Dear TVM group members, Having not received any requests from absentees from our last meeting. we did not consider it necessary to hold a teleconference. I imagine this was because Oph?lie's minutes were suf?ciently detailed. I remind you again that you can use email to continue the discussion. The meetings in Rome (meeting of experts and numerous potential European users), in Florida (the International Urogynecological Association (IUGA) sub- working group dedicated to prosthetics). in Copenhagen (IUGA), in Montreal (IUGA) and most recently in P?rigueux con?rm the interest in, even the enthusiasm for, Prolift. So Oph?lie is quite right to insist that we publish without delay for others, especially our little American friends, are in the starting blocks! As such I con?rm my request to_o obtain the prospective French data at six months to try to extract more consistent data than what we have received thus far. But while it is important to remember that we are the designers, it is all the more important to prove that Prolift is an advance: an inventory is necessary but not suf?cient, and recourse to randomised trials cannot be avoidedapproved uestionnaires. have worked closely with_for the update of the French version of the CD-ROM that brings together anatomical data, the technique in 30 and the surgical video made by Michel. We are up to the ?nal edits and I think we should be able to submit it to you very soon. I hope our colleagues in private practice will receive some prostheses so as not to forget how to use And that each one of you will continue to be involved in training future users and reducing potential complications as much as possible. Thanks all of you for this investment which perhaps one day, if the patent is accepted in the United States, will be remunerated! I hope everyone will be able to be at our next meeting, as long as? sends us the right date as, unless I'm wrong, there is no Monday anuary. Best reiards to all of you. Cc: Subject: Classification: n?dential Just a little note on sexuality! FrOm: Sent To: Cc: My dear- I am surprised there was no reaction to your magni?cent couplet on neither anyone to congratulate you on this wake-up call. admittedly belated, but apparently so sincere: there is more to life than sex. At last wisdom, solitary I completely agree with many of your reflections, and in particular with the difficulty, even the ridiculousness, of asking almost-unhealthy I had given this type of response to a meeting of urologists, who had asked me for my view on different variants of these questionnaires. of which one was particularly detailed. I also agree with you when you say that an analogous visual scale or just the conventional ?is it better. the same. or worse" already provides us with a lot of information. However, I think that?s insufficient if we want to ive a bit more objectivity to our evaluation, as human sexuality is very it's not a simply something that concerns academics who have not published enough; it's the question that consistently comes up as soon as we address the issue of the use of prosthetics via vaginal surgery. whatever the activity of the person Wlth. whom we are discussing it. In contrast, our questionnaires need to be relatively speCI?c in order to analyse the real consequence of this prosthe5is In the vaginal wall or walls. Isn't it this concern that makes me say (and I don't think I wull be alone for some time to come) that I would not like my wife to undergo this procedure? We really have to take the necessary steps to answer this fundamental . question and to be able to make a well-founded recommendation that this be used in young women. It is no less true that sodomy could be a goI alternative. but only in the case of prior TVM [Tensuon-free Vaginal Mesh]. 80 the debate is open: has looked seriously at the issue. Ive aske and -(the in our service. for those who don?t know her) to think hard about it. Yours, I feel as though I have ?nally discovered sexuality at the Congress in P?rigueux. (lt was time). It was the only word on everyone?s lips. I didn't open mine because as President I was viewed as a loudmouth! But I read with interest the PISQs There will soon be more of them than there are condylomas. I said to myself: there you go, for your next prolapse {patient}, you talk to her about orgasms. But also about fellatio, sodomy, the clitoris with or without G-spot. Etc. I am sure of one thing: that I would very quickly be treated like some kind of sex maniac (which. perhaps, I am). or a pervert, or an unhealthily curious person. and I think that in a little town like Brive1 I would quickly see a drop off in the number of prolapse [patients] to be operated through a fear of sex. Sexuality is, in fact, a thing for university towns (for publications!) To date, I have had no problem asking patients whether intercourse was better, good, worse or really impaired compare to before the procedure. If a problem has been caused by the procedure, directed questions become easier, but they may miss a signi?cant sexual abnormality. So I will not ?ll out the questionnaire on sexuality that is more directed to Anglo- Saxon teens than to mature age women from the Corr?ze region. But I will read the results of your questionnaires with avid interest. Claude From: Sent To: Cc: Subject: Follow up of meeting of Thursday 15 September Classi?cation: Con?dential Good afternoon, Please ?nd attached a summary of the principal issues discussed at our meeting in Pengueux: Clinical Studies . . The randomised trial of PROLIFT versus promonto?xatlon IS on track and one eetin has been organised by Clinical Affairs. at which Mr ?and ere present. In relation to the establishment of an observational inquiry to collect data on PROLIFT with a view to submitting a request for reimbursement. the project is progressing since we will soon be able to circulate per op. post opland 3 month follow up sheets for your comments, At the meeting on Thursday, it was suggested Translator's note ane-Ia-Gaillarde that an approved questionnaire on sexuali several questionnaires presented by 12 translated obtained by- email. be in luded ->assed to me in P?rigueux (including the PISQ which I will send to you scanned in a separate As for the data from the prospective study at 6 months the results will be communicated to the whole group very shortly by? ?fo owing his meeting in Florida, con?rmed that the IUGA was going to implement a randomised trial comparing traditional techniques with techniques using a prosthesis. Publications Two publications are planned for international submission (of. our last meeting in June) in 2005: 1 on the technique and 1 on retrospective data from the group. ?-Publication on the technique and review of retrospective CT data on the team from Clermontz, the idea is to publish in an international journal (European Journal. Gynaecological Surgery. Int Urogyneae Jour) in the form of a technical note. the descri tion of the technique with some short-term PROLIFT datamin order to envisage the submission of an article be een now an en 0 year. ?-Publication on retrospective TVM data: 884 cases:-and his team; is working on writing several articles as part of his thesis (29 Sept). The plan is to submit an article very quickly to an international journal between now and October-November. ?-Publication on prospective data at 1 year: It was decided to produce two distinct articles: 1 on the American range and 1 on the French range. For the French range. will start someone in his department working on it. will contact the US to collect the data at 6 months in the ?rst instance. The data at 1 year will only be available during 2006, the ?nal inclusions having been concluded in December 2004. The publication by the teams from?about risk factors for erosion accepted by the Int should appear shortly. Anatomical Study . .. I have been in contact with the person who worked With the team from Liege on the production of the and the publication for the IV I O. Will get back to you as soon as have more information. Patient lea?et . . The patient lea?et in French is almost ?nalised- IS working on it. Translators note Trainin surgeons iwas able to send to those concerned the feedback questionnaires collected during the European sessions [held] since our last meeting in June. Training materials The PROLIFT should be available in French quite quickly and we will send you a c0py as soon as it is ready. I will also need you to send me the following presentations by email (if the ?les are not too large) or on a CD in order to be able to send each of you a compilation of each other's most recent presentations. resentation of the sympo to the ICS and presentation on the managemen complications (prosthetic exposures) from P?rigueux entation from P?rigueux Presentation from P?rigueux on anatomy Prolift presentation from the ?nal session of Prof Ed Europe IV I O/Prolift Next meetings of the group ?-On the occasion of the JPEG in Paris: Monday 24 January ?-On the occasion of the Pelvic Surgery Society in Nimes: date to be determined as a function of the programme. from 11 to 13 May. We had thought of organising with?a conference call in the next two weeks with those who were unable to come to the meeting. Could you let me know by email if you would like ust i hi onference call and if so what are our availabilities in the evening Don't hesitate to get back to me if I've forgotten something. See you very soon, European Marketing Manager Tel: +33 1 55 00 3199 Mob: +33 6 64 05 4913 Fax: +331 55 00 2818 Wanadoo advises you that this email was checked by email anti-Virus software No known was detected the twenty -third day of June 2017. NAATI ProLssronal Iranslator no. 101059