Mother claims unapproved heart valve implanted in her child by UPMC Children's Hospital
PITTSBURGH (KDKA) — An Erie County mother claims UPMC Children's Hospital of Pittsburgh wrongfully implanted an experimental heart valve in her son without their knowledge.
As KDKA-TV money editor Jon Delano reports, that has led to a congressional inquiry and strong denials from UPMC.
At age 14 in 2017, Michael Carlo had a heart valve implant at UPMC Children's Hospital that he and his mother say was experimental and unapproved by the Food and Drug Administration.
"I was implanted with what I was told was a MASA valve, which was made of Gore-tex, which I didn't know at the time wasn't approved," he said.
Neither did his mother, Ann-Marie Swanson, who signed the consent form without full knowledge, she says.
"We followed the recommendation of the doctor at UPMC," she said. "Yet, he did not disclose to us that it was not FDA approved, that it was experimental."
A few years later, Carlo said, the valve started to fail.
"For about a year, I went through congestive heart failure, and the valve was quite literally falling apart inside of me," he said.
He credits doctors at the Mayo Clinic with saving his life by removing the UPMC implant and replacing it with an FDA-approved valve.
But he worries about others. He and his mother reached out to Congressman Mike Kelly, who referred the matter to a congressional committee that is asking the FDA to clarify the use of experimental devices and informed consent.
"I'd like them to get to the bottom of this," Carlo said. "I want them to find out how many kids did they do this to. How many people didn't know that their kid was implanted with an experimental heart valve? These people experimented on children without their parents knowing."
UPMC strongly rejects claims it did anything wrong, noting, "We've never implanted any experimental valves in anyone. Period. For all patients who undergo cardiac procedures, all materials used in their treatment are FDA-approved. And we always obtain the proper consent."
However, Swanson says this experience has led to this conclusion when it comes to her child's health care.
"Research for yourself," she said.
So far, the FDA has not responded to the House Commerce Committee's letter of inquiry.