Doctors Experimenting on Humans

What is this about?

The case is about a factual controversy that surrounded the experimental usage of a heart valve device called a Myxo ring. Dr. Rajamannan accused the inventor of the device, Dr. McCarthy, with using the Myxo ring on patients with surgical needs without their knowledge that the device is not licensed. McCarthy and university refuse the accusations arguing that the ring is FDA approved. Some conflict of interests issues are also discussed.

Why is this important?

The development of innovative materials and devices for better treatment and health care are significant goals of medicine. New materials and devices must be tested on patients in professional infrastructure, in controlled settings with properly following the ethical and legal regulation on clinical trials on medical devices. Informed consent and independent REC approval are necessary conditions.