TIPP CITY, Ohio — The Centers for Disease Control and Prevention (CDC) said the "nationwide investigation is ongoing" into a rare tuberculosis outbreak involving more than 100 patients in several states, including Ohio, who may been infected after having spinal and orthopedic procedures using a bone repair product contaminated with the bacteria that causes TB.
Tuberculosis, a bacterial disease that most commonly attacks the lungs, can become contagious and is deadly if left untreated, according to Dr. Charles Bark, Medical Director, TB Clinic, The MetroHealth System.
The CDC said there are 113 patients and eight deaths linked to a single contaminated lot of FiberCel, a bone putty made from the cells of cadavers.
An Ohio Department of Health spokesperson confirmed one of the deaths occurred in Ohio. Six Ohioans "underwent procedures with the affected lot," according to ODH.
The FDA requires human tissue used for products like FiberCel to be tested for several communicable diseases, including hepatitis, HIV, and syphilis, but not tuberculosis, according to a spokesperson.
The U.S. Food and Drug Administration (FDA) announced the recall on June 2 of one donor lot of FiberCel product. Aziyo Biologics, the product's manufacturer, voluntarily recalled 154 containers. The CDC said the containers were shipped to 37 facilities in 20 states between March 1 and April 2.
The CDC said there is no indication other units of FiberCel "are affected by this situation," adding that, "all facilities and states have been contacted and all unused units have been sequestered."
The CDC said "all surgical patients exposed to this product lot are now on treatment for TB disease." Eight states sequestered 18 units of the affected lot, according to the CDC.
Here are the states where the CDC says patients received the contaminated product:
18 States impacted by TB outbreak:
Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Minnesota, North Carolina, Ohio, Oregon, South Dakota and Virginia
2 States pulled the product before it was implanted in any surgical patients:
Texas and Washington
According to our sister station WRTV, there are at least 30 cases in Indiana of tuberculosis and 2 deaths. Eleven lawsuits have been filed.
The Ohio investigation
An ODH spokesperson said 5 units of the affected lot of FiberCel were received by three Ohio healthcare facilities, including:
- Mayfield Spine Surgery Center (Cincinatti)
- Miami Valley Hospital North (Dayton)
- Western Reserve Hospital, LLC (Cuyahoga Falls)
The Ohio Department of Health (ODH) said it is "working with the CDC, local tuberculosis (TB) control units, and affected healthcare facilities to investigate and respond to the TB outbreak associated with a contaminated bone allograft material (FiberCel)."
An ODH spokesperson said "The CDC notified ODH that three Ohio facilities had received the allograft product; ODH contacted the appropriate local TB control units to initiate communication with the specific healthcare facilities. CDC has issued guidance for the evaluation and treatment of patients who received a unit from the affected lot, and ODH has worked with the local TB control units to ensure anyone who received the product receives appropriate treatment. The local TB control units are providing care to affected individuals and report data to ODH who, in turn, reports outcome data to CDC."
OH hospital responses
Mark Bosko, VP Marketing and Public Relations, Western Reserve Hospital sent the following statement:
"Western Reserve Hospital was notified by the device manufacturer of the recall. Upon notification of the recall, the Ohio Department of Health took the lead on recommendations and investigation and we worked to identify one (1) patient with which the device was utilized approximately one month prior to the recall notice. Due to HIPAA regulations and patient confidentiality, no further details concerning this specific matter may be shared."
The Mayfield Spine Surgery Center sent the following statement:
“We cannot speak to a specific situation, however we take patient safety very seriously, and are committed to providing the highest level of quality care and experience for our patients."
Miami Valley Hospital North did not respond to News 5's voicemail or email requests for an interview.
'A wound that won't heal'
Michelle Weethee said she is one of the six Ohio patients who received the recalled FiberCel. She tested positive for TB and is undergoing treatment.
She had spinal surgery in April at Miami Valley Hospital North after suffering for years from back pain.
"The back pain that I initially had before my surgery is gone," she said. "But it’s been replaced with a different type of pain. Pain from a wound that won’t heal."
A few weeks after the operation, Weethee was at work when her wound split open. “All of a sudden, I felt a pop," she said. "That was the first sign that there was something wrong." The wound created a gaping hole in her back.
Inside, infection raged out of control. At first, she said her doctors were baffled, especially since nothing they were doing healed her wound, including three additional surgeries to clean out the infection and help the wound close. "I was afraid that there was something really wrong," she said.
The photo below of the wound on Michelle Weethee's back was taken on June 11, two days after her last surgery.
Source: Michelle Weethee / Sara C. Nichols, Beausay & Nichols Law Firm
Then, her doctors received a call from the CDC, she said, informing her she was one of the 113 patients who was implanted with the FiberCel that was recalled after other patients reported TB infections.
Michelle tested positive for TB. "I just don’t understand how somebody could miss this," Weethee said about the recalled FiberCel. “I feel like this is on the company and they dropped the ball.”
The TB facts
"This is a rare event," Bark said regarding the TB outbreak linked to the recalled FiberCel. "What would be the risk for this sort of infection with TB? It’s got to be extremely low."
Bark said TB cases are "not common" in the U.S., but still occur "on a regular basis." He said there are about 30 cases a year in Cuyahoga County.
Bark said it is estimated there are as many 13 million Americans infected with TB but who do not have symptoms. He said there are close to 9,000 cases diagnosed each year.
Prior to COVID-19, TB was the leading cause of death from infectious disease around the globe. "TB is a still a major problem throughout the world. It’s really an ongoing global pandemic with 11 million or 10 million cases every year," he said.
He said he doesn't know how difficult it would be to test allograft tissue for TB or how the bone repair product could have become contaminated with TB.
"I think when you have these sort of outbreaks, or these sort of issues, especially when they lead to pretty dire consequences, I imagine that it’s something that they’re going to go back and look at and often these sort of regulations change over time and also with testing technology," Bark said.
Aziyo Biologics, Inc. statement
News 5 made multiple requests for an interview with Aziyo Biologics. A spokesperson declined our requests, but sent News 5 the following statement:
“Ensuring patient health and safety is our highest priority at Aziyo Biologics, Inc. We are fully committed to determine the medical root cause of these adverse events. We will be fully transparent through this process and continue to cooperate with both the FDA and the CDC in an ongoing investigation to understand whether there is any causal relationship between the post-surgical infections and the FiberCel single donor lot used.
"We have reviewed our procedure for screening donors and producing this product and have not identified any deviations from our established protocols, which are based on industry standards and government requirements.
"We are evaluating adjustments to our donor screening and testing methodology and process to broaden detection of disease beyond existing industry standards.
"Our culture is built on the principle of continuous improvement in the safety, efficacy and quality of our products.”
When asked where the infected tissue was procured and whether it was tested for tuberculosis, the spokesperson responded, "The company does not have any further comment at this time."
A lost summer
"I thought this was going to be the summer of getting back out and kayaking and tubing and hiking with our dog and doing all the things that I haven’t been able to do," Weethee said.
Instead, Weethee has been mostly stuck inside her home. After being diagnosed with TB, she said her wound finally began to heal. However, her medical treatments for TB are intense.
She said she now takes 12 pills a day to treat the infection, which she has to take for up to a year — maybe longer. "The antibiotic is pretty rough," she said. "My whole life right now centers around me being sick."
The side effects of her medication include nausea, vomiting, and fatigue. She said her joints are sore. She has little appetite and has lost weight.
"That’s the only treatment for TB," she said. "So I just have to take it and the take the side effects with it in order to try to get healthy."
Weethee recently had a wound vac that was attached to her removed after it was used to help her heal more quickly. During our interview, she said, "I feel like I’m tethered to like a ball and chain or something."
“It breaks my heart that this is what my life has come to," she said.