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Are meshes dangerous for pelvic floor repair ?

Why FDA recommendations are insufficient.

SUMMARY OF RECOMMENDATIONS (for full data see article )


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For surgeons who do not currently perform transvaginal placement of surgical mesh for pelvic organ prolapse, but wish to begin performing this procedure:
a. General knowledge should be documented either by completing a fellowship training program in Urogynecology, Female Pelvic Medicine and Reconstructive Surgery, or Female Urology or by completing adequate CME in pelvic anatomy and reconstructive pelvic surgery.
b. Specific knowledge for a particular procedure should be obtained
c. Skill may be documented by surgeons who have completed a Urogynecology, Female Pelvic Medicine and Reconstructive Surgery or Female Urology fellowship program via cases lists showing experience with transvaginal placement of surgical mesh for pelvic organ prolapse. Surgeons who do not have documentation of prior training with a specific transvaginal mesh prolapse procedure should be proctored on no fewer than 5 procedures or as many as is necessary to demonstrate that they can independently perform the specific procedure.
d. Experience in treating women with pelvic floor disorders should be documented either by completing a fellowship training program in Urogynecology, Female Pelvic Medicine and Reconstructive Surgery or Female Urology or by demonstrating that they offer a full spectrum of surgical options for pelvic floor disorders and that surgery for pelvic floor disorders represents >50% of their surgical practice including a minimum of 30 surgical cases for pelvic organ prolapse annually.
e. Demonstrate experience and privileges in nonmesh vaginal repair of prolapse including anterior colporrhaphy, posterior colporrhaphy, and vaginal colpopexy (eg, uterosacral or sacrospinous ligament fixation), and experience and privileges to perform
intraoperative cystoscopy to evaluate for bladder and ureteral integrity.
f. Annual internal audits should be performed. For surgeons who currently perform transvaginal placement of surgical mesh for pelvic organ prolapse and wish to maintain this privilege:
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 including anterior colporrhaphy, posterior colporrhaphy, and vaginal colpopexy (eg, uterosacral or sacrospinous ligament fixation), and experience and privileges to perform intraoperative cystoscopy to evaluate for bladder and ureteral integrity.
d. Annual internal audits should be performed prior to adoption of a new transvaginal mesh technology or device, specific knowledge of the new procedure should be demonstrated as previously described and the surgeon should be proctored on no fewer than 5 procedures or as many as is necessary to demonstrate that they can independently perform the newly adopted procedure.

What is missing is these recommendations

Knowledge and technical skills are only documented by assisting lectures, training courses etc. If knowledge and experience are not evaluated it is like accepting assisting piano concerts as proof of being capable of playing the piano.
Demonstrate experience in vaginal surgery only. Unless the surgeon is also skilled in laparoscopic surgery and promontofixation, it is unlikely that a fair balance of vaginal versus laparoscopic surgery will be offered to the patient.
The skills itself are never assessed. This is another nice example that videoregistration should be mandatory.

Privileging or Video-registration

Privileging and internal audit are useful. It would however be far better that videoregistration would become mandatory since much more efficient to judge potential complications.

The meshes are not the problem, the surgeons are.

Vaginal mesh surgery is erroneously considered relatively easy surgery and often performed by incomplete surgeons not able to do a laparoscopic pelvic floor repair. The consequences are
- insufficient overall surgical skills
- incomplete counseling . It is indeed unlikely that a fair informed consent can be obtained by a surgeon who only performs vaginal surgery.

Conclusion

It is unwise to be operated for pelvic floor repair by a surgeon that is not a laparoscopic surgeon level II.

Philippe R. Koninckx and Anastasia Ussia
Gruppo Italo Belga
European group for advanced endoscopic surgery.

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