Recent US FDA Warning over Fecal Transplants.


Medical news from America recently has featured the sad death of an immune-compromised client receiving a “fecal transplant” as part of a clinical trial in America. We wish to add our condolences to the client’s family at this difficult time. It is an emerging speculation that US clinicians supplying the “fecal transplant” material failed to adequately screen the donor(s) for antibiotic-resistant strains of the pathogenic ESBL-producing E. coli bacteria. Whilst infection with ESBL E coli species frequently has little effect on a healthy person, when a client whose immune system is grossly compromised is exposed to it it can lead to fatal results.

Taymount wishes to make a comment on this situation: Firstly the supplier of our implants, TML.science Laboratory’s screening process has always screened for the pathogens associated with this tragic event. TML.science also do not make “fecal transplants” instead they manufacture Faecal Microbiota Transplant (FMT) implant material for medical order. Since 2015 Taymount Limited, now trading as TML.science Laboratory elected to migrate away from using outside contractor testing laboratories and instead they have heavily invested in sophisticated state-of-the-art DNA/RNA PCR testing equipment to ensure in-house screening for pathogenic species.

Unlike many suppliers, the sophisticated screening procedures used by TML.science, mean that each and every single one of the implants is screened for pathogens before being released. There is no reliance on just a regular periodic screening of each donor. It is directly because of a lack of a global standardised approach to donor testing and procedures that the Taymount Group has been urging regulators to standardise all aspects of Faecal Microbiota Transplantation to improve client safety standards.

To help to illustrate the safety of TML.science Laboratory’s’ procedures, a video is currently being made about the testing procedures and standards which will include the TML.science Laboratory’s’ BioFire® FilmArray® PCR analysis equipment that targets detection of specific pathogens. This video will be released shortly.

In summary, all FMT implants used in-house at the Taymount Clinic (supplied by TML.science) are screened in-house by molecular analysis of DNA and RNA for the pathogens that led to the untimely passing of the client in the American trial program. We also wish to make very clear that neither the Taymount Clinic nor the TML.science (Taymount Ltd) Laboratory were involved in the US clinical trial.

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