Abdominal Sacral Colpopexy: Better, Safer than Transvaginal Mesh for Prolapse?

Smith vs. Johnson & Johnson #11-60624

The Woman Behind the Case Tells Her Story...Part 1

A shocking story of how one woman's death destroys a family only to lead to almost the same fate for one of her daughters....

Deborah Lane Smith talks!

www.meddeviceexpertllc.com

Click Menu Tab: Abdominal Sacarl Colpopexy: Better and Safer than Transvaginal Mesh?

http://www.meddeviceexpertllc.com/abdominalsacralcolpopexybettersaferalternativethantransvaginalmesh.html

PATIENT STAKEHOLDERS INVITED TO THE TABLE LATE BY THE FDA

Although I was honored to receive this invitation from Michelle McMurry-Heath, Acting Chief Scientist of the CDRH at the FDA, I would have been more honored had I received it in a timely manner so I would have been able to be there. This is a serious ongoing problem for all patients.

99.9% of what happens in Washington, D.C. that affects your health and mine happens without any input from patient advocates and patients themselves. And then it is a handful of organizations who have banded together to strengthen our position.

It seems our input is only heard when there are thousands of already severely injured patients filing adverse event reports on the MAUDE database.

Get involved and stay involved, any way you can to raise awareness patient stakeholders belong at the head of the table, not being invited at the last minute.

Best, blessings, Lana Keeton
Mesh Injured Patient
Pro Se Plaintiff who became a
Patient Advocate and a
Medical Device Expert...
Just do the work and it will get results!! :)



JOSHUA SHARFSTEIN, FDA CHIEF
SCIEINTIST & LANA KEETON
FDA-CMS SUMMIT 12-09-10







LANA KEETON & TAMARA SYREK-JENSEN
CMS, DEPUTY DIRECTOR
FDA-CMS SUMMIT 12-09-10














HERE'S THE INVITATION AND MY REPLY...I ASK THEY PAY FOR ME TO GET THERE, KNOWING THEY WOULD NOT, TO MAKE A POINT THIS IS NOT MY DAY JOB.


----- Original Message -----

From: Lana Keeton
To: Williams, Letise
Sent: Friday, November 30, 2012 11:05 AM
Subject: Re: Announcing: “Medical Device Innovation Consortium”

Hello Mrs. McMurry-Heath and Ms. Williams,

Thank you so much for the invitation. As a patient advocate for hundreds of thousands injured by synthetic surgical mesh, I represent many patient stakeholders. Patient stakeholders take all the risk, and the benefit, of implanted medical devices and should be at the head of the table when it comes to the work of the FDA and the CDRH.

As you see, I did not receive this invitation until yesterday even though this has been in the works for almost a year. The airfare is $465.60 because of the late notice. I understand you gave a grant to the National Research Center for Women and Families in the amount of $50,000.00 for patient advocates from outside the beltway to be able to participate in this type of event. Will you provide the funds for me to be there on Monday so I will be able to represent patient stakeholders at this important event? I would really appreciate it.

Yours truly, Lana

Lana C. Keeton
Founder and President
Truth in Medicine Incorporated
1521 Alton Road, #198
Miami Beach, FL 33139
e-mail: lanakeeton@truthinmedicine.us.com
website: www.truthinmedicine.us.com
blog: www.theladyisachamp.blogspot.com

Become a Member!
http://www.truthinmedicine.us.com/becomeamember.html

Donate to Our Cause!
http://www.truthinmedicine.us.com/donatetoourcause.html

The information provided is for educational purposes only. It is not meant to diagnose or treat any health condition and is not a replacement for treatment by a healthcare provider.

----- Original Message -----
From: Williams, Letise
To: lanakeeton@truthinmedicine.us.com
Sent: Thursday, November 29, 2012 1:44 PM
Subject: Announcing: “Medical Device Innovation Consortium”

Greetings,

The Center for Devices and Radiological Health at the U.S. Food and Drug Administration would like to make you aware of an upcoming event. Next Monday the independent non-profit Medical Device Innovation Consortium (MDIC) will be announcing a new public-private partnership between the MDIC, FDA, other government agencies, non-profits, academia, and the medical device industry designed to address emerging device regulatory science issues. Additional information on the MDIC can be found at http://www.deviceconsortium.org/

As key health technology stakeholders, we would be pleased for you to join us to hear the Commissioner discuss this important new initiative. The Consortium is designed to improve outcomes for patients by fostering innovation, increasing the tools available to evaluate new medical devices to make sure they are safe and effective, and to ensure these improvements in care get to patients as expeditiously as possibly while safeguarding public health.

Please join us if you can,

Michelle McMurry-Heath
Associate Director for Science, Acting Chief Scientist
Office of the Center Director
Center for Devices and Radiological Health
U.S. Food and Drug Administration
---------------------------------------------------------

You are invited to attend the Senate MedTech Caucus briefing:

Monday, December 3rd, 10:30 am – 12:00 pm
Room 106, Dirksen Senate Office Building

Announcing: “Medical Device Innovation Consortium”

Featuring:

FDA Commissioner, Margaret Hamburg, M.D. & FDA’s Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., J.D.

The program will include a briefing on the creation of the Medical Device Innovation Consortium (MDIC).

The MDIC is a Public-Private Partnership (PPP) whose mission is to improve health through the application of shared knowledge in medical device regulatory science. It is the first-ever PPP created to focus exclusively on advancing medical device regulatory science.

The MDIC will create a collaborative environment where nationwide representatives from industry, non-profits, and FDA can work together to keep pace with the needs of patients in the United States.

Speakers will include:

Senator Amy Klobuchar
Senator Al Franken
FDA Commissioner, Margaret Hamburg, M.D.
FDA’s Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., J.D.
Centers for Medicare & Medicaid Services, Deputy Director, Coverage & Analysis Group, Tamara Syrek Jensen, J.D.
Immucor, Inc., CEO, William Hawkins
LifeScience Alley CEO, Dale Wahlstrom

P.S. I BELIEVE THEY MAY ANNOUNCE THE REGISTRY FOR PELVIC ORGAN PROLAPSE MESH AT THIS EVENT. HOPE SO! WE WILL SEE!

MAJOR VICTORY FOR WOMEN AND WOMEN'S HEALTHCARE...PELVIC ORGAN PROLAPSE MESH KITS BITE THE DUST!

Breaking News…..Major Victory for Women!


And for Women’s Health Care!

Dateline: Miami, November 28, 2012

By Lana C. Keeton (copyright protected)

The Center for Devices and Radiological Health (CDRH) will be up classifying all Synthetic Surgical Mesh for Pelvic Organ Prolapse repair from Class II to Class III within one year.

Even better, in the very near future, all but one of the most popular prolapse kits, will no longer be sold.

The CDRH will be announcing important new regulations in December. Companies will have to pay an upfront fee of $250,000.00 to be part of a registry along with conducting 3 year clinical trials to prove safety and effectiveness of these “kits” which is not possible and will cost them millions.

And there will be major new requirements for surgeons implanting surgical mesh in the pelvis. No longer will surgeons be able to take a weekend course taught by an industry paid “medical advisor/consultant” to start implanting a filthy petroleum waste by product into women.

Medical mercenaries will now think twice before they mutilate women internally with a foreign body polymer that shrinks, hardens and moves at will within their pelvis mercilessly destroying their lives.

Doctors on the prolapse kit bandwagon who have ignored what they earned in med school about foreign bodies, checked their medical training at the door when they walked into the operating theatre and spouted the ridiculous mantra that foreign body polymers are biocompatible and inert will now be held accountable for their actions. Praise the Lord!!

Just as I was quoted in Bloomberg News in January when the FDA mandated 522 studies of 99 synthetic surgical mesh products used for prolapse and incontinence, industry knows it will not be able to prove these “medical devices” safe or effective and it will cost them millions they are unwilling to spend.

And there it is. It was never about health. It was always about the money, no matter how many millions of people were harmed or put at risk for serious harm or even death.

Now we are seeing the death of insanity in women’s health. Another “Dalkon Shield” bites the dust.

Patients and patient advocates have won a very long and significant battle for the safety of patients who will not be harmed in the future!!

ABDOMINAL SACRAL COLPOPEXY with MESH....NOT BETTER, NOT SAFER!

Open Letter from Lana Keeton, patient advocate and medical device expert....

[this letter and any and all content on this blog is copyright protected]

Dear Transvaginal MDL Litigators,


For those of you who don’t know me, my patient advocacy organization, Truth in Medicine, and I were instrumental in getting the FDA warnings on synthetic surgical mesh issued in 2008 and 2011. Based on that work, I appeared as a speaker on the Transvaginal Mesh Panel at Mass Torts Made Perfect April 20, 2012 in Las Vegas.

It’s important to understand, this is a bigger fight than a lawsuit and a product. Use of synthetic surgical mesh is a fatally flawed concept which remains unchallenged. Hernias, incontinence and pelvic organ prolapse are conditions caused by torn or weakened tissue. These are not diseases, only conditions. Implanting a foreign body polymer, synthetic surgical mesh, does not treat causation.

Treating the symptoms with synthetic mesh is a confounding factor in these conditions. The complications are complicated. The cause is not. It’s the device, not the doctor, not the procedure, not the patient.

ABDOMINAL SACRAL COLPOPEXY

Abdominal sacral colpopexy is not a better, safer alternative than mesh kits for pelvic organ prolapse. It has a high complication rate and a long recovery. In addition, a significant complication is stress urinary incontinence (SUI) leading to further surgery and the use of synthetic mesh slings, which is the subject of current litigation.

Recurrent prolapse: 8% - 24%

Repeat surgery: 5% - 9%

Stress Urinary Incontinence: 10%

TVT/Ob-Tape: 3% - 13%
(recommended postoperatively for SUI)

The severity of this procedure and its complications are well documented in long standing literature. It is a very intrusive procedure drastically cutting the internal pelvic organs with a long recovery period.

There are significantly better, safer surgical and non-surgical alternatives.

Please do not use this procedure in the Transvaginal Mesh Cases as a better, safer alternative! It Is Not!

BOSTON SCIENTIFIC "SHOW ME THE MONEY" STILL HARMING WOMEN 15 YEARS.....AND COUNTING

Copyrighted by Lana C. Keeton November 9, 2012
*all rights reserved

Boston Scientific brought its’ first bladder suspension sling, the Protegen Sling, to market based on a 90-day rat study, and the wide use of its Hemashield fabric for cardiovascular grafts. Nov. 15, 1996, the FDA granted clearance for the Protegen Sling but 56 serious adverse events were reported in the first 9 months on the market. 57 were reported in the next 6 months.


During a June 1998 inspection of the company’s manufacturing plant, the FDA found the company was not reporting a large percentage of adverse events. Internal company documents showed at least 233 other reports never given to the FDA. Boston Scientific had selectively reported cases of surgical removal of the mesh and omitted other equally dangerous medical complications.

So what has changed at Boston Scientific since 1998? Based on the current investigation of BSX by California Attorney General Kamala Harris and other states attorneys, not much. Boston Scientific continues to market deadly synthetic surgical mesh for pelvic organ prolapse and bladder suspension through its Urology/Women’s Health division.

Promotion of dangerous medical devices to unsuspecting patients is the norm because of lax regulatory authority, the snails pace of FDA actions and the device industry’s strangle hold over doctors, professional medical societies and billions of dollars spent on direct to consumer advertising and lobbying in Congress.

But we as patients and patient advocates have made a difference and here’s why!

We have influenced the national conversation on the regulatory process with our testimony about the failures of the 510 (k) at the Institute of Medicine in 2010 and we decreased their sales because of the FDA’s July 2011 Transvaginal Mesh Warning! Read and enjoy….

From Boston Scientifics’ 3rd Quarter 2012 Form 10Q SEC filing:

Under “Women’s Health/Urology” they say:

However, our Women's Health business declined 11 percent primarily due to continued pressures on elective procedures and lower sales levels following the FDA release of a Public Health Notice update in July 2011 regarding complications related to the use of urogynecologic surgical mesh for pelvic organ prolapse.

Under “Litigation and regulatory compliance” they state:

Our ability to minimize or avoid future field actions or FDA warning letters relating to our products and the on-going inherent risk of potential physician advisories or field actions related to medical devices;

Legislative or regulatory efforts to modify the product approval or reimbursement process, including a trend toward demonstrating clinical outcomes, comparative effectiveness and cost efficiency, as well as other healthcare reform legislation.

And we are hitting their bottom line!!

“Our accrual for legal matters that are probable and estimable was $411 million as of September 30, 2012 and $299 million as of December 31, 2011…”.

And for the early 2000’s even before the current investigations, “the total incremental tax liability now asserted by the IRS for the applicable periods is $1.162 billion plus interest.”

MOST MESH INJURED PATIENTS HAVE BEEN HORRIBLY INJURED BUT AT LEAST THERE IS HOPE OTHERS WILL NOT BE HARMED IN THE FUTURE!

DAVID DID NOT THINK GOLIATH WAS TOO BIG TO HIT. DAVID THOUGHT GOLIATH WAS TOO BIG TO MISS.

From John Riley Bible Study Atlanta, GA early 1990’s


MUELLER NEEDS TO BE HELD ACCOUNTABLE FOR FALSE, MISLEADING ADVERTISING IN OCTOBER 2012 ISSUES OF TEXAS MONTHLY AND SUPER LAWYER MAGAZINE  ( see red type below)

“M... Mueller, M... Thompson, MD.,* and Wi..ard Bear, along with friend and Georgia lawyer Henry Garrard, have developed much of the science and liability supporting transvaginal mesh litigation, leading to recalls, FDA changes and bellwether trials. “

Mueller makes a mockery of hundreds of thousands of mesh injured patients worldwide.


- and Wi..ard Bear:It is an affront to men and women everywhere that Mueller includes a stuffed bear on the “legal team”. It belittles his clients and makes a mockery of a serious medical disaster.

And publishes false, misleading advertising:

- have developed much of the science and liability supporting transvaginal mesh litigation,

I worked as a paid legal consultant and research analyst to M... Mueller starting in the summer of 2010. He sought me out and contacted me because of the work I had done starting in 2005 when I sued Johnson & Johnson/Ethicon/Gynecare Worldwide for their defective Gynecare TVT Prolene (polypropylene) Bladder Suspension System as a pro se plaintiff.

Mueller and M Thompson and W...d B..ear did not develop the science or all of the litigation strategy. Myself and other experts benefitted him with our expertise and knowledge. He may have paid for access to some of the science and liability we experts developed long before he was ever involved in transvaginal mesh litigation.

- leading to recalls,
Mueller did not become involved in synthetic surgical mesh at all until mid-2010. To say, his work led to recalls is a ridiculous assertion. The work leading to the recalls began at least as early as 2005.

- FDA changes
Again, Mueller did not become involved in synthetic surgical mesh until mid-2010, long after the 1st FDA Public Health Notification warning of the serious risks and complications associated with transvaginal mesh was issued October, 2008. So exactly how did his work and that of M.... Thompson, W...rd Bear and Henry Garrard lead to FDA changes?

- and bellwether trials:
The bellwether trials were precipitated by thousands of adverse event reports filed by patients and their healthcare providers, persistent long term patient advocacy and the FDA’s Public Health Notifications, not M... Mueller.

“R... Kleinman* and J... Larrimore* add unique skills. Mueller terms the pelvic mesh fiasco ‘medieval treatment of women’.”

- “medieval treatment of women.”

Mueller himself demeans women. His office staff turnover would be envied if it was a manufacturer’s inventory. However, how does he maintain continuity for his mesh injured clients when a huge percentage of his staff turns over every 6 -12 months, starting with the loss of his long time partner, Hunter Hillin, in 2010 and key litigator, Kay McCartan in 2011? Why is he dropping women's mesh cases with abdominal sacral colpopexy and not taking any more of their cases?

Mueller needs to lose the bear and take the plight of mesh injured patients seriously. 


Mueller needs to be held accountable for false, misleading advertising.

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!