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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
Coloplast (out of business)
Cook Medical System (out of business)
Ethicon Division (Johnson & Johnson)
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.”
Here are easy to follow instructions for reporting your own mesh injury. If you have new injuries? File a new report!
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.
(A little comic relief after so much pain)
Pudendal Pasta Primavera Recipe
1 Take pain killer. At the same time:
2 Fill a huge pot with water with water and turn on to “high.” Salt well. Set your strainer in the sink, turn on your timer to 13 minutes and go lay down with your feet up as high as you can tolerate.
Note: You will want a dry white wine with this, ideally a chilled dry French white. Put the bottle against your pelvis for ten minutes at a time until pain relief is felt.
Leave dishes for someone else.
Tried, tested and enjoyed by ©Peggy Day
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.
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?
Two things happened this past week that make it imperative to write about the connection between two traumas: sexual abuse and pelvic mesh injury.
First, Melynda, a dually-traumatized woman wrote a tearful story of her trip to get a transvaginal ultrasound:
I arrive at my scheduled time, make my way to radiology and wait for someone to take me back to the room. My pain is an 8-9 at this point and I am starting to shake because, goddammintalltohell, I am so exhausted of having strangers fiddling with my lady parts, I can’t even sit down and relax. (Remember also I am a survivor of child sexual abuse/incest and rape when I was 17 and have had all the wretched trauma of mesh, too).
In walks this older gentleman in scrubs and says, “Are you here for an ultrasound?”
I was so confused. Why is there an old man telling me he is going to be doing my transvaginal ultrasound!!!!??????
I started crying right then and there. “No, no, no, no, NO. I can’t do this with you. I am so sorry, I need a woman tech.”
He tells me it’s him or I will be forced to reschedule. I lose it. I tell him I need some time to calm myself down and then I go lock myself in the bathroom and sit there for 15 minutes while I sob uncontrollably and struggle to breath.
Before this mesh disaster, I wasn’t like this. I could have pelvic exams with no problem. I have been to years of counseling to help me overcome the abuse/incest and rape and I count myself as a survivor of both of those things. But these mesh injuries and the resulting treatments I have to endure. That is what left me sobbing in the hospital bathroom, shaking so hard I couldn’t even hold my phone.
Two days later, Buzzfeed published a document written to an arrogant rapist. The letter set off a maelstrom of outrage. The valiant victim described those hellacious moments when she slowly came to the realization she’d be brutally raped:
I … went to pull down my underwear, and felt nothing. I still remember the feeling of my hands touching my skin and grabbing nothing. I looked down and there was nothing. The thin piece of fabric, the only thing between my vagina and anything else, was missing and everything inside me was silenced. I still don’t have words for that feeling. In order to keep breathing, I thought maybe the policemen used scissors to cut them off for evidence.
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.
I wrote this for the Yankton County Observer (20 April 2016):
When We Need A Surgeon
How we choose a surgeon depends on many factors, and some make more sense than others. For example, for most everyday procedures, such as removing the appendix or gallbladder, a well-trained community surgeon should be a safe bet. For more complex procedures, studies have consistently shown better results from surgeons working in hospitals where such procedures are done more often. A very talented surgeon working in a small community hospital may, in his/her own series, have even better or equivalent results, but such surgeons are the exception. Dr. Chet McVay was that exception and attracted patients from far and wide to South Dakota to have their hernias repaired. He was a meticulous surgeon who kept track of his patients and published his very successful results.
Complex operations, in general, have an increased likelihood of serious and lethal complications, whose diagnosis and successful intervention are more challenging to places that rarely do them. In fact, “failure to rescue” is new concept in healthcare that describes the ability of a hospital to “get it right” when “something goes wrong” and leads to better patient survival.
Bottom line: work closely with your physician to make sure you are referred to the right surgeon and the right place for your operation. Read up on your problem and become familiar with the medical terms. Being informed gives you a head start. Driving the distance easily trumps a life-changing disability. And, finally, ask your physician the question: “Doctor, is this the surgeon you would trust with your own health and that of your family?”
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 finding 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 firstname.lastname@example.org.