Tag Archives: informed consent

10 Facts of Life for the Pelvic Mesh Newbie

  1. Mesh injuries and illness rates are much higher than medical studies show. Most published research favorable to mesh is funded by the manufacturer.
  2. Mesh is mesh. There is no “old mesh.” It is all that same thing with minor changes in shape or route. Polypropylene is just plain damaging to human tissue.
  3. The pelvis is a perilous place to conduct surgery. Even human or pig mesh or simple suture repairs can cause problems–but not as frequently as pelvic mesh.
  4. Your new pelvic problem is very likely caused by the mesh itself. Fearing litigation and believing the manufacturer’s advertising, doctors are reluctant to blame the device.
  5. Some pain and infection get better with removal–but not all.

    KIM Mesh

  6. Very few surgeons know how to take mesh out, so they fake it with partial revision surgeries that lead to new complications and more surgeries. More surgeries = more scar tissue.
  7. There is no justice. There are almost no medical malpractice lawsuits anymore. There is no money in malpractice litigation for the lawyers since “Tort Reform” was enacted in all 50 states. Doctors and the AMA lobbied and paid for Tort Reform.
  8. About class actions, there is no money for a lawyer who represents a patient with pain, infection, nerve damage, etc. because recent settlements are based on the number of surgeries you’ve had and not how sick or injured you are.
  9. Don’t wait for legal recourse before finding a competent surgeon. Consider crowd-funding to get well.
  10. You shouldn’t have to do this alone. Join a mesh support group but keep a critical mind and don’t accept advice just because another person is adamant in their post Be careful. Be sure to double check any answers you receive. A good internet search can provide your best education.

 


Peggy Day is working on a book to combine all these stories. This is an excerpt from Pelvis in Flames: Your Pelvic Mesh Owner’s Guide. Your input is welcome to help make Pelvis in Flames the book you need to read.

If you’d like to join an online support group and learn about erosion, partial removals, surgeons, or just find out that you are not alone, 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.

FDA Responds to Pelvic Mesh Counterfeit Resin Allegations

Mostlyn Law alleged that Boston Scientific smuggled counterfeit resin containing toxic selenium and used it in mesh products after 2010. The FDA responded  January 5, 2017 by requiring BSC to prove that the material is safe for human use and to analyze the contents of their own mesh.
In its response, FDA doesn’t recommend removal of the suspected counterfeit material claiming the removal surgery is more risky than keeping selenium in your body.


Counterfeit Class Actions:
“In addition to the mass tort docket, Boston Scientific said it also faces two class action lawsuits by plaintiffs who allege that the company used counterfeit or adulterated resin from China to make the mesh in its pelvic mesh devices and not brand-name, American-made mesh as specified in regulatory approval for the devices. It said one case was stayed to allow the Food and Drug Administration to issue a determination about the counterfeit allegations.The company said the U.S. Attorney’s Office for the Southern District of West Virginia has also requested information about resin used in the company’s pelvic mesh devices.” — Lexis Legal News Boston Scientific Has Pacts To Settle About 37

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    • If you are helped by what you read here or if you need to know more about any particular topic, comment below or email me privately at

daywriter1@gmail.com

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Partial Pelvic Mesh Removal — Wrong Solution to Permanent Problem

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.

POLY IS FOR CUTTERS

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.

Beware of sugeons loan companies Beware of Mesh News
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 daywriter1@gmail.com.





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.




It’s Not Your Fault – By DebC

Below is an excerpt from another blog, MESHMENOT, by DebC who makes a very important point, especially for women. Simply put, it is not your fault that you had mesh implanted.

It Is Not Your Fault
Are you suffering from mesh complications and feeling guilty for “allowing” mesh to be implanted in your body in the first place?
Well then, I think, that you should think again.
No one  suffering from mesh complications should be feeling guilty.  This is not the patient/victim’s fault.  They should not have known better.  Nobody that is mesh-injured should be blaming themselves regardless of what kind of mesh it was or when they had it implanted.
Many who get mesh are not even given all the facts and options upfront.  I’ve heard from many who did not even know their doctor planned to use mesh until after the fact. The sad truth is that if you walk into almost any doctor’s office today and say you pee a little when you sneeze, he (or she) will probably recommend mesh, despite two FDA warnings, FDA adverse event reports of severe complications, and over 100,000 lawsuits.
Most likely, when you visited your doctor, he downplayed your valid concerns. He may have said the mesh, or tape, or sling he used is not the same thing that’s in the news and he’s chosen a safer product. He may have said his product was your only option. Serious and debilitating mesh complications rarely are acknowledged by most members of the medical community, so those who seek a second or third opinions find no real answers.
You are not to blame. When it comes down to it, most people trust their doctors. Period. That’s what we were taught to do: listen to our doctor.We are not medical professionals and some doctors will take advantage of that, chastising us for searching for answers online and trying to diagnosing our own complications. Many doctors take offense when their skills are questioned but, fortunately, there are doctors out there who listen and sincerely engage with their patients. There are even a few doctors who remember how to make repairs without using synthetic mesh–they are worth finding.

MESH IS NOT FOR BODIES 9
It’s human nature to kick ourselves in the ass.  Guilt comes too easily for most of us.  It may be because we like to believe we are in control of most things and feel we should be. It’s easy to feel like we should have known better, especially when we start doing more research and realize just how dangerous mesh is.  Then we wish that, somehow, we would have  known better than the doctors who recommended mesh in the first place.  But, hind-sight is 20/20 and most of us do not believe we know better than our doctors until we wind up dealing with all kinds of unnecessary mesh complications. – by DebC on MeshMeNot

 


“Even paranoids have real enemies”—Delmore Schwartz 1913-1966


 

The definition of paranoia is “an unfounded or exaggerated distrust of others.” When thousands of mesh victims gather and share stories of horrific infections, injuries, illnesses, disabilities, and even death, distrust of the maker of the product is certainly not unfounded.
If you’d like to read more on this mesh topic and many others, start at Deb C’s website here and look around while you’re there for more of her well-researched and fascinating writings.


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.




22+ Crucial Questions to Ask Surgeon Before Mesh Surgery

 1. What is the operation being recommended? Is it necessary?

 2. Why is the operation necessary?

 3. I am aware that a bladder sling or hernia mesh is made of polypropylene and the material is the same, whether it is called a “tape” or “minitape.” I do not want polypropylene in my body. Are you willing to do the surgery without the use of synthetic surgical mesh? {__ I am allergic to polypropylene (check if applies to you).}

4. What are my alternatives to this procedure? (for example: I am aware the Burch Procedure has the same rate of success as synthetic surgical mesh. Are you able to do an alternative procedure)

 5. What are the benefits of the surgery and how long will those benefits last?

 6. What are the risks and possible complications of having the operation?

 7. What are my possibilities if I choose not to have the surgery?

 8. How many of these surgeries have you performed?

9. For which specialty do you have a board certification?  Urology, Urogynecology, Gynecology, General Surgery, Colorectal Surgery?  Other?

10. Where will my surgery be performed?

11. How long will my operation take?

12. Why type of anesthesia will be administered? If it is not a hospital, is there emergency equipment if I should have trouble with anesthesia? What is the plan for emergencies? 

13. What type of incision will be used? Will it be an open procedure, minimally invasive or laparoscopic?

14. Do you have to cut close to larger nerves to complete this operation?

15. What are my chances for getting new nerve damage?

16. What is the risk of mesh erosion into healthy organs from this surgery?

17. What are my chances for getting a wound infection? What is the hospital’s nosocomial infection rate? Do you provide antibiotic prophylaxis?

18. What are the specific risks of this procedure?

19. What will my operation cost? What else will I be charged for?

20. What can I expect during recovery?

21. How will my life be changed for the good or bad after this operation?

22. How many future surgeries might I expect after this surgery if there are complications?

Added question: Are you planning to have a salesmen in the operating room with you? I do__ do not___ prefer to have a sales representative in the OR with me.

(Click here for download of copy with fill-in-the-blanks.)


 

 POLY IS FOR ADA RAMPS


 

Places to check-up on your surgeon

It is important to have confidence in the doctor who will be doing your surgery and you can make sure that he or she is qualified. Each state licenses its physicians. Take the time to search for:

       “[Name of State] physician license verification” for your own surgeon.

Make sure to check for disciplinary actions taken or whether the license is current. Example here.

  • Ask your primary doctor, your local medical society, or health insurance company for information about the doctor or surgeon’s experience with the procedure.
  • Make certain the doctor or surgeon is affiliated with an accredited health care facility. When considering surgery, where it is done is often as important as who is doing the procedure.

From PelvicMeshOwnersGuide.com                        © Peggy Day November 27, 2015





6 Personal Stories: Mesh Patients Are Not Mental Patients

Normal reactions to real parts of life are now being shifted into medical diagnoses by a medical and a psychiatric establishment that is fully embedded with Big Pharma. (Big Pharma is a nickname for the world’s vast and influential pharmaceutical industry and its trade and lobbying group, the Pharmaceutical Research and Manufacturers of America or PhRMA. These powerful companies make billions of dollars a year by selling drugs and medical devices, including the ones that cause pelvic mesh trouble.  As drug makers learned how to profit from turning normal grief into a major depression, normal pain response into anxiety or bipolar illness, and normal outrage over disrespectful, dismissive and faulty treatment by surgeons into a psychiatric disorder, more and more mesh victims are being given experimental (untested and unproven) drugs without any real proof that they work.   They don’t work. Before SSRI’s were introduced, 355,000 Americans were disabled by mental illness and after those pills went on the market, then number skyrocketed to 1.25 million!

Women who have been put through the surgical mesh mill and then treated like second-class citizens have honest to goodness, normal emotional responses. They resist being treated like emotional cripples and yet they are being sent to psychiatrists for a reacting to a very real circumstances. The six stories below are a sampling of  thousands of stories from across the world today. Names have been changed for privacy reasons.

Evelyn: “I do not have pain—just complete humiliation at having the fistula and the obvious attention I have to give it. I am a neat freak and this is most unpleasant for me! I keep telling myself that I am not going to die from this and just to carry on. I am definitely an action person, so the best way to deal with all of this for me is to have a plan and always move forward.  I remember the doctor saying that it just healed beautifully. Now the fistula!

“There is always a solution or something for you out there somewhere. Don’t be scared.”

Evelyn is employing some of the most therapeutic techniques for her distress. She is not only telling her story, she is offering help to others. Storytelling is one of the most beneficial tools for dealing with sadness and anger. Reaching out to help others is physically and mentally healing as well.

***

Fiona: “I had a TVT done last Feb, been in chronic, debilitating pain every since. Am 
trying to arrange funds to have removal surgery, scared to death to have one more surgery.”

Fiona is afraid, a normal response to a very real and present danger. When the only alternative is to go back into the very system that hurt you in the first place, being scared to death is a healthy response. He fears will help her to make very cautious and careful decisions for her future medical care.

tightwire net copy

Surprisingly, many women were implanted with more than one defective device at the same time:

Ingrid: “I had a TVT-O as well as a ProLift. Stupid and naive that I was, I blindly trusted that they knew what they were doing. What was I thinking?

 “They did this procedure through 6 portals on my inner thighs. When I woke up, the doctor stated I gave them a hard time in that he nicked a blood vessel (fishing through my legs) and I had lost a fair amount of  blood. Things went downhill from there on out.

 “The quality of my life has been really hurt by this ordeal, as one could imagine. Thank God my husband is very understanding.” 



Medicine has changed over the past half-century. It has become a business, and concentrates on turning a profit while minimizing the better good of the patient. Who would not feel betrayed by a botched surgery like this? For a doctor to tell a patient who had been paralyzed and under anesthesia, that she “gave them a hard time?” he has to have lost sight of his role in protecting her from harm. The pathology in this case is the surgeon’s. He did not own up to his own lack of  skill in using the equipment provided to him to complete a proper implant. It’s called blaming the victim.

Also, Ingrid’s husband is providing one of the best “medicines.” Supportive persons can make all the difference because they can counterbalance the inappropriate accusations and botched surgeries like the ones she experienced.

***

Michelle: “To my horror, after going to the bathroom, I discovered my uterus had dropped right out of  my vagina! I can’t possibly describe the feelings of revulsion and guilt that caused. It took me a few days to regain my composure and go to the doctor.”

“Afterward I was in so much pain I couldn’t stand up straight, walk my usual hour a day, or ride in the car more than 15 minutes without getting into so much pain I broke down in tears.”

Michelle’s story illustrates just how important a woman’s pelvic area is to her. Michelle reacted normally for someone injured in her most pivotal, most private place. Michelle was traumatized even though she was asleep during her surgery. Tears for pain and tears for grief are often combined for trauma victims.

MESH INFB Man Woman

Lucille: “I had a TVT and Marina coil fitted at the same time. The surgeon said, ‘Lucille, this is a simple operation with an overnight stay and you will be a new woman.’ He did not mention any complications or risks involved with the TVT. I took his word and trusted he knew what he is doing and accepted to go ahead with the surgery.



“I was and still am a smoker, although I did mention it to him. Once this is all over I will quit! The stresses of life and this awful leakage are disrupting my life.

“Came around from the operation, coughing so bad and my chest really hurt. I was scared. I could not breathe properly. All I could hear was ‘Lucille, you must give up smoking.’

“That night I could not sleep. I was so uncomfortable I kept watching the clock and wishing for morning. Breakfast arrived and I could not eat, had no energy, and told the nurse, ‘I do not feel well.’

The nurse dismissed Lucille’s complaints several times. Instead, she insisted Lucille go for a walk. About 6 steps into the walk, Lucille collapsed and was carried back to bed.

“An urgent x-ray was done, and I was given oxygen. They discovered pulmonary emboli (clots in my lungs) and collapsed lung. I ended up in hospital for the next 10 days!”

“I came home and had severe bleeding. Back into the hospital had marina coil taken out as the doctor assumed it is the coil causing the bleeding. I was not told it could be the TVT!



“Over the next couple of years, I was constantly in and out of hospital, diagnosed with diabetes type 2, heart attack symptoms, tremors, slurred speech, and trouble walking. They could not work out what was wrong with me! I had numerous tests and back and forth to hospital and doctors and was eventually diagnosed with an autoimmune disease.



Three years later, Lucille had more symptoms and her primary doctor told finally diagnosed her vaginal mesh erosion. 

“Enough is enough. We cannot allow this suffering to go on. This mesh should be banned, it has totally destroyed my life.  Although I have kept my mind going with graphic design, I cannot walk very far and now I am housebound! I cannot wait to get this thing out of my body! 

“I am a strong person and believe in inner faith, our beautiful creator has been with me and guiding me through each day, and with constant praying I know eventually this evil mesh stuff will be banned!”

Lucille is employing two of the most potent and effective methods for handling her emotional distress. She is sharing her experience with others giving her a sense of normalcy and community and she relies on her faith in God, giving her personal inner strength. Like Evelyn, she is reaching out to help others.

Polypropylene speed bump copy

Tricia: “For me it centers on ‘informed consent,’ both with the physician and the company that manufactures the mesh. The MD really did a different procedure with a different product than I consented to and that’s just not cool. The standard of informed consent is to provide to a patient with the most common and most serious complications. It also really irks me, as a nurse, that informed consent was really not provided, even after I asked for it.

 “(Before my operation), my doctor had offered several options and I took several weeks to decide. I located four women who’d had bladder surgery using monofilament slings and they all were having problems. I told my surgeon I did not want a (plastic) sling and asked about the biological swine tissue sling. The surgeon instead suggested an abdominal sacral colpopexy. I agreed to this procedure, thinking it was the swine procedure. The patient consent form was in medical terminology and listed the procedure as ‘abdominal sacral colpopexy, transobturator sling.’  The risks listed were ‘bleeding, infection, recurrent cystocele, persistent incontinence, urge incontinence, bladder/bowel injury.’

“(After the surgery,) I had fever, severe abdominal cramping, my right leg was numb, and I felt as if something was lodged at the top of my vagina. I made several visits to the (two) surgeons involved and neither thought I had any valid complaints. Neither would offer a straightforward answer. They never mentioned an implant could be causing my symptoms. 

“At week five I obtained the operating room notes and to my astonishment discovered that two implants were now securely placed in my abdomen: a Gynecare polypropylene 10×10 inch mesh and an AMS Monarc polypropylene mesh sling. I was furious. Because of my anger, the surgeons suggested such things as tranquilizers and psychological help.

“It has been three months and I have seen six surgeons.  I’m told these implants cannot be removed.  My symptoms have intensified.  I am in pain and I am angry.  I recently obtained literature listing the manufacturers risks: ‘foreign body response, vaginal extrusion, erosion through the urethra and surrounding tissue, migration of the device,  fistula formation, adhesion formation, pain, scarring that results in implant contraction, damage to vessels, nerves, bladder, urethra, bowel’ and more. Had I known any of these risks, I would not have had the surgery. I am not alone. I have since spoken with hundreds of men and women who are having complications with implants. Some, like me, didn’t know an implant was part of their surgery until complications arose.”

Tricia’s anger is understandable and normal. She felt she did not need pills or  psychological help and she later turned her anger into action by contacting her congressman and governor and starting a petition to put an end to the practice of performing implants without proper informed consent.

If you’d like to join an online support group and learn about mesh problems, 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.

 

When Bleeding After Mesh Surgery is Urgent

When dealing with “mesh trouble,” you deserve to take good care of yourself, especially after surgery. One of the most common questions women ask is about post-operative bleeding.
Pelvic mesh surgery is a very common procedure and most people have a normal, healthy recovery. Surgical areas in the pelvis and bladder are, by design, rich in blood vessels. A certain amount of vaginal bleeding is common—but too much bleeding is a problem, especially after surgery to remove a bladder sling or transvaginal tape. Those surgeries are done vaginally, abdominally or through groin incisions and involve a higher risk of postoperative bleeding.
Normal post operative bleeding is like a period and tapers off over time and can last up to six weeks. Occasionally, especially in the first week of healing, you may experience an episode of heavy bleeding when you stand up or after urinating or moving your bowels or when you are doing too much. Resting and taking lots of fluid can help.
Call your doctor if you bleeding is heavier than a menstrual period, completely soaks a large sanitary pad within an hour, or heavy bleeding continues for more than one hour.
Hemorrhage is rare but can become life-threatening. If you feel your bleeding is becoming out of control, make sure someone is with you. Symptoms of hemorrhage include feeling light-headed, become pale, clammy, confused, or passing out. Seek immediate treatment or call 9-1-1.
Pelvic surgery is major surgery and the most important thing is to allow yourself time to rest, time to heal. Read that book you’ve been meaning to get to. Make sure you drink plenty of liquids and gradually build yourself up with gentle exercise. Come back again to Meshtroubles.com and let’s work together to keep healthy and keep you free from Mesh TroublesMESH IS NOT FOR MOVING BODIES