Category Archives: Products

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


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

Polypropylene – “Not for use in human body”

Do not use this Phillips Sumika material in medical applications involving permanent implantation in the human body or permanent contact with body fluids or tissues.

Do not use Phillips Sumika Polypropylene Company material in medical applications involving brief or temporary implantation in the human body or contact with human body fluids or tissue unless the material is provided by Phillips Sumika Polypropylene Company under an agreement which expressly acknowledges the contemplated use.

Phillips Sumika Polypropylene Company makes no representation, promise, express warranty or implied warranty concerning the suitability of this material for use in implantation in the human body or in contact with internal body fluids or tissues.”

Phillips Sumika Polypropylene Company Material Product Safety Sheet (undated)

 

Here is an early warning about polypropylene predating pelvic mesh

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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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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 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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