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"!

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

Friday, December 14, 2012

HEALTH CARE DECISIONS IN THE COURTROOM: MASS TORTS "LET'S MAKE A DEAL" WITH DOCTORS AND DEVICE COMPANIES

Current pre-trial Multi District Litigation (MDL) for Transvaginal Mesh Implants in West Virginia before Judge Goodwin throws women implanted via Abdominal Sacral Colpopexy under the bus, sacrificial lambs for other women implanted transvaginally.

How does this happen? Attorneys use whatever means necessary to win cases for their clients, no matter other women will be harmed for decades to come.


Unfortunately for any plaintiff involved in mass torts or class action law suits, they are not privy to the deal making between attorneys and doctors. Attorneys don't typically sue doctors for their part in surgically implanting a defective medical device, whether they committed medical malpractice or were simply duped by the device company.

Why is this? Medical malpractice caps in some states on attorneys fees is one reason. The other reason is they want the testimony of the doctors against the companies.

This creates a terrible scenario of continuing harm to patients. Attorneys decisions not to sue doctors maintains the status quo. Health care decisions are then based on the winning verdict in the court room. Doctors, fearing legal liability, will depend on antiquated surgical procedures "proved" in court by an attorney who has now made health care decisions that will impact patients for decades to come.

Medical advisor/consultant doctors continue their cozy, lucrative relationships with the device companies. These same "advisor/consultant" doctors go on to the next popular medical device promoted by the companies and start the cycle all over again.

It is definitely a lose-lose proposition for patients. Patients take all the risk for the profits of the doctors, hospitals and device companies and support the day jobs of attorneys, people working in the court system, doctor experts  as they become a permanent part of the health system because of their injuries.

Women with synthetic surgical mesh via abdominal sacral colpopexy will be thrown under the bus in the West Virginia MDL as sacrifices for other women. How awful. I highly disagree with this.

Hopefully in the future, attorneys see their part in perpetuating the status quo which causes massive harm to women. And perhaps they will start prosecuting the real culprit, the mesh product, not the surgical procedure.

Tuesday, December 4, 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  

Sunday, December 2, 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

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!