Tuesday, January 31, 2012

MESH "EROSION": NOT A MINOR COMPLICATION!

Doctor Disconnect:
Synthetic Surgical Mesh Myths and Lies
By Lana C. Keeton
My Views as a Synthetic Surgical Mesh Patient Survivor
lanamiami@bellsouth.net

January 31, 2012

If you went to your barber for a haircut and he cut out a chunk of your scalp, along with your hair, you would find another barber. Yet it is accepted practice, and even recommended by prominent surgeons…and paid for by insurance companies…to remove “chunks” of a woman’s vagina or bladder, or other tissue or organ, to remove pieces of “eroding” surgical mesh – without anesthesia, I might add. The latest position of a group of surgeons says it’s a “minor” complication easily dealt with in the office. From a patient’s perspective, this is a barbaric practice which doesn’t stop mesh erosion from recurring year after year. Let me tell you, I have had many of those “haircuts” by Dr. G. Willy Davila at the Cleveland Clinic in Weston, FL and it is excruciating pain, not to mention demeaning and expensive.

You have to ask yourself, “Why would any doctor recommend such a procedure?” It’s quite simple. “Erosion” of synthetic surgical mesh, implanted during pelvic organ prolapse repair and/or bladder suspension surgeries, occurs repeatedly in an alarmingly high percentage of women. To tamp down the vast legal liability created by the widespread use of synthetic surgical mesh for these procedures in major institutions such as Cleveland Clinic, Mayo Clinic, Vanderbilt University and the University of Michigan over at least the last decade, surgeons, institutions, major medical professional societies and industry are purposely diminishing the severity of the mesh complication so benignly called “erosion”. They even created a completely new lexicon of terms to describe mesh. “Exposure” is one of the new terms du’ jour. Marketing, marketing, marketing!

Writing major protest letters to the FDA, and testifying before the FDA’s Ob-Gyn Advisory Committee Panel Meeting in September 2011, surgeons, numerous professional medical societies, institutions and industry spoke out on behalf of foreign body polymers, petroleum waste by-products, and against the authority of the FDA’s warning of the serious complications, with no apparent benefit to women, of trans-vaginal mesh. “Pharmageddon”, as Paul Hilton wrote years ago, has arrived.

As a patient advocate, thousands of men and women have written to me for help. Now I am sure you are asking yourself, Why would mesh injured patients write me, another patient and not a medical professional? Why not just go to the original surgeon who implanted the mesh and get those complications straightened out? They write me because the medical profession and industry are not addressing the vast array of debilitating complications of synthetic surgical mesh. Patients are routinely abandoned or discarded by their physicians. So why is this? For one, the complications are frequently permanent and irreversible.

Other scenarios I am aware of….
- The surgeon is a paid medical consultant/advisor to a mesh manufacturer who is protecting his/her job, the clinic or hospital he/she works for and the mesh manufacturer. He/she does not want to validate what he/she knows to be truth about the dangers of mesh.
- The surgeon is not a paid medical consultant/advisor but paid minions of industry have been less than honest in informing the doctor about the nature, severity and real percentage of complications. The surgeon is unprepared to deal with the unexpected complications.
- The use of the body’s natural inflammatory response prevents the surgeon from explanting what he/she has implanted because, as intended by the manufacturer, the patients tissues have scarred into the interstices of the mesh.
- The surgeon knows the dangers of mesh and fears the loss of his/her career, reputation and financial security if he fails in his attempts to help the patient.



DOCTOR DISCONNECT

So what do these surgeons typically do? Most patients tell me the response is, what I term, the classic mesh lie: “It’s not the mesh.” They deny it is the mesh. Deny the association between the complications and the mesh. Say it is the patients fault. Say the pain does not exist. Say it is a pre-existing condition. Tell the woman she has back problems. Tell her the pain is in her mind and does not really exist. Prescribe an anti-depressant. Tell her the autoimmune disease she suffers is not related to the mesh. Send her for physical therapy (a highly invasive treatment where another person puts their hands into a woman’s vagina to manipulate it). Send her for trigger point therapy. But then, how is it a doctor identifies which injured nerves to inject in a woman’s pelvis for the trigger point therapy to succeed? Or send her for pain management. Or maybe they give her one of those in-office “haircuts”.

In other words, despite multiple physical manifestations to the contrary, doctors disconnect from the reality the pelvis is connected to the rest of a woman’s body and the mesh a surgeon has implanted IS the cause of the complications. In my opinion, the highly touted benefits of synthetic surgical mesh are a lie and the complications are a life sentence for anyone, and I do mean anyone man or woman, implanted with it.

I have to emphasize these myths and lies are the same for men and women implanted with surgical mesh for hernia repair. Mesh hernia repair surgeries just have a different, but very similar, set of dangerous complications. The horror of the majority of mesh complications is that they are permanent and irreversible. Even complete mesh removal does not mean major nerve damage will not result in severe chronic pain and/or permanent disability.

In my very informed opinion, the unnecessary use of synthetic surgical mesh for hernia repair, bladder suspension and pelvic organ prolapse is a disgrace to the medical profession, major hospitals and clinics, educational institutions and medical device makers. Synthetic surgical mesh does not self-implant. Surgeons should protect their patients by putting down the scalpel which only they control. Surgeons must STOP implanting surgical mesh, except in the rare cases where there is no human tissue available.

Based on my near death experience more than 10 years ago following the implantation of Ethicon’s Gynecare TVT mesh bladder sling, I can promise you “erosion” is a debilitating complication, not an in-office “haircut”! 17 procedures and/or surgeries attempting to remove it, chronic debilitating pain, autoimmune disease, bankruptcy and homelessness directly related to “erosion” are not minor complications. Surgery #18 is planned for later this year. Who knows when it will stop? For me, maybe never.

Changing the lexicon from “Erosion” to the word “Exposure” is not the answer. NEVER having had an untested, unsafe petroleum based medical device implanted in me would have been the best option. Surgeons must take a stand for their patients to stop this major medical scandal!

12 comments:

Joleen Chambers said...

Federal legislation is the source of this scandal and is also the solution. Congress must quickly act to align with the IOM Institute of Medicine report of 7/29/11 that states that the current FDA 510(k) program must be scrapped. Pre-market clinical testing, post-market registry available to consumers, FDA charter update to give Patient/Consumer stakeholders a vote and rescind medical device industry judicial entitlements (Riegel v Medtronic) will provide for safer and more effective implanted medical devices and a trusted industry that would provide sustainable and ethical jobs that would be a global standard.

biagina said...

Thisis excellent
I endured oneof those haircuts. One good outcome: my tears stopped my daughter from having mesh put in her- all set for amonth later.

I found a great URO GYN who rmeoved the mesh but two tabs (Mentor ARIS). It is 5 months out and I have somepain which the Md thinks is IC.

If itis I think the IC came from themesh as itstarted 2 years after the mesh was put in.

Theindustry lies to good md's; uses those Md's who are only intrested inmoney; and harms and kills innocent menand women.
Kepp up the good work, Lana.

jony parker said...

Thank you very much for this details. I am glad that you that you shared your thoughts on this.

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pelvic mesh lawsuit said...

I'm glad you posted on authorsincognito or I wouldn't have found this. Thanks for taking time.

Anonymous said...

H. My Mom is looking to have this procedure done. She had her consult with the female surgeon, who did use the words "exposure" and she said that the only complication would be some discomfort. So I started reading up on this mesh thing to see what else is being said about it and I came across your site. I will suggest to my Mom to not have the mesh done, but instead to just have herself stitched up - since she has major complications with bowel movement and constant urination due to her collapsed uterus after a histerectomy several years earlier.
Thanks for this post and I am looking to hear others stories about this. It is Pharmageddon out there. This aligns with their "war on cancer"...They feed that war in order to create more meds, more societies and more cures...all the while people are dying while the allopathic doctors swim in money.
Anna (gibinaggiar at yahoo dot com)

Anonymous said...

Very well said! I too have endured the pain of so many surgeries and procedures and am still unable to move without severe pain, I have tried so many medicines that do not take care of this pain adequately. So basically I lay down most of the time - that's the only way I can get relief. Still have more procedures coming. 3 years into this. It is like being put in a prison cell. All this for leaks when I coughed or sneezed! I have had the same classic lies told to me over and over. Accountability, integrity, honesty and just plain compassion need to be put back in style and all the greed that is causing these issues needs to be punished to the full extent of the law. It is criminal what is happening to too many. Thanks for speaking out.

Surgical mesh for stress urinary incontinence said...

I have read many articles about this topic and it was clear that the problems are not minor. Those who are hiding behind statistics, which shows that the surgery has a high success rate, should reconsider their opinions after reading about the many negative experiences presented by patients. Articles like these should be on the first page of any news site, not a formal, medical presentation of the topic. This way, maybe more and more women could understand what the risks really mean.

Anonymous said...

I had my surgery, last year, Feb 15,2011. I complain to my doctor about painful intercourse and being sore, swollen and itchiness. and he told me because of my age and menopause. Yeah right! I also have problems walking, I have back pain,pain in lower stomach and down my legs. I also can't stand uprightright away after sitting because it hurts in my lower stomach and tops of my legs. After doing some reading and talking to a lawyer I fould out it is from my mesh implant. Right now I am looking for a doctor in the pittsburgh pa area. My email address is mommalove2009@yahoo.com

El said...

Many doctors are PODs aka Physician Owned Distributors. During FDA clinical trials the device makers bribe the doctors by making them distributors.

Let's be honest, most doctors are money grubbers who place their vulgar greed above patient safety.

These repairs can be made better without the mesh and doctors know this.

J Dalrymple said...

Hi Lana, I just stumbled across your website and blog. I am writing from Vancouver Canada. My sister has a similiar TVT horror story and i am in the process of trying to get her help as the physicians here just keep prescribing her more drugs, antidepressants, opiates, sleeping pills and nothing is stopping the source of the pain. She had her surgery done in Nov 2008. After reading your blog this infuriates me as the risks were already evident but she was NEVER warned of them and trusted her doctor. Her mesh was infected with staph and had to be removed. They did not get all of the infected mesh. She went on for a year of fighting this infection, multiple exploratory surgeries and iv antibiotics. They finally did a very invasive surgery and got the last of the mesh. She then got an abscess in her pelvis and was septic. The doctors then gave her (41 at the time) a hysterectomy to see if that would help. No chance, she is left with a bladder that does not work so she has to self catheterize, severe chronic pain which has robbed her of her career as a director and a mother of three children. She has been hospitalized twice for depression and cannot function on a daily basis without assistance from friends. Help! We are trying to find anyone Canada or US that can help ease her pain so her quality of life can increase. We are willing to travel and talk to anyone able to help. If you have any ideas I would greatly appreciate them. Thank you so much for all of the hard work you have done for this cause i only pray it will help save future women from this devastating outcome.

Amy said...

Hi, Lana. Thank you for this blog. A minor comment first - the black background with white print is really hard to read! Just saying. Because there's important information here. But also mainly, my question - what are the alternatives? I've got what is beginning to be fairly problematic uterine prolapse. My gyn, bless her, has not jumped to surgery but now I'm getting to where I really need something to be done to correct this. I don't want to have this problematic procedure!!! What else can I do? My gyn give me an estrogen cream to use, and tells me to do kegels. But after several years, it's getting worse. Are there any good alternatives to treat this problem definitively?
Thank you so much for all you are doing.
Amy

Anonymous said...

I HAD THE TRANSVAGINAL MESH DONE IN 4/09. I WAS FINE FOR 3 MONTHS THEN THE SAME BLADDER LEAKAGE STARTED AGAIN. BY THE TIME I WENT BACK TO UROLOGIST THE MESH HAD ADHERED ITSELF TO MY BLADDER AND GROWN OVER THE URETHRA. THE DOCTOR COULDN'T EVEN PUT IN A CATHETER WHEN I WENT IN FOR A SURGERY ON MY HAND. THIS IS HOW I FOUND OUT ABOUT THE ERROSION AND ADHESION PROBLEM. I WENT TO MY GYNO AND HE RECOMMENED THE URO/GYNO DEPT AT CLEVELAND CLINIC, WESTON. I WENT AND DECIDED TO HAVE THE MESH REMOVED FROM THE URETHRA AS IT COULD CAUSE CYSTS, GROWTHS, PAIN, ETC. I WAS PUT UNDER ANESTHESIA AND THE ENTIRE MESH BLOCKING THE URETHRA WAS REMOVED EXCEPT FOR A TEENY PIECE. I CANNOT HAVE THE MESH REMOVED FROM THE BLADDER AS IT IS A MAJOR RECONSTRUCTIVE SURGERY WITH MANY MONTHS OF RECOVERY AND SINCE I HAVE NO SYMPTOMS FROM THIS MESH ADHESION/ERROSION TO THE BLADDER ITSELF I WON'T AND CAN'T PUT MYSELF THROUGH THIS TYPE OF PROCEDURE AND MY SURGEON AGREES. I STILL HAVE THE SAME LEAKAGE PROBLEMS AND THERE REALLY ISN'T ANYTHING LEFT THEY CAN DO FOR ME. BUT, AT LEAST THE URETHRA IS CLEAR. I SEE MY SURGEON EVERY SIX MONTHS FOR AN EVALUATION. ANYONE OUT THERE THINKING OF HAVE THE MESH DONE - DON'T EVEN THINK ABOUT IT. THIS IS DEFINATELY A MANUFACTURING PROBLEM AND EITHER THE DOCTOR KNOWS THE PROBLEMS THAT OCCUR WITH THIS PROCEDURE AND CHOOSE TO IGNORE THEM AND DO THE MESH ANYWAY OR ARE IGNORNANT OF THE COMPLICATIONS IT CAUSES AFTERWARDS. IT IS SOMETHING I JUST HAVE TO LIVE WITH FOR THE REST OF MY LIFE.