Legislation Passed in Response to TB-Related Death Linked to Contaminated Bone Graft in Michigan

In a decisive move, the U.S. House of Representatives has unanimously approved a bill prompted by the tragic death of a woman from northern Michigan last year, who succumbed to tuberculosis (TB) linked to contaminated bone graft material received during elective surgery.

The legislation was debated in the presence of the family of Shandra Eisenga, a 57-year-old who passed away due to complications from post-surgical TB. During the discussion, Representative John Moolenaar from Michigan recognized the family, noting the personal connection as one of Eisenga's relatives works on his staff.

Moolenaar emphasized the importance of this legislative action, stating that the deaths of Eisenga and nine other patients in recent years were preventable, citing insufficient oversight of tissue material suppliers as a significant issue. He detailed that while the Food and Drug Administration (FDA) mandates screening for diseases like hepatitis and HIV in tissue donations, this bill seeks to add TB screening to that list, aiming to prevent further fatalities.

Amber Herlein, Eisenga's daughter, expressed gratitude for the passage of the bill, acknowledging that while nothing can bring back her mother, the legislation represents a positive change that could spare other families from similar heartache.

Eisenga's death occurred on August 10, 2023, after she was hospitalized for a TB infection following a spinal procedure in which contaminated bone graft material was used. Dr. Robert Dickson, a physician involved in her case, confirmed that the infection was traced back to a bone graft product from a deceased donor, which was administered to multiple patients during surgeries and dental procedures in 2023.

In response to the outbreak, Aziyo Biologics, the company responsible for the contaminated graft, initiated a voluntary recall of its products. The same company had previously been linked to a 2021 TB outbreak that resulted in eight deaths and numerous infections.

Despite the company's claims that the specific lot of donor tissue had tested negative for Mycobacterium tuberculosis prior to its release, lawmakers are advocating for heightened measures to prevent such tragedies in the future. The newly approved legislation includes provisions for public awareness campaigns to educate patients about the risks associated with bone graft donations and other human cell and tissue transplants.

Representative Debbie Dingell highlighted the necessity of such awareness, recalling her own experiences with bone grafts without being informed of the associated risks. She stressed that patients must be adequately informed to avoid similar incidents.

The bill also instructs the FDA to provide updated guidance for determining donor eligibility for tissue products, aiming to mitigate the risk of transmitting Mycobacterium tuberculosis or sepsis. Additionally, it mandates the FDA to disclose its inspection activities related to human cell and tissue establishments, and it establishes civil penalties for companies failing to adhere to compliance standards.

Representative Kathy Castor pointed out the lack of significant repercussions within the human cell and tissue products industry, asserting that the legislation would equip the FDA with the necessary enforcement tools to enhance public safety effectively.