth for vegetarian option)
  • 1/2 cup heavy cream
  • 1/2 cup grated parmesan cheese
  • Salt
  • 1 chilled bottle dry French white wine.

 

Method

1 Take pain killer. At the same time:

2 Fill a huge pot with water with water and turn on to “high.” Salt well. Set your strainer in the sink, turn on your timer to 13 minutes and go lay down with your feet up as high as you can tolerate.

  1. When alarm rings, throw pasta and set timer for 7 minutes. You must work quickly. Grab all other ingredients, open them and spread them on the counter.
  2. Put your hands on the edge of counter, legs back about 2 feet away and bend forward, breathe out a big loud sigh and stretch your pelvis so it doesn’t lock up on you while you’re standing. Hold this position for 30 seconds or until timer rings.
  3. At the 7-minute timer, throw broccoli in with the pasta. Boil for 1 minute. (You may try standing on one leg for 30 seconds and then the other if it helps.) Add the snow peas, and the 1./2 cup of frozen peas and boil for 30 more seconds.
  4. Quickly pour pasta and vegetables through the strainer and cool them under water. Leave them in the strainer, set the timer for 10 minutes and run back to lay down again, this time taking the bag of frozen peas with you. Apply to pelvis.
  5. When the timer rings, head back to the kitchen and throw the bag of peas back in the freezer.
  6. In a large sauté pan, heat the butter over medium-high heat. When the butter is hot, throw in the garlic powder, the diced tomatoes and sauté for 2 minutes, stirring often and shifting your weight from side to side.
  7. Pour in the chicken or vegetable broth and turn the heat to high to bring it to a boil. While waiting for it to boil, put one hand on top of another on the counter, lean forward and rest your forehead on the back of your hands, try to stretch your pelvis if it help. Add generous amounts of loud groans or tears as needed.
  8. Add the cream and stir just long enough to combine. Turn the heat down until the cream-chicken broth mixture is just simmering, not boiling.
  9. Add the Parmesan cheese and stir to combine. If the sauce seems too thick—it should be pretty thick, but not gloppy—add some more chicken broth, cream or water.
  10. As soon as the sauce is done or you are running into too much pain, transfer the pasta/vegie mess with tongs into the sauce and toss it around to combine. Add the basil now and salt if needed. Throw some black pepper over everything and grab a dish full to take back with you while you lay down again.
  11. After a half-hour rest, put remaining Pudendal Pasta Primavera in individual dishes and store in fridge. Eat for every meal until gone. If you hurt too much, eat it cold.

Note: You will want a dry white wine with this, ideally a chilled dry French white. Put the bottle against your pelvis for ten minutes at a time until pain relief is felt.

Leave dishes for someone else.

Tried, tested and enjoyed by ©Peggy Day

 

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