Category Archives: Complications

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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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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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

Doubly Traumatized: Pelvic Mesh & the Sexual Abuse Survivor

Dual Trauma

Two things happened this past week that make it imperative to write about the connection between two traumas: sexual abuse and pelvic mesh injury.

First, Melynda, a dually-traumatized woman wrote a tearful story of her trip to get a transvaginal ultrasound:

I arrive at my scheduled time, make my way to radiology and wait for someone to take me back to the room. My pain is an 8-9 at this point and I am starting to shake because, goddammintalltohell, I am so exhausted of having strangers fiddling with my lady parts, I can’t even sit down and relax. (Remember also I am a survivor of child sexual abuse/incest and rape when I was 17 and have had all the wretched trauma of mesh, too).
In walks this older gentleman in scrubs and says, “Are you here for an ultrasound?”
I was so confused. Why is there an old man telling me he is going to be doing my transvaginal ultrasound!!!!??????
I started crying right then and there. “No, no, no, no, NO. I can’t do this with you. I am so sorry, I need a woman tech.”
He tells me it’s him or I will be forced to reschedule. I lose it. I tell him I need some time to calm myself down and then I go lock myself in the bathroom and sit there for 15 minutes while I sob uncontrollably and struggle to breath.
Before this mesh disaster, I wasn’t like this. I could have pelvic exams with no problem. I have been to years of counseling to help me overcome the abuse/incest and rape and I count myself as a survivor of both of those things. But these mesh injuries and the resulting treatments I have to endure. That is what left me sobbing in the hospital bathroom, shaking so hard I couldn’t even hold my phone.

Two days later, Buzzfeed published a document written to an arrogant rapist. The letter set off a maelstrom of outrage. The valiant victim described those hellacious moments when she slowly came to the realization she’d be brutally raped:

I … went to pull down my underwear, and felt nothing. I still remember the feeling of my hands touching my skin and grabbing nothing. I looked down and there was nothing. The thin piece of fabric, the only thing between my vagina and anything else, was missing and everything inside me was silenced. I still don’t have words for that feeling. In order to keep breathing, I thought maybe the policemen used scissors to cut them off for evidence.

Women dancing copy

Freedom is for women, too.

The physical and psychic numbness, immeasurable pain, wanting to shed her own body, and begging for time to process her trauma; while her attacker and the judge continue to intensify his horrific attack by turning the spotlight of blame onto her instead of him. Her words set off a campaign to remove the judge and, at the same time, further ignite the opprobrium of pelvic mesh-injured women who suffer so many of the same symptoms. A pelvic mesh-related injury feels like a rape in the aftermath. For all intents and purposes, it is rape, sometimes with genital mutilation.
For sexual assault victims, mesh pain takes them right back into a post traumatic state. Pelvic mesh victims are offered little redress while the device makers are permitted to increase sales, rush new versions to market, and continue to profit unfettered.

You took away my worth, my privacy, my energy, my time, my safety, my intimacy, my confidence, my own voice…

How many pelvic mesh victims have uttered these same words? And these:

I am no stranger to suffering. You made me a victim. … For a while, I believed that that was all I was. I had to force myself to … relearn that this is not all that I am. … I am a human being who has been irreversibly hurt, my life was put on hold …
My independence, natural joy, gentleness, and steady lifestyle I had been enjoying became distorted beyond recognition. I became closed off, angry, self deprecating, tired, irritable, empty. The isolation at times was unbearable. You cannot give me back the life I had before that night either. While you worry about your shattered reputation, I …hold … spoons to my eyes to lessen the swelling so that I can see.
I … excuse myself to cry in stairwells. I can tell you all the best places … to cry where no one can hear you. The pain became so bad that I had to explain private details to my boss to let her know why I was leaving. I needed time because continuing day-to-day was not possible. I used my savings … I did not return to work full time … My life was put on hold for over a year, my structure had collapsed.
There are times I did not want to be touched. I have to relearn that I am not fragile, I am capable, I am wholesome, not just livid and weak.

If you would like to join a small support group for people with both mesh injuries and a history of sexual abuse/assault, join here. ,–LINK UPDATED

Post Traumatic Stress Syndrome is common to both injuries and healing involves stages. No two women are ever alike and no healing patterns are identical. In hopes for your continued, safe, comforted, and thorough healing, here is a list of the stages:

Stages of healing from sex abuse

Page 1

Stages of healing from sex abuse pg 2

Page 2

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Partial Pelvic Mesh Removal — Wrong Solution to Permanent Problem

Your surgeon says he or she can snip the part of the mesh sling they can see, a quick operation and you’ll be better. Or says he can cut it to release it because it was put in too tight. Or, he promises a full removal but the operation takes less than an hour and, if the parts go to pathology, most of the mesh is still not accounted for.

Women who knowingly or unknowingly have partial removal surgery come to regret it. They issue strong warnings for the lucky women who read or search for answers online before signing up for a partial removal. Thousands of Urogynecologists and Urologists do partial removals. The very people who profit from mesh tell those specialists how to handle complaints: just cut a little out. Some heartless doctors cut it right there in the office with no anesthesia whatsoever.

The woman who have been through this tell newcomers not to allow a surgeon to cut bits and pieces of mesh but to leave it whole for a qualified surgeon with the skills to necessary to remove the entire device in one operation. They warn that doctors are not telling the truth about those partial surgeries.

Frayed rope is like sliced mesh

Partial removal can be a temporary solution to a permanent problem. Nearly everyone gets temporary relief after a partial surgery. When a rope breaks, the ends fray. That’s what happens with partials. All the ends leak toxic chemicals, stirring up a immune storm inside your body and spring back, eventually attaching to other parts of your vagina, bladder, intestines, bones, nerves, and blood vessels. After a year or two, you develop new symptoms and go looking for a doctor who can help. More than 99% of board certified surgeons will do another partial. Some women have dozens of surgeries before finding help from advocacy groups.

Be very careful. Get the whole thing out in any way you can because you are in the best possible shape to have a good outcome when your surgeon goes after the whole thing and it’s still intact! When mesh is cut, the next surgeon must go searching for shreds of it. They compare that surgery to trying to get bubble gum out of hair or searching for shrapnel.

POLY IS FOR CUTTERS

If your surgery took less than four hours, consider that it may not be a complete removal, get your medical and surgical records and your pathology report. Learn the dimensions of your implant and ask for an accounting for every piece of it. Before your explant surgery, demand a micro and macro pathology be done. Afterward, get those reports!

We’ve found only five surgeons in the U.S. who consistently prove they removed complete pelvic mesh including arms or anchors (fixation devices):

  • Shlomo Raz, UCLA
  • Dionysis Veronikis, St. Louis, MO
  • Una Lee, Seattle WA
  • Dmitriy Nikolavsky, Syracuse, NY
  • Michael Hibner, Phoenix, AZ

The surgery is very risky but research has shown that is in no more risky that partial removals.

Beware of sugeons loan companies Beware of Mesh News
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.
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.