A children’s hospital in Pennsylvania has been accused of implanting an unapproved medical device in a 14-year-old patient without receiving proper consent—and now members of Congress want the U.S. Food and Drug Administration (FDA) to investigate.
The Pittsburgh Post-Gazette highlighted the accusation—and a mother’s search for answers—in a thorough report dated March 25. According to the report, this story begins when Ann-Marie Swanson’s son was 14 years old and received an artificial heart valve at UPMC Children’s Hospital of Pittsburgh in 2017. He had been experiencing heart issues his whole life, and UPMC’s care team implanted a valve similar to the experimental MASA valve to treat the issue.
Swanson’s son started experiencing heart complications four years later. By early 2022, it was clear the implant had failed and blood was leaking into the right ventricle; it was surgically removed at Mayo Clinic and replaced with a bioprosthetic valve.
Swanson’s son, now 21, is doing well—but she still wants more details about what happened. She alleges that the heart valve implanted in her young son was still experimental at the time and had not yet been approved by the FDA. While she did give the hospital permission to implant the device, she says the full situation was not properly explained to her at the time.
Swanson wrote multiple letters in her search for clarity, and her story eventually made its way to the House Committee on Energy and Commerce, one of the oldest committees in the U.S. House of Representatives. That group then sent a letter to the FDA asking the agency to review what happened and turn over any relevant documentation.
UPMC has responded to these allegations by saying it followed standard procedures and its action were “appropriate,” as the Pittsburgh Post-Gazette explained in its report. The hospital also emphasized that the off-label use of devices is permissible when believed to be necessary.
Click the link below for the full story, including more context about the valve in question and the FDA’s initial reaction to this incident:
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.