Patients Unknowingly Had Medical Devices Implanted, Claims Doctor-Whistleblower

| by Michael Allen

Dr. Nalini Rajamannan was a cardiologist at Northwestern University in Evanston, Ill. from 2000 until 2008, when she was terminated.

Dr. Rajamannan was promoted to Valve Director in 2006, but in 2007 she reported that a doctor at the university was implanting non-FDA approved, experimental medical devices into patients without their knowledge.
According to a story by, posted on CNN, Dr. Patrick McCarthy was testing his own inventions, an IMR annuloplasty device and a Myxo annuloplasty device, on patients without their consent.
The patients are reportedly still not aware of the devices inside their bodies.
Dr. Rajamannan discovered what was going on July 2007 when one of her patients, Antonitsa Vlahoulis, required a second surgery to replace the Myxo annuloplasty device.

Vlahoulis claimed that the Myxo annuloplasty device had caused stenosis, which is the abnormal narrowing of a blood vessel or an artery. Eventually Vlahoulis had to have a pacemaker surgically inserted.

Dr. Rajamannan also claimed that negative results of the experimental surgeries were not reported.

Maureen Obermeier had a heart attack during surgery, which wasn't reported until five years after the fact. But Dr. Rajamannan says Dr. McCarthy had previously stated that no one had a heart attack.

Dr. Rajamannan blew the whistle in July 2007 when she told Chief of Cardiology Dr. Robert Bonow, The Dean of Medical School Dean Jameson, the Institutional Review Board and the NMFF general counsel.

However, Dr. Rajamannan claims that she was simply told not to see any more of Dr. McCarthy's patients.

When it comes down to motivation as to why this practice goes on, the easy answer would be that doctors receive royalties for medical devices that are tested and approved.

According to Dr. Nalini Rajamannan, who was later fired, Dr. McCarthy continues to practice medicine on unsuspecting patients.

Dr. McCarthy refused to comment on this story.

Dr. Rajamannan has started a petition entitled: "Stop Implantation of non-FDA approved heart devices in US citizens."

On her petition, Dr. Rajamannan states, "Patients who go for open heart surgery, may receive non-approved FDA heart devices. The FDA is not planning on reporting to the patients if the devices are experimental. Thousands of patients have suffered and over 650 patients have died  across the USA who have this line of annuloplasty devices in their hearts according to the MAUDE database."

According to, she is now practicing medicine in Sheboygan, Wis.

Sources: CNN,,,