Author's Accepted Manuscript Prolapse Recurrence After Transvaginal Mesh Removal T. Rawlings , R.S. Lavelle , B. Coskun , F. Alhalabi , P.E. Zimmern

PII: DOI: Reference:

S0022-5347(15)04291-3 10.1016/j.juro.2015.06.080 JURO 12720

To appear in: The Journal of Urology Accepted Date: 11 June 2015 Please cite this article as: Rawlings T, Lavelle R, Coskun B, Alhalabi F, Zimmern P, Prolapse Recurrence After Transvaginal Mesh Removal, The Journal of Urology® (2015), doi: 10.1016/ j.juro.2015.06.080. DISCLAIMER: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our subscribers we are providing this early version of the article. The paper will be copy edited and typeset, and proof will be reviewed before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to The Journal pertain.

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PROLAPSE RECURRENCE AFTER TRANSVAGINAL MESH REMOVAL. Rawlings T, Lavelle RS, Coskun B, Alhalabi F, Zimmern PE

Keywords:

pelvic organ prolapse; reconstructive procedure

recurrence;

Manuscript word count: 2556

removal;

Philippe E. Zimmern, MD UT Southwestern Medical Center 5323 Harry Hines Blvd. Dallas, TX 75390-9110 Tel: 214-648-9397 Fax: 214-648-3839 [email protected]

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Disclosures: NONE for all authors Author’s participation:

mesh

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Corresponding Author:

transvaginal

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Abstract word count: 243

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University of Texas Southwestern Medical Center. Dallas, Texas

Tanner Rawlings: Manuscript writing, data collection/management, data analysis

2.

Rebecca S. Lavelle: Manuscript writing, data collection/management, data analysis

3.

Burhan Coskun: Data collection/management

4.

Feras Alhalabi: Protocol development, data collection/management

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5.

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1.

Philippe E. Zimmern: Protocol/Project development/manuscript writing/editing

Brief Summary:

A longitudinal analysis of pelvic organ prolapse recurrence after transvaginal mesh removal, with intermediate follow-up.

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ABSTRACT INTRODUCTION/OBJECTIVES: To determine the rate of pelvic organ prolapse (POP)

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recurrence after transvaginal mesh removal (TMR). METHODS: Following IRB approval, a longitudinally collected database of women undergoing TMR for complications after transvaginal mesh placement with at least 1 year minimum follow-up was queried for POP recurrence. Recurrent POP was defined

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as either > Stage 1 on examination or need for re-operation at the site of TMR.

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Outcome measures were based on POP-Q at last visit. Patients were grouped into 3 groups: 1 (Recurrent POP in same compartment as TMR), 2(Persistent POP), 3(POP in different compartment as TMR).

RESULTS: From 2007-2013, 52 of 73 women met inclusion criteria. 73% presented

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with multiple indications for TMR. Mean interval between insertion and removal was 45 months (10-165). Overall mean follow-up after TMR was 30 months (12-84). Group 1 (POP Recurrence) rate was 15% (6/40). Four patients underwent surgery for recurrent

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POP at mean 7 months (5-10). Two patients chose observation. The rate of POP Persistence (Group 2) was 23% (12/52) with 3 patients undergoing POP re-operation at

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mean 10 months (8-12). Group 3 (De novo/ Different compartment POP) rate was 6% (3/52), with 1 undergoing surgical repair at 52 months. CONCLUSIONS: At a mean of 2.5 years follow-up, 62% (32/52) did not have recurrent or persistent prolapse after TMR, and 85% (44/52) did not undergo any further procedures for POP. Specifically for POP in the same compartment as TMR, 12% had recurrence with 8% undergoing POP repair.

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INTRODUCTION Vaginal placement of synthetic mesh for pelvic organ prolapse (POP) repair was introduced as early as 20001. A randomized control trial in 2011 comparing native tissue

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repair to transvaginal mesh kit placement for POP repair reported superior performance for mesh kits in anatomic and functional outcomes2. However, in this report, mesh complications were noted, thus raising concern for this surgical modality in the long-

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term. Since then, concerns for complications related to transvaginal mesh implantation such as mesh erosion, dyspareunia, or pelvic pain have mounted. Escalating numbers

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of mesh complication reports led to two FDA warnings in 2008 and 2011 which cautioned the public on the use of transvaginal mesh for POP 3,4.

In our tertiary care center, we have been involved in transvaginal mesh removal (TMR)

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for nearly a decade and have developed expertise in meshology, a fast-growing field in the management of POP mesh and synthetic midurethral sling complications such as extrusion, pelvic pain, dyspareunia, and reoperations5. Recently, we reported on a

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series of women who underwent sling and vaginal mesh removal for the sole indication of pain only. Using a visual analog scale administered pre and post-operatively, we

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observed a decrease in pain level from 7.9 to 0.9 in 69 patients with 67% achieving a pain level of zero post-operatively6.

In preoperative counseling, patients frequently ask about POP recurrence after TMR, and there is a dearth of outcome data on this topic. Furthermore, there is no established standard of care for mesh or biologic replacement at the time of TMR. Some argue it is

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best to remove the mesh that prompted the complication and let the tissues heal primarily at the risk of having to re-operate to correct a secondary or persistent POP later on. Others prefer to complete the mesh removal and then utilize native tissue

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prolapse repair and/or add a new mesh substitute. Bio-absorbable mesh is generally favored as many of these complicated patients fear replacement with another synthetic material. Our approach has been to remove the synthetic mesh material and as much

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as possible of its extension arms, without any additional mesh interposition or concurrent prolapse procedures. Based on this decision, we reviewed our POP

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recurrence rate after TMR for all indications of POP mesh removal.

METHODS

This is a retrospective analysis of an IRB approved, longitudinally collected database of

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women undergoing TMR for complications. The database was queried for POP recurrence after TMR. All primary mesh placement was performed at outside institutions, and all TMR surgeries were performed by a single surgeon at a tertiary

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referral center. Patients undergoing excision of vaginal mesh (not mesh slings or midurethral synthetic tapes) via vaginal approach for mesh-related complications were

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included. Patients who had less than one year follow up and underwent vaginal mesh removal of abdominally placed mesh were excluded. Data collected included: patient demographics, type of mesh excised, indications for excision, site and type of excision, concomitant procedures, post-operative complications, time to prolapse recurrence, and type of POP re-operation. The recent mesh complication and classification system from International Urogynecological Association/International Continence Society (IUGA/ICS)

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was utilized. This is a classification of complications directly related to the insertion of synthetic material with a coding system based on C (category), T (time) in relation to the primary surgery, and S (site) of the complication.7 Note that this review focused on POP

are beyond the scope of this manuscript.

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compartment recurrence only, and other outcomes such as pelvic pain or dyspareunia

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The surgical technique for transvaginal mesh excision has already been reported6. Briefly, the procedure included removal of the vaginal mesh as well as the lateral

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extensions of the mesh arms, all the way to the obturator foramen or sacrospinous ligament fixation sites (See Figure 1). A maximal amount of mesh was removed within reasonable margins of safety to avoid injuries to adjacent organs (bladder, ureter, rectum). Following mesh removal, vaginal incisions were closed primarily with no

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additional biologic or mesh interposition. After anterior and/or apical mesh removal, cystoscopy was performed to ensure no bladder or ureteral injury. For posterior mesh removal, rectal packing was placed at the beginning of the procedure to mold the

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rectum, and digital rectal examination was performed to confirm no rectal injury at the end of the procedure. Each mesh segment removed was photographed and sent to

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pathology for medico-legal documentation (see Figure 1d,e). Patients were discharged home on the day of surgery or the following day, on limited pain medication, preferably without codeine, and stool softeners to minimize postoperative constipation. Vaginal packing and foley catheter were routinely left in place postoperatively and removed prior to discharge on the day of surgery or the following morning. The decision for admission

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was based on the length of procedure, time of procedure in the day, patient age and comorbidities.

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Outcomes were measured at serial intervals (6 weeks, 6 months, 1 year, and yearly thereafter) and included physical examination and evaluation for possible complications and/or POP recurrence. Anatomical outcomes were assessed using the pelvic organ

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prolapse quantification system (POP-Q). Recurrent POP was defined as either > Stage 1 on examination or need for re-operation at the site of TMR. Apical vaginal prolapse

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was defined as any descent of the vaginal cuff or cervix below a point which is 2 cm less than the total vaginal length about the plane of the hymen. Outcome measures were based on POP-Q at last visit and were compared with POP-Q points preoperatively.

Secondary outcomes included intraoperative complications such as

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bleeding requiring transfusion, bladder or ureteric injuries, rectal injury, were tallied. Postoperative complications were reported using the Clavien classification of surgical

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complications and were inclusive of adverse events within 30 days of TMR.

Based on recent IUGA/ICS POP outcome guidelines8 three distinct POP recurrence

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groups were identified. Group 1 (POP Recurrence) included patients with symptomatic POP recurrence after TMR and in the same TMR compartment. Group 2 (POP persistence) included patients who presented with persistent POP despite transvaginal mesh placement. Group 3 (De novo/ Different compartment POP) consisted of patients who developed secondary POP in a different compartment than where the TMR was performed. The overall POP recurrence after TMR was calculated by tabulating the

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results for Groups 1 and 2. The IUGA/ICS document referenced above also provided for follow-up periods ranging from early (5 years).8 Our series focused on intermediate and longer follow-up due

Symptomatic patients wishing for POP recurrence repair underwent anterior vaginal wall

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suspension (AVWS) with cystocele repair9 or mesh sacrocolpopexy (MS) for anterior/apical or triple compartment prolapse10,11. The women with less than 1 year

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follow-up were contacted by phone to determine if they have POP symptoms (bulge or pressure) and if they underwent subsequent POP surgical repair after TMR.

Descriptive statistics including means and ranges were obtained with SPSS Version

RESULTS

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19.0 (IBM Corp. Armonk, NY).

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From 2007 – 2013, 73 women were followed longitudinally after prolapse mesh removals, of which 52 met all inclusion criteria. Twelve had less than one year follow-up

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and 9 underwent an abdominal approach. Of the 12 women with less than 1 year followup, 9 were able to be contacted by telephone. Per report, none had recurrent POP symptoms or POP procedures since their TMR.

Baseline patient characteristics and demographics are reported in Table 1. No women had greater than Stage II POP at baseline, and no women had apical prolapse at

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baseline.

The

most

common

indications

for

TMR

in

our

patients

were

dyspareunia/vaginal pain, mesh extrusion, and pelvic pain, with 73% of women presenting with multiple indications. Patient mesh complication characteristics classified

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according to the IUGA/ICS guidelines11 are listed in Table 2. Mean interval between mesh placement and removal was 45 months (10-165). The overall mean follow-up after TMR for all 52 patients was 30 months (12 -84). Based on operative records, mesh

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types excised included Prolift (Ethicon): 23, Perigee (American Medical Systems): 8, Avaulta (Bard Medical): 7, Elevate (American Medical Systems): 3, Pinnacle (Boston

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Scientific): 2, Prosima (Ethicon): 1 and unknown (8) and the sites of mesh excision were summarized in Table 1.

The rate of POP recurrence after TMR and in the same TMR compartment (Group 1)

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was 15% (n=6/40) with a mean follow-up of 39 months (22 – 75). Four of those patients underwent surgery for recurrent POP at a mean of 7 months (5-10). The re-operation rate for POP recurrence was 10% (n=4/40). The location of mesh excision, recurrence

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characteristics and procedures performed for Group 1 (POP Recurrence) are summarized in Table 3. Of the two patients who chose observation for their recurrent

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prolapse, one had apical TMR with apical recurrence (Initial exam was limited due to narrowing and pain, so POPQ was not fully recorded but reportedly there was no apical prolapse from limited vaginal exam. Post TMR POPQ Points: C -2, TVL 6) and the other had anterior and posterior TMR removal, with only anterior prolapse recurrence. The number of patients in the persistent prolapse group (Group 2) was 23% (n=12/52). The re-operation rate in this subset was 25% (3/12) with a mean follow-up of 30 months (12

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– 84). Of these 12 patients with persistent prolapse, three underwent native tissue repair with AVWS for persistent anterior compartment prolapse at 8, 10, and 12 months. One patient had recurrent prolapse at the apex after AVWS and subsequently

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underwent a MS.

The rate of de novo or prolapse in a different compartment after TMR (Group 3) was 6%

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(n=3/52) with a mean follow-up of 30 months (15 – 53). Two patients chose observation and one underwent secondary POP repair. The two patients that chose observation had

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posterior TMR but secondary anterior compartment prolapse developed later on. The patient who chose surgery had anterior and apical TMR but had posterior compartment POP. This patient underwent MS at 52 months.

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Overall, 62% (32/52) did not have recurrent or persistent prolapse after TMR, and 85% (44/52) did not undergo any further procedures for POP. Thirty-six patients had intermediate term follow-up (1-3 years), 12 patients had late follow-up (3-5 years), and 4

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patients had very late follow-up (>5 years).8

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One intraoperative complication was a minuscule ureteral tear during an anterior mesh removal. The injury site was recognized with IV indigo carmine. The ureter was stented, the injury was repaired transvaginally with a small absorbable suture, and the perivesical tissues were reapproximated underneath the ureter to protect the repair. After stent removal 6 weeks later, a renal ultrasound was obtained and then a follow-up intravenous pyelogram was performed 6 months later, and all these imaging studies

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were read as normal. Patient underwent ureteroscopy for stone treatment 2 years later with no ureteric issues. There were three 30 day complications, consisting of 1 Clavien I (clogged catheter requiring irrigation) and 2 Clavien II (vaginal yeast infection and

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urinary tract infection requiring antifungal/antibiotic treatment).

DISCUSSION

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In the current era of vaginal mesh complications, the risk of POP after TMR has not been well established and continues to be a patient and surgeon concern. In addition,

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the TMR technique and concurrent repair has not been standardized. Our study addresses the risk of POP recurrence after TMR without addition of mesh or biologic material or native tissue repair at the time of TMR. We found that 62% of women did not have recurrent prolapse after TMR, and 85% did not undergo any further procedures for

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POP at a mean overall follow-up of 30 months (12-83). The patients who chose to defer corrective surgery for prolapse recurrence in our study may have done so for a variety of reasons including fear of further surgery after previous mesh surgery and/or

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additional surgical complications, or less bother from POP symptoms. However, we did not have access to the patient’s preoperative POPQ examinations prior to their mesh

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procedures at outside institutions to compare their stage of prolapse and bother.

Table 412,13,14,15 summarizes four current series reporting on POP recurrence after mesh removal. As mentioned earlier there is no consensus on concurrent POP repair at the time of TMR and the 4 summarized series have variable rates of concurrent repairs. The excision technique performed in each study varied as well. The series by Jeffrey et

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al. performed complete excisions while the other series performed a mixture of complete and partial excisions. Follow-up length varied from 0 to 24 months with the majority of patients having less than one year follow-up. The recurrence rates varied

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from 12% to 19%, but the series by Jeffrey et al. reported as high as 33% in the patients that followed up at 12 months. Of the three series that performed complete and partial mesh excisions, two reported that recurrent POP was more common after complete

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mesh excision. Retreatment rate was reported in 3 of the 4 series as 0 to 17%.

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In our study, of the patients who underwent a secondary POP repair, the majority underwent that surgical repair after 6 months follow-up from TMR. Potential reasons for the discrepancy in recurrence and retreatment rates between previous studies and our cohort are the increased length of follow-up and the absence of concurrent POP repairs

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at the time of TMR. Our practice is to remove the mesh without concurrent repair. With 85% of women having vaginal pain/dyspareunia as an indication for TMR, we have preferred to remove as much mesh material as possible and not add any additional

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material or perform native tissue repair at the time of TMR. Furthermore, the introduction of the ICS/IUGA POP outcome reporting guidelines8 has streamlined

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outcomes reporting in this field. Without this standardization it is difficult to compare our results to many recent studies where this classification was not utilized.

Strengths of our study include the intermediate or greater duration of follow-up, consistent TMR technique by the same surgical team, and outcome reporting using recent guidelines on mesh complications and POP outcomes. Our study limitations

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include a non-randomized design with a control group and a tertiary care practice with patients coming from out of state resulting in some loss to follow-up. Though we had 12 patients who did not meet inclusion criteria due to follow-up less than 12 months, we

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were able to contact 75% (9/12) of the patients by telephone. No patients reported prolapse symptoms or POP repairs after TMR. Another limitation is the inability to conclusively state that our approach resulted in complete or partial mesh removal.

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Though we removed the maximal amount of vaginal mesh within reasonable margins of safety through a transvaginal approach, there is no gold standard imaging modality

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available to verify or quantify the amount of mesh remaining in place. We also did not use a validated questionnaire to provide a composite recurrence definition. Instead, as other studies have done12,14,15, we defined failure based on a strict anatomic definition

CONCLUSIONS

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of recurrence or need for reoperation.

In the current literature, there is no consensus on TMR technique as well as concurrent

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prolapse procedures at the time of TMR. In our cohort of patients undergoing TMR without concurrent prolapse procedures, POP recurrence at the site of TMR was seen

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in 12% at an intermediate follow-up. However, 62% of patients had no recurrence in any compartment following TMR and 85% did not undergo a secondary POP repair. This data could be used to counsel patients on the risks for POP reoperation following TMR alone.

References

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1.

Migliari, R., M. De Angelis, G. Madeddu, et al. "Tension-free vaginal mesh repair for anterior vaginal wall prolapse." European urology 38, no. 2 (2000): 151.

2.

Altman D, Väyrynen t, Engh ME, et al. "Anterior colporrhaphy versus transvaginal

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mesh for pelvic-organ prolapse." New England Journal of Medicine 364, no. 19 (2011): 1826-1836. 3.

FDA public health notification: serious complications associated with transvaginal

incontinence.

Issued

October

2,

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placement of surgical mesh in repair of pelvic organ prolapse and stress urinary 2008.

Available

at:

ions/ucm061976.htm. 4.

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http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotificat

FDA public health notification: serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary

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incontinence. For updated information about surgical mesh for pelvic organ prolapse: update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. Issued July 13, 2011.

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Available at:

http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm.

Lee D, Bacsu C, and Zimmern PE. "Meshology: a fast-growing field involving

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5.

mesh and/or tape removal procedures and their outcomes." Expert review of medical devices 0 (2014): 1-16.

6.

Hou JC, Alhalabi F, Lemack GE, Zimmern PE. Outcome of transvaginal mesh

and tape removed for pain only. J Urol. 2014 Sep;192(3):856-60 7.

Haylen BT, Freeman RM, Swift SE et al. "An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint terminology and

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classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery." Neurourology and urodynamics 30, no. 1 (2011): 2-12. Toozs‐Hobson P, Freeman R, Barber M, et al. "An International Urogynecological

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8.

Association (IUGA)/International Continence Society (ICS) joint report on the terminology for reporting outcomes of surgical procedures for pelvic organ

9.

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prolapse." Neurourology and urodynamics 31, no. 4 (2012): 415-421.

Wilson T, Zimmern PE: Anterior Vaginal Wall Suspension. In: Female Urology,

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Urogynecology, and Voiding Dysfunction. Edited by A. Vasavada, Sand, Raz. New York: Marcel Dekker, vol. 1, pp. 283-290, 2005 10.

Belsante M, Murray S, Dillon B, and Zimmern PE. "Mid term outcome of robotic mesh sacrocolpopexy." The Canadian journal of urology 20, no. 1 (2013): 6656-

11.

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6661.

Gilleran JP and Zimmern PE. "Abdominal mesh sacrocolpopexy for recurrent triple‐compartment pelvic organ prolapse." BJU international 103, no. 8 (2009):

12.

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1090-1094.

George A, Mattingly M, Woodman P, et al. "Recurrence of Prolapse After

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Transvaginal Mesh Excision." Female pelvic medicine & reconstructive surgery

19, no. 4 (2013): 202-205.

13.

Marcus-Braun N, von Theobald P. "Mesh removal following transvaginal mesh

placement: a case series of 104 operations." International urogynecology journal

21, no. 4 (2010): 423-430.

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14.

Jeffery ST, and Nieuwoudt A. "Beyond the complications: medium-term anatomical, sexual and functional outcomes following removal of trocar-guided

journal 23, no. 10 (2012): 1391-1396..

Tijdink MM, Vierhout ME, Heesakkers JP, et al. "Surgical management of meshrelated complications after prior pelvic floor reconstructive surgery with mesh."

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International urogynecology journal 22, no. 11 (2011): 1395-1404.

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15.

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transvaginal mesh. A retrospective cohort study." International urogynecology

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FIGURE LEGENDS Figure 1:

Intraoperative Views of Anterior Compartment TMR Surgical Technique. a: Inverted U marking of vaginal incision. b: Anterior Mesh visualized

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after anterior vaginal flap dissection. c: Bladder wall after mesh excision.

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d/e: Mesh fragments.

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Table 1: Baseline Patient Characteristics and POPQ Measurements Mean age (±SD)

58 (±10)

Median parity (Range)

2 (0-6)

Mean BMI (±SD)

28 (±6) 39 (78%)

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Post-menopausal patients (n=50)* Hormone replacement therapy (n=51)*

21 (41%)

Patients reporting sexual activity (n=50)*

24 (48%)

Indication for TMR

(N)

44 (85%)

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Dyspareunia/Vaginal Pain Mesh Extrusion

33 (63%)

Pelvic Pain

20 (38%) 1 (2%)

Rectal Pain Groin Pain Defecatory problems POPQ Before Mesh Excision Mean Ba Point (±SD) Mean Bp Point (±SD) Stage II Anterior compartment Posterior compartment Apical compartment

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Baseline POP Before Mesh Excision

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Buttocks Pain

TMR Locations

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Anterior

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Stage III or Stage IV

2 (4%) 1 (2%) 2 (4%) -2.5 (±0.8) -2.8 (±0.7) 12 (23%) 8 (15%) 4 (8%) 0 (0%) 0 (0%) (N) 13 (25%)

Anterior & Posterior

6 (12%)

Anterior & Apex

6 (12%)

Posterior

8 (15%)

Apex

16 (31%)

Anterior, Posterior, & Apex

2 (4%)

Apex & Posterior

1 (2%)

* (n= number of patients who had baseline information available)

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Table 2: Frequency Table of IUGA/ICS Complication Classification Frequency Category Total Explanation of symptoms 1

1Bc-T1-S1

1

Wrinkling or shrinkage of the mesh, pain during sexual intercourse

1Bc-T2-S1

4

Wrinkling or shrinkage of the mesh, pain during sexual intercourse

1Bc-T2-S2

1

Wrinkling or shrinkage of the mesh, pain during sexual intercourse

1Bc-T3-S1

3

Wrinkling or shrinkage of the mesh, pain during sexual intercourse

1Bc-T4-S1

2

Wrinkling or shrinkage of the mesh, pain during sexual intercourse

1Be-T1-S1

1

Wrinkling or shrinkage of the mesh, spontaneous pain

1Be-T1-S5

1

Wrinkling or shrinkage of the mesh, spontaneous pain

1Be-T2-S1

2

Wrinkling or shrinkage of the mesh, spontaneous pain

1Be-T2-S1

1

Wrinkling or shrinkage of the mesh, spontaneous pain

1Be-T2-S5

1

Wrinkling or shrinkage of the mesh, spontaneous pain

1Be-T3-S1

2

Wrinkling or shrinkage of the mesh, spontaneous pain

1Be-T3-S1

1

Wrinkling or shrinkage of the mesh, spontaneous pain

1Be-T3-S4

1

Wrinkling or shrinkage of the mesh, spontaneous pain

1Be-T4-S1

1

Wrinkling or shrinkage of the mesh, spontaneous pain

1Be-T4-S5

1

1B-T1-S1

1

C2

2Aa-T3-S1

1

1

C3

3Aa-T4-S1

4

31

3Bc-T1-S1

5

3Bc-T2-S1

1

3Bc-T3-S1

6

3Bc-T4-S1

9

3Be-T2-S1

1

Mesh exposure >1 cm, spontaneous pain

3Be-T3-S1

2

3Be-T3-S1

1

3Be-T3-S5

1

3Dc-T4-S1

1

6B-T3-S4

2

Total

Asymptomatic wrinkling or shrinkage of the mesh

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Wrinkling or shrinkage of the mesh, spontaneous pain Wrinkling or shrinkage of the mesh, symptomatic, unspecified

Mesh exposure ≤1 cm, asymptomatic Mesh exposure >1 cm, asymptomatic

Mesh exposure >1 cm, pain during sexual intercourse Mesh exposure >1 cm, pain during sexual intercourse Mesh exposure >1 cm, pain during sexual intercourse Mesh exposure >1 cm, pain during sexual intercourse

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C6

24

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1Aa-T2-S1

Mesh exposure >1 cm, spontaneous pain Mesh exposure >1 cm, spontaneous pain Mesh exposure >1 cm, spontaneous pain Mesh exposure >1 cm, abscess, pain during sexual intercourse

2

Skin and/or Musculoskeletal pain, spontaneous

58*

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C1

Code

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Category

*58 codes were given to 52 patients, 6 patients were assigned two codes in different categories C: Classification, T: Time, S: Site

C1,2,3: Vaginal, C4: Urinary tract, C5: Rectal, C6: Skin/musculoskeletal, C7: Patient compromise

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T1: Intraoperative to 48 hrs, T2: 48 hrs to 2 mo, T3: 2 -12 mo T4: >12 mo S1: Vaginal: suture line, S2: Vaginal: away from suture line, S3: Trocar passage, S4: Skin or musculoskeletal, S5: Intra-abdominal

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Table 3: Group 1 POP Recurrence Characteristics (in women who underwent secondary POP repair) Recurrences (n)

Site

Procedure

Time to POP repair

Initial

Post-op

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TMR Locations

Last visit

Ba

Bp

Ba

Bp

Ba

Bp

-2

-3

-1

-3

-3

-3

1

Anterior

AVWS

5 months

Anterior & Posterior

1

Anterior

MS (1)

6 months

-2

-3

0

-2

-3

-2

1

Anterior

AVWS (1)

8 months

-3

-3

-1

-2

-2

-1

1

Anterior

AVWS

10 months

-3

-3

-1

-3

-2

-3

AVWS: Anterior Vaginal Wall Suspension

b

MS: Mesh Sacrocolpopexy

AC C

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a

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Anterior & Apex

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Anterior

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Table 4: Series Reporting on POP Recurrence after Mesh Removal Marcus-Braun et al.13

Tijdink et al.15

Jeffrey et al14

George et al.12

Year

2010

2011

2012

2013

TMR (n)

70

75

21

71

Concurrent Repair

No

17% n=14

100%

38% (27/71)

Complete n=57

Complete n=30

a

Partial n=14

Partial n=51

b

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Excision Technique

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Study

Complete 37% (26/71)

Complete Partial 63% (44/71)

Follow-up

M AN U

6 weeks (n= 20)

6 mo

6 mo (mean)

(19 patients lost to f/u)

Recurrence Rate

Recurrence Complete vs. Partial Retreatment Rate

c

19% (8/42)

Not reported

9/11 anterior 2/11 posterior

POPQ ≥ Stage II or ≥ 1 POPQ Stage increase from persistent POP

POPQ ≥ Stage II POP (despite symptoms)

POPQ ≥ Stage II, reoperation for prolapse, or postop pessary use

TE D

Not defined

24 mo (n=3)

8/9 anterior

EP

Recurrence Definition

8 anterior

39 wks (mean) 12 mo (n=6)

Range: 0-50

AC C

Recurrence Locations

6 mo (n=15)

d

6 wks: 5% (n = 1/20) 6 mo 13 % (n = 2/15)

12% (9/75)

d

15.5% (n=11/71) 12 mo 33% (n=2/6)

d

24 mo: 0%

7 after complete 1 after partial

Complete 29% Partial 5%

Not reported

Not reported

17% (7/42)

Not reported

0%

1.40%

ACCEPTED MANUSCRIPT

a

AC C

EP

TE D

M AN U

SC

RI PT

Patients who underwent sling removal with TMR are reported together b 6 patients underwent multiple excisions c (42 = # of anterior mesh removal) d No patients reported POP symptoms despite anatomic recurrence

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

ACCEPTED MANUSCRIPT

TMR

Transvaginal mesh removal

IRB

Institutional Review Board

POP-Q

Pelvic organ prolapse quantification system

AVWS

Anterior vaginal wall suspension

IUGA

International Urogynecological Association

ICS

International Continence Society

MS

Mesh sacrocolpopexy

SC

Pelvic organ prolapse

AC C

EP

TE D

M AN U

POP

RI PT

KEY OF DEFINITIONS

Prolapse Recurrence after Transvaginal Mesh Removal.

We determined the rate of pelvic organ prolapse recurrence after transvaginal mesh removal...
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