A Michigan woman is among the two deaths that federal officials have linked to bone graft material infected with bacteria that causes tuberculosis.

Family members said Shandra Eisenga, 57, of Marion in Osceola County, developed TB, a bacterial infection that can cause serious illness, after undergoing an elective back surgery in April. She died Aug. 10, according to her obituary.

The U.S. Centers for Disease Control and Prevention (CDC) has identified 36 people across seven states that received grafts from the same lot, including two people who have died. Officials have said they’re working to respond to the cases and get treatment to those potentially infected.

Bone grafting is a surgical option that uses transplanted or artificial bone to repair diseased or damaged bones. Bone grafts have been used for centuries and about 2.2 million procedures are done each year, according to data from 2021.

Health officials said the cases appear to be linked to a single product lot used in surgical and dental procedures. Shipments were sent to 13 facilities across seven states, including Michigan, between Feb. 27 and June 20.

On July 13, the product manufacturer, Maryland-based Aziyo Biologics, announced a recall of its viable bone matrix products, which are bone repair products made from human tissue and used primarily in orthopedic and spinal procedures.

Aziyo said samples from the lot had initially tested negative for TB by an independent lab using a nucleic acid test before being released. The company said it is cooperating with the CDC and U.S. Food and Drug Administration (FDA), and has notified physicians of the patients who received grafts from the donor lot.

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In a letter to the FDA and CDC, U.S. Rep. Debbie Dingell, D-Ann Arbor, said the outbreak demonstrates an urgent need for stronger safety standards and a “frightening wake-up call about the need to educate patients about the potential risks.”

“As someone who has received several bone grafts in the last couple of years and signed consent forms on automatic pilot, I admit I didn’t take the time to even understand the potential risks,” she said in a prepared statement.

Eisenga’s family hopes that by sharing her story, it will reach the right people to prevent this from ever happening again.

DaNay Tossey said her aunt will be remembered for being “sweet, simple and good.” She loved big without judgement, and had a way of making everyone around her feel like the most important thing to her in the moment.

“I hope that we can all live a little more like Shandra,” Tossey said. “Choose sweetness over bitterness, choose to keep life simple and see the good in even the worst days -- just like Shandra did.”

In Dingell’s letter to the FDA and CDC, she said the Michigan patient -- who she didn’t name -- spent a month being treated for a severe post-surgical TB infection in an intensive care unit in Washtenaw County before she died. She had “no other possible way of contracting tuberculosis and the primary site of infection was the site of the ViBone Moldable insertion,” the letter reads.

The congresswoman also raised concern about the company’s “troubled history,” noting a similar outbreak in 2021 involving contaminated products. In that case, units of the bone graft product were implanted into 113 recipients in 18 states. At least 87 patients developed TB, and eight died.

“It is unacceptable another outbreak of this kind to occur at all — let alone another outbreak from the same company — due to TB-contaminated materials,” Dingell wrote.

The letter concludes with a list of 10 questions about the response to the current outbreak, donor eligibility and testing requirements, and plans to update the FDA’s bone tissue testing requirements.

“No family should have to grieve the loss of a loved one due to a preventable death,” Dingell wrote in her letter to the FDA and CDC. “I look forward to working with you to strengthen the regulation of human tissue implantation to ensure these outbreaks do not continue. We must ensure that our laws and regulations are strong enough to prevent this from happening again.”

Federal health officials are working with local health departments, hospitals and dental offices in the affected states to identify patients that received bone grafts from the tainted lot. Treatment is recommended, even without symptoms, for those patients and any healthcare personnel who may have been exposed to the bacteria during surgery or patient care.

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