2. DIMENSIONE DEL PROBLEMA
• Lifetime risk di intervento chirurgico per
prolasso: 11.1%
• Negli USA circa 200.000 interventi di correzione
chirurgica di prolasso in 1 anno, di cui 22.6%
colporrafia anteriore e posteriore e 10.5% solo
colporrafia posteriore
• Riportato tasso di reintervento dopo chirurgia
per prolasso del 30%
Smith 2010
Shah 2008
Olsen 1997
3. DIMENSIONE DEL PROBLEMA
• Ricorrenza di prolasso anteriore dopo
colporrafia anteriore > 40%
• Nel 2001 la FDA approva l’utilizzo delle
mesh per via vaginale, mutuando
l’esperienza della chirurgia dell’ernia
• (… e anche della TVT…)
Sand 2001
Weber 2001
4.
5. MEMENTO…
• Scarsa conoscenza dei fattori di rischio di fallimento
della chirurgia (giovane età, elevato BMI, prolassi III-IV
grado)
• Swift dimostra che il 98% delle donne risulta
asintomatica se la parete vaginale prolassata si presenta
entro il margine imenale
Whiteside 2004
Diez-Itza 2007
Salvatore 2009
Swift 2005
IL SUCCESSO IN CHIRURGIA E’ CONSEGUENTE A QUESTO CONCETTO:
LA MAGGIOR PARTE DEGLI ARTICOLI UTILIZZA LO STADIO I O II, MA IL
CRITERIO FONDAMENTALE DOVREBBE ESSERE L’ASSENZA DI SINTOMI
SENSO DI PESO E/O CORPO ESTRANEO VAGINALE ASSOCIATO A
DISFUNZIONI URINARIE, DEFECATORIE O SESSUALI
6. LA CHIRURGIA DEL
COMPARTIMENTO POSTERIORE
• Approccio transvaginale
- Colporrafia posteriore (duplicatura fasciale
mediana) associata o meno a miorrafia
degli elevatori
- Riparazione sito-specifica del difetto
- Reti protesiche
• Approccio transanale
• Approccio addominale (LPT, LPS, robot)
12. OUTCOMES DELLA CHIRURGIA FASCIALE
• Colporrafia posteriore con duplicatura fasciale
mediana: tasso di successo oggettivo 87% a 12 mesi e
79% a 24 mesi considerando prolasso residuo ≤ stadio
I; tasso di successo oggettivo 97% a 12 mesi e 89% a
24 mesi e 87% sulla defecazione ostruita (Maher 2004)
• Colporrafia posteriore vs riparazione sito-specifica: 4%
vs 11% a 12 mesi con stadio > II grado (Abramov
2005)
• Tasso globale di risoluzione anatomica con almeno 12
mesi di follow up 80-96% per colporrafia posteriore
(Mellgren 1995, Kahn 1997)
• Tasso globale di risoluzione anatomica con almeno 12
mesi di follow up 82-92% per riparazione sito-specifica
(Cundiff 1998, Kenton 1999, Singh 2003)
13. OUTCOMES DELLA CHIRURGIA PROTESICA
• MESH BIOLOGICHE: tasso di fallimento anatomico
del 20% (prolasso ≥ II grado) a 12 mesi con mesh
derma porcino (Altman 2006) e del 12% con
sottomucosa intestinale porcina (Sung 2012)
• MESH SINTETICHE: tasso di successo 84-92%
(Lim 2005, de Tayrac 2006, Milani 2005)
• KITS: tasso di successo 82-89% (Elmer 2009,
Simon 2011)
14.
15.
16. NB: non viene analizzato il compartimento posteriore separatamente
17. NB: outcomes specifici per il compartimento posteriore sono stati analizzati e la
recidiva posteriore si è manifestata nel 21.9% delle donne sottoposte a
chirurgia protesica vs 18.2% delle donne sottoposte a chirurgia fasciale
18. TROCAR-GUIDED MESH COMPARED WITH CONVENTIONAL VAGINAL REPAIR IN RECURRENT
PROLAPSE: A RANDOMIZED CONTROLLED TRIAL
Withagen MI, Milani AL, den Boon J, Vervest HA, Vierhout ME.
Obstet Gynecol. 2011 Feb;117(2 Pt 1):242-50
OBJECTIVE:
To compare efficacy and safety of trocar-guided tension-free vaginal mesh insertion with conventional vaginal
prolapse repair in patients with recurrent pelvic organ prolapse.
METHODS:
Patients with recurrent pelvic organ prolapse stage II or higher were randomly assigned to either conventional
vaginal prolapse surgery or polypropylene mesh insertion. Primary outcome was anatomic failure (pelvic
organ prolapse stage II or higher) in the treated vaginal compartments. Secondary outcomes were subjective
improvement, effects on bother, quality of life, and adverse events. (…)
RESULTS:
Ninety-seven women underwent conventional repair and 93 mesh repair. The follow-up rate after 12 months
was 186 of 190 patients (98%). Twelve months postsurgery, anatomic failure in the treated compartment was
observed in 38 of 84 patients (45.2%) in the conventional group and in eight of 83 patients (9.6%) in the
mesh group (P<.001; odds ratio, 7.7; 95% confidence interval, 3.3-18). Patients in either group reported less
bulge and overactive bladder symptoms. Subjective improvement was reported by 64 of 80 patients (80%) in
the conventional group compared with 63 of 78 patients (81%) in the mesh group. Mesh exposure was
detected in 14 of 83 patients (16.9%).
CONCLUSION:
At 12 months, the number of anatomic failures observed after tension-free vaginal mesh insertion was less
than after conventional vaginal prolapse repair. Symptom decrease and improvement of quality of life were
equal in both groups.
NB: recidiva posteriore 4.2% nelle mesh vs 24.5% nella chirurgia fasciale
19. Int Urogynecol J. 2015 Aug;26(8):1161-70
VAGINAL MESH FOR PROLAPSE: A LONG-TERM PROSPECTIVE STUDY OF 218 MESH KITS FROM A
SINGLE CENTRE
Karmakar D, Hayward L, Smalldridge J, Lin S.
INTRODUCTION AND HYPOTHESIS:
The aim was to assess the long-term surgical outcomes and complications in patients undergoing mesh-
augmented vaginal repair of pelvic organ prolapse.
METHODS:
This is a report of a prospective long-term follow-up experience from the Urogynaecological Service, Counties
Manukau District Health Board, Auckland, New Zealand. The subjects were 158 symptomatic women
undergoing mesh-augmented prolapse repair (218 kits, Feb 2005 to July 2013) using the Apogee and/or Perigee
kits.
RESULTS:
The median follow-up times were 138 and 105 weeks for the Apogee and Perigee kits, respectively; 56.6% and
48.8% of these kits, respectively, were inserted for recurrent prolapse. Cure rates for prolapse using mesh kits in
patients with a history of native tissue POP repair in the same compartment were 90.91% for the anterior
compartment (60 of 66) and 95.74% for the posterior compartment (45 of 47). The cumulative mesh
extrusion/exposure rate was 15.8% of patients (11.5% of mesh kits) and was significantly higher with the
Apogee kit than with the Perigee kit (P=0.03). There was a significantly higher rate of extrusion/exposure with
the Perigee kit in women with previous anterior compartment native tissue repair than with the Apogee kit in
women with previous posterior compartment native tissue repair (21.2% versus 6.4%; P=0.03). Only 8% of
extrusions/exposures needed revision of the mesh.. Overall success rates were 81.4% (110/135) for the Perigee
kit and 74.7% (62/83) for the Apogee kit.
CONCLUSIONS:
This is one of the longest prospective mesh follow-up studies to date from a single centre and highlights the
need for continuing surveillance despite high overall success rates.
20.
21.
22.
23.
24.
25.
26.
27.
28. In particular, the literature review 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
U.S. Food and Drug Administration
Protecting and Promoting Your Health
UPDATE on Serious Complications Associated with Transvaginal
Placement of Surgical Mesh for Pelvic Organ Prolapse: FDA Safety Communication
Date Issued: July 13, 2011
29.
30. TAKE HOME MESSAGES
• Duplicazione fasciale posteriore > riparazione
sito-specifica in termini di outcome oggettivi
(grado B)
• Miorrafia elevatori aumenta la dispareunia
(grado C)
• Approccio transvaginale superiore a transanale
(grado A)
• Nessuna evidenza di qualsiasi beneficio da uso
di mesh o di patches biologici (grado B)
• La sintomatologia migliora nella maggior parte
delle pazienti (grado B)