Category Archives: Uncategorized

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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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

 

  • 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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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

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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4 Kinds of Pelvic Mesh and 4 Properties

Four Types of Transvaginal Mesh

     Transvaginal full-length or patch slings are implanted through both abdominal and vaginal incisions and secured with either absorbable sutures or anchors (miniature screws). The full-length sling is roughly two by seven-inches long. A patch is about one by two inches. Examples include: the Gynecare Prolift and the Gynecare Prolift+M.

     Tension-free transvaginal tape is mainly used to treat SUI. The mesh is inserted through your vagina and two small incisions in your lower abdomen near your pelvic bone. To pull the mesh inside, using his finger to identify anatomical markers, the surgeon passes a specialized needle through the area above your pubic bone called the retropublic space, which contains highly vascular tissues and is close to your bowel and bladder. Sutures and bone anchors are not required because it relies on your own tissues to hold it in place. Example: Gynecare Exact.

The transobturator tape procedure eliminates the need for a needle to go into your retropublic space. One or two needles are placed blindly through your groin area. Your surgeon then uses a vaginal incision to help guide the tape under your bladder. Example: Boston Scientific Obtryx.

The mini sling procedure uses only one incision in the vaginal area under the urethra. The mesh is secured with two “self-retaining tips” which are punched into your obturator foramen, the site of many permanent nerve injuries. Some doctors say this reduces the risk for injuries but recent scientific literature reports an equal number of complications. Example: AMS MiniArc Single Incision Sling.

POlypropylene IS FOR VEGIES NetsOnRolls

Properties of Synthetic Surgical Mesh

Synthetic materials are categorized according physical properties: composition (mono-filament or multi-filament), pore size, flexibility, and architecture (knitted or woven). Mesh used in pelvic reconstruction is different from hernia mesh in order to provide ease of use and the capability for the host tissue to grow into it while reducing your risk for erosion, infection, extrusion, and cancer.

     Type I monofilament macroporous polypropylene mesh (preferred synthetic material) has a large pore size, greater than 75 micrometers, facilitates the infiltration of the mesh by macrophages, fibroblast and blood vessels (your body’s wound healing defenses). It is believed to cause less infection as your tissue grows into it. Lightweight Type I mesh has a lower density of polypropylene and is believed to cause less foreign-body response.

     Type II monofilament microporous mesh – allows bacterial infiltration and it is harder for blood vessels and fibers to grow into because of the small pore size (smaller than 10 micrometers) resulting in a higher risk of recalcitrant infections.

     Type III multifilament mesh – has small interstices, (less than 10 micrometers) and bacteria that is less than one micrometer can replicate within its interstices. It is less than optimal because it allows access to macrophages and limits your ability to fight bacterial colonization within the spaces. There is also an increased risk of bacteria adherence due to increased surface area of the mesh (biofilm).

     Type IV meshes – are sub-microporous coated biomaterials with pores of less than one micrometer. They are generally avoided in pelvic reconstructive surgery.





Pelvic Mesh: How People Died

Rosey Y, died in 2013 after a string of illnesses after she was implanted in 2006 with a the Gynecare Prolift transvaginal mesh to treat pelvic organ prolapse. The Prolift had been introduced by Johnson & Johnson (J&J) in 2005 without an approval from the Food and Drug Administration (F.D.A.) and wreaked havoc on unsuspecting women until it was taken off the market in 2012.

Rosey’s sling sawed itself out of place, slicing right into her vagina and causing her last few years to be filled with infections and chronic suffering. She became totally disabled. “I sure never thought that some day I’d be crying just cause I can’t stand to wear underwear, much less pick up my grandkids,” she said. “After the surgery I couldn’t walk properly and was in constant cutting pain. Doctors say I am the first patient to ever have these problems.”


Screen Shot 2015-12-17 at 10.58.31 AM

Pelvic Mesh MAUDE Deaths

Very little is known about forty-nine people who died unexpectedly after pelvic mesh implant surgery. Small traces of their loves, their lives, and their lost futures appear “between the lines” in sparse, single paragraphs written by complete strangers and submitted to the F.D.A. in an Adverse Event report. There is no report for Rosie Y. For privacy reasons, the F.D.A. limits the amount of information that is made public. Using the short “Event Narrative” and “Manufacturer Narrative” attached to most of these 49 reports, we can piece together a few circumstances surrounding their deaths. Alone, each story makes little sense; gathered together, a much larger story unfolds.

When someone becomes ill, injured, or dies after they have a surgical implant, the manufacturers, importers and device user facilities are mandated by law to report the case to the F.D.A.’s MAUDE, (Manufacturer and User Facility Device Experience) database. In addition, health care professionals, patients and consumers are encouraged to make voluntary reports. (Instructions for filing a consumer report can be found here.)

The FDA MAUDE search tool is grossly limited. While it seems easy to search for “death” and “pelvic mesh” and find a complete list of all the people who died after pelvic mesh implants, it’s just not that simple. Words are misspelled; companies have two names or change names. Simply adding a location to the company name, such as Johnson and Johnson’s (J&J) Ethicon division does, will eliminate “hits,” so I must begin this report with this caveat:

“It is important to consider the multiple sources of potential error and bias in the underlying data.” It is my opinion that quantitative assessment of reporting rates to the FDA’s spontaneous reporting site (MAUDE) cannot be used to prove assertions about actual incidence rates for any events.
However, after twenty-years of registered nursing (where I witnessed unreported events) and eight years spent supporting mesh patients with injuries, I believe the number of reports on the FDA database is greatly underrepresented and the real tragedy of surgical mesh: the debilitating illnesses and injuries, the deaths, hospital-acquired infections, surgeon errors, and suicides, is exponentially higher than MAUDE represents.

* * *

On the first day of Summer, 2013, a woman underwent surgery for an anterior prolapse (sinking of the bladder or urethra into the vaginal wall). As the surgeon prepared to insert a Gynecare Gynemesh, the procedure required him to use a puncture needle to make a hole to secure a corner of mesh. When the surgeon punched the needle through her sacrospinous ligament, she began to bleed. The mesh was still lying on the Mayo Stand, ready to be implanted as she died. Try as he might, the surgeon was not able to stop the bleeding.

An Ethicon representative later wrote to the FDA about the event. With an air of cool detachment coming from someone who had not held her own breath while watching the woman on the operating room table slowly loose her color, see the nurses and doctors race unsuccessfully to save her, or sit beside the woman’s husband as he was told the devastating news. The Ethicon employee typed these stark words: “…but the patient was dead.”

The woman died three years after Ethicon pulled four other pelvic mesh products from the market while announcing it would continue to sell the one she was supposed to get. J&J wrote a letter to the FDA in 2010 stating “Ethicon also plans to update the product labeling for GYNECARE GYNEMESH® PS, including the Indication for Use, to restrict the indication for use to the abdominal sacrocolpopexy procedure (A surgical technique for repairing pelvic organ prolapse, an open abdominal or minimally invasive  technique) for the treatment of pelvic organ prolapse.”

If Ethicon had pulled the Gynemesh along with the other four, would that woman still be alive? (Gynecare Gynemesh)

Twenty-four of the forty-nine deaths were associated with a pelvic mesh that was made by J&J’s Ethicon Division, nearly half the deaths we found. Of the 24, Ethicon’s Gynecare Prolift Pelvic Floor Repair Mesh and Tension Free Vaginal Tape Mesh were the most lethal, eight and seven deaths respectively. The patients I help say thought the Tension Free Tape was different because their surgeon assured them that a tape is not the same thing as “the one in the lawsuits.” Both are made of polypropylene, a substance that early scientists declared unfit for the human body and both involve surgery in a place where mother nature had better plans. Whether or not the design of the Prolift and the Tension Free Tape is directly responsible for the fourteen deaths is nearly impossible to prove because it just wasn’t investigated.

* * *

Three other women died of hemorrhage. One woman, who also left her mesh behind on the Mayo Stand in the OR, was about to get a Prolift mesh. During the procedure, Ethicon noted, “the surgeon injured a large vessel” while he was performing a “finger dissection.” The surgeon was unable to stop the bleeding and gave her twenty units of blood trying to save her life. The device reporter, a little more compassionate than the one above, wrote, “unfortunately, she died on the operating table.” The company requested additional information but none was provided, so little more is known about the woman or her family.

One question lingers: how could a finger dissection tear open a major blood vessel when blood vessels are tough and fingers are covered by gloves? (Ethicon Prolift)

* * *

A woman hemorrhaged and died on October 3, 2004 after receiving Ethicon’s Tension Free Vaginal Tape. Her surgeon knew she was on a potent a blood thinner medication and took precautions by putting her on the weaker anti-coagulant, clexane. Although surgery went well, the woman collapsed seven hours later. She was resuscitated once and taken back to surgery where the surgeon cut the tape in half and performed a Burch suspension (suspending the bladder by a strong suture, equally effective and less hazardous as synthetic mesh). Her surgeon removed over two quarts of blood but couldn’t find the source of the bleeding. After three days, she died of a heart attack (a blood clot to a heart vessel). Astoundingly, there was no autopsy so her story will never be complete. Clexane carries this warning: “Major hemorrhages including retroperitoneal and intracranial bleeding have been reported. Some of these cases have been fatal.” (Ethicon Tension Free Vaginal Tape)

Three years later, a woman had surgery to receive a Gynecare TVT (transvaginal tape) Obturator Mesh and her surgeon described her surgery as “successful.” After surgery, her abdomen became distended and her blood pressure dropped. A vascular surgeon could not find the source of her bleeding. She refused blood transfusions because of her religious preference and the next day she died. Although there was an autopsy planned, there is no MAUDE report with the result. (Ethicon Gynecare Transvaginal Tape)

I wonder if women who are in a very unpleasant situation, suffering from emotionally-charged embarrassment with pelvic organ prolapse or stress urinary incontinence, truly understand that death is a very real danger connected to pelvic mesh surgery. Would they still sign a surgical consent? Would their husbands so easily leave them at the door to surgery if they knew that, one day, this very hospital would serve as a reminder of their deepest loss? Would a woman walk out of her home one morning, mentally check if the stove was off and plan for her next Thanksgiving dinner, if she realized she might never walk again? Never have sex again? Never meet grandchildren? I wonder.

Mesh is for screens 2                                       * * *

Pulmonary embolism has long been feared and respected as a major risk of surgery. Today, the incidence of this tragedy has been markedly reduced due to changes and interventions in post operative care. People no longer linger in bed for two weeks–instead  encouraged to get up and walk right after surgery. Compression stockings are applied and anticoagulant medication is given. Still, four of every thousand gynecological surgery patients have a pulmonary embolism.

On November 19, 2005, a woman received a Tension Free Vaginal Tape implant. Her MAUDE facts are scarce. She died a week afterward from a pulmonary embolism but no autopsy was done, yet Ethicon reports that her doctor did not think her death was related to the mesh. (Ethicon Tension Free Vaginal Tape)

March the thirteenth of 2010 was the another patient’s last day. She died of pulmonary embolism following surgery to implant both the Tension Free Tape and the Prolift devices. After surgery, she got up to urinate, felt weak, passed out and died. There was no more information offered on the MAUDE report. (Ethicon Prolift and Tension Free Vaginal Tape)

Another woman who died of pulmonary embolism had Coloplast Company product on January 25, 2013. The patient received a Restorelle® L synthetic mesh at some unknown date and later experienced a recurrence of her prolapse with the mesh exposed through her rectum. She had a pulmonary embolism, which lead to a fatal heart attack.

Before she died, her surgeon inserted a pessary ring into her vagina to treat the new prolapse. An x-ray revealed that her device had migrated away from her tailbone at the rear of her implant. The MAUDE report reads, “it was a pull-out of mesh from the anterior longitudinal ligament.” She had a surgery called a sacral colpopexy and was sent home from the hospital. On her way home, she became dizzy, short of breath, had chest pain, blurry vision and then passed out. Her heart stopped. She was resuscitated and admitted to the ICU but after two days, according to the MAUDE reporter, “the patient was made DNR (do not resuscitate) and her care was withdrawn.” She then died of pulmonary emboli (more than one) and a cardiac arrest. (Coloplast Restorelle® L)

A doctor was the MAUDE reporting party for the second of two Coloplast patients. This woman died of sepsis after a gruesome post operative course. To treat her vaginal prolapse and fix her enterocele (posterior vaginal hernia), she was implanted with one of the Restorelle products. She went home with no apparent problems but soon returned with a fever, nausea, vomiting and diarrhea. A CT showed she had a pelvic abscess which was drained. Soon after, she her blood pressure dropped to a dangerous level and she was transferred to the ICU in septic shock.

Surgeons tried to help by removing the vaginal mesh and took out all of the necrotic (infected and dead) tissue—she lost part of her vagina. Despite the interventions, her sepsis continued. Surgeons again took out more dead tissue, rerouted her intestines to a colostomy and implanted a Wound VAC (a somewhat painful device to drain serous fluid and blood and close the wound). Within days, she was only alive because of the assistance of a mechanical ventilator. She developed pneumonia. Sadly, her family felt it best to ask the doctor to take her off the ventilator. She died on May 13, 2012. (Coloplast Restorelle®)

Sepsis is a serious and often life-threatening condition with the presence of bacteria (bacteremia), other infectious organisms, or toxins created by infectious organisms in the bloodstream with spread throughout the body. On Oct 19, 2007, one woman had a sacral colpopexy done in conjunction with the implantation of Ethicon Gynecare Gynemesh PS Mesh. Her manufacturer reported to MAUDE that the surgery was “uncomplicated and easy.” (One wonders, for whom?) About six or eight hours after surgery, her blood pressure dropped and, suspecting she had aspiration pneumonia, doctors put her on antibiotics. After a rough ten-day course in the hospital, they finally discovered she had a bowel perforation—not pneumonia. Her colon was removed and her rectum closed. During that surgery, doctors found she had an infected hematoma “up the right side colic gutter” (slang for parabolic gutter: one of two open areas between the wall of the abdomen and the colon). The woman died two days later and the cause of death is reported to be, “multiple organ failure from sepsis due to a bowel perforation related to the surgery.” It all started with her pelvic organ prolapse. (Ethicon Gynecare Gynemesh PS Mesh)

Three years later, on 06/28/2010, another woman had an eerily similar experience after an Ethicon Prolift+M Pelvic Floor repair. J&J’s representative reported that her bowels and bladder stopped working one day after her surgery. An ultrasound was done and they found a tennis ball sized blood clot. Surgeons operated again suspecting her colon had been nicked and, sure enough, found part of the mesh, the right posterior arm, had been attached to her sigmoid colon (a grave and life-threatening surgical error). Tragically, the surgeons felt she was in too fragile a condition to withstand a removal of the arm so she was treated with heavy-duty antibiotics and sent home.

She was rushed back for an emergency admission in grave condition with septic shock. She was resuscitated and placed on a ventilator, underwent one more surgery, but did not make it. Her official cause of death was, “multi-organ failure with urosepsis.” (Ethicon Prolift+M Pelvic Floor Repair)

The manufacturer’s representative who reported this incident to MAUDE must never have been in the room with a family while the doctor carefully chooses his words to deliver life-shattering news; never watched taut shoulders suddenly drop, or lips quiver as family members wait for the doctor to finish the most horrific sentence they’ll ever hear—as if they know what he’s going to say but keep hoping won’t he won’t say it. The risk manger who sent this report probably never felt her own shoulder turn wet and warm while she held a patient’s sobbing adult child, trying to keep them from collapsing to the floor under the unbearable weight of their grief. Never heard a daughter sob and ask, “What do I do now?” and silently struggle for an answer. Never heard the loud, deep, long, guttural sound of a devastated loved one resounding through her own body and down the hallways of the hospital—a sound that would ring in her ears throughout the rest of her day. Never walked softly through the remainder of her shift, carrying her own grief for her patient as she emptied bedpans for her others.

Ethicon’s rep just did her job. She took shortcuts as she wrote her testimony of this woman’s disastrous death. Here it is exactly as it appears on MAUDE,

…“the device instructions for use warn ‘use the gynecare prolift+m systems with care, and with attention to pt anatomy and to proper dissection technique, to avoid damage to vessels, nerves, bladder, bowel and vaginal wall perforation. Users should be familiar with surgical procedures and techniques involving pelvic floor repair and synthetic meshes before employing the gynecare prolift+m systems.’”

A fisherman casts his fishing net on the coast at sunset Gabon

A fisherman casts his fishing net on the coast at sunset Gabon

Of all the reports we found, only one was written by a civilian. It was written by a son who watched his mother go downhill, tried everything within his power to stop her downward trajectory and is, to this day, is haunted by her suicide. He aggressively continues her fight against the use of synthetic surgical mesh.

I’ll let you read his own words:

“My mother had the Johnson and Johnson Gynecare Prolift (posterior) Repair system and the Uretex Synthetic Sling implanted on [date redacted by FDA] 2008. Approximately four months ago, she started having problems such as erosion out of her vagina with severe pain. She was going weekly to have her bladder flushed with antibiotics because of erosion into her bladder too. She was having severe constipation problems believed to be associated with the sling. She tried pain pills but they would not help with the pain. She would set up in bed laying across several pillows begging for relief. My mother was in such pain that she went in the backyard and shot herself. She is now gone due to the FDA (allowing) this mesh to be put in women. Reason for use: prolapse. Just given a prescription for pain.” (Gynecare Prolift (posterior) Repair system and Uretex Synthetic Sling)

* * *

Ethicon’s MAUDE risk managers often copy and paste phrases from one report to another. Here is an example: “Conclusion: no conclusion can be drawn at this time. Should additional info  be obtained, a supplemental 3500a form will be submitted accordingly.” The 3500a form is a voluntary report.

* * *

Other women whose deaths are memorialized by MAUDE include:

•    1/25/2010 – One whose had a sponge left inside by her surgeon, an all too frequent surgical error. The surgeon went back in and removed the sponge but left the mesh inside her. She went home where, after a few days, she collapsed and died of a pulmonary embolism. (Ethicon Prolift+M)

•    One who had a heart attack the day after her surgery. Her surgeon said it was unrelated to her surgery. (Ethicon Prolift)

•    One who developed a massive strep infection (necrotizing faciitis) in the days after surgery and had her mesh and much of her vaginal tissue removed. She soon died from the infection. All bodies carry strep. The very brief MAUDE report mentions her body carrying strep, but does not link her massive infection to the surgical technique used to implant the tape. Her mesh was implanted by dragging it through her vagina, an area considered “clean contaminated” and impossible to sterilize. (Ethicon Tension Free Vaginal Tape Mesh)

•    In 2005, no autopsy was performed after a woman who developed excessive bleeding six weeks after a transobturator bladder sling (TOT) implant died. Despite the lack of investigation, the report says, “ physician indicated that the obtape sling did not contribute to the patient’s condition.” (Mentor Corporation Obtape Sling Transobturator)

•    Another woman who had a TOT, knew right away she had a big problem. She had “excruciating pain” and couldn’t pee which lead to multiple bladder infections and eventually to sepsis just before she died.

[Take note: the name of the product in the FDA report was misspelled as “Oburator”—it would not pop up in a MAUDE search engine if the user searched for “Obturator.”] (Ethicon, Inc. Gynecare TVT Obturator System Mesh)

•    In July of 2005, a Risk Manager from a “User Facility,” (hospital, outpatient diagnostic or treatment facility, nursing home or ambulatory surgical facility) reported the death of a woman who died three days after getting an obturator tape. The day after her surgery, she was feeling “punky” and was told to stay home and take over the counter medications for pain and fever. The following day, she was rushed to the ER in full sepsis, put on a ventilator, and died the day after. The cause of death: “Overwhelming sepsis of undetermined etiology, acute renal failure, metabolic acidosis, and ARDS.” The reporter added: “Autopsy=no spesis (sic) source identified, all postmortem cultures negative.”

This woman’s case got some additional attention. There are three “Event Descriptions” for her, each a little different and all seemingly written in haste; descriptions included multiple misspellings, grammatical and typographical errors, and casual abbreviations. The second report added dates to the first. The last one, which appears to be written by the same author, is copied here without editing: “company’s original communication stated ‘during normal course of design verification, co has concluded material mediated pyrogenicity studies in rabbits for the device. All results have been positive. Generally co would only conduct a lal test to confirm a positive mm  pyrogen study. As none of the tvt tests have shown positive mm results, company does not have lal results available for the tvt.’ The use of the term ‘positive’ in the second sentence was in conflict with it’s use later. The use of ‘positive’ was meant to mean the tests passed, i. e. Did not have a pyrogenic result. A more appropriate statement is ‘all test results have shown no pyrogenic response.'”*

One only has to wonder how her family might feel after they read Ethicon’s narrative noted above. (Ethicon Gynecare TVT System Obturator)

* Author note:  Pyrogenic means producing or produced by fever. The MM, or Material Mediated Pyrogen Test, is used to determine whether a saline extract of a medical device causes a pyrogenic response (fever) in rabbits. LAL test is endotoxin testing to ensure injectable therapeutics are safe for human use.   


Peggy Day is working on a book to combine all these stories. She welcomes any input you may have.

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.




The Pelvis in Flames – Autoimmune Diseases and Pelvic Mesh

Why does one woman instantly react to a plastic mesh implant and another not even notice it, at least for several years? Every body reacts to the polypropylene mesh because the mesh is biologically incompatible with human tissue. The level of bio-incompatibility  “determines the host’s inflammatory response, scar plate formation, tissue ingrowth, and subsequent mesh performance, including prosthetic compliance.” It may be a decade or so before some women experience rejection symptoms: the burning, constant gnawing like there is a fire inside, debilitating damage, erosions, infections, urinary troubles and more, because as the body changes as it ages.

Screen Shot 2015-08-17 at 7.44.56 AM

Polypropylene mesh was designed to provoke a chronic inflammatory response that varies from woman to woman; from mild to severe. The minute the synthetic mesh came in contact with your healthy tissue, the fire started. Your body’s immune response recognizes non-native citizens like bacteria, viruses, and toxins, a splinter, foreign substances, or a synthetic mesh implant and responds to antigens (proteins attached to the surface of cells, viruses, or bacteria) by initiating a fierce defense. However, no matter how much your body tries to reject the plastic mesh implant, it can’t because it is trapped in the structures of your pelvis.

Eventually your healthy immune response may become compromised and give way to autoimmune disease. Those same antibodies that are charged with protecting your body from foreign matter may begin to attack your body’s own proteins and tissues, thinking they are foreign. Although the problem in autoimmune disorders is the immune system, the symptoms are displayed by the organ that is under attack. Essentially, autoimmune disease is an immune system with gone wild and turning on itself.

MESH IF FOR FOODpolypropylene NETONROLL

In the general population autoimmune disorders predominantly affect women and about three percent of the general population. More research is need to to determine how many mesh recipients have developed autoimmune diseases but, anecdotally, mesh victims who gather on the internet in groups of between 200 and a thousand participants connect the onset of an autoimmune process to the date of their mesh implant. Once a patient develops one autoimmune condition, the odds of developing another are greatly increased. Research about one autoimmune disease, Celiac Disease, showed that maintaining a gluten-free diet will dramatically reduce the number of antibodies in an affected child’s body. We recommend more research to determine if complete mesh removal will improve autoimmune symptoms.

Below is a list of autoimmune diseases found in the anecdotes of pelvic mesh owners:

Screen Shot 2015-08-18 at 4.24.38 PM

Do you have an autoimmune disease after a mesh transplant? What do you think?


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 MeshTroubles.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.

Woman Explains Why Mesh Litigants Are Not Money-Hungry Fools

Personal Story by Sandra T.*

I just responded to an extremely cocky Endo Pharmaceuticals sales representative. They aren’t the nicest, nor brightest. He was saying some pretty nasty things about one of the first surgeon to sound the alarm about mesh, Dr. Ostergard, and the women who get the mesh– how they are all just trying to have their big payday….HAH….as if.
My reply wasn’t as good as I’d wanted, but I believe he got the point.

MESH IS FOR scrubbers

Here is Sandra’s reply:
If you are a sales person for any of these medical devices, kits, etc, you really don’t want the truth now, do you? Do you have children? Or if you are a male sales rep, do you have a wife? Knowing how disabling this mesh (and all mesh) can be would certainly give me pause. 
I would love to believe that you all really do care, but to be honest, I doubt any of you really of you do—not until it hits home.
I do believe in order to obtain the jobs you have, you must have a basic idea of biology, and how things work. If not, you shouldn’t be in this field. As corrupt as it already is, you’re not doing anyone a favor.
Now, back to your wife, or God forbid your daughter, niece, or Mom. Would you want a surgeon with so little skill that she merely attended the weekend cadaver course to learn how to implant a product that is made of the same material as a hula-hoop? There is oil in them there mesh kits.
Do you know what polypropylene does to your system? Well, it’s not inert as the makers would want you to believe. No. It shrinks, it scars, it wraps itself around really important organs like your bowel or bladder. I had mine cutting through my urethra. The surgeon had to scrape it off my bladder and, for eight hours, he tried to get that crap out because very well meaning surgeons who can implant this crap were never given a single lesson on how to take it out. Not until 155px-NWTND_bag_Page_8-1 only recently have just a handful of qualified surgeons been able to remove this crap.
Now, once again, I ask you this question: Look at your beautiful wife, daughter, or whichever female has ever meant anything to you. Would you seriously want this crap in any of them, knowing they have a 40% chance of erosion, foreign body reaction, pain that is equivalent to giving birth, having cancer, or wanting to die but knowing that dying would just hurt their babies more?
Think about what you’re doing to women. Please try to find that place where you were when you began working in this business and wanted to make a difference.
They called Dr. Ostergard a dinosaur. They tried to make him irrelevant. He’s not irrelevant. I wish that ten years ago, when I was brutally assaulted by a seemingly well-meaning surgeon, I had access to his papers. Ostergard knew the ramifications of using mesh. He tried to warn everyone yet he was laughed at. He is not laughed at all that much anymore. More enlightened surgeons are “getting it.” But, despite his warnings, Ostergard could not stop that money making machine from rolling out all over the U.S. and on into the world.
My surgeon was just “trying to help.” She had a miracle cure for me. “Hey,” she said, “it is the ‘gold standard,’” but she never mentioned what it was made of. I had the surgery because I trusted her. Then I trusted her while she operated on me unsuccessfully three more times to cut here, snip there—never removing it.
I finally found a real surgeon competent enough to remove this stuff. He likened it to removing gum from hair, or rebar from concrete. That eight-hour surgery has done little for my pain, but it’s out. My surgical report reads like someone has been brutally assaulted.
I no longer attend soccer games or honor assemblies. Once I was extremely active, now I lay in bed most of the time—only occasionally going out with my trusty walker. This is the face of mesh. It’s not too pretty. My kids will never have what I worked so very hard for them to have: A normal childhood, that’s all.
Now I ask you  one more time. Could you do this to someone you love?
I can’t wait for the little pricks answer.

*(Not her real name)

My Saddles Are So Sore, They’re Numb – Femoral Nerve Injury

If your pain is in your outer thigh after pelvic mesh surgery, femoral nerve damage may be to blame. Of the people who develop nerve pain after pelvic surgery in one study, 3 out of 23 developed femoral neuropathy. Femoral neuropathy can occur from surgical dissection (cutting) of your femoral nerve, prolonged pressure on the nerve (including improper positioning during pelvic surgery) or hemotoma that arises from surgery.  Injury to or bleeding from your femoral artery can cause also compression on that nerve.
5 Femoral cutaneous
In addition to surgical problems, diabetes is the most common cause of femoral neuropathy. Other causes include radiation therapy, tumors, or pelvic fractures. Most of the time, it goes away on its own. You might also feel abnormal sensations from your knee down to your toes. It can be extremely bothersome and even affect the way you move your leg and your ability to bear weight on that leg or walk safely. Your leg or knee might feel weak and you may not be able to put pressure on that leg.

Your femoral nerve is one of the largest nerves in your leg. It is near your goon and controls the muscles that help you straighten your leg and move your hips. It provides feeling to the lower part of your leg and the front of your thigh and foot.

Symptoms
•    numbness over the front of the thigh and inside of your leg
•    tingling over the front of the thigh and inside of your leg, lower leg and foot
•    dull aching pain in your genital area
•    lower extremity weakness
•    difficulty extending your knee
•    feeling like your leg or knee is going to give out on you

Having a femoral nerve injury can weaken the muscles of your leg, make it difficult to walk properly and can cause your to fall.

Testing for femoral neuropathy may include an electromyogram (EMG), MRI or CT.
MESH IS FOR GARDENS
Treatment: If the problem does not go away after a few months, corticosteriod injections may help reduce inflammation and swelling and pain medications may help relieve pain. Physical therapy can build up strength and relieve your pain and improve your ability to walk safely. Orthopedic devices may also be needed.

Naturopaths recommend acupressure and acupuncture are other alternative modes, certain herbs such as lobelia, white sage, and valerian root, known to be effective in nerve disease.

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 MeshTroubles.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.

Obturator? Get Me The Surgeon General! – Obturator Nerve Injury

When talking to women who are suffering the consequences after pelvic mesh implant surgery, the obturator nerve is one of the most common injuries they describe because transobturator tapes (slings) cause mesh trouble. Your obturator nerve begins at your psoas major muscle, travels through your obturator foramen (an opening in the pelvic bone) and then enters your thigh, where it divides into two branches, anterior and posterior.

1 OBturator nerve
Signs & Symptoms
•    Pain localized to medial thigh radiating to groin or knee
•    Pain exacerbated with activity
•    Adductor weakness
•    Paresthesia over medial aspect of distal thigh
•    Loss of adductor tendon reflex with preservation of other lower extremity reflexes
•    Positive EMG (electromyogram)  and nerve conduction tests.

Damage to this nerve can be felt as pain, numbness your skin on the inside of your thighs and weakness of your thighs. This injury can affect the workings of you hip and knee joints and your abductor muscles and gracilis muscle which move the thighs when they close.

Your obturator nerve can be damaged through injury to your nerve itself, but also when the surrounding tissue is injured, causing swelling and inflammation which constricts blood flow inside the nerve itself.

Treatment: Mild damage to your obturator nerve can be treated with physical therapy, including stretching, deep tissue massage, and ultrasound. Medication for pain and anti-inflammatory drugs may help. More severe cases may require surgery to release the anterior division through the obturator canal.

MESH IS FOR STRAWBERRIES

We will explore each of the nerve injuries on our list in upcoming blog posts at meshtroubles.com

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 MeshTroubles.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.

“I’m (Still) Incontinent” – Mesh Surgery Failures

Doctors are saying that the nearly 100,000 mesh trouble lawsuits don’t mean the mesh is bad–it’s just that lawyers are greedy and “everybody is out for a buck,” and you need to believe them that synthetic surgical mesh is the gold standard. Women report that, as well as causing new mesh troubles, more than one in three mesh surgeries fails to cure incontinence. Knowing that, a woman might not want to have plastic mesh implant surgery.

Mesh is for Butterflies

“I had bladder sling surgery about a month ago and am actually having worse incontinence than I had before the surgery. I was diagnosed with stress incontinence before the surgery and had to wear a pad for leakage when I coughed or sneezed. Now I am wearing adult diapers because when I move from a sitting to a standing position,  all of the urine leaks out.”

“I had a hysterectomy and bladder sling surgery for a prolapse… I never leaked before having the surgery. Now I void every few minutes and leak constantly. The surgery was done robotically. If I knew this was going to happen I never would have had my bladder done.”

“All I can do is stand there with my bladder as tight as I can while I wet myself like a 2-year-old.”

“We found the solution by going to a urologist at Mayo Clinic in Scottsdale, AZ. I found that going to a clinic/Doctor that actually works in a team environment … was the answer. After the second surgery I am now at least back to where I was before all of this started. I do wear a diaper at night but during the day just a pantyliner. Try a different doctor and see what their assessment for your situation is.” (reference)

Numbers: I know statistics are boring but bear with me here for just a bit. 565 women where asked if they were continent a year after they had slings put in, “How satisfied or dissatisfied are you with the result of bladder surgery related to urine leakage?”  their answers were from 55.8 to 62.2 percent “yes.”  That means or 37.8% to 44.2%  said “no.” In this study, only 15 women “required” new surgery although approximately 231 women were still leaking. That just doesn’t seem like success to me. But then, I imagine the researchers were not crossing their legs tightly, avoiding standing up, changing poise very two hours, or trying to hide their Depends under bulky clothing as they questioned those women.
Here, I created a pie chart if you hate reading numbers in a paragraph as much as I do:

: graph
If we look at the same study more carefully, it calls into question whether urodynamic testing is a good measure of incontinence. When the machines were used to measure stress urinary incontinence, between 77.7 and 80.8 percent of women were fine yet when they themselves were asked, many more women said they were not. Here is another pie chart. If surgeons rely on the higher number for a “success” rate, more slings get sold. What the women actually experienced may be a better number to help guide you in making your decision about whether a mesh sling is worth the trouble.

Uro vs women

Handling incontinence is an major problem for anyone who would rather stay home than walk around smelling like a latrine. If your incontinence is so bad that changing position makes you gush, you’ll be paying close attention to how long it takes a drink of water or a cup of tea to make its way through your system and lowering your intake before going out in public. You’ll be taking baby wipes or cleaning cloths everywhere you go (in your over-sized purse), limiting your time out and avoiding social events. Be careful if you are drinking less because of the leaking because when your urine gets more concentrated, you are more vulnerable to urinary tract infections and your urine smells stronger.

Some women have had success with an injection of collagen for incontinence after sling surgery. Some end up with repeat surgeries—some even say they have three slings inside them. Before you have another surgery, think about finding another surgeon who may be more skilled in handling your problem and who does not implant mesh. While very few in number, there are surgeons who make repairs without using plastic surgical mesh and this blog will be publishing the names soon.

If you’d like to compare incontinence products, try this site.

In the study above, there were many complications found, especially nerve pain going down one leg and an inability to urinate normally. Next time on meshtroubles.com, we’ll take a look at the opposite problem, urinary retention and soon we’ll look at neurological mesh problems. Stay tuned.

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 MeshTroubles.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.