Sunday, January 27, 2013
LANA KEETON SPEAKING ENGAGMENTS 2013
LANA KEETON IS GUEST LECTURER AT
OSHER LIFE LONG LEARNING INSTITUTE
UT QUEST PROGRAM – UNIV OF TEXAS AT AUSTIN
TUESDAY - JANUARY 29, 2013 - UT CAMPUS
"THINK YOU'RE PROTECTED? YOU'RE NOT! WHAT DOCTORS DON'T KNOW AND THE FDA IS NOT TELLING YOU!" ©
By Lana C. Keeton
Americans go to doctors, whom they trust, who perform surgery on them in accredited hospitals using FDA “approved” products. They believe in the system. Americans don’t ask questions. They trust a system that actually betrays them...Lana Keeton whose journey as a surgical mesh injured patient led her to become a patient advocate, a legal consultant and a voice for those thousands of injured patients at the FDA, on Capitol Hill and in America's healthcare system. Coordinator Jane Howerton
"SELLING SICKNESS" 2013 'PEOPLE BEFORE PROFITS' WEDNESDAY - FRIDAY, FEBRUARY 20-22, 2013, WASHINGTON, D.C.
Panelist on "Grief to Action". Headed by author Rosemary Gibson. How I took my own experience with the horrors of mesh and turned it into a patient advocacy organization, Truth in Medicine Incorporated, to help others.
Mine will be more "Anger to Action" based on the doctor implanting a permanent medical device without my knowledge or consent.
This conference will bring together academic medical reformers, consumer activists, and health journalists to examine the current scope of disease mongering and to develop strategies and coalitions for change. Topics will include misleading marketing, journalistic standards, over-treatment, over-diagnosis, whistleblowers, new roles for advocates, pharmacovigilance, clinical trials, activist narratives, new conflict of interest areas, evidence-based screening, igniting citizen outrage, and more. We will have plenary roundtables, panels, workshops, a unique Good News Exhibit Hall, and Booktivism training. Students and young activists are welcome!
http://sellingsickness.com/
February 20-22, 2013
Hyatt Regency Washington on Capitol Hill
Washington D.C.
UNIVERSITY OF MIAMI/FLORIDA BIOETHICS CONFERENCE- FRIDAY . APRIL 5, 2013 . MIAMI MARRIOTT BISCAYNE BAY - MIAMI, FLORIDA
It is with great pride, I am an invited speaker at the 2013 UM Bioethics Conference. Ken Goodman, PhD, and Robin Fiore, PhD, head up the University of Miami Bio-Ethics Programs having a direct impact every day on future doctors. I highly respect their work.
“It is a professional conference attracting physicians, nurses, health law practitioners, clergy, social workers, public health staff and hospital administrators. This is a terrific opportunity to speak to the decision makers and the actual health care practitioners who influence health care every day and have the chance to influence their thinking in regard to patient safety.
In 2012, they celebrated the 20th anniversary of the Florida Bioethics Network and the largest sustained professional bioethics conference in the US, one that regularly draws 300 or more in attendance.”
“Kenneth W. Goodman, Ph.D.FACMI, is founder and director of the University of Miami Bioethics Program and its Pan American Bioethics Initiative and co-director of the university’s Ethics Programs, including its Business Ethics Program. The Ethics Programs have recently been designated a World Health Organization Collaborating Center in Ethics and Global Health Policy, one of six in the world and the only one in the United States.”
Monday, January 21, 2013
"DR. MESH" JOHN MIKLOS: EXPERT FOR THE PLAINTIFF?
I met +Dr. John Miklos in September 2002 after being referred to him by another doctor planning surgery on me to deal with the massive internal and external abdominal scars from necrotizing fasciitis, the result of a hysterectomy and bladder suspension in December 2001.
Little did I know I was face to face with DR. MESH who was teaching doctors across the United States, and later in other countries, to do the same procedure to thousands of other women.
Little did I know he worked for multiple drug and device companies doing "clinical trials" and "clinical studies".
Little did I know I would later come in contact with many women who also had consulted with DR. MESH Miklos.
His "mesh" journey started when Ethicon paid his way, along with other U.S. surgeons, to Sweden in September 1998 to learn the Transvaginal Tape procedure from Dr. Ulf Ulmsten using the Gynecare TVT Prolene (polypropylene) bladder suspension sling.
While stopping along the way to promote "Vaginal Rejuvenation", the Johnny Appleseed of mesh has caused untold harm to thousands and thousands of women implanted with various transvaginal mesh kits and bladder sling kits by promoting mesh to other doctors.
Hundreds of thousands of dollars in his pocket later, DR. MESH is still raking in the dough, this time as "Expert Witness" for the plaintiffs. It is such a mockery of the plaintiffs and of the legal system to think someone who has caused so much misery to so many thousands of women should now be on the plaintiff's side.
I personally think DR. MESH Miklos is a mole for the device makers, learning the plaintiff's strategy in all the transvagiNal lawsuits and then handing over the info to the device makers.
Oh, did I mention he falsified my medical records and then later admitted it in sworn deposition testimony?
There's lots more, but let's not talk about it here.
Come on over to www.medicalmeshtalk.com to hear the rest.
Little did I know I was face to face with DR. MESH who was teaching doctors across the United States, and later in other countries, to do the same procedure to thousands of other women.
Little did I know he worked for multiple drug and device companies doing "clinical trials" and "clinical studies".
Little did I know I would later come in contact with many women who also had consulted with DR. MESH Miklos.
His "mesh" journey started when Ethicon paid his way, along with other U.S. surgeons, to Sweden in September 1998 to learn the Transvaginal Tape procedure from Dr. Ulf Ulmsten using the Gynecare TVT Prolene (polypropylene) bladder suspension sling.
While stopping along the way to promote "Vaginal Rejuvenation", the Johnny Appleseed of mesh has caused untold harm to thousands and thousands of women implanted with various transvaginal mesh kits and bladder sling kits by promoting mesh to other doctors.
Hundreds of thousands of dollars in his pocket later, DR. MESH is still raking in the dough, this time as "Expert Witness" for the plaintiffs. It is such a mockery of the plaintiffs and of the legal system to think someone who has caused so much misery to so many thousands of women should now be on the plaintiff's side.
I personally think DR. MESH Miklos is a mole for the device makers, learning the plaintiff's strategy in all the transvagiNal lawsuits and then handing over the info to the device makers.
Oh, did I mention he falsified my medical records and then later admitted it in sworn deposition testimony?
There's lots more, but let's not talk about it here.
Come on over to www.medicalmeshtalk.com to hear the rest.
Monday, December 31, 2012
INJUSTICE REIGNS: GYNECARE TVT PROLENE MESH & ITS' COMPLICATIONS....SAY GOODBYE 2012!
11 years and 10 days ago, December 21, 2001, an unscrupulous doctor, Dr. Bernard Cantor, implanted a piece of polypropylene, a Gynecare TVT Prolene bladder sling, in me without my knowledge or informed consent. I had never heard of a medical device but now i had one in me.
Since that time my life has revolved around dealing with the complications, surgeries, physical pain, financial cost, loss of my home and suffered countless indignations as I saw doctor after doctor after doctor. And attorney after attorney after attorney.
Navigating the insanity of a permanently implanted filthy piece of petroleum waste byproduct inside your body is awful. At the same time, I decided to use what I learned from my journey to help others. That too has been gut wrenching.
Not to mention how the health system and the legal system profited off of myself and thousands and thousands of other innocent victims. And continue to profit, day after day after day. I wish I did not have such a full realization of how many unscrupulous doctors and attorneys profit off myself and others year after year after year.
Injustice reigns in our "civilized" society. Not sure 2013 will be much better but I am happy to say "Goodbye 2012"!
Since that time my life has revolved around dealing with the complications, surgeries, physical pain, financial cost, loss of my home and suffered countless indignations as I saw doctor after doctor after doctor. And attorney after attorney after attorney.
Navigating the insanity of a permanently implanted filthy piece of petroleum waste byproduct inside your body is awful. At the same time, I decided to use what I learned from my journey to help others. That too has been gut wrenching.
Not to mention how the health system and the legal system profited off of myself and thousands and thousands of other innocent victims. And continue to profit, day after day after day. I wish I did not have such a full realization of how many unscrupulous doctors and attorneys profit off myself and others year after year after year.
Injustice reigns in our "civilized" society. Not sure 2013 will be much better but I am happy to say "Goodbye 2012"!
Thursday, December 20, 2012
OVERSTENTING LEADS TO PRISON SENTENCE FOR LOUISIANA DOCTOR. WILL OVER-MESHING LEAD TO THE SAME?
Serious harm, and even death, from implanted synthetic surgical mesh is widespread. Hopefully over-meshing will have the same results for some urologists, gynecologists and urogynecologists as over-stenting did for Dr. Patel. Over-meshing of women for over a decade now is a crime against humanity for the inhumane torture inflicted on women.
And even if these women actually needed these operations, the use of mesh is still completely unacceptable in my opinion. There are better, safer alternatives.
These surgeons continue to ignore the obvious. Foreign body polymers implanted to misuse the body’s inflammatory process is a prescription for disaster.
I nominate these surgeons to the “Hall of Shame” along with medical device companies who manufacture and promote the use synthetic surgical mesh for pelvic organ prolapse and for bladder suspension.
Dr. Bernard Cantor
Dr. G. Willy Davila
Dr. John Miklos
Dr. Alan Garely
Dr. Cheryl Iglesias
Dr. Matt Barber
Dr. Vincent Lucente
Dr. Mickey Karram
Dr. Robert Moore
And there are countless others who deserve to be nominated right along with these prominent doctors. When some of these doctors start getting in trouble, maybe the unnecessary abusive use of synthetic surgical mesh will stop. Thousands of adverse event reports to the FDA, 2 FDA warnings and thousands of lawsuits have not stopped it yet.
“Over-stenting doc submits to 10-year prison sentence”
“Louisiana interventional cardiologist Dr. Mehmood Patel begins a 10-year prison sentence after losing an appeal bid.
A Louisiana interventional cardiologist accused of performing heart procedures on patient unnecessarily began his 10-year prison sentence this month after years of attempting to appeal his verdict.
Dr. Mehmood Patel, 64, was convicted in 2009 of 51 counts of fraudulently billing Medicare and other insurance groups for medical procedures that were deemed unnecessary. Patel was given a 10-year prison sentence, which was to start in July 2009.
Patel has been attempting to appeal the conviction, but this month agreed to begin his sentence after a 5th Circuit Court of Appeals upheld the lower court's decision, Heartwire reported.
Unnecessary stenting has gotten quite a few heart doctors in trouble in recent years”….
Please click the link below to read the entire article on Mass Device December 18, 2012.
http://www.massdevice.com/news/over-stenting-doc-submits-10-year-prison-sentence?page=show
And even if these women actually needed these operations, the use of mesh is still completely unacceptable in my opinion. There are better, safer alternatives.
These surgeons continue to ignore the obvious. Foreign body polymers implanted to misuse the body’s inflammatory process is a prescription for disaster.
I nominate these surgeons to the “Hall of Shame” along with medical device companies who manufacture and promote the use synthetic surgical mesh for pelvic organ prolapse and for bladder suspension.
Dr. Bernard Cantor
Dr. G. Willy Davila
Dr. John Miklos
Dr. Alan Garely
Dr. Cheryl Iglesias
Dr. Matt Barber
Dr. Vincent Lucente
Dr. Mickey Karram
Dr. Robert Moore
And there are countless others who deserve to be nominated right along with these prominent doctors. When some of these doctors start getting in trouble, maybe the unnecessary abusive use of synthetic surgical mesh will stop. Thousands of adverse event reports to the FDA, 2 FDA warnings and thousands of lawsuits have not stopped it yet.
“Over-stenting doc submits to 10-year prison sentence”
“Louisiana interventional cardiologist Dr. Mehmood Patel begins a 10-year prison sentence after losing an appeal bid.
A Louisiana interventional cardiologist accused of performing heart procedures on patient unnecessarily began his 10-year prison sentence this month after years of attempting to appeal his verdict.
Dr. Mehmood Patel, 64, was convicted in 2009 of 51 counts of fraudulently billing Medicare and other insurance groups for medical procedures that were deemed unnecessary. Patel was given a 10-year prison sentence, which was to start in July 2009.
Patel has been attempting to appeal the conviction, but this month agreed to begin his sentence after a 5th Circuit Court of Appeals upheld the lower court's decision, Heartwire reported.
Unnecessary stenting has gotten quite a few heart doctors in trouble in recent years”….
Please click the link below to read the entire article on Mass Device December 18, 2012.
http://www.massdevice.com/news/over-stenting-doc-submits-10-year-prison-sentence?page=show
Wednesday, December 5, 2012
AMERICAN MEDICAL SYSTEMS PAYS CONSULTING FEES TO TOP DOCS AT CLEVELAND CLINIC
Sure wish I knew this when Dr. G. Willy Davila testified as my treating physician at the medical malpractice trial I won against Dr. Bernard Cantor in December 2009 (because Dr. Bernard Cantor, among other things, had falsified my medical records in addition to sending me home with untreated, uncontrolled necrotizing fasciitis in December 2001.)
Dr. Davila didn't mention the work he was doing for American Medical Systems on their new "Elevate" mesh prolapse kit in his deposition testimony or his testimony at trial. And my attorney, Darryn Silverstein, didn't ask. Wow, how gullible was I? I sure never thought Dr. Davila would do a thing like that.
I trusted him emphatically with my health for 7 years, surgery after surgery after surgery believing what he told me about how the problems with mesh were surgical error by other doctors. Not until I became so involved in surgical mesh research for others did I understand the truth and find another doctor to care for me.
I believed the American medical system and the U.S. legal system were here to protect me. I was wrong. Pretty sad stuff when all the professionals around you, medical and legal, are profiting off of your misfortune all the while not doing their best for you.
But that is what happens every single day to hundreds of thousands of patients injured by drugs and devices. It may be happening to you, too. Never hesitate to ask all the questions of your doctor and of your attorney. They are being paid because they are treating you or representing you. They work for you!
THE FOLLOWING STATEMENTS ARE DIRECT QUOTES FROM THE CLEVELAND CLINIC WEBSITE:
“As of 9/17/2012, Dr. (G. Willy) Davila has reported the financial relationships with the companies listed below.....
Consulting and/or Speaking. Dr. Davila receives fees of $5,000 or more per year as a paid consultant, speaker or member of an advisory committee for the following companies:
• American Medical Systems, Inc.
• Astellas Pharma US, Inc.
Royalty Payments. Dr. Davila receives or has the right to receive royalty payments for inventions or discoveries commercialized through the companies shown below:
• American Medical Systems, Inc.
Right to Future Distribution of Cleveland Clinic Financial Interest. Dr. Davila may receive future financial benefits from the Cleveland Clinic for inventions or discoveries commercialized through the companies shown below:
• American Medical Systems, Inc.
http://my.clevelandclinic.org/staff_directory/staff_display.aspx?DoctorID=3144
As of 2/13/2012, Dr. (Mark) Walters has reported the financial relationships with the companies listed below....Consulting and/or Speaking. Dr. (Mark) Walters receives fees of $5,000 or more per year as a paid consultant, speaker or member of an advisory committee for the following companies:
• American Medical Systems, Inc.
http://my.clevelandclinic.org/staff_directory/staff_display.aspx?doctorid=724
Dr. Davila didn't mention the work he was doing for American Medical Systems on their new "Elevate" mesh prolapse kit in his deposition testimony or his testimony at trial. And my attorney, Darryn Silverstein, didn't ask. Wow, how gullible was I? I sure never thought Dr. Davila would do a thing like that.
I trusted him emphatically with my health for 7 years, surgery after surgery after surgery believing what he told me about how the problems with mesh were surgical error by other doctors. Not until I became so involved in surgical mesh research for others did I understand the truth and find another doctor to care for me.
I believed the American medical system and the U.S. legal system were here to protect me. I was wrong. Pretty sad stuff when all the professionals around you, medical and legal, are profiting off of your misfortune all the while not doing their best for you.
But that is what happens every single day to hundreds of thousands of patients injured by drugs and devices. It may be happening to you, too. Never hesitate to ask all the questions of your doctor and of your attorney. They are being paid because they are treating you or representing you. They work for you!
THE FOLLOWING STATEMENTS ARE DIRECT QUOTES FROM THE CLEVELAND CLINIC WEBSITE:
“As of 9/17/2012, Dr. (G. Willy) Davila has reported the financial relationships with the companies listed below.....
Consulting and/or Speaking. Dr. Davila receives fees of $5,000 or more per year as a paid consultant, speaker or member of an advisory committee for the following companies:
• American Medical Systems, Inc.
• Astellas Pharma US, Inc.
Royalty Payments. Dr. Davila receives or has the right to receive royalty payments for inventions or discoveries commercialized through the companies shown below:
• American Medical Systems, Inc.
Right to Future Distribution of Cleveland Clinic Financial Interest. Dr. Davila may receive future financial benefits from the Cleveland Clinic for inventions or discoveries commercialized through the companies shown below:
• American Medical Systems, Inc.
http://my.clevelandclinic.org/staff_directory/staff_display.aspx?DoctorID=3144
As of 2/13/2012, Dr. (Mark) Walters has reported the financial relationships with the companies listed below....Consulting and/or Speaking. Dr. (Mark) Walters receives fees of $5,000 or more per year as a paid consultant, speaker or member of an advisory committee for the following companies:
• American Medical Systems, Inc.
http://my.clevelandclinic.org/staff_directory/staff_display.aspx?doctorid=724
Monday, December 3, 2012
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
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
Sunday, December 2, 2012
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!! :)
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!
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!
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