Patient Dies After Receiving Contaminated Fecal TransplantNovember 18, 2019
Fecal microbiota transplants (FMT) is a procedure that involves transplanting feces from a healthy donor into the bowels of a sick patient. While this may sound like a questionable procedure, it has been proven to be highly effective at restoring a sick patient’s microbiome with the beneficial bacteria and other organisms that exist in the intestines. It has been particularly effective at treating Clostridium difficile, a deadly bacterial infection that kills thousands of Americans each year. Recently, a cancer patient at Massachusetts General Hospital died, and another became very sick after receiving a fecal transplant that was contaminated with a type of drug-resistant E. coli bacteria after the lab failed to test the donor stool.
The incident was reported to the U.S. Food and Drug Administration (FDA), and the agency immediately issued a nationwide alert notifying health care providers and patients about the potential health risks associated with the procedure. In addition, the agency recommended that researchers suspend all transplants until the labs were able to screen the samples and ensure that there were no drug-resistant microbes present. The E. coli that caused the patients at Mass General to become ill produced an enzyme called extended-spectrum beta-lactamase. This bacterium is usually harmless in healthy people but can cause serious health issues in patients with compromised immune systems. A medical malpractice lawyer can help you explore your legal options if you believe you have been wronged by a hospital.
According to a disease specialist at Mass General, doctors had been following FDA protocols to test stool donations for a range of infectious bugs. In January 2019, the FDA updated its screening standards to include the drug-resistant strain of E.coli, as well as other emergent organisms. The specialist also said that the FDA did not tell doctors to test or get rid of older samples that were in storage.
Future of FMT is Unclear
The specialist and other practitioners involved in the field of fecal microbiota transplantation are concerned about how this incident will impact the future of FMT. The FDA will hold a public hearing in Washington to obtain more information about the risks and benefits of FMT. In the meantime, the FDA allows enforcement discretion, an approach that allows Clostridium difficile patients who have not responded to standard therapies to have fecal transplants. The FDA released a statement saying that the use of FMT to treat C. difficile is investigational, and the efficacy and safety of the therapy has not been established.
The incident at Mass General is an example of how challenging it is to develop therapies using fecal transplants. Certain organisms have been able to evolve and become resistant to a wide range of antibiotics. There is always the fear that a new, more virulent bug will find its way through the screening process. This can have very serious consequences on the health of patients, particularly those who have a compromised immune system.
Baltimore Medical Malpractice Lawyers at LeViness, Tolzman & Hamilton Advocate for Victims of Contaminated Fecal Transplants
If your health was compromised after undergoing a fecal transplant, contact the Baltimore medical malpractice lawyers at LeViness, Tolzman & Hamilton as soon as possible. We will thoroughly investigate the details of your case and determine whether your health care provider was negligent in any way. Our experienced legal team will secure the maximum financial compensation you deserve. To schedule a free consultation, call us today at 800-547-4LAW (4529) or contact us online.
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