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Suffering in Silence From A Medical Device - Surgical Mesh (Part 3)

Posted by Jane Akre
Tuesday, April 28, 2009 11:59 PM EST
Category: Major Medical, Protecting Your Family
Tags: TVT, Ethicon, Johnson & Johnson, Women's Health, Incontinence, Prolapse, Hernia, Medical Devices, Riegel

Ethicon is the producer of the TVT vaginal mesh for urinary incontinence, considered the gold standard of mesh commonly used.  

LEARN MORE

IMAGE SOURCE:  Ethicon Web site 

Background: About 13 million American women experience stress urinary incontinence (SUI), a leaking of urine during moments of physical stress that can include coughing or laughter.   Suzanne McClain of Maben, Mississippi  went to her doctor with the problem in 2004. He assured her he had an easy fix.   

“He told me it was the most wonderful thing invented,” McClain says, “and that I’d never have this problem again.”  Readers of Suffering in Silence- Part 1 and Suffering in Silence- Part 2 have reported a myriad of complications with nowhere to turn. Here in Part 3, the experts weigh in.  

Suffering in Silence

43-year-old Suzanne McCain’s doctor recommended outpatient surgery to support weakened muscles and support the bladder. He would implant a sling, made by Ethicon, made from a synthetic mesh material roughly the size and shape of a ribbon, placed under the urethra and the bladder. 

Ethicon says its TVT tension-free vaginal tape procedure has been the preferred treatment for female stress urinary incontinence (SUI) since 1995 and is now considered by many to be the “gold standard” procedure because of its simplicity“ and excellent long-term efficacy.”

In fact Ethicon claims a 84 to 95 percent success rate among the one million procedures using TVT.   

“It’s the most studied vaginal sling on the market for the treatment of female stress urinary incontinence,” says Jackie Jankewicz, of the Ethicon division of Johnson & Johnson located in Somerville, New Jersey.

And it’s profitable too.  Ethicon’s first quarter of 2009 reports earnings of meshes and bio-surgical helped drive Ethicon to double digit growth.

FDA Warning

The FDA issued an unusual Public Health Notification on October 20, 2008: "Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence” and said it had received over 1,000 reports from nine surgical mesh manufacturers of complications.

In some cases, the mesh had traveled in the body and perforated the bowel, bladder, and blood vessels, leading to infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.

Doctors were told to tell patients that ‘implantation of surgical mesh is permanent” and additional surgery may be needed. Patients with problems should report them to the FDA’s Adverse Event Reporting System online.

Suzanne McClain knows the mesh is permanent. In July 2008, her new doctor, a urogynecologist, confirmed the mesh had eroded through her vaginal wall. One month later she had surgery to extract about one-third of the mesh medical device.  The rest had to be left behind. To remove it was too dangerous. 

Interestingly, the FDA does not say whether it accessed its own MAUDE database (Manufacturer and User Facility Device Experience database) of adverse events or problems that is set up for patients, doctors, or institutions to report their personal experience with a medical device.

If it had, the database would have shown an additional nearly 1,000 adverse reports, including several deaths.   


The Experts Weigh In

Dr. Larissa Rodriguez extracts mesh and says there are more complications than reported.

Dr. Larissa Rodriguez- UCLA Health

 

Surgical mesh that is synthetic appears to have inherent problems when it is used for treatment in the body ini some individuals.
Surgical mesh, Nylon 66 top left, IVS top right, Soarc bottom left, TVT bottom right/ Int. Urogynecol J. 2003,
Web image 

 

Dr. Miller extracts hernia mesh that has traveled in the body and caused harm.

Dr. Richard Miller - Vanderbilt University faculty image 

 

Dr. Larissa Rodriguez believes the numbers are underreported.

She should know. At the University of California, Los Angeles School of Medicine, Department of Urology, Dr. Rodriguez deals with the complications of vaginal slings made of mesh.  

Dr. Rodriguez, who reviewed 28 published series on slings, finds complications include bowel perforations, nerve injuries, vascular injuries, bladder perforations, bleeding, and abscesses requiring drainage.

“Devastating complications involving urethral and bladder perforations can present with mild urinary symptoms and are likely under-diagnosed and under-reported” she writes in her 2007 article in Neurology and Urodynamics.

“A major problem is the lack of a national registry for all slings performed in the United States and therefore we lack a true denominator in determining the incidence.” 

The huge discrepancy becomes clear when you look at the literature and compare it to the FDA’s database of adverse events (MAUDE). 

“There are four times as many major complications in the FDA reports as compared to the literature. In addition, 10 deaths were reported in MAUDE and none in over 11,000 cases in large published series.”

“It can certainly be argued that the denominator for MAUDE may be 20-fold greater than the 11,000 + cases included in our analysis of the literature. Unfortunately it is the literature that most doctors look at when gathering information on complications.”

“The under-reporting of major complications of sling procedures is likely a result of surgeon experience, referral patterns and failure to diagnose.” She urges more awareness about the nature and symptoms of tape-related complications for prompt diagnosis and appropriate postoperative management. 

She concludes that “Stress urinary incontinence has emerged as a highly prevalent medical condition and, as such, has created a large and competitive marketplace for new age, commercially available slings."

Dr. Richard Miller

Dr. Richard Miller is a Professor of Surgery, Medical Director, Trauma Intensive Care Unit, Division of Trauma and Surgical Critical Care at Vanderbilt University Medical Center inNashville, Tennessee.

He sees abdominal wall hernia repair patients after they’ve had complications with synthetic mesh, some made out of Gortex or Marlex.  

“The problem with synthetic mesh is as a foreign body the body tries to reject it and encapsulate it.   You can bathe it in antibiotics, but the bottom line is that has to be removed and start over again. Because it’s a foreign body you have to be a lifelong risk" he tells IB News.

The key to minimizing that risk, Miller believes, is in patient selection. 

“Smoking is the worst. I will not operate on a patient who continues to smoke.  Diabetes, obesity, malnutrition, all increase the risk of wound infections. I don’t use synthetic mesh in any of those patients,” he says.  Even prior infections increase the risk of a bad outcome.

“It never made sense to put a foreign body in a person to repair abdominal wall reconstructions.  “Synthetic mesh, they never feel the same,” he says noting that Ethicon worked hard to create a material that didn’t have an inflammatory reaction.

For the patients who Miller rejects, a cadaver or pig skin mesh is a better alternative. But there’s the cost. “Synthetic may cost $1,000 to $10,000 for biologic mesh. Hospitals decide what material to use based on cost efficiency,” he says.

Dr. Miller says hernia repair complications can occur in up to 40 percent of patients, based on his experience that he admits is a “skewed group, obviously”. 

“They can erode into the bowel, that’s a half million dollar problem. They can erode through the abdominal wall and into the skin.  I’ve seen a couple of circumstances when you remove the synthetic mesh the symptoms resolve.  And many do fine.”

Miller too encourages the establishment of a national database to support his theory of patient selection. Over the next decade he predicts that biologic mesh material will be refined to form a scaffold that incorporates the body’s own tissue and allows it to incorporate immediately.

“My goal is to help these patients and a lot have huge problems. I’m not here to bash synthetic mesh but in certain subgroups there is a better alternative. Certainly, absolutely, they should not be used."

Dr. Denniz Zolnoun

 

Dr. Zelnoun tries pain blocks to help women who have been hurt by surgical mesh.

Dr. Denniz Zelnoun- UNC Healthcare 

 

Dr. Zelnoun is an assistant professor at the University of North Carolina, Chapel Hill in the Department of Obstetrics & Gynecology, division of Advanced Larascopy & Pelvic Pain. 

She says her job has become “damage control,” and she’s seeing so many new cases in the last six to seven months that their intake form has added a new category,  “post-mesh pain”.

Dr. Zelnoun believes pre-packaged mesh kits are leading to the problem.  The prevalence of kits means doctors are not measuring according to the anatomy of the patient, she says.

For women suffering post-mesh pain, many are suffering scarring and nerve injury. Frequently women are written off as suffering from marital discord.

“In order to solve the puzzle you have to first acknowledge it” Dr. Zelnoun says to IB News

“But part of the problem is that neurologists don’t often understand a woman’s pelvic region, and gynecologists are often unfamiliar with nerve and mechanical sources of pain.”

UNC is working on nerve blocks to help with the pain, which may be caused by direct injury or by one nerve irritating another in the proximity of the spinal cord. The field has many mysteries and when you combine that with patients who have been convinced that their pain may be psychological or due to marital problems, you have what Dr. Zelnoun calls a “Conspiracy of Silence” that keeps the problem and solution from the forefront.

(Continue reading:  Suffering in Silence- Part 4- Lana Keaton, founder Truth in Medicine)  #


11 Comments

Posted by Sherrie Palm
Wednesday, April 29, 2009 11:46 AM EST

I am always so happy to see continuing education for women in regards to prolapse issues. There are so many problems that women face with the different types of prolapse and it is such a hush-hush scenario most of the time.
A book I have recently written about pelvic organ prolapse also addresses the many faceted issues of prolapse; I feel so strongly that all women should be aware of this condition so when they start to have symptoms, whether with bladder leakage or any of the many other symptoms like fecal incontinence, pain, or sexual dysfunction, they are aware of what may be occurring and seek help before the condition progresses to a stage needing radical treatment. It is imperative to research procedures you will have performed, also finding the correct type of surgeon is huge. The title of my book is
"Pelvic Organ Prolapse, The Silent Epidemic"
and information is available at the website below. I'd be very happy to share my views on this topic with anyone interested.

Sherrie Palm

LINK

Posted by Jane Akre
Wednesday, April 29, 2009 12:30 PM EST

Sherrie-

Thank you for writing. Please visit part 1 and 2 of our stories on surgical mesh and see if the findings echo what you have found.

Patients with mesh told me they had no idea and found little information on the side effects (outside of industry literature) before they had their mesh implanted - so it's good to know you have been writing and researching the topic.

Can you tell us where to find your book? Are excerpts available? Thank you.

Anonymous User
Posted by Suzanne McClain
Wednesday, April 29, 2009 5:17 PM EST

To all wishing to conduct their own search of the MAUDE Database, (link below) below is the criteria I used to obtain the maximum number of adverse events on file for Ethicon’s Gynecare Tension Free family of mesh products. There are currently 1273 adverse on file in regards to this one companies Tension Free Mesh products. The database will only load 500 records at a time, therefore, multiple searches will need to be conducted, changing the date range to account for them all.

MAUDE DATABASE LINK: (Copy and paste into your browser if necessary)

LINK

Criteria:

1.) Product Class: Mesh, Surgical, Polymeric (You will have to scroll through the M’s to find this phrase.)

2.) Brand Name: Tension Free

3.) Date Report Received by the FDA: (Date Range) 05/12/1999 to Current Date.

(I used 05/12/1999 as the beginning date, because this is the date the first adverse event was recorded in regards to Gynecare’s TVT)

4.) Records Per Report Page: Change to 500 and click Search.

This will pull the most current 500 records dated between 01/06/2006 - 03/20/2009.

Using the same criteria, with the exception of the date range, you will then need to do an additional search using the date range 05/12/1999 to 01/06/2006 to pull up the next 500 adverse events on file.

(I used the same ending date, as there may be more than the number of adverse events listed on page one for any particular day.)

Within this second date range, you will see that a new manufacturer, MEDSCAND MEDICAL AB is listed. These records should also be included with Ethicon’s adverse events, as Ethicon launched this product on the market in 1997, and later acquired this device from MEDSCAND in 2000. Please see: LINK

The last date range you will need to use is: 05/12/1999 to 09/06/2001, which will pull up the remaining (first block) adverse events on file in reference to Ethicon’s Mesh Products.

To date, there are twelve hundred seventy three (1273) adverse events on file in regards to the Ethicon family of mesh products with the FDA, including my own. Before my problems arose, I had never even heard of the MAUDE Database. When I began researching this product, I was appalled to find that the MAUDE Database, maintained by a government agency is not a uniform database. One must conduct multiple searches, decreasing the amount of information you provide, in order to find the maximum number of adverse events. In order to do this effectively, one must be fairly good at research.

** Please note - Providing too much information, (i.e. the Manufacturer’s name, the FDA K- number, etc...) will limit the number of results you can retrieve.

Anonymous User
Posted by Suzanne McClain
Thursday, April 30, 2009 12:24 AM EST

On July 29, 2008, I received this generic type email response from MedWatch, a division of the FDA, after I filed a follow-up report to my initial adverse event report from mid-July, 2008.

Please pay CLOSE ATTENTION to what paragraph 3 states! As I see it, this isn't happening! I am of the opinion that the FDA's Public Health Notice of October 20, 2008 was put out to try to cover their behinds. Until they take this garbage off the market, no one is safe!

From: medwatchcomments@cder.fda.gov
To: editwrtr@...
Subject: Thank you for your submission
Date: Tue, 29 Jul 2008 10:03:13 +0000

Dear Reporter:

Thank you for submitting your report to MedWatch, The FDA Safety Information and Adverse Event Reporting Program. This acknowledgement confirms that your report was received.

Reports are added to a postmarketing safety database with similar reports and reviewed by the FDA’s postmarketing safety staff. Voluntary reports are essential for ensuring the continued safety of FDA-regulated products.

One or two well-documented case reports may provide an early signal of unexpected problems and lead to additional evaluation. This may result in FDA regulatory actions that improve the safety of the products used in patient care each day.

You might be contacted by an FDA staff member if additional information on your report is needed.

Again, thank you for taking the time to submit your report.


Sincerely yours,

MedWatch

--------------------------------------------------------------

Subscribe to the MedWatch E-list, LINK , to receive
e-mail safety alerts about FDA regulated medical products.

Anonymous User
Posted by Suzanne McClain
Thursday, April 30, 2009 12:40 AM EST

Letter I wrote on September 9th. and emailed to Medwatch on September 10, 2008 to inquire as to the status of the "One or two well-documented case reports...)

I do not believe I ever got a response to this period! No email for certain, and I see nothing that came via USPS either to address this. Nor did I receive the documents I requested, that are public record under the Federal Disclosure Act.

I think the FDA "Hears no Evil, See's no Evil, and Speaks no Evil" in regards to their culpability for the harm done to thousands of us. Do they really think we are going to go away?

From: editwrtr@...
To: medwatchcomments@cder.fda.gov
Cc: editwrtr@...
Subject: "One or two well-documented case reports. . .
Date: Wed, 10 Sep 2008 04:49:06 +0000

September 9, 2008

Medwatch:

Your recent email to me of July 29, 2008 specifically states that "One or two well-documented case reports may provide an early signal of unexpected problems and lead to additional evaluation. This may result in FDA regulatory actions that improve the safety of the products used in patient care each day." I am fully aware of dozens of reports being filed with you regarding the Gynecare TVT Device, model/catalog number 810041B, and polypropylene surgical meshes in general, yet there is no indication that anything is being done about it. How many more people must be harmed by these types of devices, before you take us seriously?

My life has been destroyed by this product, and because the pharmaceutical companies appear to be in bed with the Supreme Court Justices, (ruling of February 20, 2008) I have no recourse to hold anyone accountable. I am an AMERICAN CITIZEN, harmed by a device that the FDA deemed as safe many years ago, and still deems as a safe product today; all the while knowing that patients have been filing, and are still filing adverse event reports saying how they were harmed by this and other polypropylene products.

It doesn't take a rocket scientist to figure out that a medical device, made of polypropylene, a very abrasive fabric, having holes throughout, so that tissues can intertwine within the fabric, implanted in the human body would erode away healthy tissues. My doctor showed me a Gynecare TVT sling the last time I was in his office, and when he pulled on the end pieces, many small pieces of the mesh were falling onto his table top. He then wrapped it around his finger and rubbed it on my hand. This is a very abrasive material. He said that he has treated men who have racing strips on their penises from being scratched by this device, after having intercourse with a woman who is experiencing erosion through the vaginal wall. This device mimics a cheese grater.

Tell me, do you REALLY believe this is safe? I imagine, had it been your wife, mother, grandmother, sister or daughter harmed by this device, heads would already have been rolling. So, please, send them all out to have this procedure done immediately, so that when they start experiencing complications, those of us who have already been harmed can get some relief in the form of a recall!

It is your responsibility to keep victims to a minimum, and each day that this product stays on the market, more women are subjected to vaginal erosion, bladder erosion, and nerve damage. I urge you, please take your responsibility seriously, and remove this product from the market. For that matter, if you were to remove all surgical mesh devices made of polypropylene from the market, you would be doing a world of justice, as these devices all seem to share the same characteristics when implanted in the human body.

Under the federal disclosure act, I would like copies of the clinical studies, if any, that were performed using this device prior to FDA approval, and any other documents and/or letters the FDA has pertaining to this device.

Respectfully yours,

Suzanne McClain
editwrtr@ ...

---------- Original message from medwatchcomments@cder.fda.gov: --------------

Anonymous User
Posted by teresa hughes
Thursday, April 30, 2009 8:55 PM EST

i commend suzanne for her hard work in trying to get this mesh of the market this is a barbaric operation and should not be allowed to still be ongoing. it is about time someone stood up and took accountability for the damage which has been done to our bodies. i am in the united kingdom and i am trying also to have investigations into this tvt sling. the petition is on the number 10 downing street web site teresahughestvtslingmisery.

if all of you out there who read this article and know anyone in the united kingdom please ask them to sign up to this petition as we need to get this petition to Parliament in England also.

to all of you who are suffering like myself also lots of love and keep this campaign going.

teresa hughes united kingdom england

Anonymous User
Posted by teresa hughes
Thursday, April 30, 2009 8:55 PM EST

i commend suzanne for her hard work in trying to get this mesh of the market this is a barbaric operation and should not be allowed to still be ongoing. it is about time someone stood up and took accountability for the damage which has been done to our bodies. i am in the united kingdom and i am trying also to have investigations into this tvt sling. the petition is on the number 10 downing street web site teresahughestvtslingmisery.

if all of you out there who read this article and know anyone in the united kingdom please ask them to sign up to this petition as we need to get this petition to Parliament in England also.

to all of you who are suffering like myself also lots of love and keep this campaign going.

teresa hughes united kingdom england

Posted by Jane Akre
Tuesday, May 05, 2009 9:51 AM EST

We are continuing with this series in Part 4. Lana Keeton has heard from hundreds of people who believe they too were injured by synthetic surgical mesh.

LINK

Anonymous User
Posted by Dana
Tuesday, May 05, 2009 2:53 PM EST

I would also like to commend Suzanne on all the work she has done. I know you have opened the eyes of many people who have read these articles. Your compassion for others and your amazing ability to stand up for the things that you belive in are evident in your letters and comments. Keep up the good work!

Anonymous User
Posted by Naomi
Tuesday, May 19, 2009 8:51 PM EST

I would like to thank Jane Akre for telling Suzanne's story. She is an amazing woman. I cannot imagine the trauma she has been through...all from an "FDA Approved" product. This series has truly opened my eyes to the governmental approval process and I will definitely do my research when I have to make any decision related to products approved by the FDA.

Anonymous User
Posted by Krystil
Monday, June 01, 2009 1:51 AM EST

Thank you Dr. Richard Miller for telling the true colors of the corporate world of surgical healthcare. "...Hospitals decide what material to use based on cost efficiency." This pretty much sums up what is wrong with healthcare today - it is no longer about caring about what is best for the patient it is all about caring about the bottom line.

Comments for this article are closed.

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