Category Archives: Complications

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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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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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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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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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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. When the timer rings, head back to the kitchen and throw the bag of peas back in the freezer.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. 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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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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