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

By Jane Akre

Lana Keeton

Lana Keeton - Not Suffering in Silence

LEARN MORE Suffering in Silence- Part 1 Suffering in Silence- Part 2 Suffering in Silence Part 3 Ethicon Web site - Women's Health and Urology Medical Mesh Yahoo - discussion site (requires registering) Lana Keeton Blog Medtronic, Inc. v. Lohr Surgical mesh, Nylon 66 top left, IVS top right, Soarc bottom left, TVT bottom right/ Int. Urogynecol J. 2003, Web image  Truth in Medicine- Web site  Truth in Medicine - Blog  Truth in Medicine - TV story WPLG Miami  National Institutes of Health - on SUI  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, the division of Johnson & Johnson, maker of one of the more popular polypropylene or petroleum-based synthetic mesh tape, the TVT, tension-free tape, or sling as mesh is called, boasts one million procedures have been done 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), the medical literature claims an 84 to 95 percent cure rate for SUI 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 de jour, mesh is the surgery de jour," Keeton believes. 

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 believes the complication rate is more like 18 to 30 percent with symptoms that can include coma, diabetes, bladder perforations, an inability to walk, back pain and allergies. 

Last October, her group was behind an acknowledgement from the FDA. In a Public Health Notice, 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 studying surgical mesh. Her advocacy is a natural outgrowth of being a victim 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 I didn'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 polypropylene mesh. But a soft tissue infection began eating her flesh, and turned her body purple and red from her knee to her left arm.

36-hours after she was released from a Miami hospital, her friend left a Christmas Eve dinner to drive her back to the emergency room of another hospital, Jackson Memorial, where he was a resident.

"I was in the ob-gyn area of the ER and four or five of them looked at me and one said, 'prepare her for surgery',"  she says.

Keeton was told there was a 40 to 50 percent chance she would not survive. She called her family to say goodbye.  By the next morning she work 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, that is the ultimate betrayal."

She later sued her doctor at Mt. Sinai (the case is not yet resolved) preparing her own case. Along the way she discovered the mesh package insert says it 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. I was standing in middle of my living room in August. I said that's what God wants me to do, to help those people 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 for construction, allowed her to understand the qualities of surgical mesh.  A one-inch piece of mesh shares many of the chemical and physical properties of a 100 foot length of steel.

"A fabric cut with the grain you get a nice clean piece, cut it against the salvage it will buckle. Exactly the same thing applies to mesh.   How they cut it matters, they now cut it mechanically. The edges of the mesh are the problem."

And Keeton says when you stretch the mesh in the body improperly it becomes a cutting edge. Add bodily fluids and it can harden and move.

"Every single time a piece of mesh go into someone it's a different doctor, a different type of mesh, different type of cutting in a different type of body. It's impossible to do it correctly, they can't.   Nobody is thinking about this," she says.

Preparing for her lawsuit and disabled, in 2004 she declared bankruptcy, losing her hard-earned American dream - her Miami Beach condo and lush lifestyle supported by her $15,000 to $25,000 a month salary as a steel broker. She was unable to work, to date, do kickboxing, even on some days sit or stand.

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 approval process does not pre-empt a state lawsuit if the device had been "grandfathered" into use.

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.

Besides having surgical mesh recalled, "the most important thing is to 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 serve a purpose?"

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.  #

Originally posted at Jane Akre

Full post as published by InjuryBoard on May 04, 2009 (boomark / email).