By Alaynah Pelton
Shandra Eisenga was 57 years old when she passed away from complications of tuberculosis after receiving an infected bone graft from a doner.
This preventable tragedy has pushed lawmakers to call for the FDA to enhance regulations, especially after the company who supplied the infected tissue has a history of such issues.
Azyio Biologics, who supplied the bone graft to Eisenga’s doctor, had a similar outbreak in 2021 which led up to 100 patients receiving harmful grafts. Of those patients, eight unfortunately passed away.
Azyio took further precautions with testing after the incident in 2021, but unfortunately it wasn’t enough to prevent the same thing from occurring again. Along with Eisenga, 36 other patients throughout seven states received tissue from the same infected donor.
This pattern has resulted in a letter from congressmen and senators to FDA commissioner Robert Califf “to issue guidance or regulations based on sound science to protect patients and increase accountability for human tissue transplant products.”
Eisenga was loved by her family and her community. As noted in her obituary, Eisenga was a local in Marion and known for her warm smiles. She was known at local grocery stores where she worked until her health forced her to stop.
“The tragic loss of Shandra Eisenga must be a call to action for Commissioner Califf and the FDA so that no family goes through something like this again,” said Congressman John Moolenaar. “It is clear that the precautions taken after the 2021 TB outbreak have not been enough and that the FDA must do more to protect patients. Commissioner Califf should act urgently to prevent more outbreaks like this one from happening in the future,”
In their letter to the FDA Commissioner the lawmakers stated that “No patient should suffer such devastating health outcomes from a transplant product.” They are eager to address these issues and “look forward to your response and welcome any opportunity to work together to prevent future outbreaks.”
Eisenga is laid to rest at Highland Hillside Cemetery. Should one wish to send flowers, the family asks that memorial contributions be made to help with the cost of the funeral or to a charity.