Dr. Minini Corso GLUP TV - 22-23 marzo 2013

2. Implicazioni medico-legali:
come fare
cosa fare
Dott. Gianfranco Minini

3. La divulgazione mediatica ha indotto nella opinione
pubblica la percezione che l’errore medico sia
frequente e non giustificabile in un’epoca in cui si può
curare tutto e si deve guarire sempre.

4. Da “Obiettivo-Risarcimento”
… non hai i soldi per tutto questo?
Non preoccuparti, rischiamo le nostre competenze; ci
paghi solo in caso di risarcimento ottenuto.
Per le spese di perizia, visite e terapie, puoi beneficiare
gratuitamente del nostro servizio di anticipo spese …

5. L’incidenza dei risarcimenti in campioni di strutture a rischio – USA
Discipline Richieste Richieste
di risarcimento/ di risarcimento/
100 letti* 1000 ricoveri*
Chirurgia 9,67 2,62
Ortopedia 14,85 4,11
Ginecologia 10,29 1,67
Media 9,80 2,59
*Medical Claims survey 2010 realizzata da Marsh su 74 ospedali pubblici

6. - Le richieste di risarcimento sono lievitate del
250% in 15 anni.
- In 20 anni di attività ogni medico ha circa
l’80% di probabilità di ricevere un avviso di
garanzia o una richiesta di risarcimento danni

7. Secondo un’indagine dell’Ordine dei Medici di Roma e
dell’Università Federico II di Napoli, c’è stato un
aumento dell’8% del tasso di rischio clinico ogni 100
medici, mentre il costo assicurativo medio per
medico è salito del 23,86%.

8. Attualmente si può ritenere, senza tema di smentita, che
ogni anno circa il 10% dei medici italiani, venga
raggiunto da una nuova richiesta di risarcimento o
da una denuncia.
Siccome l’iter giudiziario dura mediamente 8 anni,
possiamo affermare che l’80% dei medici italiani (nel
caso dei chirurghi la percentuale supera il 90%) passerà
sicuramente un quarto della propria esistenza
lavorativa a districarsi tra le carte legali. Primato
invidiabile, irraggiungibile anche per le categorie che
dovrebbero essere più avvantaggiate in questa
competizione come gli spacciatori, i ladri o gli assassini.
Oggi i medici devono fare conto con questa realtà!

9. Piero Calamandrei, illustre giurista, sostiene che il
processo, anche civile, costituisce già di per sé una
grave pena per chi lo subisce, a prescindere dal
risultato che detto processo potrà avere

10. Dati ENPAM:
2001 2010
medici pensionati < 65 a.
2,5% 27,4%

12. Movimento per i Diritti del Malato:
- 93% delle denunce vengono archiviate per mancanza
di reato

13. Responsabilità Professionale
Medicina Difensiva

14. Concetto di “cautela giudiziaria”
La medicina difensiva consiste nell’operare scelte
terapeutiche condizionate dall’osservanza
giurisprudenziale più che dai propri convincimenti
scientifici

15. I concetti cardine della responsabilità medica
- Negligenza: omissione volontaria di una attività
imposta da un dovere di diligenza (ricomprende
disaccortezza e disattenzione).
- Imprudenza: attività compiuta senza quelle cautele
suggerite da ordinarie regole.
- Imperizia: difetto delle necessarie cognizioni
ordinariamente richieste.

16. commissiva
Una condotta colposa può essere o
omissiva

17. Decreto Balduzzi (n 158 – 13.09.2012, art. 3)
il medico che segue le linee guida
non potrà essere imputato di colpa lieve

18. CASSAZIONE: “SE IL MEDICO HA SEGUITO LE
LINEE GUIDA LA COLPA LIEVE NON È PENALE”
La Corte di Cassazione ha depenalizzato la colpa lieve
dei camici bianchi. La decisione della suprema corte
prende l’avvio dall’articolo 3 della legge 189 dell’8
novembre 2012 “responsabilità professionale
dell’esercente le professioni sanitarie”

19. Oggi nelle aule dei Tribunali si è
progressivamente giunti ad un
atteggiamento giurisprudenziale
a favore delle posizioni dei Pazienti

20. - Danno patrimoniale
- Danno morale
- Danno biologico
- Danno psichico e psicologico
- Danno esistenziale

21. GOOD CLINICAL PRACTICE / STANDARD OF CARE
- Linee guida
- Percorsi assistenziali
- Protocolli diagnostico-terapeutici

22. - LINEE GUIDA: è essenziale fare riferimento ai
livelli di evidenza e forza delle raccomandazioni.
- Tali livelli condizionano l’uso nella pratica clinica.
- La loro applicabilità deve essere supportata dall’
utilizzo di criteri validati a livello internazionale.

23. Esistono tre criteri per definire la qualità metodologica
delle linee guida:
1) multidisciplinarità del gruppo di lavoro
2) processo esplicito di ricerca bibliografica
3) grading delle evidenze

24. CONSENSO

25. - la responsabilità del danno deriva
dall’inadempimento dell’informazione
- l’onere di dimostrare di avere informato
esaustivamente il paziente ricade sul medico

26. “Non vi è chi non veda come il consenso
(rectius: la sua acquisizione) rappresenta
elemento essenziale del rapporto tra il medico e
il suo assistito, ad esso e alle sue caratteristiche
di espressione subordinandosi la validità
dell’atto e la conformità delle obbligazioni al
contratto assunto; di tutto ciò dovendosi fornire
dimostrazione probatoria, il cui onere incombe
di fatto sul professionista”
(Norelli e Mazzeo, 1998)

27. “Il perimetro del consenso non può ritenersi di
dimensioni sconfinate né uguale per tutti, perché
l’informazione che esso racchiude deve essere
personalizzata alle peculiarità psicologiche del
paziente, al suo stato di malattia e alle
possibilità della terapia in un’armonica sintesi”
(Buccelli et al., 2002)

28. La responsabilità civile è distinta in:
scaturisce da qualsiasi rapporto
contrattuale obbligatorio precostituito
(contratto, legge, ecc.)
o
extracontrattuale non presuppone alcun rapporto
(o aquiliana) preesistente, ma deriva da un atto
illecito posto in violazione del
generale principio del “neminem
laedere”

33. •Recommendations
Physicians should:
- Obtain specialized training for each mesh placement techmique, and be aware of its risks.
- Be vigilant for potential adverse events from the mesh, especially erosion and infection.
- Watch for complications associated with the tools used in transavginal 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 complications.
- Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual
intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
- Provide patient with a written copy of the patient labeling from the surgical mesh manufacturer, if available. Additional
patient information s can be found on the following FDA Consumer website.

34. AUGS Transvaginal Mesh Informed Consent Toolkit
Question 1: Are you planning to use mesh in my surgery?
While the 2011 Safety Communication focuses on the transvaginal placement of mesh for prolaspse repair, it is prudent to discuss
mesh-related issues even if you are planning to implant mesh for stress urinary incontinence or abdominally for prolapsed repair.
Question 2: Why do you think I am a good candidate for mesh?
The answer to this question certainly has to be tailored to each individual patient. However, a fair starting point in this discussion
would be to state that your anticipate that the benefits of using mesh outwight the potential risks associated with it. If the patient
has an anterior compartment defect, you can refr to a number of studies that show a decreased rate of anatomic recurrence with
mesh use in cystocele repair. If the patient has had prior surgery to repair pelvic organ prolapse, you can likewise refet to literature
showing the benefit of mesh versus native tissue repair in that clinical situation.
Question 3: Why are you choosing surgical mesh for my repair?
The patient should understand that surgical mesh is an option. It may be recommended, but it is never the only choice. If, after
discussing the pros and cons of mesh, the patient would rather not use mesh, she may choose a native tissue repair. Usually, mesh is
used with the goal of increasing the durability of a repair (i.s., decreasing the risk of prolapse recurrence). The most common
clinical scenarios in which the risk of failure appears to be increased include: recurrent prolapse (prior failed surgery), prolapse of
the anterior compartment, advanced prolapse (stage III or IV), and age (< 60 years). Certain kinds of procedures, such as
sacrocolpopexy, require the use of graft or mesh, and no native-tissue forms of these procedures are available. There may be other
particular scenarios in which the surgeon may recommend the use of mesh.

35. Question 4: What are the alternatives to transvaginal surgical mesh repair for POP, including non-
surgical options?
Non-surgical options that shouls be discussed for POP repair include expectant management (“wait and watch”) and conservative
management (pelvic floor muscle exercises and/or pessary). Surgeons may want to divide the other surgical alternatives into two
categories: surgical options that they perform and other surgical options that exist, but that they do not perform. The options for
patients who do not desire future coital function include reconstructive and obliterative techniques. There are many options for
patients who desire to preserve possible coital function. However, these options can be divided into a few basic categories for sake
of simplicity: transvaginal native tissue repairs (i.e. colporrhaphy, sacrospinous and uterosacral ligament suspension),
transabdominal native tissue repairs (i.e. paravaginal defect repairs and uterosacral ligament suspension), and transabdominal
surgical mesh repair (i.e. sacral colpopexy). It should be noted that the abdominal procedures can be performed via laparotomy or
laparoscopy. Also mention uterine-sparing procedures vs. pelvic reconstruction with hysterectomy in patients with uterovaginal
prolapse.
Question 5: 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?
Refer to question 2 & 3 to answer this question, and mention relative paucity of data regarding there issue. Also, a surgeon’s own
personal experience and patient outcomes with various procedures will be helpful to add here. There is almost no clinical scenario
where the repair cannot be performed without using surgical mesh; it is more a question of the degree and speed of possible
recurrence that must be discussed. Since there are very few RCTs with greater than one year of follow-up, it can be challenging to
give an evidence-based response to the second half of this questions. There is one RCT of the anterior compartment comparing
colporrhaphy to transvaginal mesh with three-year follow-up. This study shows a lower rate of anatomic “recurrence” with the
mesh but the difference in symptomatic bulge failed to each statistical significance. Of course, the one con that always exists with
mesh that does not exist with native tissue repairs is mesh erosion/exposure.

36. Question 6: Will my partner be able to feel the surgical mesh during sexual intercourse? What if the
surgical mesh erode through my vaginal wall?
Unless there is exposure or erosion of the mesh, your patient and her partner should not be able to feel the mesh. However, changes
to the vaginal (scar tissue, decreased elasticity, vaginal lenght and caliber) that can affect sexual sensation can occur after any
surgery for pelvic organ prolapse. Tell the patient that if the mesh erodes through the vaginal wall, her partner may feel it.
Depending on a number of factors, different options exist for the managemet of mesh erosion. In some cases (small, asymptomatic
erosion), expectant management can be employed. In other cases, conservative management, usually in the form of vaginal
estrogen therapy, can be used. Some physicians advocate surgical revision of any mesh exposure, but in one trial only one-third of
the mesh exposure case needed revision during 12 months of follow-up.
Question 7: If you plan to use surgical mesh, how often have you implanted this particular product?
This response should be determined from the experiences of the surgeon. The surgeon may wish to create several versions of this
document to reflect the experiences with each of the specific procedures offered.
Question 8: What results have your other patients had with this product?
If surgeon have collected data to answer this question, then the question can be answered based on that data. Otherwise, it may be
useful to ask patients who have had mesh procedures in your practice if they would be willing to discuss their experience with
patients who care candidates for the same surgery. Alternatively, you can ask them to prepare a written statement of their
experience that they are willing tho share with others.

37. Question 9: What can I expect to feel after surgery and for how long?
Data fron the surgeon’s practice will be helpful in answering this question. A simple chart review can reveal the average hospital
length of stay and amount of narcotic pain medication necessary for the average patient. Otherwise, since this is a relatively
subjective issue, resources from question 8 may be useful.
Question 10: Which specific side effects should I report to you after surgery?
Standard postoperative precautions should be followed (asking the patient to call with fever, chills, worsening
pain, etc.), but with specific regard to mesh, the patient should be aware of symptoms of mesh erosion. These
include vaginal bleeding or discharge beyond the usual 6-8 week postoperative period. They should also report
ani complaints from their partners regarding any sense of encountering a foreign body in the vagina (scratching
sensation with [or abrasions on the penis after] intercourse). Patients also should be alerted to the possibility of
neuropathic pain or scar tissue/retraction; although these conditions are not limited to patients with mesh repairs,
they still warrant specific discussion.
Question 11: What if the mesh surgery doesn’t correct my problem?
Each surgeon should have a plan regarding management of recurrent prolapse after pelvic reconstructive surgery. The patient
should be aware that if a uterine-sparing procedure is performed, that ii is no guarantee that a hysterectomy may not be needed in
the future. She should also be aware that sometimes when one compartment is treated, a new prolapse can develop in the other
compartment. The patient should be aware of whether you tend to treat your own recurrences or if you are likely to refer them out
to a different surgeon.

38. Question 12: If I develop a complication, will you treat or will I be referred to a specialist experienced
with surgical mesh complications?
You should provide an honest appraisal of your experience in managing mesh-related and other potential complications. It is
worthwhile to inform patients that subspecialty referral may be warranted (Urology, Colorectal, or other colleague with greater
experience in these issues) in some cases, but that you will remain involved until any problems have been throughly addressed.
Question 13: 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?
Different clinical scenarios should be discussed with the patient with regard to this question. If there in asn early complication that
is prompty diagnosed (such as a visceral perforation during mesh placement), the wole mesh can be removed. If there is a vaginal
mesh exposure later on, she should know that most of these can be treated with removel of the section of exposed mesh. However,
she should know that if complications arise lonf after tissue ingrowth (beyond 12 weeks), it is quite difficult, and in some cases
impossible, to remove the mesh in its entirety. If the mesh is removed, there is a chance that prolapse could recur or that symptoms,
such as pain and dyspareunia, might persist.
Question 14: If you plan to use surgical mesh, is there patient information that comes with the product?
Package labeling, as described by the FDA, is not consistent or always available at this point; a variety of patient information and
pamphlets exists, some of which has been assembled for use on this site. The instructions for Use (IFUs) that come with the
devices are likely to be of little use to the patient.
Manufacturers are being encouraged to be more consistent about supplying patient-based literature that can be sent with the patient
after implantation.

39. Guidelines for Providing Privileges and Credentials
to Physicians for Transvaginal Placement of
Surgical Mesh for Pelvic Organ Prolapse

40. For surgeons who do not currently place
transvaginal mesh for pelvic organ prolapse
but wish to begin performing this procedure:
1. Documenting Knowledge
- general knowledge
- specific knowledge
2. Documenting Surgical Skills
3. Documenting Experience
4. Internal Audits

41. For surgeons who currently have privileges in
transvaginal placement of surgical mesh for
pelvic organ prolapse
a) Continuing medical education in female pelvic reconstructive surgery
should be documented annually
b) A minimum of 30 surgical cases for pelvic organ prolapse (any route,
with or without transvaginal mesh) be performed each year
c) Demonstrate experience and privileges in non-mesh vaginal repair of
prolapse
d) Annual internal audits should be performed
e) Prior to adoption of a new transvaginal mesh technology or device, the
surgeon should be proctored on no fewer than 5 procedures.

42. Frequenti motivi “minori” di contenzioso
- Dolore pelvico/dolore arti inferiori
- Difficoltà alla deambulazione
- Comparsa di incontinenza/urgenza
- Evacuazione difficoltosa
- Disuria
- Erosioni/perdite vaginali
-…

44. Problema dei Consulenti Tecnici d’ Ufficio
NON
competenti su questioni altamente specialistiche

45. Negli USA esiste il diritto di rivalsa del medico
assolto, verso chi ha denunciato.
In Italia è prevista la possibilità di contro-
denuncia per “temerarietà” dell’azione legale.