AN EVIDENCE –BASED RESPONSE FROM PELVIC SURGEONS TO THE FDA SAFETY COMMUNICATION: UPDATE ON COMPLICATIONS ASSOCIATED WITH CORRECTION OF 128 PELVIC ORGAN PROLAPSE USING A TRANSVAGINAL PLACEMENT OF SURGICAL MESH

Edoardo Tartaglia1, Giampaolo Delicato1, Giulio Baffigo1, Francesco Corvese1, Stefano Signore1, Giuseppe Montagna1
  • 1 Ospedale Sant'Eugenio - U.O.C. Urologia (Roma)

Objective

The very topical discussion resulting from FDA Updated (1,2)on the use of mesh for vaginal repair of pelvic prolapsed has prompted consideration of method and materials which may provide counter-arguments for many of the claims made by the FDA. The need for sufficient therapeutic procedures to treat pelvic floor defects and prolapsed disorders is undisputed and, due to the current demographic development and better education on the subject that is now helping to break existing taboos, the number of patients is increasing .In this study we have revised 128 patients with prolapse treated with transvaginal placement of mesh PROLIFT and we evaluated short and long term complications

Methods and results

From November 2006 until November 2012 128 women underwent a surgery for the correction of a vaginal prolapses using Ginecare PROLIFT TM Prolene mesh . Median age was 61 ( 43-78 ) ; all patients presented III IV stage according POPQ and were studied with urodynamics and cistography; in 44 cases there was a stress urinary incontinence ;in 97 cases women presented a vesical prolapse and we performed an anterior Prolift ; 10 had a cystocele associated to hystorecele and we performed a total prolift with colpososospension ( in one case was performed an hysterectomy ); in the other 21 patients there was a vaginal vault prolapse associated to rectocele that was treated by total prolift .The surgical procedure consists of the transvaginal and extraperitoneal fixation of the prolene mesh to

sacrospinal ligament . Then this mesh is positioned on the vaginal apex or the cervico-vaginal fascia and on anterior space ( vesico-vaginal ) and/or on the posterior space ( recto-vaginal ). Forty four patients with SUI were treated by positioning a sling under the median urethra too ( tot ). All patients underwent general or spinal anesthesia and the median operating time was 52 minutes (28 – 86 ). The median blood loss was 200 cc . No vascular or visceral lesion occurred .All patients had vaginal pack for 24 hours and catheter for 48 or 72 hours . They left the hospital in 3 or 4 days after surgery. In 11 cases a mild perineal hematoma occurred and in 14 cases coxofemoral pain needed antinflammatory no steroid drugs . Median follow-up was 24 months and urogynaecological evaluation was performed at 1,3,6,12,18,24,30,36 months. Some patients were controlled also after 6 years from surgery. No severe prolapsed recurrence was observed in 108 women; 12 had a first stage popq recurrence and 8 had a second stage recurrence. 4 patients had dyspareunia and 5 patients had SUI recurrence. No severe extrusion or erosion of the mesh was recorded. We had 8 partial vaginal erosion and only 6 needed a new surgery under local anesthesia with partial removal of the mesh and a new suture of the vagina overlapping the healthy margins

Discussion

Data contained in the Cochrane analyses 2010 and 2011 ( 3,4 ) which along with other publications formed the basis for the FDA warnings, require closer scrutiny. There are only two studies relating to quality of life , one study analyses the results obtained with a precut mesh and therefore implies complications such as mesh shrinking, sintering, erosion and dyspareunia. TUNN (5) commented objectively that there is no conclusive proof that complications cited are connected with the mesh implant, that mesh erosion was named as the most frequent complication and that every year were implanted more than 7000 mesh and there is a low mesh erosion rate and that the erosion rate is higher in the centre who implants less than 15 mesh per year. Patients must certainly be

Informed about the lack of long term results and the availability of other surgical alternatives that do not involve mesh. However they should know that in case of recurrence there is no alternative to mesh surgery. At this time the question is if the frequent cited complications might be reduce or prevent by suitable techniques and materials ( 6 ) Our series too demonstrates that the high experience and good technique can reduce the incidence of complications of mesh implants . The use of new materials will be able to improve the outcome of this surgery

References

1)HTPP://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm
2)Bader W., Baessler K. FDA Sicherheitswarnung zum alloplastichenmaterials in de rag urogynaekologie und plastische Fraunarzt 2011, 52 865-867
3)Maher CM, Fewiner B, Baessler K. Surgical management of pelvic organ prlapse in women :The update summary version Cochrane review, Int Urogynarecological Journal 2011 ;22 1445 -1457
4)Murphy M, Holzberg A, van Raalte H Lucente V, Pelvic Suregeons Network Time to rethink Update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapsed Int Urogynaecological J. 2012 ;23 5-9
5)Tunn R FDA mitteilung zum einsatz syntitisher 9netze 2011 16:40
6)Fuenfgeld C Foreword pelvic floor meeting Shruns, Austria 2012

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