INDIANAPOLIS — The Indiana State Department of Health and the Centers for Disease Control (CDC) are investigating an unexpected tuberculosis outbreak in Indiana tied to a bone-repair product used in Indiana hospitals.
Tuberculosis, a disease caused by bacteria, can attack the lungs and become contagious, even deadly.
The Indiana State Department of Health tells WRTV Investigates they’re aware of 30 tuberculosis cases in Indiana linked to FiberCel, a product used for spine and orthopedic procedures.
Machell Hargrave of Ridgeville Indiana thought she was going in for a routine spinal surgery—a disc fusion on April 20 at Reid Hospital in Richmond.
“The surgery was a success,” said Hargrave.
But days later, Hargrave knew something wasn’t right.
"I was having chills, fever,” said Hargrave. “I just felt like somebody beat me up."
Hargrave’s doctors told her the product used on her spine, FiberCel, had been recalled following reports of patients developing tuberculosis.
“I was just scared to death,” said Hargrave. “I’ve never been so scared ever.”
FiberCel’s website shows it is manufactured by Aziyo Biologics and sold through Medtronic.
The U.S. Food and Drug Administration (FDA) announced the recall on June 2 of one donor lot of FiberCel product.
Hargrave was initially placed in isolation, as tuberculosis can be contagious, even deadly.
“I was in a hospital room by myself and was trying to process everything,” said Hargrave. "I can't even express how scared I was that day."
Hargrave did test positive for tuberculosis.
She’s not contagious, but now must take four medications a day.
A nurse with the health department has to watch her take her pills in person and over Zoom.
"I can't just go to the sink and take the pills and be done,” said Hargrave. “I have to be on a face call with her and she has to watch me take it."
Hargrave is not alone.
State health officials are investigating a link between at least 30 cases in Indiana of tuberculosis and one particular donor lot of FiberCel.
Records show the product was used at the following facilities between March 5 and April 20 of this year:
- DuPont Hospital in Fort Wayne
- Surgicare in Bloomington
- Reid Hospital in Richmond
The CDC says 37 facilities in 20 states received the impacted product in March and April.
“At present, there is no indication that other units of FiberCel are affected by this situation,” read a statement from the CDC to WRTV Investigates. “All facilities and states have been contacted and all unused units have been sequestered.”
Carmel law firm Wagner Reese filed four lawsuits just last week on behalf of patients who contracted tuberculosis during surgeries at Indiana facilities.
Machell Hargrave is represented by Wagner Reese, and she filed a lawsuit on June 23.
"All they wanted to do was go in for a simple surgery and now their life has been forever altered,” said Tim Karns, attorney at Wagner Reese.
Patients represented by Wagner Reese are suing FiberCel’s manufacturer, Aziyo Biologics, as well as the product’s sellers and distributors— Medtronic, SpinalGraft Technologies and Rapp Medical Systems.
They allege the bone repair product was defective, “unreasonably dangerous,” and that its labeling had no warning about the risk of tuberculosis infection.
Karns said FiberCel is harvested from cadavers and is tested for HIV, hepatitis, and syphilis.
"They either didn't test for tuberculosis or whatever they did do was inappropriate and didn't work,” said Karns.
Karns said the impact on patients in Indiana has been devastating.
"It's not just medical bills, it's lost wages,” said Karns. “These people haven't been able to go back to work. They’re on a medication regime and they have a disease that can prove communicable – they may be in isolation for 12 months and at that point it’s not clear if the disease could resolve or go latent.”
Machell Hargrave has been out of work since her surgery in April and is struggling financially and physically.
"People just don't understand that this isn't just going to go away,” said Hargrave. “I'm on medication for twelve months and it could be longer. It isn't just a 10-day regimen of antibiotics. It's nothing like that."
She filed a lawsuit in the hopes of getting help with her medical bills and to hold the companies responsible.
"Something went wrong and they need to figure that out before this happens down the road to somebody else,” said Hargrave. "These companies do need to be held accountable for the lives they've touched. Everybody this has gone in."
The CDC says all patients who received the impacted product are getting full treatment for tuberculosis even if they don’t have symptoms.
The CDC is investigating how the tuberculosis contamination may have happened.
“At this point, the available evidence suggests that TB was transmitted through the product,” read a statement from the CDC. “The risk of TB transmission through bone grafts has been rare, with only one case report available in the published literature (from 1953).”
The CDC is also working with state and local health departments, hospitals to prevent similar outbreaks in the future.
Reid Hospital in Richmond tells WRTV they’ve identified seven patients who received the affected product and all patients have been notified.
“Reid notified all seven patients of their involvement in the Aziyo Biologics recall and advised them of the company’s stated risk of surgical infections with a potential link to Tuberculosis,” read the statement from Reid Hospital. “All seven patients were advised to immediately see Dr. Matthew Vail, Reid’s Infectious Disease physician for appropriate testing and treatment.”
DuPont Hospital Statement
In conjunction with the Indiana State Department of Health and Allen County Department of Health, Lutheran Health Network has completed testing for patients who received a product recently linked to potential post-surgical infections. We are following the Centers for Disease Control and Prevention (CDC) recommendations and continue to work closely with health department officials on this matter.
Reid Hospital Statement
On June 2, 2021, Rapp Medical, in conjunction with Medtronic and Aziyo Biologics, Inc., notified Reid Health that a single lot of FiberCel Allograft product manufactured by Aziyo Biologics, Inc. had been recalled. Reid was identified as being one of several facilities in the state and nation that received product from this specified lot. Reid officials identified seven patients who received the affected product. Reid notified all seven patients of their involvement in the Aziyo Biologics recall and advised them of the company’s stated risk of surgical infections with a potential link to Tuberculosis. All seven patients were advised to immediately see Dr. Matthew Vail, Reid’s Infectious Disease physician for appropriate testing and treatment.
Aziyo Statement
We cannot comment on pending legal matters. Aziyo continues to work with the FDA and the CDC and is committed to a thorough, timely, and transparent investigation. Aziyo’s June 22 8-K filing with the SEC here [nam02.safelinks.protection.outlook.com] provides updated information on the status of this investigation and notification of patients who were treated with the product lot.
Medtronic Statement
Consistent with the company’s commitment to patient safety, Medtronic fully supports Aziyo’s decision to issue a voluntary recall of the affected lot of FiberCel Viable Bone Matrix (VBM), which was manufactured by Aziyo Biologics and shipped directly to healthcare providers. As the exclusive distributor of Aziyo’s FiberCel VBM, Medtronic is working closely with Aziyo and the Centers for Disease Control and Prevention (CDC) to notify all customers who may have received product from the affected lot that is subject to this voluntary recall. Medtronic is also working with Aziyo and the CDC to ensure that healthcare providers and patients have the necessary guidance to manage care and treatment of impacted patients, and to establish a patient support program. In keeping with its commitment to patient safety, Medtronic has suspended all distribution of Aziyo’s FiberCel VBM until completion of the CDC investigation with Aziyo.
CDC Statement
CDC is working with health departments to respond to a tuberculosis (TB) cluster in spinal surgery patients in several states. These surgical procedures all used a single product lot of FiberCel, a bone allograft, manufactured by Aziyo Biologics and distributed by Medtronic (FiberCel lot NMDS210011). On June 2, the manufacturer proactively issued a voluntary nationwide recall [fda.gov] of the single lot of FiberCel linked to these patients.
The manufacturer reported that 154 units of the FiberCel product, from a single donor, were shipped to 37 facilities in 20 states from March 1 to April 2. At present, there is no indication that other units of FiberCel are affected by this situation. All facilities and states have been contacted and all unused units have been sequestered.
Here is more information about the patients and sequestered units as of June 21, 2021:
- Healthcare providers contacted 105 patients who had surgery using this product lot to evaluate and treat them for TB disease
- All surgical patients exposed to this product lot are now on treatment for TB disease.
- Eight states were able to sequester 18 units, preventing additional surgeries using the affected lot.
CDC recommends that all patients who received this product lot immediately begin full treatment for TB disease, even if they do not have any symptoms. CDC’s recommendation is based on the risk of localized TB disease in areas involved in surgery, in the spine or other bones, and in other parts of the body. CDC is also providing guidance to healthcare facilities to prevent transmission of TB between patients and protect healthcare personnel who may have exposed during patient surgery and patient care, including environmental services personnel and decontamination reprocessing personnel.
TB is caused by a bacterium called Mycobacterium tuberculosis. The bacteria usually attack the lungs but can also attack any part of the body such as the kidney, spine, and brain. TB can cause severe health problems and death if untreated.
CDC is working with partners, including the U.S. Food and Drug Administration (FDA), to determine how the TB contamination may have happened. At this point, the available evidence suggests that TB was transmitted through the product. The risk of TB transmission through bone grafts has been rare, with only one case report available in the published literature (from 1953).
CDC, state and local health departments, hospitals and surgical centers in the affected states, and FDA are working together to prevent further patient harm and determine if additional measures can be taken to prevent similar outbreaks in the future.
If you have questions about patients or healthcare facilities in a particular state, please call that state’s health department.
ISDH Statement
The Indiana Department of Health is working with local health departments and providers to investigate individuals across the state who received a bone repair product that has been linked to tuberculosis infections across the United States. All affected individuals have been notified and appropriate public health actions have been taken. Tuberculosis cases must be reported to the local health department within 24 hours per Indiana’s Communicable Disease Rule [in.gov] [protect2.fireeye.com]. There are 30 cases reported because according to the CDC, anyone who received the product is considered a case. An outbreak is an increase in the expected number of TB cases, but this is a unique situation and not a typical tuberculosis outbreak. Historical tuberculosis data may be found here [in.gov] [protect2.fireeye.com].
