Category Archives: Complications

This is Why You Hurt with Mesh Inside by Stacy Dean Seymour

Today’s blog is by a guest host: Stacy Dean Seymour

Why we hurt?
The anchors are thread through the sacrospinous ligament that parallels the pudendal nerve and branches. (Nerve damage) They are anchored with a grommet on both sides of pelvis. This is why you have pelvic pain, hip pain and every pain, as well as lower back pain. Then two more needles are thread through blindly ( by touch and expert: cough cough) to both sides of obturator foramen. This is why you are unable to sit, your hips are killing and your bum feels like glass is in it.

And as time goes by- providing you didn’t wake up in the PACU hanging from the ceiling saying “WTF” the mesh tightens as you heal, it calcifies like hard melted plastic, and or when you heal your body heals from the inside out and eventually rejects it and or begins the protrusion into your orifices. Your bodies autoimmune response kicks in immediately and produces killer cells-that begins another cascade of immuno response! I can’t sleep tonight and saw a few new people and took my nursing knowledge, research and personal experience of WTF happened to me. I hope this helps and sometimes visualizing is the best way to understand a process. I wish you all well and hope we all can find peace in some shape or form. – Stacy Dean Seymour

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Keep Mesh Owners Guide Going


Eyes Wide Open – Poem by Leslie Capel Werner

Eyes Wide Open

I can hear my silent scream bursting and pounding through my mind…
Feel tears flow freely down my face
In sorrow
Not only for me but also for you.

How do selfish hearts of our loved ones turn away from our suffering
As their time is spent meaningless
while people they claim to love are dying with their eyes wide open?

It is not their fault-they are also suffering the loss of us
Their fathers and mothers, husbands and wives, sisters and brothers

Naruto Whirlpool, Awa Province, from the series Views of Famous Places in the Sixty-Odd Provinces Circa 1853

We all will go when it’s our time they say
But what about us whose time was robbed
By greedy people who put money before humanity?

I cry for me but more for you
Me the victim, you the perpetrator-
How dark your soul is
To profit from my suffering.

Do you really think the years you stole from me
Will be added to the sum total of your time spent living in the lap of luxury?

No, no, no-for surely as I surrender the last days of my life because of you
I will spend my eternity with God who loves me.
Surely, when your end draws near, the score will be settled
And you will die with your eyes wide open.

Open to see and feel the fire surround you, the sum total of it gathered from the burning you afflicted upon us.

Your greed will turn to desperate wanting for anything to soothe you but your cries will go unanswered
Because you stole everything we had.

Though dead you will feel our collective pinches and pulls and searing pain in your spiritual body’s groin
You will feel your phantom skin itch a zillion fold as the plastic seeks to escape but there is no way out.

Your skeleton will scream for the bundles of nerves that will be bound up in places to be relieved from where your pelvis use to be and still is.

You will see your victims that you damaged and violated off in the distance and you will beg for mercy but it will not come.

Telepathically we will transport to your mind all the memories of when we came to you for help and you knowingly took our lives in your hands and murdered us.

You will remember loud and clear, all of our faces and how we came back to you to share our suffering and beg for relief

Clearly you will remember your apathetic response as if it is amplified and then you will gaze upon our faces

As we stand together en masse and
Return our apathy to you.

Your suffering will be eternal
As you lie there forever
Dead with your eyes wide open.

Leslie Capel Werner – February 18, 2018

Why So Many Deaths From Monarc Slings? Pelvic Mesh Disasters

The FDA received 193 reports of death after Monarc Subfacial Hammock placements—by far the highest number for a specific brand of pelvic mesh. The FDA MAUDE system admits their reports are notoriously unreliable for accurate statistics.  It isn’t inconceivable that the number is nearer to thousands because the Government Accounted Office estimated only about 1% of complications are reported. (Physicians aren’t mandated to report illnesses, deaths, or injuries.) If the one percent statistic is accurate, then 19,300 deaths have occurred. Given that 4.5 million women across the globe had pelvic mesh implants, it is entirely possible.

With the FDA’s blessings, American Medical Systems rolled out the Monarc in 2005. The half-inch wide strip of loosely-knitted, clear polypropylene monofilament sling came with two stainless steel curved needle passers with plastic-handles that looked like grappling hooks. The top of each passer is intended to grab the ends of the sling and pull it through the vagina and obturator membrane. The sling assembly also included two plastic insertion sheaths attached to the mesh and removed after placement. An absorbable tensioning suture, threaded lengthwise through the mesh, allowed the surgeon to adjust the tension before closing the surgery. AMS declared the mesh would remain in the body permanently.

Illustration used under Fair Use Act for Educational Purposes

AMS’s illustration (and it’s understanding of female anatomy?) of the obturator was pictured as a vacant space with no purpose, but in reality, it is flush with blood vessels and nerves supplying the bladder, vagina, vulva, and hips. Those were more vulnerable to injury than AMS acknowledged.

On October 15, 2014, the FDA issued a recall for Monarc sling passers along with other AMS products due to compromised sterile packaging.

If the sterile packaging was the only problem, the deaths might be predominantly due to infection, but the MAUDE death reports include autoimmune diseases like diabetes and several types of cancer (e.g., lymphoma, large and small cell, and lung cancers).

Jenny Wallace (pseudonym) traded her prolapsing bladder for urinary tract infections, pain, infection, vaginal scarring, urinary problems, adhesions, recurrence, emotional distress, apical mesh erosion, extruded vaginal mesh, and bleeding. She was implanted with a Monarc in 2008. She underwent several partial removals and, on October 24, 2010, died of metastatic small cell cancer.

More research needs to be done to determine why Monarc has so many more death reports than other products and to quantify types of death. But, for now, if you have a Monarc, you might consider having it removed by a competent removal surgeon. Fortunately, AMS no longer sells slings.

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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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Monarc™ Subfascial Hammock

Gallery

Find Your Nerve Injury

This gallery contains 4 photos.

If you are having trouble figuring out which nerve is causing the sensations you are feeling, see if you can find it here and click on it. Please let us know if this helps.           ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ … Continue reading

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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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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Peggy Day is working on a book to combine all these stories. This is an excerpt from Pelvis in Flames: Your Pelvic Mesh Owner’s Guide. Your input is welcome to help make Pelvis in Flames the book you need to read.

If you’d like to join an online support group and learn about erosion, partial removals, surgeons, or just find out that you are not alone, join my group, Surgical Mesh or check the list of support groups here.

Subscribe to PelvicMeshOwnersGuide.com to learn more about pelvic mesh. I’d like to hear from you if you are helped by what you read here or if you need to know more about any particular topic. Comment below or email me privately at daywriter1@gmail.com..

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FDA 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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Peggy Day is working on a book to combine all these stories. This is an excerpt from Pelvis in Flames: Your Pelvic Mesh Owner’s Guide. Your input is welcome to help make Pelvis in Flames the book you need to read.

If you’d like to join an online support group and learn about erosion, partial removals, surgeons, or just find out that you are not alone, join my group, Surgical Mesh or check the list of support groups here.

Subscribe to PelvicMeshOwnersGuide.com to learn more about pelvic mesh. I’d like to hear from you if you are helped by what you read here or if you need to know more about any particular topic. Comment below or email me privately at daywriter1@gmail.com..

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What Does a Bladder Really Look Like? Pelvic Mesh Implants

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

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

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

Figure 2. Offset oil funnel.

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

Figure 3. Healthy non-prolapsing bladder.

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

It is no wonder patients become confused.

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Peggy Day is working on a book to combine all these stories. This is an excerpt from Pelvis in Flames: Your Pelvic Mesh Owner’s Guide. Your input is welcome to help make Pelvis in Flames the book you need to read.

If you’d like to join an online support group and learn about erosion, partial removals, surgeons, or just find out that you are not alone, join my group, Surgical Mesh or check the list of support groups here.

Subscribe to PelvicMeshOwnersGuide.com to learn more about pelvic mesh. I’d like to hear from you if you are helped by what you read here or if you need to know more about any particular topic. Comment below or email me privately at daywriter1@gmail.com..

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FDA Ups Enforcement After Pelvic Mesh Counterfeit Resin Allegations

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


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

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Peggy Day is working on a book to combine all these stories. This is an excerpt from Pelvis in Flames: Your Pelvic Mesh Owner’s Guide. Your input is welcome to help make Pelvis in Flames the book you need to read.

If you’d like to join an online support group and learn about erosion, partial removals, surgeons, or just find out that you are not alone, join my group, Surgical Mesh or check the list of support groups here.

Subscribe to PelvicMeshOwnersGuide.com to learn more about pelvic mesh. I’d like to hear from you if you are helped by what you read here or if you need to know more about any particular topic. Comment below or email me privately at daywriter1@gmail.com..

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Adverse Events Statistics Misleading – Transvaginal Mesh is Dangerous

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

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

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

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

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

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Peggy Day is working on a book to combine all these stories. This is an excerpt from Pelvis in Flames: Your Pelvic Mesh Owner’s Guide. Your input is welcome to help make Pelvis in Flames the book you need to read.

If you’d like to join an online support group and learn about erosion, partial removals, surgeons, or just find out that you are not alone, join my group, Surgical Mesh or check the list of support groups here.

Subscribe to PelvicMeshOwnersGuide.com to learn more about pelvic mesh. I’d like to hear from you if you are helped by what you read here or if you need to know more about any particular topic. Comment below or email me privately at daywriter1@gmail.com..

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