MARION TOWNSHIP, Mich. (WXYZ) — A Michigan woman has died just months following an elective back surgery after doctors discovered the bone graft material used in her surgery was contaminated with tuberculosis.
The material came from a now-recalled product that was distributed to seven states and implanted in 36 patients.
The Centers for Disease Control and Prevention and the Food and Drug Administration are now investigating after at least two confirmed deaths so far. Members of Congress are also getting involved.
Family has identified the woman as 57-year-old Shandra Eisenga of Marion, a small northern Michigan community near Cadillac.
In a small town like Marion, many people know your name but after years managing a local grocery store, Eisenga was well known in town, revered by many including her niece DaNay Tossey.
“Shandra was like another mom to me. She was the most selfless, kind, caring person you could ever meet,” Tossey said. “Everybody loved this woman. I don't think you could think of a bad thing to say about her. She just lived her life so full.”
When Eisenga had health issues, Tossey was one of three relatives who donated her a kidney. Otherwise healthy at age 57, Eisenga had back pain and opted for an elective back surgery, hoping it would help her keep up with her grandkids
“People are going into this thinking they are going to have a better life coming out, and some of them don't get a life at all,” Tossey said.
But it turns out Eisenga was one of 36 patients nationwide to receive a bone repair product from a lot contaminated with tuberculosis bacteria. After more than two months of strange symptoms and confusion among doctors, specialists at the University of Michigan diagnosed her tuberculosis and figured out where it came from.
“I think we were all in a bit of disbelief. For one, how can that happen?” Tossey said.
Shortly after, the company behind the product, Aziyo Biologics, issued a recall saying samples had tested negative by an independent lab before being sent out. The company along with the CDC and FDA are now investigating.
Aziyo released a statement:
We are saddened to learn that a second patient has passed after contracting an MTB infection linked to a single product lot from our viable bone matrix product.
Upon first learning of the infections, we immediately initiated voluntary withdrawal of our viable bone matrix products so that we could investigate the circumstances related to the MTB infections with health and regulatory authorities as quickly as possible. To our knowledge all affected product from the recalled lot has been removed from the field and has not been used in any procedures since that time.
Aziyo follows industry guidelines for the screening of donors and product release. Neither the American Association for Tissue Banks (AATB), the premier standard-setting body promoting the safety and use of donated human tissue, nor the U.S. Food and Drug Administration (FDA) mandate testing for MTB in cellular products.
With the intent to protect patients, Aziyo worked with outside experts to develop a test to screen for MTB where none was previously commercially available. Samples from the specific lot of bone matrix that was related to the MTB infections were tested prior to release by an independent laboratory using this nucleic acid test that is designed to specifically detect the MTB organism. The utilization of this test in our product release process exceeds guidelines set by both the AATB and the FDA.
Aziyo is committed to the highest quality and testing standards of our products to ensure the safety of patients. We continue to work closely with the AATB, FDA and CDC to further investigate the circumstances surrounding this event.
U.S. Congresswoman Debbie Dingell of Dearborn says Eisenga’s doctor was so concerned about what happened that he contacted her to do something.
“Her death is a real tragedy for everybody,” Dingell said.
She discovered the same company had a similar incident just two years ago that resulted in at least eight deaths. She also learned testing for tuberculosis is not required.
“This kind of material is not subject to being tested for TB or if the donor is susceptible to TB. I don't know how that could be or how that could happen,” Dingell said.
Dingell sent a letter to the FDA and the CDC with a list of questions. She says at least one other member of Congress is behind her.
“Trust me, we will be talking to all of our colleagues to say why did this happen and how are we going to make sure it never happens again,” Dingell said.
Like Dingell, Tossey wants answers but above all wants changes. By sharing Eisenga’s story, her family only hopes it won't be repeated.
“There's got to be some accountability for how it happened and what kind of changes are going to happen to make sure it doesn't happen again,” Tossey said “It's easy to be angry and easy to blame somebody but in anything, she wouldn't want all this attention. She would want to make sure this doesn't happen to anybody else."
The procedures being investigated all occurred at hospitals or dentist offices between late-February and late-June. The CDC is recommending all patients who received these products to begin treatment for tuberculosis regardless of symptoms.
