What alternatives can be used in case of a withdrawal of Vaginal Implants for Prolapse in Europe? The surgical Technique back on the forefront.

Renowned experts, Prof. Michel Cosson, Prof. Arnaud Wattiez and Prof. Revaz Botchorishvili will meet in Lille, from 27th to 29th November, as part of a Masterclass devoted to "Surgical treatment of Female Pelvic Organs Prolapses: back to the future?". This 1st edition comes in a thorny context, following the withdrawal of vaginal implants intended for the treatment of prolapse on the American market.

Prof. Michel COSSON is an Obstetrician Gynecologist and Head of Lille's Hospital Gynecology Department. He will be holding a Masterclass on "Surgical treatment of Female Pelvic Organs Prolapses: back to the future?" along with Prof. Arnaud Wattiez and Prof. Revaz Botchorishvili on November 27th - 29th, 2019.

INVIVOX: Can you introduce yourself?

Pr Michel COSSON: I am a University Professor specialized in urogynecology and more particularly in pelvic static disorders, i.e. genital and rectal prolapses, and urinary or anal incontinence. I also conduct research on personalized biomechanical modeling in patients: the idea is to reconstruct a patient's pelvis with its different organs, its different suspension systems, to be able to predict the outcome of surgery or childbirth, and thus adapt surgical techniques while anticipating complications. 

https://www.em-consulte.com/article/1304601

INVIVOX: Has the panic that is present in the United States reached France and Europe?

Pr M. C.: A few years ago, there was an initial alert from the FDA (Food and Drug Administration) that led to a decrease in the use of reinforcement implants. In April 2019, the FDA ordered manufacturers to remove intravaginal implants for the treatment of prolapse. The reason for the actions they have taken is due to not having been provided with the evidence of the safety and effectiveness of the devices for the treatment of pelvic organ prolapse. These implants are also banned in England, New Zealand and Australia, but they are still used in Europe and widely around the world. 

https://francais.medscape.com/voirarticle/3604907

INVIVOX: Is this Masterclass conceived in a regulatory context?

Pr M. C.: Completely, it is time to look again at the various medical devices still authorized, the possible alternatives and to revisit the surgical techniques. It is completely strategic to be able to ask these questions and consider reforming ourselves to techniques that we had not used for a long time or that we had never used before. This course has an international dimension; it concerns both surgeons who no longer have the authorization to use these devices, and others who still have possibilities of using such devices, but who do not know for how long. This is both a way of responding to the emergency and anticipating possible extensions of the ban that may occur in the near future.

INVIVOX: You have brought together important partners such as Storz, Boston Scientific, Delmont, Ethicon, Olympus, AMI, Kebomed, and Dalhausen. What does their presence bring to this Masterclass?

Pr M. C.: All these devices companies offer very complete product ranges. Fortunately, not all implants are prohibited even if they are in the sight, such as urethral slings for incontinence cures. Devices companies offer alternatives to prostheses. With the removal of vaginal implants, which has occured in a very brutal way, they are trying to support the surgeon in the solutions so that they are not left without resources in front of the patients. Maintaining collaboration with industry is important because who will want to continue to research, invest and train surgeons in this indication.

INVIVOX: This Masterclass will take place at CHU Lille - Centre Hospitalier Universitaire. What structures and equipment will you make available to the participants?

Pr M. C.: The operative broadcasts in the morning and the courses in the afternoon will take place in an amphitheatre at the Jeanne de Flandres University Hospital in Lille. The technical training will take place in the animal house of the Faculty of Medicine of Lille. Participants will therefore see live surgery during the mornings. In the afternoon, readings focus on the fundamentals and the different surgical techniques. On the 3rd day, surgeons who wish to participate in the practical sessions will be able to practice on different animal models, and learn about all the surgical techniques used for organ descents. Those who do not wish to train will continue to watch videos of the surgeries commented by specialists. It is possible, depending on the time constraints of the participants, not to attend the 3rd day which is optional but of course highly recommended.

INVIVOX: What techniques will you present?

Pr M. C.: There are many surgical techniques in the field of organ descent: laparoscopic surgery, vaginal surgery, using medical devices or without medical devices. For example, for vaginal surgeries that do not use a medical device, there are dozens of techniques, and it is sometimes difficult to find your way through all these different surgical procedures. Laparoscopy is a little more focused but new surgeries are proposed. We will present innovations and alternatives to conventional promonto fixation surgery. For vaginal surgery, it is a little more complicated to navigate through all the techniques and to have a global vision. It is necessary to choose some surgeries among the different techniques and learn how to do them specifically. We are on alert following the withdrawal of vaginal reinforcement implants from the US market. This context forces us to train again for autologous surgeries (i.e. with patient tissue only). Few surgeons master these different techniques, which have sometimes fallen into disuse. Only older surgeons are familiar with these surgical techniques, which are poorly evaluated and described. We must (re)train again.

INVIVOX: What are the main areas of training?

Pr M. C.: There are different approaches: in laparoscopy, i. e. through the upper abdomen, and in vaginal surgery, where the vagina is used to operate with advantages and disadvantages for each approach in terms of scars that are not visible to the vagina, and slightly more complicated dissections if there is already a history of surgery through the abdomen by laparoscopy, for example. Each surgery has good and bad indications and these approaches are very complementary to respond to different clinical situations: patients with different prolapses and histories, who can support general anaesthesia or not. Conventional laparoscopic surgery, which is promonto-fixation, is the reference procedure. We will also present alternatives that are lateral suspensions or pectin ligaments that are less known and can be useful when there are technical impossibilities to perform the reference procedure. For the vaginal route, we will (re)open the autologous surgical toolbox that has been set aside for years because we all thought that implants would be able to meet most of our patients' needs.

INVIVOX: What needs will you meet for gynecological surgeons?

Pr M. C.: We will respond to the need for information related to the situation: where we stand, the current state of regulation and the prospects. The experts will be able to say whether there are plans to prohibit, extend or limit the use of certain devices. We will benefit from the feedback of colleagues who are already facing difficulties in terms of materials deposited, and study the alternatives they prefer and which will be the easiest to learn. Our concern is how, on a practical level, we will be able to continue to care for our patients.

"Our American colleagues are, at this time, in shock at the decision of the Food and Drug Administration (FDA) to remove vaginal implants."

INVIVOX: Why will it be difficult for patients to understand the difference between vaginal and abdominal implants?

Pr M. C.: Patients have trouble figuring it out. For many Anglo-Saxons, for example, a prosthesis that is in contact with the vagina, whether they are placed by the vagina, by laparoscopy, whether it is a strip or for a prolapse or for incontinence, these patients are opposed to everything. Will we be able to continue to use prostheses even by laparoscopy? For the time being, it's not prohibited. Won't our patients refuse to use urethral slings when it is the standard procedure for stress urinary incontinence? The future of these surgical techniques is very uncertain.

INVIVOX: Will you develop a patient information strategy?

Pr M. C.: We will review the status of bans and requests from the National Agency for Health and Medicines (ANSM). Changes in recommendations are announced. We will explore the possibilities we have to inform our patients. To date, when a surgeon uses reinforcement implants, it is very important that he inform patients.

"Today, all the surgical techniques available to us to treat urinary incontinence or pelvic organ descent have disadvantages; none treat 100% of patients with 100% success and 0% complication."

INVIVOX: Why are sacrocolpopexy mesh and TVT / TOT mesh not covered?

Pr M. C.: They are not covered by the bans, but they are covered by patient associations, especially in Anglo-Saxon countries, which are calling for a ban on all these devices, and rather wrongly because they are not the same materials, nor the same uses, nor the same quantities used, nor the same types of complications. Amalgam is detrimental. This means that patients refuse foreign objects: a request that is difficult to satisfy today. For certain surgical indications, we need medical devices or reinforcing tissues when, for example, we operate on patients with too fragile tissues or victims of multiple recurrences. It's a step backwards. I am talking about surgery that I studied when I was an intern, that I practiced when I was a young surgeon and that I know very well. I note that the generations we have trained over the past twenty years do not know these surgical techniques and are unable to practice them. Surgeons are left without a solution creating a detrimental situation for them and for patients.

INVIVOX: What alternatives will you propose?

Pr M. C.: It is fortunate that we have alternatives. For example, for non-prosthetic vaginal surgery, without a medical strengthening device, there are surgeries to suspend the vaginal fundus or uterus where we simply attach to the sacrospinous ligament, rather than remove it or put a foreign body to suspend it. Consequences: fewer complications but also less efficiency. Today, to be able to offer patients the best chances of success, this means knowing the surgical techniques well, having understood how they are carried out and having practiced them on an animal model. We are in a complicated but very interesting context because it is an opportunity to reflect on the techniques. We had been talking about materials for years. We were drowned in the debate "with or without prosthesis" and we no longer talked about how to put things down, how to suspend organs. The surgical technique is back in the spotlight. Laparoscopy for prolapse is a recognized surgery but is not always applicable to all patients for anatomical or other reasons. In this case, there are variants to address these difficulties. There are therefore alternatives by laparoscopy with technical simplifications. And by natural means to propose alternative surgical solutions to laparoscopic surgeries.

INVIVOX: What do you think of vaginal surgery without mesh such as colpectomy, which is a rare indication?

Pr M. C.: This is the reference indication in the United States. When there is a descent of the bladder, the surgeon removes tissue from the vagina. It is a simplistic surgery, which reduces the size of the vagina. It is not a technique that we wish to promote. There are other alternatives that are more respectful for patients' tissue and vagina.

INVIVOX: Why would this Masterclass encourage gynecological surgeons to attend especially since it brings together renown experts in gynecology?

Pr M. C.: Many of these surgical techniques depend on the operator's experience. Well-trained surgeons experience fewer complications and fewer failures. It is necessary to be able to offer patients a range of surgery that meets their needs, i.e. surgery without scarring through the vagina or, on the contrary, surgery by natural means under spinal anesthesia. It is necessary to have a range of surgical techniques available in which we use reinforcement materials or not, and to be able to adapt to the different prolapses of the patients. Time should be taken to discuss and reproduce the advantages and disadvantages of each surgical technique so that women can clearly choose what is best for them.

INVIVOX: What are the prospects for development?

Pr M. C.: Stem cells and animal tissues could be solutions in the future. A lot of work is currently underway on very slow resorbable prostheses (over 1 to 3 years) that do not leave any foreign body but can support reconstructions in the initial phase of healing which is fragile.

INVIVOX: What will be the concrete benefits for the participants? What key points/knowledge will they receive?

Pr M. C.: The experts are all recognized for their mastery of all surgical techniques in which they will answer the participants' questions. The live videos will be very informative as well as the lectures, anatomical references and especially the hands-on sessions (quite exceptional for vaginal surgeries). It is better to acquire expertise in one surgery than to perform two or three surgeries in all indications. Surgeons must specialize and achieve a minimum volume of activity. Our goal is to train surgeons in urogynecology in order to obtain an above-average level of knowledge and technical know-how.

INVIVOX: What is your "feeling" about a possible withdrawal in France?

Pr M. C.: The "Vigimesh" survey is currently underway in France. It allows to monitor the complication rates of these different surgeries with or without prosthesis, from above or below. The question is whether there are many cases with complications in our territory. If there are a little too many, the authorities may not ban these products, but will seek to reduce these rates. We would like to see fewer surgeons performing their procedures and better trained, with a good command of the technique and a minimum volume of activity.

https://www.ansm.sante.fr/Activites/Surveillance-des-dispositifs-medicaux-implantables/Surveillance-des-bandelettes-sous-uretrales-et-implants-de-renfort-pelvien/(offset)/3

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