Survey on Canadian Experience in Pelvic Organ Prolapse Repair and the Use of Transvaginal Mesh Systems

Abstract

Objective: The purpose of this article is to describe the practice of gynecologists and urogynecologists in pelvic organ prolapse repair, and their experience with transvaginal mesh systems. Design: The study was designed as an electronic survey. Materials and Methods: An electronic survey was distributed to members of the Society of Obstetricians and Gynaecologists of Canada. Questions pertained to preferred surgical procedures treating pelvic organ prolapse and experience with transvaginal mesh systems. Results: Twenty-eight percent of respondents who perform surgeries for pelvic organ prolapse have used transvaginal mesh systems, including 56.5% of surveyed urogynecologists. Seventy-eight percent of respondents using transvaginal mesh systems reported a mesh exposure rate of 0%–5% in their practice. The most common reason for not using transvaginal mesh systems was the lack of available long-term evidence about their success and complication rates (42.6%). Knowledge of the United States Food and Drug Administration (FDA) notification concerning complications associated with transvaginal mesh systems influenced the practice of 42.9% of respondents. The preferred procedure for primary and recurrent repair of pelvic organ prolapse was traditional colporrhaphy (92.4% and 42.4% in the anterior compartment; 80.9% and 51.5% posteriorly, respectively). Transvaginal mesh systems were used for recurrent cystoceles by 20.0% of surveyed general gynecologists and 22.7% of urogynecologists (p=0.307). Fifteen percent of all respondents used them for recurrent rectoceles. Conclusions: Transvaginal mesh systems were most commonly used for recurrent anterior compartment prolapse by only 20% of respondents. Close to one third of surveyed gynecologists are waiting for stronger evidence prior to using them. There is an ongoing need for rigorous long-term studies regarding the benefits and risks of these procedures. (J GYNECOL SURG 30:129)

Introduction

Eleven to nineteen percent of women will undergo surgery for pelvic organ prolapse in their lifetime.^1,2 Approximately 30% of these women will require a second procedure to treat a recurrence.³ In order to attempt to decrease this high re-intervention rate, commercial systems of polypropylene transvaginal mesh have been developed. Recent data seem to demonstrate a superior short-term anatomic cure rate with these procedures for the anterior compartment.⁴ A survey of American Urogynecologic Society (AUGS) members published in 2008 revealed that 49% of respondents sometimes used transvaginal mesh systems in the repair of primary cystocele, and that 47% used them for a recurrence in the anterior compartment.⁵

In October 2008, the United States Food and Drug Administration (FDA) published a public health notification to inform the public about rare serious complications associated with the use of vaginal mesh in the surgical treatment of pelvic organ prolapse and stress urinary incontinence.⁶ The FDA then updated their publication in 2011, stating that complications associated with vaginal mesh are not rare.⁷ Health Canada published a notice to hospitals in 2010 providing similar information.⁸ Finally, in 2012, the FDA recommended that the companies that manufacture these products conduct “postmarket surveillance studies” to “address specific safety and effectiveness concerns.”⁹ Some of the most pertinent complications reported included mesh exposure, with rates averaging 10%,^4,10 and dyspareunia, in up to 9% of cases.^7,10–12 Postoperative chronic pelvic pain has also been found to be of concern, with a reported rate of 0%–30% in case series.¹³

There is an ongoing lack of consensus regarding the most appropriate surgical management of different types of pelvic organ prolapse, resulting in a heterogeneous practice. A web survey was created with the objective of better describing this heterogeneity in surgical repairs, and determining the role of transvaginal mesh system use in this context. Finally, the aim was to determine the impact of the FDA notification and of the Health Canada notice on the use of transvaginal mesh systems in Canada, as well as to identify barriers to their use.

Materials and Methods

A web survey was developed by the three investigators (two urogynecologists and a gynecology resident) and validated by a Canadian urogynecologist working in another academic university center. The questionnaire consisted of 25 questions. Topics addressed in the questionnaire included training in pelvic organ prolapse repair, previous and current use of transvaginal mesh systems, preferred surgical approaches for each compartment of pelvic organ prolapse, and outcomes of procedures using transvaginal mesh systems. Full institutional approval to distribute the survey was received from St. Mary's Hospital, in Montreal, Canada (SMHC # 11-33). The questionnaire was distributed through the Society of Obstetricians and Gynaecologists of Canada (SOGC)'s e-mail list. An initial e-mail, which was linked to the survey web site, was sent in January 2012. Two reminders were then sent in January and February 2012.

The answers were collected anonymously. Surveys that were >75% complete were included. Responses were compiled and results are displayed in absolute numbers and percentages. The χ² test was used to compare the answers of urogynecologists to those of general gynecologists. A p value <0.05 was set to determine statistical significance. SPSS 20.0 (SPSS Inc., Chicago, IL) was used as statistical software.

Results

A total of 648 surveys were sent. A total of 176 responses (27.2%) were received. Out of those, 162 were complete enough to be included in the analysis. A total of 131 respondents performed surgeries for pelvic organ prolapse, including 23 urogynecologists. Seventy-one respondents had performed >20 such procedures in the past 12 months.

Thirty-seven respondents (28.2%) had used a commercial transvaginal mesh system. A higher percentage of urogynecologists had used them compared with general gynecologists (56.5% vs. 22.2%, p=0.001). The most common additional training obtained after residency in order to carry out procedures using transvaginal mesh systems was mentorship (n=30, 81.1%). Nine respondents (24.3%) were taught to use them during fellowship. Eleven respondents (29.7%) received part or all of their training with transvaginal mesh systems from courses on cadavers, workshops, or conferences. One respondent reported having received no additional training prior to using transvaginal mesh systems.

The most common reason for not using transvaginal mesh systems was the lack of available long-term evidence about their success and complication rates (n=43, 42.6%). Other main reasons included lack of training (n=32, 31.7%), and conviction that risks outweighed benefits (n=24, 23.8%). Five physicians responded that they would simply refer the patient to a colleague, if they were to require such a procedure. Three of the respondents answered that they did not believe that one “kit” could fit all individuals, and preferred to use self-tailored mesh or no mesh at all. Two respondents reported that the costs associated with these procedures were too high for their department's budget.

A total of 119 out of 131 respondents (91.5%) were aware of the 2008 FDA notification or the Health Canada safety information issued in 2010 about the potential serious complications associated with transvaginal placement of surgical mesh for stress urinary incontinence and pelvic organ prolapse. Knowledge of those statements influenced the practice of 51 respondents (42.9%), including 14/30 (48.4%) of those who are still using transvaginal mesh systems.

Of respondents who had performed procedures with transvaginal mesh systems, 75.7% (n=28) believed that cure rates in their own practice were better with these systems than with traditional repairs. Eight respondents (21.6%) stated that their cure rates after both procedures were equivalent, and none believed that their cure rates using transvaginal mesh systems were inferior to traditional repairs. Sixteen respondents (43.2%) stated that the complication rate in their practice seemed to be greater with transvaginal mesh systems than with traditional repairs. Fifteen respondents (40.5%) stated that their complication rates were similar with both types of procedures. One (2.7%) respondent stated that complication rates in practice seemed to be lower with transvaginal mesh systems. Table 1 summarizes the most commonly encountered intraoperative and postoperative complications. Twenty nine respondents (78.4%) reported a mesh exposure rate of 0%–5% in their practice, including nine urogynecologists. Five respondents reported a mesh exposure rate between 6% and 10%, and one respondent estimated the rate to be ≥11%.

Table 1.

Respondents who have Encountered Listed Complications with Transvaginal Mesh Systems in their Practices ^a

Complications	Gynecologists	Urogynecologists	All respondents
Intraoperative complications
Hematoma requiring transfusion	5 (28.0)	3 (23.1)	8 (21.6)
Bowel injury	2 (8.3)	0 (0.0)	2 (5.4)
Bladder injury	7 (29.2)	3 (23.1)	10 (27.0)
Postoperative complications
Mesh exposure	20 (83.3)	12 (92.3)	32 (86.5)
De novo dyspareunia	10 (41.7)	6 (46.2)	16 (43.2)
Chronic pelvic pain	6 (25.0)	5 (38.5)	11 (29.7)
Fistulas	1 (4.2)	3 (23.1)	4 (10.8)
De novo stress incontinence	3 (12.5)	7 (53.8)	10 (27.0)
De novo urge incontinence	4 (16.7)	7 (53.8)	11 (29.7)
Total respondents	24	13	37

Data presented as number of respondents (%).

There were a variety of procedures preferred by respondents for the management of primary and recurrent prolapse in each compartment, for sexually active patients (Tables 2 –4). Each respondent was allowed to select more than one procedure for each type of prolapse. Forty-eight percent of respondents (n=44) stated that they would use a graft material to vaginally repair a recurrent an anterior compartment prolapse. Thirty gynecologists stated that they would refer a patient with recurrent cystocele to a colleague or a urogynecologist. For a recurrence in the posterior compartment, 28 gynecologists would refer the patient to a colleague. For a primary repair in the apical compartment, 17 respondents stated that they would have referred the patient, and 27 respondents stated that they would have done so for an apical prolapse recurrence. Fifty-three percent of respondents stated that they would routinely perform a hysterectomy as part of their prolapse repair.

Table 2.

Procedures of Choice for Repair of Anterior Compartment Prolapse ^a

Type of prolapse	Procedures	Gynecologists	Urogynecologists	All respondents	p
Primary	Traditional colporrhaphy (midline plication)	102 (94.4)	19 (82.6)	121 (92.4)
	Vaginal/laparoscopic paravaginal repair	12 (11.1)	3 (13.0)	15 (11.5)
	Sacral colpopexy (open/laparoscopic)	5 (4.6)	2 (8.7)	7 (5.3)
	Biological mesh	2 (1.9)	1 (4.3)	3 (2.3)
	Synthetic absorbable mesh	1 (0.9)	2 (8.7)	3 (2.3)
	Self-tailored synthetic nonabsorbable mesh	1 (0.9)	0 (0.0)	1 (0.8)
	Commercial synthetic transvaginal mesh system	3 (2.8)	0 (0.0)	3 (2.3)	0.419
	Sacrospinous ligament suspension	0 (0.0)	0 (0.0)	0 (0.0)
	Colpocleisis	0 (0.0)	0 (0.0)	0 (0.0)
	Total number of respondents	108	23	131
Recurrent	Traditional colporrhaphy (midline plication)	33 (47.1)	6 (27.3)	39 (42.4)
	Vaginal/laparoscopic paravaginal repair	9 (12.9)	3 (13.6)	12 (13.0)
	Sacral colpopexy (open/laparoscopic)	11 (15.7)	4 (18.2)	15 (16.3)
	Biological mesh	4 (5.7)	4 (18.2)	8 (8.7)
	Synthetic absorbable mesh	8 (11.4)	3 (13.6)	11 (12.0)
	Self-tailored synthetic nonabsorbable mesh	4 (5.7)	2 (9.1)	6 (6.5)
	Commercial synthetic transvaginal mesh system	14 (20.0)	5 (22.7)	19 (20.7)	0.307
	Sacrospinous ligament suspension	3 (4.3)	0 (0.0)	3 (3.3)
	Colpocleisis	0 (0.0)	0 (0.0)	0 (0.0)
	Total number of respondents	70	22	92

Data presented as n (%), multiple answers permitted.

Table 3.

Procedures of Choice for Repair of Posterior Compartment Prolapse ^a

Type of prolapse	Procedures	Gynecologists	Urogynecologists	All respondents	p
Primary	Traditional colporrhaphy	90 (83.3)	16 (69.6)	106 (80.9)
	Site-specific defect repair	24 (22.2)	8 (34.8)	32 (24.4)
	Sacral colpopexy (open/laparoscopic)	6 (5.6)	0 (0.0)	6 (4.6)
	Biological mesh	2 (1.9)	0 (0.0)	2 (1.5)
	Synthetic absorbable mesh	2 (1.9)	1 (4.3)	3 (2.3)
	Self-tailored synthetic nonabsorbable mesh	0 (0.0)	0 (0.0)	0 (0.0)
	Commercial synthetic transvaginal mesh system	3 (2.8)	1 (4.3)	4 (3.1)	0.691
	Sacrospinous ligament suspension	2 (1.9)	0 (0.0)	2 (1.5)
	Colpocleisis	0 (0.0)	0 (0.0)	0 (0.0)
	Total number of respondents	108	23	131
Recurrent	Traditional colporrhaphy	42 (55.3)	9 (39.1)	51 (51.5)
	Site-specific defect repair	18 (23.7)	4 (17.4)	22 (22.2)
	Sacral colpopexy (open/laparoscopic)	11 (14.5)	1 (4.3)	12 (12.1)
	Biological mesh	3 (3.9)	4 (17.4)	7 (7.1)
	Synthetic absorbable mesh	4 (5.3)	2 (8.7)	6 (6.1)
	Self-tailored synthetic nonabsorbable mesh	1 (1.3)	1 (4.3)	2 (2.0)
	Commercial synthetic transvaginal mesh system	11 (14.5)	4 (17.4)	15 (15.2)	0.359
	Sacrospinous ligament suspension	4 (5.3)	0 (0.0)	4 (4.0)
	Colpocleisis	0 (0.0)	0 (0.0)	0 (0.0)
	Total number of respondents	76	23	99

Data presented as n (%), multiple answers permitted.

Table 4.

Procedures of Choice for Repair of Apical Compartment Prolapse ^a

Type of prolapse	Procedures	Gynecologists	Urogynecologists	All respondents	p
Primary	Sacrospinous ligament suspension	40 (47.6)	1 (4.3)	41 (38.3)
	Uterosacral ligament suspension	16 (19.0)	10 (43.5)	26 (24.3)
	Ileococcygeal suspension	1 (1.2)	0 (0.0)	1 (0.9)
	Laparoscopic sacral colpopexy	8 (9.5)	6 (26.1)	14 (13.1)
	Abdominal sacral colpopexy	30 (35.7)	12 (52.2)	42 (39.3)
	Colpocleisis	1 (1.2)	0 (0.0)	1 (0.9)
	Commercial synthetic transvaginal mesh system	4 (4.8)	2 (8.7)	6 (5.6)	0.340
	Enterocele repair	1 (1.2)	0 (0.0)	1 (0.9)
	Total number of respondents	84	23	107
Recurrent	Sacrospinous ligament suspension	15 (22.1)	1 (5.0)	16 (18.2)
	Uterosacral ligament suspension	5 (7.4)	2 (10.0)	7 (8.0)
	Ileococcygeal suspension	1 (1.5)	0 (0.0)	1 (1.1)
	Laparoscopic sacral colpopexy	7 (10.3)	7 (35.0)	14 (15.9)
	Abdominal sacral colpopexy	33 (48.5)	11 (55.0)	44 (50.0)
	Colpocleisis	2 (2.9)	0 (0.0)	2 (2.3)
	Commercial synthetic transvaginal mesh system	7 (10.3)	3 (15.0)	10 (11.4)	0.271
	Self-tailored synthetic nonabsorbable mesh	0 (0.0)	0 (0.0)	0 (0.0)
	Biological mesh	0 (0.0)	0 (0.0)	0 (0.0)
	Enterocele repair	1 (1.5)	0 (0.0)	1 (1.1)
	Total number of respondents	68	20	88

Data presented as n (%), multiple answers permitted.

Discussion

The findings of this survey indicate that the most common indication for transvaginal mesh system use by Canadian pelvic floor surgeons is recurrent cystocele (20.7% of all respondents), with similar rates of use between urogynecologists and general gynecologists (22.7% and 20.0%, respectively). It seems that the prevalence of transvaginal mesh system use in Canada (28.2% of respondents) for pelvic organ prolapse repair is relatively low. Of those who use them, the general feeling is that transvaginal mesh systems produce better anatomical cure rates than traditional colporrhaphy, and a low incidences of mesh exposure (close to 80% of respondents report ≤5%). These findings correlate well with those reported in the literature.^4,12

A strength of this study is that the findings are likely representative of the general practice of gynecology across Canada. This survey was sent to all SOGC members, which reaches a population that includes a large majority of generalist gynecologists. A 27.2% response rate may appear low, but it is comparable to that of other published surveys involving pelvic organ prolapse repair in the literature (response rates range from 13% to 40%).^5,14–16

However, sending the survey to such a broad audience probably limited the focus of the study. A large number of physicians who do not perform surgeries for pelvic organ prolapse, including other subspecialists, likely account for a majority of the survey nonresponders, as only 31 (19.1%) of the respondents reported not performing surgeries for pelvic organ prolapse. Finally, as many questions in the survey addressed perceived outcomes of transvaginal mesh systems, answers obtained may have been influenced by recall bias.

In this survey, the perceived overall graft use in recurrent prolapse repair (47.8% in the anterior compartment and 30.3% in the posterior compartment) seemed to be less than what previous publications have shown. Jha and Moran showed that graft material was used by 56% in the anterior compartment and by 49% in the posterior compartment,¹⁴ whereas Vanspauwen et al. had reported its use by 75% in the anterior compartment and 61% in the posterior compartment.¹⁵ This may reflect a difference in the Canadian practice compared with that of the United Kingdom, Australia, and New Zealand, where those other studies had been conducted.

Previously published surveys about surgical management of pelvic organ prolapse did not specifically address transvaginal mesh system use, apart from the survey of AUGS members in 2007 that focused specifically on the management of cystoceles.^5,14–16 In the survey reported here, only 28.2% of respondents had ever used a transvaginal mesh system, and they were most commonly used for recurrent cystocele by only 20.7%. These rates seem to be low, compared with the AUGS members' survey, which showed that 49% of respondents were using transvaginal mesh systems for primary repair of cystoceles and 47% were using them for a recurrence.⁵ The survey reported here found that the practice of 42.9% of respondents was altered subsequent to the FDA advisories of 2008 and 2011, and the 2010 Health Canada notification, possibly explaining this difference. Forty-three percent of respondents who did not use transvaginal mesh systems were concerned about the lack of long-term evidence justifying their use, and 23.8% believed that the risks associated with these procedures outweighed their benefits. These findings reinforce the need for long-term safety and efficacy studies for procedures using transvaginal mesh systems.

More than half of respondents routinely performed a hysterectomy as part of their prolapse repair. A growing proportion of gynecologists are now considering uterine-sparing prolapse repair surgery. There are still limited data about the outcomes of such procedures, but short-term studies on apical suspension procedures without hysterectomy, including transvaginal mesh systems procedures, seem promising.¹⁷

Conclusions

In Canada, there is heterogeneity in the surgical approach to the repair of pelvic organ prolapse. As transvaginal mesh systems having been popular for less than a decade, this survey seems to indicate that they are still not widely used in the Canadian practice. They are most commonly used for the repair of recurrent anterior wall prolapse by only 20.7% of respondents. The practice of 43% of respondents was altered following the 2008 and 2011 FDA notifications concerning transvaginal mesh complications. There is an ongoing need for rigorous studies about the long-term benefits and risks associated with these procedures.

Footnotes

Acknowledgments

This study was funded by the Academic Enrichment Fund of the McGill University Health Center's Obstetrics and Gynecology Department, Montreal, QC. We thank K. Yourie Kim, from the St-Mary's Hospital Research Center, Montreal, QC, for her technical assistance in building the web survey.

Disclosure Statement

Dr. Walter is a consultant for Boston Scientific, and has received financial compensation from presentations for Boston Scientific, Duchesnay, and Gynecare. Dr. Merovitz has received financial compensation from a presentation for Duchesnay. Dr. Larouche has no financial associations to disclose.

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