Feds to probe UPMC heart implant practices

As part of a national inquiry, the House Committee on Energy and Commerce is asking the FDA to investigate whether patients received experimental heart implants at UPMC Children's Hospital of Pittsburgh without consent or proper information, the Pittsburgh Post-Gazette reported March 24.

The panel asked the FDA to determine whether physicians at UPMC had the necessary permission to insert a MASA valve device, which is used to regulate blood flow between the heart and lungs, in children. The case comes after the mother of a 14-year-old boy said she was not aware that the implant her son received was not FDA approved.

As part of the inquiry, the FDA was asked to turn over records of any other investigations by the agency into experimental medical devices used on patients since 2019 without their consent. The probe could determine whether the FDA is using its authority to ensure patients are informed of the risks before undergoing certain procedures.

The MASA implant is partially made of a material not approved for use in heart implants, according to the committee, and it is unclear if families should have been notified.

The procedure was developed by cardiothoracic surgeon Masahiro Yoshida, MD, PhD, who joined UPMC in 2008 but now works in Japan. He carried out nearly 90 implants on children with congenital valve defects, according to an article in the system's Pediatric Insights publication. The version of the valve that was approved in 2022 for clinical trial by the FDA came years after UPMC allegedly started using the device in surgeries, according to the Post-Gazette

The device could be implanted into some patients with FDA approval; however, some allege the system was using the devices without approval.

A hospital spokesperson told the Post-Gazette that UPMC provides necessary information to patients to obtain their consent and that the valve implants were carried out under an established medical practice.

"This technique of building and implanting specific valved-conduits for pediatric patients is a longstanding standard of clinical care," the hospital system said, adding that the fabric used in the device is approved by the FDA.

A hospital spokesperson also told Becker's that "We have never participated in any clinical trials involving PECA Laboratory or PECA Laboratory's created and produced MASA valve. We have never implanted any PECA Laboratory created and produced MASA valve on any patient at UPMC Children's Hospital of Pittsburgh. For all patients who undergo cardiac procedures, all materials used in their treatment are FDA-approved."

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