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Suffering In Silence From A Medical Device - Surgical Mesh (Part 4)

Posted by Jane Akre
Monday, May 04, 2009 11:52 PM EST
Category: Major Medical, Protecting Your Family
Tags: TVT, Ethicon, Johnson & Johnson, Prolapse, Hernia, Incontinence, Federal Preemption, Tort Reform, Surgical Mesh

Lana Keeton is heading a patient advocacy group for individuals injured by synthetic surgical mesh.
Lana Keeton

Lana Keeton - Not Suffering in Silence

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Synthetic surgical mesh is made by nine companies.
Surgical mesh, Nylon 66 top left, IVS top right, Soarc bottom left, TVT bottom right/ Int. Urogynecol J. 2003,
Web image 

Lana Keeton wants a Congressional hearing to remove synthetic surgical mesh from the market.
Lana Keeton and friends

IMAGE SOURCE:  Lana Keeton/ Courtesy Lana Keeton 

 

“Don’t call me a victim,” says Lana Keeton, of the advocacy group Truth in Medicine in an e-mail.

“And don’t say I’m suffering in silence,” she tells IB News.

And that is Lana Keeton.

The 61-year-old Miami Beach resident, sometimes steel broker, sometimes actress and tough talking former Texan knows who she is not and doesn’t mind telling you.

What she is, is a patient advocate for hundreds of people who claim their lives have been ruined by the implantation of synthetic surgical mesh to repair hernias, and to treat stress urinary incontinence (SUI), or pelvic organ prolapse (POP). 

Ethicon, a division of Johnson & Johnson, is the maker of the trademark Prolene polypropylene mesh, one of the more widely used petroleum-based synthetic surgical mesh tapes for bladder suspension. Ethicon boasts one million procedures have been done with the TVT tension-free tape with a one percent complication rate.  

While doctors who try to extract mesh report a 30-to-40 percent complication rate (Suffering in Silence - Part 3), Ethicon claims an 84 to 95 percent cure rate for incontinence from the “safe and minimally invasive” procedure most doctors promise they can do in their office.

Keeton has become an online magnet for the thousands who say their surgery was anything but.

They contact her online through her patient advocacy blog and her medical mesh discussion site. Some are men trying to help their wives.

  • “My wife had a TVT put in last May and has had pain since. We’ve been through a number of doctors, MRI, EMGs, etc that all show nothing, with the doctors basically shrugging their shoulders at us and handing out pain meds or blaming it on a back problem that she doesn’t have. Any guidance would be appreciated.”


Some men question their own hernia repair with synthetic or polypropylene, a petroleum-based, synthetic surgical mesh.

  • “The decision to have this done was unquestionably the worst decision I have ever made in my life. Almost immediately I knew something was wrong. Eventually my whole pelvic area feels like it is on fire. This is now how I am 24/7.”
     
  • “I am a 45 year old mom of 4 and 2 beautiful grandchildren, my life is ruined.”

  • “My mother had surgery in January to remove prolene mesh that was eroding her insides (that was a gross oversimplification, but it's a good place to start).  Today she has still not recovered from her surgery.  This is the first time I sat down to research the product and your article.” 

“Americans believe in the system, in the doctor, in the FDA, in their hospital. They believe it but they are betrayed by the system every single day.   So that’s the long and short of it. They are used as guinea pigs and operated on.  Like hysterectomies were the surgery du jour, mesh is now the surgery du jour,” Keeton believes. 

More than 1,000 people have visited her blog since July 2007, she says, many asking for help. Almost universally their doctors say they’ve never seen this complication.

“See the trend?” Keeton asks.  “See why I am so adamant there are thousands and thousands of injured people. I am just one person. They are answering blogs from two years ago. If there was someone out there currently helping, it would be at the top of the search engines. Help is not out there for these people desperately searching the internet to find help that should be available through the healthcare system. The system has failed them miserably.” 

Instead of the industry’s glowing success stories, Keeton agrees the complication rate is more like 30 to 40 percent with complications that can include death, coma, bladder and bowel perforations, recurrent infections, an inability to walk, back pain, and allergies, among others. 

Last October, her group was behind an acknowledgement from the FDA. In a Public Health Notification, the agency encouraged doctors to receive more training and for the public to be aware that the permanent medical device is responsible for 1,000 adverse events and 10 deaths linked to peforated bowels and strangled organs.  

Often patients find out years later, after an exhaustive search to correct mysterious symptoms, that they even have the mesh. 

Lana Keeton says she’s spent more than 3,000 hours researching surgical mesh. Her advocacy is a natural outgrowth of having suffered from having mesh implanted in herself. In preparation for a hysterectomy in December 2001, she mentioned to her doctor she also had incontinence.

“He said there’s a new tape you’ll really like it.  Because he was the head of gynecology at Mt. Sinai Medical Center in Miami Beach, I didin't question him. I didn’t know what he was going to put in me.”

The doctor sent her home after surgery implanting the Ethicon, TVT Prolene polypropylene mesh with a soft tissue infection eating her flesh that turned her body purple and red from her knee to her left armpit.

36-hours after she was released from a Mt. Sinai Medical Center, a neighbor left a Christmas Eve dinner to drive her to the emergency room of another hospital, Jackson Memorial, where he was a resident.

“When they finally admitted me at Jackson, four or five doctors walked in, took one look at me and without discussion told the nurses, 'Prepare her for surgery'," she says.  

Keeton was told there was a 40 to 50 percent chance she would not survive, she might not have any skin on her stomach and there might be multiple surgeries to follow. She called her family to say goodbye.  By the next morning she woke up, “and I was shocked I was alive.”

“Here’s this infection on you that can literally eat you alive. That was traumatizing and hard to overcome because you can’t get out of your body. When it’s life or death and you are betrayed by the system you trust, that is the ultimate betrayal.”

She later sued Dr. Bernard Cantor and Mt. Sinai Medical Center for medical negligence. The case is still pending. She filed a separate product liability lawsuit against Gynecare Worldwide, Ethicon Inc and Johnson & Johnson, preparing her own case. Along the way she discovered the mesh package insert says the Prolene mesh may have to be removed because it can "potentiate an infection".  

“It’s a breeding ground for infection.   That’s why the people have repeated infections because the mesh is in there and it’s a breeding ground.” She says she started finding hundreds of people talking to each other online.

“I was stunned. I couldn’t believe what I was reading. I was standing in middle of my living room in August 2007. I realized that's what God wants me to do, to help those people and to get synthetic surgical mesh off the market so this never happens to anyone else again.”

That’s when the online discussion groups and the foundation for her advocacy group Truth in Medicine were born.

Steel Broker

Keeton’s background selling steel to metal building manufacturers allowed her to understand the qualities of surgical mesh.  A one-inch piece of mesh has chemical and physical properties similar to a one inch piece of steel.  

"When you slit steel from a 48,000" coil into 1 ' strips, you release the tension in the coil and can create camber, or wavy edges, in the 1 ' strip. The same holds true for synthetic surgical mesh. When itis cut from a sheet into a strip, or from any size to any other size, tension is released and the edges are deformed" she says. 

"Think about cutting a piece of fabric. After it is cut, it may or may not lay flat, depending on whether you cut it with or against the grain, what kind of fabric it is and where you use it. Also, if you use really good scissors, the edge should be clean. Use poorly maintained scissors and chances are the edge will be imperfect."

"The edges of the mesh are the problem," Keeton continues. "When you implant the mesh into the human body it can become a cutting edge. Add bodily fluids and it can harden, shrink and/or move. It's not a pretty picture.

“Every single time a piece of mesh is implanted into someone it’s a different doctor, a different type of mesh, different type of cutting in a different type of body. Iit's Russian roulette what the outcome will be. Nobody is thinking about this,” she says.

In 2003, Keeton had to declare bankruptcy losing her hard-earned American dream, a beautiful Miami Beach condo and lush lifestyle supported by a $15,000-$25,000 a month salary because she was unable to work for months following the December 2001 surgery.

National Registry

The purpose ultimately of Truth in Medicine is to stop the marketing and implantation of synthetic surgical mesh.  Information collected on an international user-friendly registry would be passed onto Congress to accomplish that goal. 

As it stands now, the injured have to find the FDA’s MAUDE database (Manufacturer and User Facility Device Experience Database) and understand the criteria to enter to pull up injuries resulting from your mesh. It can be intimidating, and if they are involved in litigation are generally advised not to enter information.

For example, in the case of Suzanne McClain (Suffering in Silence- Part 1) finding data on Ethicon’s Gynecare Tension Free family of mesh products involves knowing the 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.

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

Surgeons who remove surgical mesh (Suffering in Silence-- Part 3) also support a registry to get some idea of the big picture of complications of synthetic surgical mesh.   


Riegel

Keeton says she also wants to educate lawyers who are reluctant to represent people injured by a medical device because of the February 2008 Riegel v. Medtronic Supreme Court decision which provides a shield of immunity to device makers under the concept of federal preemption.

The Riegel decision concerns medical devices that went through premarket approval (PMA). Most devices, such as Class I and Class II (surgical mesh) were marketed after the FDA found them to be “substantially equivalent” to those devices already on the market before the Medical Device Amendments of 1976.

Keeton says Riegel never applied to surgical mesh, because it, like the bulk of Class I and Class II medical devices, never faced the more rigorous premarket approval (PMA). And the Supreme Court ruled in 1996 (Medtronic, Inc. v. Lohr) that the less stringent 510 (k) approval process does not pre-empt a state lawsuit if the device had been approved in that manner.  

Besides stopping the implantation of all petroleum-based synthetic medical/surgical meshes in humans with the help of Congress, Truth in Medicine is focused on:

* Requiring changes in surgical consent forms regarding implantable foreign bodies to include: the name of the implantable; whether it was a Pre Market Approval or Pre Market Notification 510(k) product; results of clinical trials, if any; and all known risks and complications. Many patients suffering complications are surprised to find out they have mesh.

* Providing patients, upon discharge, with adverse event reports that they could directly send to FDA if necessary. Information about the implantable would already be filled in by the hospital.

* To set up a Superfund by taxing all Pharmaceutical Companies to help those harmed by surgical meshes, which would alleviate the need for some patients to sue.

Above all, Keeton says, "The most important thing we do is to educate people, help people get well, to find a doctor and find moral support and help them get their lives back together,” she says.

Meanwhile, Keeton is scheduled for more surgery to have surgical mesh removed from in and around her already surgically-reduced bladder, sort of like taking gum out of hair, she says but adds, “I am truly blessed that I have this purpose, what I am happy about is that God chose me and he’s using me.  What more is there in life than to know you are serving God's purpose for you? " 

Her favorite saying is, saying,” Poco a Poco, se va lejos” –  Little by little one goes far.”

##

Last January in a report to Congress, the GAO found that 25 of the most potentially dangerous medical devices that fall under Class III, had never undergone premarket approval, even though they were being used around and in patients.

The FDA announced plans in April to require the makers of these outstanding devices to submit safety and effectiveness information on devices such as implantable pacemaker pulse generators, ventricular bypass assist devices, and hip joint metal.   

Synthetic surgical mesh is not scheduled for review.  #


9 Comments

Posted by Wayne Parsons
Tuesday, May 05, 2009 5:09 AM EST

Jane: your articles are a great primer on surgical mesh cases and the tort reform that protects these manufacturers. I also blogged on this subject: FDA Warns About Surgical Mesh Used for Pelvic Organ Prolapse and Stress Urinary Incontinence - LINK

Posted by Jane Akre
Tuesday, May 05, 2009 9:47 AM EST

Thank you Wayne-

We have even heard from one of the FDA insiders who complained to the incoming Obama administration that the medical device area of the FDA was broken because the tail, the manufacturers, was wagging the agency.

All this at a time when the Riegel decision makes it unlikely someone will take these cases. Lana appears to be correct that Riegel does not apply to mesh because as a Class II device, it never received FDA approval. Any thoughts?

Posted by Jane Akre
Tuesday, May 05, 2009 10:36 PM EST

The New York Times apparently is trying to catch up to IB News (it could happen!!)

See their story today-


Woman sues over mesh- NYT
LINK

Anonymous User
Posted by Donna
Wednesday, May 06, 2009 10:09 PM EST

Jane, thank you for your article.

Suzanne and Lana, keep on working to make the public aware of this dangerous device. It needs to be removed from the market before more people are harmed. I saw the NYTimes article today. Obviously, the ramifications of the sling have harmed more than a few. I hope that by bringing this to the public's attention more people will be spared this appalling medical fiasco.

Donna

Posted by Jane Akre
Wednesday, May 06, 2009 11:55 PM EST

Donna thank you-

It seems ridiculous in doing the research for this medical device, that no national registry exists that is user-friendly in light of the complications that even urogynecologists say troubling.

Sometimes you have to wonder what is going on!

Posted by Lana Keeton
Sunday, May 10, 2009 12:30 AM EST

SAVE THE DATE!! MORE DETAILS COMING SOON!!

TRUTH IN MEDICINE
FIRST ANNUAL CONFERENCE
FRIDAY AND SATURDAY, SEPTEMBER 25-26, 2009
FT. LAUDERDALE, FL
USA

OUR FABULOUS SPEAKERS:

DR. DIANA ZUCKERMAN, PRESIDENT
NATIONAL RESEARCH CENTER FOR WOMEN & FAMILIES

NANCY MULLER, EXECUTIVE DIRECTOR
NATIONAL ASSOCIATION FOR CONTINENCE

DR. G. WILLY DAVILA, CHAIRMAN OF THE DEPT OF GYNECOLOGY, HEAD OF UROGYNECOLOGY & RECONSTRUCTIVE PELVIC SURGERY
CLEVELAND CLINIC WESTON, WESTON, FL

DR. RICHARD MILLER, PROFESSOR OF SURGERY,
MEDICAL DIRECTOR, TRAUMA INTENSIVE CARE UNIT,
DIV OF TRAUMA AND SURGICAL CRITICAL CARE
VANDERBILT UNIVESITY MEDCIAL CENTER
NASHVILLE, TENNESSEE

Unofficial Events for the Conference:

A MEET AND GREET COCKTAIL PARTY on Thursday, September 24, 2009

WORSHIP SERVICE followed by BRUNCH ON SUNDAY, September 27, 2009!

HOPE YOU WILL BE ABLE TO ATTEND ALL THE EVENTS!!!

I REALLY LOOK FORWARD TO MEETING ALL MY WONDERFUL MESHIE FRIENDS!!:):)

GOD BLESS, LANA

LANA KEETON
FOUNDER and PRESIDENT
TRUTH IN MEDICINE INCORPORATED
1521 ALTON ROAD,#198
MIAMI BEACH, FL 33139

truthinmedicine @bellsouth .net

www. truthinmedicine. us. com
www. lanakeeton. com
www. theladyisachamp. blogspot.com

Posted by Lana Keeton
Sunday, May 10, 2009 12:41 AM EST

ALL MESHED UP?

HELP ME AND THOUSANDS OF OTHERS WHOSE LIVES HAVE BEEN DESTROYED BY THE COMPLICATIONS OF SYNTHETIC SURGICAL MESH.....

KICK SOME FARMACEUTICAL FANNY!

Go to www. truthinmedicine. us. com

REGISTER ON THE WORLDWIDE REGISTRY OF COMPLICATIONS OF SYNTHETIC SURGICAL MESH!!

SOMEBODY'S GOTTA DO IT!

IT'S FOR SURE GOVERNMENT AND THE HEALTH SYSTEM ARE NOT GOING TO DO IT!!

THEY LIVE IN THE ANTIQUATED WORLD OF THE MAUDE DATA BASE....

MANUFACTURER AND USER DATA BASE EXPERIENCE ?

@#!&?^>!@#!&%$#@

THAT'S WHAT I THOUGHT YOU WOULD SAY...

ARE YOU KIDDING ME? WHAT IS THAT? HEAR ANYBODY TALKING ABOUT IT AT THE WATER COOLER? I DON'T THINK SO!

THE TRICK HERE IS THE MANUFACTURER WANTS TO MAKE SURE YOU NEVER HEAR OF IT. WHY IS THAT?

EASY...YOU DON'T REPORT YOUR NEAR DEATH EXPERIENCE, OR HORRIFIC COMPLICATION, FROM THEIR NIFTY ? ? LIFE-SAVING ? ? MEDICAL DEVICE....THEIR DEFECTIVE MEDICAL DEVICES ARE NOT RECALLED.

THEY GO ON TO DESTROY MORE LIVES.....PHYSICALLY, MENTALLY, EMOTIONALLY, FINANCIALLY...

LET'S STOP THAT CYCLE!

LET'S STEP OUTSIDE THE BOX!

REGISTER YOUR COMPLICATIONS AT

WWW. TRUTHINMEDICINE. US. COM!!!

LET'S SHOW EVERYONE THE TRUTH!

JOIN THE TEAM AT TRUTH IN MEDICINE!

LET'S STOP THE USE OF PETROLEUM-BASED SYNTHETIC SURGICAL MESH IN HUMAN BEINGS!!!

LET'S KICK SOME FARMACEUTICAL FANNY!!!

HAVE QUESTIONS? NEED ANSWERS? WE'RE HERE TO HELP!!!

LANA KEETON
FOUNDER & PRESIDENT
TRUTH IN MEDICINE INCORPORATED

truthinmedicine @bellsouth .net

first posted May 5, 2009 at:

www. theladyisachamp. blogspot. com

Posted by Lana Keeton
Sunday, May 10, 2009 12:44 AM EST

Anyone desiring membership in Medical Mesh, please send the following data to miamiblog@ bellsouth. net.

Medical Mesh is a private membership only Yahoo health group.

This information is needed for several reasons:

1)to insure you are legitimately an injured person, not a pharmaceutical employee or an attorney

2) to help you with your specific problems.

When people ask to join Medical Mesh, I send them an e-mail asking them to fill out the application. I have no way of knowing if people actually receive the applications. If you have applied for membership but have not received the application, please send the information below.

I look forward to approving anyone's membership who provides this information.

blessings, Lana Keeton
miamiblog@ bellsouth. net

Link to Yahoo Health Group - Medical Mesh:

http :// health. groups. yahoo. com /group/ medicalmesh

Name:

Date:

Phone Number(s):

E-mail address:

Age/Sex:

Medical Mesh Surgery/Surgeries:

Name of Doctor(s):

Medical Mesh Device(s) Implanted:

Surgical Method of Implantation of Medical Mesh:

Complications of Medical Mesh Implantation:

THERE IS HOPE!! WE WILL HELP YOU TO FIND SOLUTIONS TO THE COMPLICATIONS YOU ARE SUFFERING FROM MESH! GOD BLESS, LANA

Posted by Lana Keeton
Sunday, May 10, 2009 12:53 AM EST

Dear Jane,

Thanks so much for your hard work and dedication to a very important cause, a health crisis of epic proportions no one is even talking about.

You recognized what everybody else did not...this is a BIG STORY! You did an amazing job!

Your coverage of the horrible complications of synthetic surgical mesh will help thousands and thousands of people!!

Thanks again and God bless! Lana

Comments for this article are closed.

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