Dr. Rajamannan Replies to FDA's Demands of New Evidence Surrounding Harm to Patients in an Open Letter to Members of Congress, the FDA Commissioner Hahn and HHS Secretary Azar and the CDC and the World Health Organization
An Open Letter to The Who/CDC/FDA/HHS/Congress Regarding Faulty Heart Devices
CHICAGO, IL, March 3, 2020 (Newswire.com) - I received the following email from FDA Ombudsman Desta on Feb. 20:
"Your email to FDA Commissioner Dr. Stephen Hahn dated January 27, 2020, and your email to HHS Secretary Dr. Alex Azar dated February 6, 2020, were forwarded to me for review and response in my capacity as Ombudsman for the Center for Devices and Radiological Health. The Agency has reviewed the material you provided, and it does not appear that you have provided new information, which was not previously provided to FDA. I respectfully request that you provide any new information relevant to the safety or efficacy of the dETlogix annuloplasty ring, IMR ETlogix annuloplasty ring, or an Atricure device to me in writing at CDRHOmbudsman@fda.hhs.gov so FDA may properly evaluate the information and make a determination on what action, if any, is warranted."
Below is the information you requested regarding Edwards Lifesciences' IMR Ring, the Model 5100 (Myxo Ring), the Atricure device and also the Batista Study, including a chronology and links to the evidence submitted to the FDA District office in Minneapolis, MN.
I am sending the information to the FDA, HHS, CDC and WHO. All of these agencies hold a responsibility to inform patients and their physicians of experimental procedures. These agencies also should be fully aware when companies are moving forward with the global development of new therapies for patients.
The Federal Code for research and development prohibits the testing using minimal risk patient registry for the design control testing of heart devices.
I request help for thousands of patients, who received the heart devices listed in your email above. Experimental protocols were performed without their consent, prior to FDA registration, clearance and on recall. Many have suffered heart attacks, many have died and many have required re-operations to remove the faulty devices or repair the faulty experimental surgical technique. Others are still at risk.
The McCarthy Myxo ETlogix Ring Model 5100
The McCarthy Myxo ETlogix Ring Model 5100 tested in patients from March 2006 through November 2007, without consent and without FDA authorization, placed on recall without ever informing the patients of the testing, recall and change in status to the device. Details have been provided in the letter dated 2-24-2020.
The IMR ETLogix Device
The IMR ETlogix Device testing from October 2003 through August 2005 at three major medical centers, Cleveland Clinic, Mount Sinai, and Northwestern Memorial Hospital. The device went on sale on the US market in 2006 and placed on recall on December 4, 2008.
The Atricure Device
The Atricure device was tested in patients at the Cleveland Clinic and the surgeons, as published by the Journal editor for the American Association of Thoracic Surgeons.
The Left Ventriculectomy Procedure
Dr. Michael Carome (formally the Director of OHRP now the Medical Director at Public Citizen) sent a letter from the HHS Office for Human Research Protections to Cleveland Clinic concerning papers at the Clinic. OHRP "finds that investigators at the Clinic prospectively collected identifiable private information about living individuals in a systematic manner in order to develop generalizable knowledge about the safety and effectiveness of partial left ventriculectomy in the management of patients with dilated cardiomyopathy, using a database that was exempt from patient consent."
"OHRP determined that the research was non-exempt and required informed consent."
A similar determination by Northwestern University's IRB for the Myxo ETlogix Protocol 1532-004.
As a former investigator, I hold a life-long reporting responsibility under Federal HHS reporting laws. The hospital, university, device manufacturer and FDA have a federal responsibility to review the evidence and inform the nearly 700 patients about this device's experimental status and any ongoing risks and harm as recently published in 2019. I am cc'ing the members of Congress, who have patiently waited for a statement of the ongoing risk to the citizens of the United States of America and the patients globally who received these devices prior to federal and global authorization for use in human subjects.
Respectfully,
Nalini M. Rajamannan, MD
Most Sacred Heart of Jesus Cardiology and Valvular Institute.
Adjunct Visiting Scientist Mayo Clinic Biochemistry and Molecular Biology
Dr. Nalini Rajamannan is a heart valve expert in the field of cardiovascular medicine. She earned her undergraduate science pre-professional degree from the University of Notre Dame, her Medical Doctorate from Mayo Medical School and her post-graduate training in Internal Medicine and Cardiology at the Mayo Clinic and Research Fellowship on the NIH training Grant. She also worked at the Mayo Clinic as a staff consultant in Internal Medicine and an Associate Professor of Medicine at Northwestern University and the Lakeside and Westside VA. Currently, she practices consultative valvular medicine and Osteocardiology at Most Sacred Heart of Jesus Cardiology and Valvular Institute, WI.
Press Contact
Oscar Delgado
Press Officer for Most Sacred Heart of Jesus Cardiology and Valvular Institute
Former NBC Bureau Chief Latin America
773-573-6890
heartvalves@sacredcardiology.com
Source: Most Sacred Heart of Jesus Cardiology and Valvular Institute