Heart valve patients say they still feel a prototype's effects a decade later

Posted at 10:00 PM, Sep 14, 2017
and last updated 2017-09-15 23:31:19-04

More than 10 years ago, nearly 60 people went in for a heart valve procedure. A Sheboygan doctor says Chicago's Northwestern Memorial Hospital leaders never told the patients the devices put in their chests were prototypes. 

Toni Vlahoulis says she went into heart surgery more than 10 years ago thinking her quality of life would drastically improve. She says she hasn't been the same since.

"The surgery was not successful because I felt worse than before the surgery," said Vlahoulis.

Vlahoulis says she had a McCarthy annuloplasty ring put in 2006, while hospitals still used the prototype model. It had not been approved by the FDA at that time.

"They only have it in their heart because they were never informed. Not at the time of the surgery, not before the surgery, or even after the surgery," said Dr. Nalini Rajamannan, Most Sacred Heart of Jesus Cardiology and Valvular Institute.

Dr. Rajamannan said often times the valve ring is too tight, putting pressure on an artery, which can cause heart attacks.

"I know we're ultimately in charge of our own health and our decisions, but with these kinds of things, we have to really count on the government, the FDA, to be working for the people," said Maureen Obermeier, heart valve patient.

In a statement the FDA says the device is safe, but that provides little comfort to those who say they suffered side effects. The administration also said further contacting those who received the devices could, "Unnecessarily alarm patients and raise unwarranted concerns."

"My daily activities that I used enjoy doing are limited. I work but I push myself. At the end of the day I'm short of breath," said Vlahoulis. 

Northwestern sent out two letters to patients who received the device saying the hospital does not consider the device experiential. Neither letter mentions possible side effects.

More than 650 people ended up with a slightly updated version of the device. 

We reached out to the manufacturer, Edwards Lifesciences, who referred us back to the FDA's studies showing the device was safe. 

A Northwestern spokesperson said in a statement, "The claims made by Dr. Rajamannan against Dr. Patrick McCarthy and Northwestern Memorial Hospital are without merit. A Cook County Circuit Court jury who heard these claims found in favor of Dr. McCarthy and Northwestern. In that case, in which Dr. Rajamannan testified as an expert witness against Dr. McCarthy, the court stated that the testimony that the Myxo ring was not an experimental device was “overwhelming." Dr. McCarthy is a renowned cardiothoracic surgeon that throughout his career has put his patients’ best interests first. We are proud to have him leading our cardiothoracic surgery staff in providing the best possible patient care."

Dr. Rajamannan says she's working with Rep. Glenn Grothman, (R) Wisconsin, to get more information from the federal government.

In a statement, a spokesperson for Grothman said, "Dr. Rajamannan came to Congressman Grothman with a concern about faulty heart valves. The congressman takes every constituent concern very seriously, and our office has sent two letters to the FDA inquiring about this issue. The health and safety of his constituents is one of Congressman Grothman’s main priorities, so he hopes to have these claims adequately investigated."

Correction: An earlier version of this story said both versions of the device were under voluntary recall by the FDA. The devices were recalled by Edwards Lifesciences after they were originally under investigation by the FDA. An Edwards Lifesciences spokesperson says that recall is no longer in effect.