Category Archives: The “WHY” of Mesh

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 slings or sutures after surgeries). 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.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

    • 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

    .

twitter-iconfacebook-icon


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

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

    • 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

    .

twitter-iconfacebook-icon


Comprehensive List of Pelvic Mesh Products

Since the 1950’s, surgical mesh has been used for all types of internal repairs, particularly hernia repairs to strengthen the abdominal wall. In the 1970’s, gynecologist and urogynecologists began to develop and patent products which used surgical mesh to treat urinary incontinence (most often due to early bladder sagging) and later more pronounced pelvic organ prolapse. Gynecologists began to cut small pieces of hernia surgical mesh into precise shapes.

A company by the name of Versica Medical introduced a product called the “Vesica Bone Anchoring System”, which used sutures attached to small screws to urinary incontinence. Vesica’s system was one of the precursors to transvaginal mesh devices that followed, beginning with the ProteGen. 

Below is a comprehensive list of transvaginal (pelvic) mesh products. Expect this list to be updated with more information like dates of use soon.

American Medical System

  • Apogee
  • BioArc
  • Elevate
  • In-Fast Ultra Transvaginal Sling
  • MiniArc Precise Single Incision Sling
  • Monarc Subfascial Hammock
  • Perigee
  • SPARC Self-Fixating Sling System
  • Straight-In

Boston Scientific

  • Advantage Fit System
  • Advantage Sling System
  • Arise
  • Lynx Suprapubic Mid-Urethral Sling System
  • Obtryx Curved Single
  • Obtryx Mesh Sling
  • Pinnacle Pelvic Floor Repair Kit
  • Pinnacle Pelvic Floor Repair Kit II
  • Polyform Synthetic Mesh
  • Prefyx Mid U Mesh Sling System
  • Prefyx PPS System
  • Solyx SIS System
  • Uphold Vaginal Support System

Covidian

  • Duo
  • IVS Tunneler Intra-Vaginal Sling
  • IVS Tunneler Placement Device
  • Parietene Polypropylene Mesh
  • Surgipro Polyproylene Surgical Mesh

C.R. Bard

  • Align
  • Avaulta BioSynthetic Support System
  • Avaulta Plus BioSynthetic Support System
  • Avaulta Solo Support System
  • Avaulta Solo Synthetic Support System
  • CollaMend Implant
  • Faslata Allograft
  • Pelvicol Tissue
  • Pelvilace
  • PelviSoft Biomesh
  • Pelvitex Polypropylene Mesh
  • Ugytex
  • Ugytex Dual Knit Mesh
  • Uretex
  • Uretex TO
  • Uretex TOO2
  • Uretex TOO3

Coloplast (out of business)

  • Minitape
  • Omnisure
  • Smartmesh
  • Restorelle
  • T-Sling-Universal Polypropylene Sling System
  • Aris-Transobturator Sling System
  • Supris-Suprapubic Sling System

Cook Medical System (out of business)

  • Surgiss Biodesign Tension-Free Urethral Sling
  • Surgiss Biodesign Anterior Pelvic Floor Graft
  • Surgiss Biodesign Posterior Pelvic Floor Graft
  • Cook Urological Stratasis Tension-Free Urethral Sling.

Ethicon Division (Johnson & Johnson)

  • Prosima
  • Gynemesh PS
  • Prolene Polypropylene Mesh Patch Secur
  • Prolift
  • Prolift+M
  • Prosima
  • TVT
  • TVT Abbrevo
  • TVT Exact
  • TVT Obturator (TVT-0)
  • TVT Retropubic System
  • TVT Secur

Mentor Corporation

  • Obtape (recalled – was implanted between 2003 and 2006)

Other companies:

  • Caldera
  • Sofradim
  • Neomedic Sling

______________________________________________________

Early device, Perigee, with insertion tools. Note frayed ends of mesh.

  • 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.twitter-iconfacebook-icon

Why So Many Doctors are Bad Doctors – Mesh Trouble

To those who have been participating in surgical mesh discussions, it comes as no surprise that the practice of medicine in 2016 has completely broken down. It is not safe to become a patient these days yet, by the very nature of living in this world of fast cars and eating unhealthy food, it is inevitable that most people will need to enter the Healthcare System someday and take their chances that they professionals will do right by them.

Discussions abound about how surgical mesh was cleared for implantation inside human bodies by corrupt Food and Drug Administration officials — insiders from the pharmaceutical industry. The number of deaths that occur from medical mistakes is over 300,000, and is considered the third leading cause of death in the U.S. Many other discussion participants report cruel, dismissive, even dangerous treatment by doctors in office and hospital settings; yet most of us are unaware of two things that should be — but are not — changing the game in favor of the patient.

prison mesh welded wire copy

In 1986 Congress passed legislation that bad doctors must be reported to a national database called the National Practitioner Data Base [PD2] in order to protect the consumer (The Healthcare Quality Improvement Act). That is you. But you have no access to the database either to report bad doctors or to find out if your doctor is bad. Usually, the only way to discover you have chosen a bad doctor is to find out the hard way, by being exposed to rude, aggressive, dismissive, or harmful treatment yourself. You may get lucky and be part of an private discussion group between patients and hear about some of the bad ones and avoid trouble, even disaster, for yourself. Websites like Vitals.com, etc. submit to pressure from lawyers and doctors to remove feedback that would have negative consequences to the doctors and are not reliable if you are trying to protect yourself from harm.

Every battle has its heroes and for patients and we found two: Bob Wachter and an anonymous emergency doctor (Shadowfax) who runs a fittingly named blog, “Moving Meat.” Both of them acknowledge that today’s medicine puts the priority of the patient well below the protection of the doctor’s career and reputation. Both say the NPDB is not doing its job.

What do you think? What is your experience in today’s medical world? Do you feel safe? Protected? How is the Healthcare Improvement Act working for 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.
    twitter-iconfacebook-icon




    http://community.the-hospitalist.org/2009/06/01/is-hospital-peer-review-a-sham-well-mostly-yes/

    http://allbleedingstops.blogspot.com/2009/06/review-of-peer-review.html

    [PD1]https://www.npdb.hrsa.gov/resources/titleIv.jsp

    [PD2]https://www.npdb.hrsa.gov/topNavigation/aboutUs.jsp

Why Not Talk About Hernia Mesh?

I often hear that people think that there is too much attention paid to pelvic mesh victims at the cost to the hernia victims. After all, it’s the same material that is used, just cut in a different shape and placed in a different part of the body. And, truth is, pelvic organ prolapse is very similar to a hernia —both are caused by a weakening of muscles.

When I planned this blog, I decided to focus on one type of mesh because it is the one I know best and because I planned to go into depth with my research. In the back of my mind, I want to do another blog called the Hernia Mesh Owner’s Guide —some day.

POLY IS FOR CUTTERS

I hope hernia sufferers will look at the parts of this blog that apply to them because so many complications are the same: the denial by doctors, the nerve injuries, the salesmen in the operating room, the body’s foreign body reaction and the resulting autoimmune diseases, the cancer risk, the pain, loss of consortium, and the loss of ability to work. The great difficulties getting it removed are similar. Mesh shreds, twists, curls, folds, stretches, migrates, disintegrates, etc. no matter where it is placed.

In looking at why the two entities got separated in the first place, it is important to look at the history of several legal battles. Hernia mesh underwent similar legal attacks about 20 years ago. Many versions of hernia were removed, recalled, and quietly taken off the market. Many people sued and won and many lost. In the end, really, the makers won. They just changed a few elements of hernia mesh, paid for scientific studies that proved it was a great product, and went right on marketing it (the same thing is happening with transvaginal mesh).

So, when the makers found a new application for mesh, putting it into women’s most private, most valued and most delicate place, it cause NEW problems because of the anatomy of the pelvis. The lawyers, like chairs on a tipping ship, rushed to represent this new disaster and abandoned the hernia meshes because there is no longer any money in those cases.

Hernia mesh victims: please be aware that not a single victim made this separation; it was done by lawyers.

Sadly, there are probably no lawyers who represent hernia mesh victims unless it involves malpractice and even that is very hard to prove. BigPharma and the AMA put legislation in place long ago to limit the amount you can win. (Tort reform only benefits those entities). BigPharma also controls much of major media. Thank goodness for social media!

 

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.




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.




Did a Salesman Oogle Your Pelvic Mesh Surgery? – Salesmen in the OR

You may be surprised to learn just how your doctor purchased the pelvic sling he put in your body. Truth is, he didn’t have to lift a finger. His sales rep brought it to him. Moreover, there is a good chance your salesman watched your doctor put it in you and, he may even have “scrubbed in” and performed part of your surgery.

It is no accident that your surgeon “forgot” to mention the manufacturer’s rep might be in your surgery. Manufacturers are well aware that the practice is very controversial and don’t want you to know. David S. Hilzenrath discovered the obfuscation while preparing for his 2009 Washington Post story about salesmen boosting sales by participating in operations:

“(S)ome companies want nothing to do with a story about sales rep in the operating room.
“‘I would hope that you would not mention Boston Scientific in your story,’ a spokesman for that company e-mailed.
“Major device makers such as Johnson & Johnson, Stryker and Zimmer declined to arrange interviews for this article.”

POLY IS FOR ELECTRIC WIRES

Mesh injured women began realizing that manufacturers invaded their surgeries, not when they were asked to sign a consent for an observer to be there while their genitals were being operated on, but afterward when they found evidence by reading their own charts. Detail men around the world routinely attend surgeries to make sure doctors don’t use competitors’ products.

In 2008, Ronda Yancy (not her real name) was appalled when she retrieved her own medical record: “I found out, after my surgery, that a Johnson & Johnson Gynecare sales representative was in the O.R. with me.”

Yancy, who died at 52, after living her final years dealing with mesh complications and a string of illnesses, had been implanted the Gynecare Prolift (a polypropylene-based surgical mesh device used to treat pelvic organ prolapse). The Prolift was first introduced by J&J in 2005 without an F.D.A. approval and was soon the source of alarming federal complaints. It wasn’t removed from the market until a year after Ronda’s death, in 2012.

Ronda’s pelvic sling sawed itself out of the space it was supposed to be and into her vagina, causing her suffer years of infections and disabling pelvic pains. “I sure never thought that some day I’d be crying just cause I can’t stand to wear underwear anymore, much less pick up my grandkids,” said Ronda. “After the surgery I couldn’t walk properly and am in constant cutting pain. Doctors say I am the first patient to ever have problems.”

After Ronda posted in an online support group, others began to look at their operative reports and at least three found that salesmen had been in the room with them while they slept. One said she felt like she’d been “drugged and raped.”

One nurse wrote to the group, “The hospital loves for the reps to come in because their labor is free and they provide free products to use. The reps bring in pizza dinners and cater lunches from time to time and so the O.R. staff loves them too.

Trendelenberg

Jack-knife position for vaginal surgery. (Posed by clothed woman)

Bill Mackay, a high school drop-out and device salesman who performed the major part of a surgery that crippled a man in 1975, was never mentioned in that patient’s chart. He later wrote in a tell-all book, Salesman Surgeon, that he took over lead surgeon, David Lipton’s position during a hip replacement, ordered the nurse to hand him sharp instruments, hammered and chiseled away at bones and removed one hip prosthesis and implanted another. He said it was the “one of nicest pieces of surgery (he’d) ever seen or done”  but the patient, Franklin Mirando didn’t agree. The forty-two-year-old service station owner never walked again after Mackay was done with him.

In 1977, criminal charges for assault and misrepresenting business records were made against salesman Mackay, two surgeons, a nurse and the Smithtown General Hospital. Investigations were launched by both state legislators and the Sulfolk County Medical Society. Despite all the hoopla, the charges were eventually dropped and the manufacturers across the country began to have free rein inside operating rooms.

What could possibly go wrong when you send wet-eared salesmen into an operating room? In 1998, another device rep was sued after he operated a machine during a fibroid removal surgery and 30-year-old Lisa Smart died within hours. Lawyers found Lisa’s surgeons had botched many aspects of her surgery including overloading her with fluid. She drowned. Her husband’s lawyers were also shocked to discover Johnson & Johnson sales rep, David Myers, was operating the dials on the unauthorized machine that delivered electrical impulses to her uterus. “The patient was never given the chance to consent to the use of the equipment or the presence of the salesman,” the New York Times reported at the time. The hospital a was fined $30,000 and Myers disappeared from sight. Yet again, in the face of another disastrous outcome, device marketers stepped up their pace.

Classes for prospective salesmen include topics like: “how to get inside a surgical suite without an invitation” or how “to sell without making the surgeon feel that he’s being sold” or even “the art of engaging surgeons in conversation.”  Candidates are invariably young, good-looking go-getters whose training lasted no longer than a few weeks. Although a college education is recommended, it is not always required. Despite the fact that pelvic mesh sellers are given an unfettered view of your genitals, there is no evidence that they were ever required to go through a background check–although your nurse sure was.

bathing-machine-with-men-ogling-women

Recently, two pelvic mesh recipients found out that salesmen had been with them by reading their charts. One woman noticed a set of unfamiliar initials next to “Ass.,” or assistant surgeon, on her operative report and set out to investigate. She found another document with the full name spelled out and remembered her surgeon mentioning he was going to “ask the advice” of his salesman with the same name. She was never told he would be there. A modest woman, she can’t digest the fact that a total stranger was afforded a clear view of her most private area. As if to compound the emotional harm from realizing a salesman had seen her tilted backward, legs spread on an operating table, she said the same sales rep later visited her in her home–right after she made an official complaint about her mesh injuries.

It the manufacturers are working hard to hide the presence of salesmen in operating rooms, there is no way to know if, when your transobturator-tape was pulled to tight, it was really the detail man who tugged too hard on that trocar or if his scrubbing technique was not up to standard and that’s why you had a post-operative infection.

If you would like to look up your medical record, be prepared to put a little wear and tear on your shoe leather. Go to your hospital medical record department in person and ask for the complete report of your surgery, including the label for you implant. Most medical record departments provide only the surgeon’s dictated report, especially when you ask by mail, but there is a lot more paperwork than that. Look for your consent, your anesthesiologist’s minute-to-minute accounting, your nurse’s count of sponges and instruments, and your interoperative report, which should contain the names of everyone who attended your surgery.

Yancy felt she was invalidated every step of the way after her implant. Doctor after doctor told her, “Mesh is the gold standard, it can’t be the mesh.” She summed it up in one word saying she had been “Gaslighted,” a reference to the 1944 movie, Gaslight, in which Charles Boyer pulled dirty tricks on Ingrid Bergman and then told her she must be going crazy–all the while pretending he had her best interest at heart. What a perfect phrase. Are you being Gaslighted?


Peggy Day is working on an investigative report on pelvic mesh salesmen in the operating room. She welcomes any input you may have about the questionable practice.

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)

8 Reasons You’ll Want to Subscribe to this Blog

MeshTroubles is a website built upon years of experience as a frontline nurse and as someone who has personal experience with pelvic mesh. Subscribe to this blog for bi-weekly updates with new and important information.

8 Reasons You’ll Want to Subscribe to this Blog

1. You want to know if your implant is causing your new troubles/problems.
2. Your surgeon suggested a bladder tape or mini-tape and says it is not the same mesh that has caused all the trouble (over 100,000 lawsuits). Is this really true?
3. You have pelvic or hernia meshMesh is for FIshing.
4. You have Pelvic Organ Prolapse (POP).
5. You have Stress Urinary Incontinence (SUI).
6. You had a bladder sling put in and now there’s trouble with mesh.
7. You developed Lupus, Multiple Sclerosis, Scleroderma, Thyroid problems since getting mesh.
8. You want some help.

1. You want to know if your implant is causing of your mesh troubles or problems.
Studies show surgical mesh has been known to cause severe complications in about 24% of patients. Polypropylene mesh is not inert but is actually designed to irritate healthy tissue and stimulate growth of nerves, blood vessels, and connective tissue inside the weave of the mesh. Surgical mesh is identical in composition to the screen in your window—cut down to size. Some  suffer lifelong pain immediately after the implant, and others start to have trouble much later.  It’s not a matter of if the mesh will cause trouble, it’s when. Learn more in upcoming blogs.
2. Your surgeon suggested a bladder tape or mini-tape and says it is not the same mesh that has caused all the trouble (over 100,000 lawsuits). Is that really true?
Unless your surgeon is offering to use real live tissue like your own muscle, donor’s muscle, pig muscle, etc., the surgeon is planning to put in polypropylene mesh. Polypropylene is made from crude oil which has been put through a series of chemical changes. Tape, mini, strip: they are words to hide the fact that Johnson and Johnson, Boston Scientific, Bard, etc. have not stopped using plastic mesh. It’s all the same.
3. You have pelvic or hernia mesh.
You had pelvic mesh implanted and now you are in a world of trouble. Mesh stimulates a “foreign body response” when it is implanted. The body goes into a state of continually trying to reject the mesh. Surgical mesh creates an environment in the body that plays host to rare bacteria sometimes resulting in major antibiotic resistant infections. Mesh begins to change shape once the body begins to move after implant surgery.
Hernia mesh is the same thing as pelvic mesh, just cut into a different shape. Once it is implanted, mesh begins to harden up, sometimes retracting and curling up in a ball taking your blood vessels, nerves, muscles, even healthy organs with it. You hurt but surgeon does not take your pain seriously.
4. You have Pelvic Organ Prolapse (POP).
Nothing can be more distressing for woman than to find her own uterus poking out of her vagina or learning from her gynecologist that her bladder, uterus or rectum is falling down. Before you sign on the dotted line for a pelvic sling or mini-tape, learn about other alternatives. Most surgeons, not wanting to alarm you, don’t tell you that you may be about to start a life without sex or in constant unbearable pain or staying in bed most of the time, or heading into many many more surgeries. How much risk are you willing to to take if the mesh operation goes south?
5. You have Stress Urinary Incontinence (SUI).
The odors, the wetness, the embarrassment is enough to kill any good day. You are an active and successful woman want a quick-fix to get back to normal life. Is a transobturator tape the right answer? Are you ready to trade in those problems in order to join the one in four women suffering from severe infection, life-long and debilitating pain, can’t even sit up straight—for the rest of your life after a pelvic sling?
6. You had a bladder sling put in and now there’s mesh trouble.
Or, you are one of those who got the sling and you woke up from your surgery knowing it was too tight right away. Your pain level topped the charts. You have had one infection after another since your implant. The mesh didn’t work. You have pins and needles, numbness or pain in your groin and radiating down your leg.
7. You developed Lupus, Multiple Sclerosis, Scleroderma, Thyroid problems since getting mesh.
Mesh breaks down and leaches into your body, traveling through your blood and lymphatic system and has been know to cause autoimmune disease. Subscribe to this blog for links to authenticated medical journal articles which point straight to the surgical mesh.
8. You want some help.
You feel all alone. Your doctors are telling you it is not the mesh causing you the new problems. You know something is just not right but need some help figuring it all out in a way that makes sense. It will help to find others in your shoes. The trouble is not you. It is the mesh. Welcome to MeshTroubles.com

Welcome to Mesh Troubles

Your doctor said, “It can’t be the mesh. It isn’t the mesh.” But your troubles began soon after you had mesh (bladder sling, or pelvic mesh or mini tape) implanted. You’ve been referred to pain specialists, neurologists, bowel surgeons, urologists, physical therapist, even a psychiatrist but your pain is not getting any better. That’s the trouble with mesh.

The practice of medicine has changed over my lifetime. There is no such doctor Mesh is for Butterfliesas Marcus Welby anymore. Today’s doctors are under pressure from all directions and, sometimes have forgotten that you expect them to have your best interest at heart. Inserting a pelvic sling, (TVT, TOT, etc.) is a quick procedure and a money maker for your doctor and, although the implants have been found defective and some recalled when things go terribly wrong: hobbling, crippling or even killing you, you’re told “It is not the mesh.”

Unlike Dr. Welby’s days, surgeons now get their information from salesmen, and the sale representative told your doctor the the risk from mesh implants is low. When things go wrong manufacturers, also known as “Big Pharma,” point their fingers at a defective patient or even have the temerity to blame the surgeon himself. Nobody wants to look at the truth. That was, until patients began to get together and compare notes. That’s when Mesh Troubles came to the light of day. Welcome and we hope you soon will be packing up your “troubles in your old kit bag…”