I started the Australian Pelvic Mesh Support Group 2.5 years ago to find an empathetic and ethical surgeon who would invite Dr. Dionysios Veronikis to Australia to remove the mesh devices from women that no other surgeons in Australia are able to remove. Veronikis can remove more prolapse mesh from the pelvis and legs than any surgeon here because he has invented equipment to reach deep into the pelvis that other surgeons can not reach. He has also removed more than 2000 meshes.
It is important that you know what the group is about. It is about Dr Veronikis; about him coming here. It is about empathy and support for women who are suffering. We do not like mesh or support mesh. We are anti mesh. We do not believe in partial removals. We believe in full removal wherever possible.
We have found a surgeon in Sydney who is a gynecology pain specialist and pudendal nerve specialist. The pudendal nerve is the area around the groin that so many women are having complications with who have mesh; when this nerve is damaged it is extremely painful and affects the groin and legs, the vulva, the vagina, the rectum, and lower back. It really is a specialised area that implanting surgeons seem to know very little about and yet it is the main problem with mesh-injured women. Proving that [to other gynecologists] though is another issue.
This surgeon has agreed to invite Dr. Veronikis to Australia to remove the large prolaspe meshes from women that other surgeons in Australia refuse to or cannot do. Dr. Veronikis is the surgeon I flew to St Louis to see to have my stress incontinence tape fully removed. This is a momentous step for mesh injured women having Veronikis come here because we have been searching for 2.5 years to find a surgeon who will agree to do this. The surgeon here has already flown to America recently to meet Dr. Veronikis and receive training in mesh removal of the smaller tapes/meshes for incontinence. However, the larger prolapse meshes are very complicated and dangerous to remove and it takes a special surgeon to remove these.
Dr. Veronikis designed his own removal equipment and instruments and patented them himself so he can get deep into the pelvis to remove the mesh. No other surgeon in the world has this equipment. However, now Australia will have it because there are two hospitals in Sydney who are paying for the equipment. The Sydney surgeon is flying back to the USA in a few weeks time to have more discussions with Veronikis about equipment and training nurses in theatre.
This is the beginning of a massive breakthrough for mesh injured women and now we have some hope. It is a huge undertaking and it has involved a hell of a lot of work from numerous people including mesh injured women and we have some fantastic, highly qualified and highly regarded medical staff backing us.
Women from all over Australia are booking in to have removal surgery with Dr. Veronikis in Sydney when he comes. Unfortunately the RANZCOG (Royal Australian and New Zealand College of Obstetricians and Gynaecologists)
stand by their statement that partial removal is an acceptable form of treatment. They refuse to get on board with full removal procedures, even though Dr. Veronikis has removed more than 2000 mesh devices and travels around the world speaking about the pain associated with mesh and that when pain occurs the only way is to remove all of the mesh. The women in the Austrailian support group do not agree with the RANZCOG about partial removal because every single woman who has had this procedure ends up with more complications and ends up going back into hospital for more surgery and they often end up with infections that don’t go away and they live on antibiotics.
The Australian Pelvic Mesh Support Group is in the process of becoming a not for profit organisation so we can apply for funding to help mesh injured women Australia wide who need pain specialists, the correct diagnosis of mesh complications, psychological help and referrals to mesh removal surgeons which, at the moment, are very few and far between. The plan is to set up clinics in each city in Australia.
Caz Chisholm winning two awards for her advocacy work.
What is really important to distinguish is the prolapse meshes and the stress incontinence meshes. The prolapse meshes are in the high risk category whereas the stress incontinence meshes are still considered the gold standard even though there are no long term studies to prove it and RANZCOG state the clinical trials still need to be done for the SUI meshes, So this means that women are still guinea pigs otherwise why would they need the trials? I do know from a poll in our group that there are more women injured from stress incontinence meshes than prolapse meshes, possibly because more surgeons are implanting them these days since they have the “all clear” from RANZCOG.
I feel that the gynaecological associations have lost control of their gynaecologists and women are being implanted with mesh unnecessarily. Most GP’s know nothing about mesh complications and most gynae surgeons are sending women out the door telling them that their pain has nothing to do with the mesh. These surgeons don’t want to know anything about the complications that their implants have caused women. In fact I have read stories in the group about surgeons being rude to the women, some shout at them, some get angry with them, simply because the woman is presenting with pain and complications. They are turning their backs on the women. It is diabolical what is happening. This is why the Australian Pelvic Mesh Support Group needs to set up clinics Australia wide and find ethical and empathetic surgeons who want to be trained in full removal and to find the right medical professionals that really want to listen to these women, to believe them and not turn them away.
It is a very specialised issue and needs to be addressed immediately.
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
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
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.
Today’s press release from the Lawfirm Newswire stresses the importance of reporting injuries from TVM.
“Former FDA Program Manager, Madris Tomes, now the founder of Device Events, firmly believes all TVM kits are dangerous. Additionally, although many of the adverse event reports deal with ongoing symptoms, a question arises whether TVMs could cause deaths.
Due to the nature of the reporting system, death may be reported as malfunctions and injuries. Based on current information in the FDA reporting system it is allegedly not clear how many deaths may be related to TVM kits. However, according to Medscape, an FDA review of records for all urogynecologic mesh products spanning the years 2005 to 2010, there were 3,979 reports of malfunctions, injuries and deaths.
“It was not until 2011 that the FDA announced that the serious complications with the TVM kits everyone was reading about in the news were not rare — a reversal of its original stance on the product issued in 2008,” said Austin TVM attorney, Bobby Lee. After the FDA released its revised position on TVM kits, it was revealed they had been sent over 4,000 complaints involving TVM malfunctions, injuries and/or deaths over a five-year period.”
Too many surgeons are sending patients to have a CT (Cat Scan) and, when the radiologist says he/she can’t see mesh, tell the patient the mesh must have disappeared or dissolved when a CT cannot identify mesh. Plastic mesh does not dissolve. Sadly too many patients have their pain disrespected or disregarded when the problem is the doctor’s. Only specialized 3D Ultrasound with the right technician and radiologist (more on this coming in another blog soon) and specialized MRI’s with the skills to see it and read it can identify mesh.
Here is a graphic, courtesy of www.scbtmr.org that you can print out an take to your doctor.
How to see mesh with an MRI
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 firstname.lastname@example.org.
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.
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:
I’d like to hear from you if you are helped by what you read here or if you need to know more about any particular topic. Comment below or email me privately at email@example.com.
Your surgeon says he or she can snip the part of the mesh sling they can see, a quick operation and you’ll be better. Or says he can cut it to release it because it was put in too tight. Or, he promises a full removal but the operation takes less than an hour and, if the parts go to pathology, most of the mesh is still not accounted for.
Women who knowingly or unknowingly have partial removal surgery come to regret it. They issue strong warnings for the lucky women who read or search for answers online before signing up for a partial removal. Thousands of Urogynecologists and Urologists do partial removals. The very people who profit from mesh tell those specialists how to handle complaints: just cut a little out. Some heartless doctors cut it right there in the office with no anesthesia whatsoever.
The woman who have been through this tell newcomers not to allow a surgeon to cut bits and pieces of mesh but to leave it whole for a qualified surgeon with the skills to necessary to remove the entire device in one operation. They warn that doctors are not telling the truth about those partial surgeries.
Frayed rope is like sliced mesh
Partial removal can be a temporary solution to a permanent problem. Nearly everyone gets temporary relief after a partial surgery. When a rope breaks, the ends fray. That’s what happens with partials. All the ends leak toxic chemicals, stirring up a immune storm inside your body and spring back, eventually attaching to other parts of your vagina, bladder, intestines, bones, nerves, and blood vessels. After a year or two, you develop new symptoms and go looking for a doctor who can help. More than 99% of board certified surgeons will do another partial. Some women have dozens of surgeries before finding help from advocacy groups.
Be very careful. Get the whole thing out in any way you can because you are in the best possible shape to have a good outcome when your surgeon goes after the whole thing and it’s still intact! When mesh is cut, the next surgeon must go searching for shreds of it. They compare that surgery to trying to get bubble gum out of hair or searching for shrapnel.
If your surgery took less than four hours, consider that it may not be a complete removal, get your medical and surgical records and your pathology report. Learn the dimensions of your implant and ask for an accounting for every piece of it. Before your explant surgery, demand a micro and macro pathology be done. Afterward, get those reports!
We’ve found only five surgeons in the U.S. who consistently prove they removed complete pelvic mesh including arms or anchors (fixation devices):
Shlomo Raz, UCLA
Dionysis Veronikis, St. Louis, MO
Una Lee, Seattle WA
Dmitriy Nikolavsky, Syracuse, NY
Michael Hibner, Phoenix, AZ
The surgery is very risky but research has shown that is in no more risky that partial removals.
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. 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 firstname.lastname@example.org.
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.
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.
You oe aomeone you know has been hurt by a device. You want to let the FDA know about it, but it is so complicated. Here is a step-by-step guide.
This worksheet works best if you print out these pages and fill them in advance. (Click here for a printable copy) You’ll be ready to make the best, most effective report you can in one sitting. Settle in with a cuppa tea or whatever relaxes you.
The first page you should see should look like this:
Go ahead and click on “Consumer/Patient.”
On the next page, check the box for medical device.
Next, check everything that applies:
Write every detail you know about the situation. Don’t hold back, this is the place to let your feelings flow. Don’t worry, you can always file a new report if new information or new details come to you.
If you have any lab results or information you’d like to make public, add them here.
Add the date of the event if you know it. (Very important!)
Here is where you fill in as much information about the device as you know. If you have no idea what the device is, write as much as you do know or write: “Unknown pelvic sling,” “Unknown hernia mesh,” etc. Do your best.
Some of the following information will be made available to others. You decide what you want to share.
The following is information to identify the reporter (you). The more information you offer, the more credible your report will be.
Should you decide to check the box below, be prepared to be contacted by the manufacturer of the device. Remember, their job is to protect the company, not to ensure or provide the best patient care.
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.”
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.
* * *
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
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 email@example.com.
This blog contains first-hand opinions about pelvic surgical mesh from a calliope of experience: from 8 years of meetings, phone calls, emails and social network with mesh victims, interviews with surgeons, years of front-line emergency nurse work and early work in biostatistics and medical research, to walking the mesh walk today. I’ve learned about the magnificent inner strength of women facing unparalleled and unimaginable pelvic injuries and, along with it physical, emotional, social and spiritual challenges that would buckle the knees of the bravest soldier. These women inspire me in their tenacity and unwillingness to let go of the true joy in their lives.
To those women, I dedicate this blog.