Tag Archives: Pelvic Pain

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 [email protected].

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Monarc™ Subfascial Hammock

How to Find What Mesh Product is Inside of You

You have a right to your medical records. Here’s what to do if you need to find out which product was implanted inside of you. It should be on your medical record, but when you simply ask for medical records, it’s often excluded, especially if you have an electronic record.

In this photo of an unopened bladder sling, there are 4 sticky labels to peel off and put on the medical record and other documents.

Not every hospital organizes medical records the same way and most made the transition from paper to electronics in the past 2 decades. You may have to do some investigating to see where your label is.

All implants come with a label (or sticker or log) with a unique tracking number and an expiration date and the country where it was made. Your hospital is required to let the manufacturer know who got which product and a record is supposed to be kept with the manufacturer. (Incidentally, I’ve never heard of a manufacturer contacting a mesh patient about a recalled defective device like car makers do).

  1. Ask your medical records department at the hospital where the surgery occurred for your complete “Operative Report” including any product labels. Tell them it might be on a separate piece of paper and may be only in your paper file.
  2. Search your operative report for it or for a notation by the circulating nurse that would name the product and include a serial number, usually preceded by a “#” symbol and, hopefully with an expiration date. (The date only refers to how long the sterilization process will last, not the device.) In an electronic record, look for a typed notation with a serial number. With that number, you can do an online search for your product name.
  3. If you do not find it, go personally to your hospital and speak with the director of Medical Records. Describe what you’re after and don’t take no for an answer.
  4. Failing all that, and if you have a copy of the note your surgeon dictated after your surgery, you are welcome to send it to me and I can narrow down to a few possibilities for what kind of mesh yours is.
  5. As a last (and expensive) resort, hire a lawyer to get it for you.

Notes: Click here for a list of how long hospitals must keep records by state.

Note: You may have to pay a reasonable fee for your paperwork.

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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 [email protected].

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Childbirth Leads to Pelvic Organ Prolapse and Adult Incontinence. Here’s How

Mother Jones recently published an article that should be required reading for women suffering from pelvic organ prolapse.

“The list of ways in which the pelvis and reproductive organs can be damaged during this process is practically endless. Most women, as mentioned, experience at least some vaginal tearing. But in severe cases, the perineum—the area between the vagina and the anus—rips completely open (http://www.mayoclinic.org/healthy-lifestyle/labor-and-delivery/multimedia/vaginal-tears/sls- 20077129?s=5) , exposing the vagina to dangerous bacteria and leaving the mother unable to control her bowels. Sometimes, as in Claire’s case, the baby is too big to fit easily through the pelvis, and the infant’s head or shoulders can break the mother’s bones on the way out. In yet another harrowing scenario, a piece of the placenta remains stuck to the uterine wall after the baby is born, causing the woman to hemorrhage. If the pelvic floor muscles stretch too far during delivery, the uterus may sag into the vagina: prolapse. And even after a woman heals from her immediate injuries, she can experience chronic nerve pain, muscle spasms, or numbness for months or years. Plenty of women make it through a birth okay, only to suffer from incontinence or prolapse years or decades later, for reasons doctors still don’t understand.”
The Scary Truth About Childbirth | Mother Jones

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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 [email protected]..

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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 [email protected]

    • 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

[email protected]

    .

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Pelvic Mesh: Your Device is Tracked Unless You Opt-Out

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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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 [email protected]..

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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 [email protected]..

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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 [email protected]..

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UPDATE: Australian Pelvic Mesh – Carolyn Chisholm

UPDATE: Carolyn (Caz) Chisholm, of Perth Australia, started a search three years ago to find a surgeon and a hospital to sponsor a visit by Dr. Dionysios Veronikis (St. Louis, Missouri) to Australia because is skilled in the removal of pelvic mesh devices from women that no Australian surgeon can. Today, women must travel to the United States to have pelvic mesh removed in its entirety. Veronikis invented equipment to reach deep into the pelvis to retrieve mesh that no Aussie surgeons can reach. He’s removed more than 2000 meshes.

Larger prolapse meshes are very complicated and dangerous to remove, and it takes a special surgeon to remove them. Dr. Veronikis designed and patented specialized pelvic mesh removal equipment and instruments, which no other surgeon in the world has.

Recently, Caz left her leadership role in the Australian pelvic support group to devote her time and efforts to finding a surgeon and a hospital to sponsor a visit from Dr. Veronikis in the hopes that he would teach Aussie surgeons safe mesh removal techniques.

Like anti-mesh advocates across the globe, Aussie’s leaders do not like mesh or support mesh. They do not believe in partial removals and encourage full removal wherever possible to minimize the trauma to women. They want Australia to have the same removal possibilities that the U.S. does.

“This is a huge undertaking, and it involves a hell of a lot of work from numerous people including mesh-injured women themselves. Unfortunately, the RANZCOG (Royal Australian and New Zealand College of Obstetricians and Gynaecologists) stand by their statement that a partial removal is an acceptable form of treatment. They refuse to get on board with full removal procedures  [even though] when pain occurs the only way is to remove all of the mesh,” wrote Chisholm.

Aussie injured women do not agree with RANZCOG’s and Professor Vancaille’s position about partial removal because “every single woman who has had this procedure ends up with more complications, [goes] back into hospital for more surgery, and often ends up with infections that don’t go away and [long-term] antibiotics.”

Aussie activists also try to help mesh injured women find pain specialists, accurate diagnoses, psychological help, and referrals to competent mesh removal surgeons—even if it means traveling half-way across the world.

Caz distinguishes between mesh used to treat prolapse and that used to treat urinary incontinence. Prolapse mesh is considered “high risk” by FDA officials but the SUI meshes are treated as the “gold standard.” There are no long-term studies proving the use of mesh is safe or efficacious. “RANZCOG states the clinical trials still need to be done for the SUI meshes; so this means that women are still guinea pigs,” wrote Chisholm.

She says women are being implanted with mesh unnecessarily and afterward, their GP’s don’t know how to treat them, and gynecologists deny care by saying their new problems are not related to mesh (duplicating the actions of doctors in the U.S. and all other countries). “These surgeons don’t want to know anything about the complications that their implants have caused women. In fact, I have read stories 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 we need t

Caz Chisholm winning two awards for her advocacy work.

o 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,” the determined activist added.

Caz Chisholm won two awards for her advocacy work.

 

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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 [email protected]..

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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 [email protected]..

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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 [email protected]..

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