The FDA issued an update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. Based on reports from 2008-2010, complications were found to not be rare and included mesh erosion, pain, infection and organ perforation. The literature review found erosion to be the most common mesh-related complication and that mesh contraction can cause vaginal pain and tightening. The FDA recommends considering non-mesh alternatives first due to risks and that mesh placement requires specialized training. Surgeons should discuss risks and benefits of all options with patients.
1. REGIONE VENETO
AZIENDA UNITA’ LOCALE N 9
OSPEDALE “Cà Foncello” TREVISO
DIPARTIMENTO MATERNO-INFANTILE
SERVIZIO DI UROGINECOLOGIA
Responsabile:
Dott. Roberto Baccichet
visitazione critica delle raccomandazioni FD
2. Food and
Drug
In sigla Administ
FDA
Salute ed i Servizi umaniration
L’Agenzia del Dipartimento statunitense per la
responsabile di
assicurare la sicurezza e l’efficacia di tutti i
farmaci, prodotti biologici, vaccini
e dispositivi medici.
3. 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 Patient
Information on serious complications associated with surgical mesh placed through
the vagina (transvaginal placement) to treat POP and SUI.
Based on an updated analysis of adverse events reported to the FDA and
complications described in the scientific literature, the FDA identified surgical mesh
for transvaginal repair of POP as an area of continuing serious concern.
In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events
reported to the FDA for surgical mesh devices used to repair POP and SUI for the
previous 3-year period (2005 – 2007) was “over 1,000.”
4. FDA Safety
Communication:
Date Issued: July 13, 2011,
..from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of
complications associated with surgical mesh devices used to repair POP and SUI, with 1,503
reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is
common for adverse event reporting to increase following an FDA safety communication, we
are concerned that the number of adverse event reports remains high.
The FDA is issuing this update to inform you that serious complications
associated with surgical mesh for transvaginal repair of POP are not rare
From 2008 – 2010, the most frequent complications reported to the FDA for surgical mesh
devices 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 recurrent
prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems.
Many of these complications require additional intervention, including medical or surgical
treatment and hospitalization.
5. 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.
6. The FDA’s literature review found that erosion of mesh through the vagina is the most
common and consistently reported mesh-related complication from transvaginal POP
surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be
debilitating for some women. In some cases, even multiple surgeries will not resolve the
complication.
Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair
with mesh that has been reported in the published scientific literature and in adverse
event reports to the FDA since the Oct. 20, 2008 FDA Public Health Notification. Reports in
the literature associate mesh contraction with vaginal shortening, vaginal tightening and
vaginal pain.
7. As stated in the Oct. 20, 2008 Public Health
Notification, the FDA continues to recommend
that 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 sexual
Provide patients with a copy of the patient labeling from the surgical
Mesh manufacturer if available.
8. 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.
9. Recommendations for Patient
Before Surgery
Be 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?
10. FDA Safety
Communication:
UPDATE on Serious
Complications Associated
with Transvaginal
Placement of Surgical
Mesh for Pelvic Organ
Prolapse Date Issued:
July 13, 2011
11. Of eight RCTs of TVM ( using nonabsorbable mesh ) Vs
nonmesh traditional surgery, only three were designed to
investigate the apex as an outcome . Of the 287 subjects in
theese 3 trials only six ( 2% ) had apical failures
Therefore, apical failure ( as defined in most RCTs ) is
not a very useful parameter to distinguish the
anatomic success between POP procedures
12. In the above –mentioned eight RCTs , only 3 included the
posterior compartment as an outcome.
Contrary to the FDA’s above statement, a study of recurrent
prolapse repair did show superiority of mesh over nonmesh
repairs 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)
13. FDA Safety
Communication:
UPDATE on Serious
Complications Associated
with Transvaginal
Placement of Surgical
Mesh for Pelvic Organ
Prolapse Date Issued: July
13, 2011
14.
15. The only study that used a composite
primary outcome of anatomyc and
symptomatic results did show a difference
The composite primary outcome showed superior
in 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
16. FDA Safety Communication:
UPDATE on Serious Complications Associated
with Transvaginal Placement of Surgical Mesh for
Pelvic Organ Prolapse
Date Issued: July 13, 2011
Erosion
Sexual function
Pain
17. Across the board, the risk of mesh erosion might
be higher with TVM butin two large multicentric
trials conducted by surgeons who perform the
index surgery an a regular basis, the result of the
abdominal and vaginalapproach are quite
similar. In the TVM trial thet randomized 400
subjects, 3,2% had undergone a procedure to
correct mesh erosion at 12 months
18. More than half of most
exposures from TVM are
ASYMPTOMATIC,
1/3 need only minor
outpatient operative
intervention
19.
20. 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)
21. 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 .
22. 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
24. 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 to
better define the disease state, as well as surgical outcome
measures. Incorporating both objective and patient-reported
subjective outcomes in defining disease states, surgical
success, 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.
25. For situations in which controversy abounds, there is
an immense opportunity to advance knowledge and understanding
of the issue in dispute. Such is the case with
using synthetic mesh for the treatment of POP. The
application of mesh should not be ubiquitous to all patients,
nor should its availability be stricken from the
surgeon’s armamentarium. Further research into disease
etiology along with improved physician training in surgical
skill and patient assessment will help identify
women who would or would not benefit from a meshbased
repair. Currently, however, it is the surgeon’s duty
to fully inform the patient and discuss the risks vs benefits
of such procedures. Just as important, the surgeon must
also reflect on and judge their surgical competency, being
allowed 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
26. 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 aziende
nel modo giusto…