Regarding "On the role of competent ligaments…".

Abstract

Dr. Petros takes exception to my mentioning the tissue fixation system (TFS), only to then enthusiastically focus on this surgical technique invented by him. He accuses me of being unwilling to witness placement of a TFS. This is true, as I consider the TFS a form of human experimentation, not legal in Australia without IRB/HREC ethical approval. He states that I have little understanding of the TFS. Unfortunately, I have had to learn how to deal with a number of unusual TFS complications which, from Dr. Petros’ comments, I may understand at least as well as the inventor. The Australian regulatory agency, the Therapeutic Goods Agency (TGA), which is “responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purpose” ( www.tga.gov.au/what-tga-regulates), has withdrawn the TFS. That decision was taken because, more than a decade after its introduction, the company and the inventor are still unable to provide data on safety and efficacy, an extraordinary state of affairs. Dr. Petros claims an erosion rate of 3% for the TFS and quotes an article by a Japanese colleague, Y. Sekiguchi. The same person was the senior author of a presentation at last year's Pelviperineology conference in Munich 1, which Dr. Petros attended. That presentation indeed claimed an erosion rate of 3.9% (41 of 1049 tapes), which does not sound so bad. Unfortunately, this actually occurred in 39/296 patients, which is 13%. What is worse, of 219 tapes placed in the perineal body, 38 eroded, a rate of 17.3% for the procedure which Dr. Petros would like us to use in the treatment of vaginal laxity. Dr. Petros’ modus operandi is exemplified by the last sentence of his letter. Neither he nor anyone else has ever asked me whether I belong to the TGA committee mentioned by him, contrary to what he states. What is more, I have never been, nor am I currently, a member of this or any other TGA committee, contrary to what he implies.