House passes bill after TB death of Michigan woman who received tainted bone graft material

The U.S. House on Monday unanimously adopted legislation prompted by the death last year of a 57-year-old northern Michigan woman who died from tuberculosis linked to contaminated bone graft material she had received via elective surgery.

The family of Shandra Eisenga looked on from the House gallery as the lawmakers debated the legislation on Monday afternoon. U.S. Rep. John Moolenaar, R-Caledonia, acknowledged them from the floor, noting that one of them was his staffer, Tarin Brunink, Eisenga’s sister.

“Today, we are taking concrete action to help stop more families from having this same, terrible experience. Shandra’s passing, as well as nine other patients over the past three years, was completely preventable, if it was not for the inadequate oversight of tissue material suppliers,” Moolenaar said.

“When it comes to tissue donations, the FDA requires screening for diseases like hepatitis, syphilis and HIV. This bipartisan bill will require screening for tuberculosis, as well, and put an end to preventable TB deaths like Shandra’s.”

Amber Herlein, Eisenga’s daughter, said in a statement that nothing can erase the heartbreak of her mother’s death, “but she would be proud that we have helped make a positive difference in her name.”

“I am so thankful the House approved this bill today so no family has to go through an experience like this,” Herlein said.

Eisenga, 57, of Marion died Aug. 10, 2023, after being treated for a post-surgical TB infection in an intensive care unit at the University of Michigan in Ann Arbor.

She had contracted the TB from a contaminated bone graft product that was placed into her back during an elective spinal procedure she underwent in April of last year, according to Dr. Robert Dickson, who consulted on her case as program physician for the Washtenaw County Tuberculosis Clinic.

The contaminated bone tissue product from the same deceased donor was used in 36 patients who underwent surgical or dental procedures in hospitals and dental offices in 2023.

After the illnesses, Aziyo Biologics initiated a voluntary recall of its “viable bone matrix products,” which are made from human tissue and used primarily in orthopedic and spinal procedures. The same company was involved in the outbreak of TB in 2021 in which eight people died and at least 87 developed a TB infection.

Aziyo Biologics said in a statement at the time that samples from this specific lot of donor tissue prior to release had tested negative for Mycobacterium tuberculosis— the bacterium that causes TB.

Lawmakers said the bill adopted Monday aims to raise awareness about the risks of such bone graft donations and other human cell and tissue product transplants by requiring a public awareness campaign.

Rep. Debbie Dingell, D-Ann Arbor, emphasized the importance of such a campaign, noting that when this incident occurred with Eisenga, she had had multiple bone grafts because of osteomyelitis, a bone infection.

“I never once was warned of any danger, and my doctor was unaware of these dangers,” Dingell said on the floor. “We cannot let that ever happen again. We must protect patients and educate patients.”

The legislation also directs the Food & Drug Administration to issue updated guidance for the industry for determining eligibility for donors of such tissue, including recommendations to reduce the risk of transmission of Mycobacterium tuberculosis or sepsis by human cells, tissues and cellular and tissue-based products.

The bill also requires the FDA to disclose information such as the agency’s inspection activities related to human cell and tissue establishments, and creates a civil penalty ($20,000 for each violation) for companies that are found to not meet compliance standards.

“There are currently few meaningful repercussions in the human cell and tissue products industry, so this legislation would change that by providing the Food and Drug Administration with additional enforcement tools to move more quickly and effectively to protect the public,” said Rep. Kathy Castor, D-Florida.

2024 www.detroitnews.com. Distributed by Tribune Content Agency, LLC.

The U.S. House on Monday unanimously adopted legislation prompted by the death last year of a 57-year-old northern Michigan woman who died from tuberculosis linked to contaminated bone graft material she had received via elective surgery.

The family of Shandra Eisenga looked on from the House gallery as the lawmakers debated the legislation on Monday afternoon. U.S. Rep. John Moolenaar, R-Caledonia, acknowledged them from the floor, noting that one of them was his staffer, Tarin Brunink, Eisenga’s sister.

“Today, we are taking concrete action to help stop more families from having this same, terrible experience. Shandra’s passing, as well as nine other patients over the past three years, was completely preventable, if it was not for the inadequate oversight of tissue material suppliers,” Moolenaar said.

“When it comes to tissue donations, the FDA requires screening for diseases like hepatitis, syphilis and HIV. This bipartisan bill will require screening for tuberculosis, as well, and put an end to preventable TB deaths like Shandra’s.”

Amber Herlein, Eisenga’s daughter, said in a statement that nothing can erase the heartbreak of her mother’s death, “but she would be proud that we have helped make a positive difference in her name.”

“I am so thankful the House approved this bill today so no family has to go through an experience like this,” Herlein said.

Eisenga, 57, of Marion died Aug. 10, 2023, after being treated for a post-surgical TB infection in an intensive care unit at the University of Michigan in Ann Arbor.

She had contracted the TB from a contaminated bone graft product that was placed into her back during an elective spinal procedure she underwent in April of last year, according to Dr. Robert Dickson, who consulted on her case as program physician for the Washtenaw County Tuberculosis Clinic.

The contaminated bone tissue product from the same deceased donor was used in 36 patients who underwent surgical or dental procedures in hospitals and dental offices in 2023.

After the illnesses, Aziyo Biologics initiated a voluntary recall of its “viable bone matrix products,” which are made from human tissue and used primarily in orthopedic and spinal procedures. The same company was involved in the outbreak of TB in 2021 in which eight people died and at least 87 developed a TB infection.

Aziyo Biologics said in a statement at the time that samples from this specific lot of donor tissue prior to release had tested negative for Mycobacterium tuberculosis— the bacterium that causes TB.

Lawmakers said the bill adopted Monday aims to raise awareness about the risks of such bone graft donations and other human cell and tissue product transplants by requiring a public awareness campaign.

Rep. Debbie Dingell, D-Ann Arbor, emphasized the importance of such a campaign, noting that when this incident occurred with Eisenga, she had had multiple bone grafts because of osteomyelitis, a bone infection.

“I never once was warned of any danger, and my doctor was unaware of these dangers,” Dingell said on the floor. “We cannot let that ever happen again. We must protect patients and educate patients.”

The legislation also directs the Food & Drug Administration to issue updated guidance for the industry for determining eligibility for donors of such tissue, including recommendations to reduce the risk of transmission of Mycobacterium tuberculosis or sepsis by human cells, tissues and cellular and tissue-based products.

The bill also requires the FDA to disclose information such as the agency’s inspection activities related to human cell and tissue establishments, and creates a civil penalty ($20,000 for each violation) for companies that are found to not meet compliance standards.

“There are currently few meaningful repercussions in the human cell and tissue products industry, so this legislation would change that by providing the Food and Drug Administration with additional enforcement tools to move more quickly and effectively to protect the public,” said Rep. Kathy Castor, D-Florida.

2024 www.detroitnews.com. Distributed by Tribune Content Agency, LLC.