REGIONE VENETO AZIENDA UNITA’ LOCALE N 9 OSPEDALE “Cà Foncello” TREVISO DIPARTIMENTO MATERNO-INFANTILE SERVIZIO DI UROGINECOLOGIA Responsabile: Dott. Roberto Baccichetvisitazione critica delle raccomandazioni FD
Food and Drug In sigla Administ FDA Salute ed i Servizi umanirationL’Agenzia del Dipartimento statunitense per la responsabile di assicurare la sicurezza e l’efficacia di tutti i farmaci, prodotti biologici, vaccini e dispositivi medici.
FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse On Oct. 20, 2008,On Oct. 20, 2008, the FDA issued a Public Health Notification and Additional PatientInformation on serious complications associated with surgical mesh placed throughthe vagina (transvaginal placement) to treat POP and SUI.Based on an updated analysis of adverse events reported to the FDA andcomplications described in the scientific literature, the FDA identified surgical meshfor transvaginal repair of POP as an area of continuing serious concern.In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse eventsreported to the FDA for surgical mesh devices used to repair POP and SUI for theprevious 3-year period (2005 – 2007) was “over 1,000.”
FDA Safety Communication: Date Issued: July 13, 2011,..from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports ofcomplications associated with surgical mesh devices used to repair POP and SUI, with 1,503reports associated with POP repairs and 1,371 associated with SUI repairs. Although it iscommon for adverse event reporting to increase following an FDA safety communication, weare concerned that the number of adverse event reports remains high.The FDA is issuing this update to inform you that serious complicationsassociated with surgical mesh for transvaginal repair of POP are not rareFrom 2008 – 2010, the most frequent complications reported to the FDA for surgical meshdevices for POP repair include mesh erosion through the vagina (also called exposure,extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse(dyspareunia), organ perforation, and urinary problems. There were also reports of recurrentprolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems.Many of these complications require additional intervention, including medical or surgicaltreatment and hospitalization.
In particular, the literature review by FDA revealed that: Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair. Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh. There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina(posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh. While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.
The FDA’s literature review found that erosion of mesh through the vagina is the mostcommon and consistently reported mesh-related complication from transvaginal POPsurgeries using mesh. Mesh erosion can require multiple surgeries to repair and can bedebilitating for some women. In some cases, even multiple surgeries will not resolve thecomplication.Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repairwith mesh that has been reported in the published scientific literature and in adverseevent reports to the FDA since the Oct. 20, 2008 FDA Public Health Notification. Reports inthe literature associate mesh contraction with vaginal shortening, vaginal tightening andvaginal pain.
As stated in the Oct. 20, 2008 Public HealthNotification, the FDA continues to recommendthat health care providers should: Obtain specialized training for each mesh placement technique, and be aware of the risks of surgical mesh. Be vigilant for potential adverse events from the mesh, especially erosion and infection. Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations. Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication. Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexualProvide patients with a copy of the patient labeling from the surgicalMesh manufacturer if available.
In addition, the FDA ( July 13, 2011 ) also recommends that health care providers: Recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications. Choose mesh surgery only after weighing the risks and benefits of surgery with mesh versus all surgical and non- surgical alternatives. Consider these factors before placing surgical mesh: Surgical mesh is a permanent implant that may make future surgical repair more challenging. A mesh procedure may put the patient at risk for requiring additional surgery or for the development of new complications. Removal of mesh due to mesh complications may involve multiple surgeries and significantly impair the patient’s quality of life. Complete removal of mesh may not be possible and may not result in complete resolution of complications, including pain. Mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh. Inform the patient about the benefits and risks of non-surgical options, non-mesh surgery, surgical mesh placed abdominally and the likely success of these alternatives compared to transvaginal surgery with mesh. Notify the patient if mesh will be used in her POP surgery and provide the patient with information about the specific product used. Ensure that the patient understands the postoperative risks and complications of mesh surgery as well as limited long- termoutcomes data.
Recommendations for PatientBefore SurgeryBe aware of the risks associated with surgical mesh for transvaginal repair of POP.Know that having a mesh surgery may put you at risk for needing additional surgery due to mesh-related complications. In a small number of patients, repeat surgery may not resolvecomplications.Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options, and understand why your surgeon may be recommending treatment of POP with mesh.In addition, ask your surgeon these questions before you agree to have surgery in which surgical mesh will be used: o Are you planning to use mesh in my surgery? o Why do you think I am a good candidate for surgical mesh? o Why is surgical mesh being chosen for my repair? o What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options? o What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh? o Will my partner be able to feel the surgical mesh during sexual intercourse? o What if the surgical mesh erodes through my vaginalwall? If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had owith this product? o What can I expect to feel after surgery and for how long? o Which specific side effects should I report to you after the surgery? o What if the mesh surgery doesn’t correct my problem? If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications? If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences? If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy?
FDA Safety Communication: UPDATE on SeriousComplications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse Date Issued: July 13, 2011
Of eight RCTs of TVM ( using nonabsorbable mesh ) Vsnonmesh traditional surgery, only three were designed toinvestigate the apex as an outcome . Of the 287 subjects intheese 3 trials only six ( 2% ) had apical failuresTherefore, apical failure ( as defined in most RCTs ) isnot a very useful parameter to distinguish theanatomic success between POP procedures
In the above –mentioned eight RCTs , only 3 included theposterior compartment as an outcome.Contrary to the FDA’s above statement, a study of recurrentprolapse repair did show superiority of mesh over nonmeshrepairs in the posterior wall at 1 year of follow-up ( 4,1%failure in the mesh Vs 24,5% in the nonmesh group, P=0,003)
FDA Safety Communication: UPDATE on SeriousComplications Associated with Transvaginal Placement of Surgical Mesh for Pelvic OrganProlapse Date Issued: July 13, 2011
The only study that used a compositeprimary outcome of anatomyc andsymptomatic results did show a difference The composite primary outcome showed superiorin both outcomes results for TVM at 2 months and at 1 year. The symptom of vaginal bulge between groups was not different at 2 months, but at 1year, 37,9% of the colporraphy group Vs only 24,6% of the TVM symptomatic bulging ( P= 0.008) M.Murphy et All Int J Urogyn Jan 2012
FDA Safety Communication: UPDATE on Serious Complications Associatedwith Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse Date Issued: July 13, 2011 Erosion Sexual function Pain
Across the board, the risk of mesh erosion mightbe higher with TVM butin two large multicentrictrials conducted by surgeons who perform theindex surgery an a regular basis, the result of theabdominal and vaginalapproach are quitesimilar. In the TVM trial thet randomized 400subjects, 3,2% had undergone a procedure tocorrect mesh erosion at 12 months
More than half of mostexposures from TVM are ASYMPTOMATIC, 1/3 need only minor outpatient operative intervention
FDA Safety Communication• Update 4-2012 – Valutare passaggio da classe rischio II a III – Richiesti a gennaio 2012 studi post-vendita (522 studi) per tutte le aziende per valutare efficacia e rischi prodotti (minisling e mesh per prolassi)
Considerazioni FDA non ha detto che le mesh non vanno più utilizzate nel trattamento del prolasso Se fosse stato così avrebbe fatto un RECALL di tutti i prodotti Non c’è stato nessun recall da parte di nessuna azienda In inglese WARNING significa avviso ,avvertimento… Quello che vuole è che ci sia maggiore controllo sull’utilizzo delle mesh e che le aziende dimostrino l’efficacacia e la sicurezza dei loro prodotti La proposta di passare da classe di rischio II a III implica per le aziende un processo più lungo e costoso per l’ottenimento dell’approvazione FDA .
Considerazioni• Il warning FDA fa riferimento al mercato USA e non al mercato Europa: – Pubblicità più forte (tv,internet…) nei confronti delle pazienti . In italia non si possono publicizzare i presidi chirurgici – Eccessivo uso delle Mesh – Avvocati• Dal 2008 al 2011 sono aumentati le complicanze ma anche gli impianti di mesh rispetto al 2005-2007. Se si considera che teoricamente tra il 2008-2011 sono state fatte 225.000 interventi con mesh risulta un tasso di complicanze <1%...• Non esiste un DATABASE che raccolga le complicanze degli interventi fasciali per prolasso!• Le problematiche sono state associate solo ai prodotti e non alla preparazione dei chirurghi. In un sondaggio presso i soci AUA (+8000 medici) è emerso che solo il 49% dei medici aveva ricevuto un supporto chirurgico adeguato• Il warning è rivolto a tutti i prodotti senza alcuna distinzione. Non si sa quindi se ci sono stati prodotti che hanno avuto più problemi rispetto ad altri…NON TUTTI I KIT SONO UGUALI
However, it must be ensured that new technologies be adequately evaluated and tested and that surgeons undergo appropriate training before large-scale market competition forces its disseminated use The AUA, the American College of Obstetricians and Gynecologists, as well as the American Urogynecologic Society have made specific recommendations that emphasize appropriate surgical education and call for high-quality comparative trials in POP while supporting the mesh’s use as a midurethral sling forSUI.It is imperative that such standardization also be applied tobetter define the disease state, as well as surgical outcomemeasures. Incorporating both objective and patient-reportedsubjective outcomes in defining disease states, surgicalsuccess, or disease recurrence is absolutely essential. 44. Committee Opinion no. 513: Vaginal placement of synthetic mesh for pelvic organ prolapse. Obstet Gynecol. 2011;118:1459-1464.
For situations in which controversy abounds, there isan immense opportunity to advance knowledge and understandingof the issue in dispute. Such is the case withusing synthetic mesh for the treatment of POP. Theapplication of mesh should not be ubiquitous to all patients,nor should its availability be stricken from thesurgeon’s armamentarium. Further research into diseaseetiology along with improved physician training in surgicalskill and patient assessment will help identifywomen who would or would not benefit from a meshbasedrepair. Currently, however, it is the surgeon’s dutyto fully inform the patient and discuss the risks vs benefitsof such procedures. Just as important, the surgeon mustalso reflect on and judge their surgical competency, beingallowed to decide what is best for individual patients 46. Rogers WB, Erickson DR. Early adoption of new devices: flying on untested wings. J Urol. 2012;187:783-784. 47. Murphy M, Holzberg A, van Raalte H, et al. Time to rethink: an evidence-based response from the pelvic surgeons to the FDA Safety Communication: “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse.”. Int Urogynecol J. 2012;23:5-9
La chirurgia fasciale è il nostro “ faro”…. Ma la chirurgia protesica non è il “diavolo” … È un’opportunità , una risorsa a disposizione se 1. Usata nei casi giusti e con le giuste informazioni alla paziente 2. Usata nel modo giusto 3. Usata dalle persone giusto…messa sul mercato e proposta dalle aziendenel modo giusto…