Two patients became seriously ill and one died after receiving fecal transplants (“bacteriotherapy”) that contained an antibiotic-resistant strain of E.coli. The patients received the procedure for treatment of Clostridium difficile (C. diff) infections, which cause inflammation of the colon. Patients with compromised immune systems in hospital settings are at the highest risk for C. diff. Used when patients do not respond to standard treatment for C. diff, fecal transplant involves transferring the stool of a healthy person to the intestines of a sick person in order to produce good bacteria and fight infection.

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The two immuno-compromised adults had fecal transplants with stool from the same donor. After the procedure, they both developed invasive infections from a rare strain of drug resistant bacteria called extended-spectrum beta-lactamase (ESBL) E.coli. A stored sample of the donor stool tested positive for the same E. coli strain found in the patients after they got sick. However, it has been reported that no one tested the donor stool for drug-resistant bacteria before the procedure. According to a gastroenterologist at the Mayo Clinic, this is the first report of a death linked to fecal transplant.

Risks Associated with Fecal Transplants

human microbiomeAfter the patient’s death, the FDA issued a warning for the risk of multi-drug resistant organisms (MDROs) through fecal microbiota for transplantation (FMT). The FDA has halted clinical trials of FMT until researchers can prove that proper testing procedures are in place. As a result of the adverse reactions, the FDA recommends that healthcare providers implement the following procedures.

  1. Obtain adequate consent for use of FMT from the patient or legal guardian
  2. Screen potential donors with questions that address risk factors for colonization of MDROs and exclude those at high risk
  3. Test donor stools and exclude those that test positive for MDROs
  4. Report adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program

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Fred Pritzker and Brendan Flaherty
Attorneys Fred Pritzker and Brendan Flaherty, lead lawyers for our medical malpractice legal team

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