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Original Article

Trends in Sterilization since the Introduction of Essure

Hysteroscopic Sterilization

Valerie I. Shavell, MD, Mazen E. Abdallah, MD, George H. Shade Jr, MD,Michael P. Diamond, MD, and Jay M. Berman, MD*

From the Department of Obstetrics and Gynecology, Wayne State University School of Medicine and the Detroit Medical Center, Detroit, Michigan (all authors).

ABSTRACT Study Objective: To investigate trends in sterilization in women at the Detroit Medical Center, Michigan (DMC), since the

introduction of Essure hysteroscopic sterilization.

Design: Retrospective study (Canadian Task Force classification II-2).Setting: Outpatient surgery center and university teaching hospitals.

Patients: Women who underwent interval sterilization procedures at the DMC (Hutzel Women’s Hospital, Sinai-Grace

Hospital, and the Berry Center) and postpartum sterilization procedures at Hutzel Women’s Hospital between January 1,

2002, and December 31, 2007.

Interventions: Permanent sterilization procedures including minilaparotomy tubal ligation, laparoscopic sterilization, Essure

hysteroscopic sterilization, and postpartum tubal ligation performed at the time of cesarean section or after vaginal delivery.

Measurements and Main Results: In all, 5509 permanent sterilization procedures were performed in the 6 years between

January 1, 2002, and December 31, 2007, at the DMC facilities analyzed: 2484 interval sterilization procedures at Hutzel

Women’s Hospital, Sinai-Grace Hospital, and the Berry Center, and 3025 postpartum tubal ligations at Hutzel Women’s Hos-

pital. From 2002 through 2007, the decrease in laparoscopic sterilizations from 97.9% to 48.5% of all interval sterilization pro-

cedures corresponded significantly with the increase in Essure hysteroscopic sterilizations from 0.0% to 51.3% (p ,.001).

Postpartum tubal ligations performed after vaginal delivery also decreased significantly during the study period from 7.9%

to 3.3% of all vaginal deliveries (p ,.001) while the percentage of tubal ligations performed at the time of cesarean section

remained constant (p 5.051).

Conclusion: At the DMC facilities analyzed from January 1, 2002, through December 31, 2007, a significant decrease oc-

curred in the percentage of laparoscopic sterilizations and postpartum tubal ligations performed after vaginal delivery. Of the

interval sterilizations performed, the percentage of Essure hysteroscopic sterilizations increased significantly from 0.0% to

51.3% of all procedures. Since the approval of Essure hysteroscopic sterilization in November 2002, this minimally invasive

method of hysteroscopic sterilization has increased in popularity at the DMC. Journal of Minimally Invasive Gynecology

(2009) 16, 22–27 2008 AAGL. All rights reserved.

Keywords: Sterilization; Tubal ligation; Hysteroscopic sterilization; Postpartum sterilization; Essure

Permanent sterilization is the most common method of

contraception worldwide. More than 600,000 tubal steriliza-tions are performed every year in the United States with an

estimated 180 million reproductive-aged women using tubal

sterilization to prevent pregnancy across the globe [1,2]. Cur-rently, laparoscopic sterilization is the conventional method

of female sterilization. However, this long-standing method

of surgical sterilization may soon be replaced by hystero-

scopic sterilization.

The Essure permanent birth control device is a relatively

new form of transcervical sterilization that was approved

by the US Food and Drug Administration in November

2002 [3]. Under hysteroscopic guidance, a dynamically ex-

panding microinsert composed of a stainless steel and poly-

ethylene terephthalate inner core and a nickel titanium

alloy outer coil is introduced into the proximal portion of

Please note that two authors (MPD and JMB) do have ties to Essure Concep-

tus. However, Conceptus had no involvement in this study whatsoever.

Essure is a product of Conceptus Inc, Mountain View, CA.

Corresponding author: Jay M. Berman, MD, Department of Obstetrics and

Gynecology, Hutzel Women’s Hospital, 3990 John R St. 7 Brush N, Box

166, Detroit, MI 48201.

E-mail: [email protected]

Submitted June 11, 2008. Accepted for publication August 29, 2008.

Available at www.sciencedirect.com and www.jmig.org

1553-4650/$ - see front matter 2008 AAGL. All rights reserved.doi:10.1016/j.jmig.2008.08.017

mailto:[email protected]

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each fallopian tube inducing local fibrosis and, ultimately,

tubal occlusion [2,4]. Complete occlusion typically occurs

within 3 months of device placement, and hysterosalpingog-

raphy is performed 3 months postinsertion to confirm bilat-

eral tubal occlusion and proper device placement [5,6].

Essure hysteroscopic sterilization is an attractive alterna-

tive to conventional methods of surgical sterilization. Thus,we were interested in estimating trends in female sterilization

procedures at the Detroit Medical Center, Michigan (DMC),

since the introduction of this minimally invasive, noninci-

sional method of permanent sterilization.

Materials and Methods

A chart review approved by our institution review board

was conducted on women who underwent permanent sterili-

zation procedures at the DMC between January 1, 2002, and

December 31, 2007. Interval tubal sterilization procedures

successfully completed at Hutzel Women’s Hospital, Sinai-Grace Hospital, and the Berry Center, and postpartum steril-

ization procedures performed at Hutzel Women’s Hospital

were categorized by year and type. Interval sterilization

procedures included minilaparotomy tubal ligations, laparo-

scopic sterilizations, and Essure hysteroscopic sterilizations.

Postpartum sterilization procedures included those per-

formed at the time of cesarean section, and minilaparotomy

tubal ligations performed after vaginal delivery. All tubal li-

gations categorized as postpartum were performed during the

same hospitalization as delivery. Of the 3 DMC facilities an-

alyzed, postpartum minilaparotomy tubal ligations are per-

formed regularly only at Hutzel Women’s Hospital. Patient age and procedure time were also extracted from operating

department records at Hutzel Women’s Hospital.

Linear trends were analyzed using the c2 test and Spear-

man rank order correlation coefficient. Fisher exact test, anal-

ysis of variance, and independent samples t test were used to

analyze differences between groups. Statistical analysis was

performed using statistical software (SPSS, Version 15.0

for Windows, SPSS Inc, Chicago, IL). Significance was de-

fined as p less than .05.

Results

In all, 5509 permanent sterilization procedures were per-

formed in the 6 years between January 1, 2002, and Decem-

ber 31, 2007, at the DMC facilities analyzed: 2484 interval

sterilization procedures at Hutzel Women’s Hospital, Sinai-

Grace Hospital, and the Berry Center, and 3025 postpartum

tubal ligations at Hutzel Women’s Hospital. Of the 2484 in-

terval sterilization procedures, 1456 were performed at Hut-

zel Women’s Hospital, 207 at Sinai-Grace Hospital, and 821

at the Berry Center. Among the 485 interval sterilizations

performed in the year 2002, 10 minilaparotomy tubal liga-

tions were performed (2.1% of all interval sterilizations that

year) along with 475 (97.9%) laparoscopic sterilizationsand 0 (0.0%) hysteroscopic sterilizations (Table 1). A major

alteration occurred in the ensuing years, such that by 2007

there was 1 (0.3%) minilaparotomy tubal ligation, 173

(48.5%) laparoscopic sterilizations, and 183 (51.3%) hys-

teroscopic sterilizations (Fig. 1). From 2002 through 2007,

the decrease in laparoscopic sterilizations corresponded sig-nificantly with the increase in hysteroscopic sterilizations

(c25 389, degrees of freedom [df] 5 5, p ,.001, r 5 .374).

The trends in sterilization procedures for each individual

facility reflected the trends for all the DMC facilities com-

bined. At Hutzel Women’s Hospital, the decrease in laparo-

scopic sterilizations from 279 (96.9%) in 2002 to 108

(57.8%) in 2007 corresponded significantly with the increase

in hysteroscopic sterilizations from 0 (0.0%) to 78 (41.7%)

(c25 155, df 5 5, p ,.001, r 5 .324). At Sinai-Grace Hos-

pital, the decrease in laparoscopic sterilizations from 37

(100%) in 2002 to 10 (19.2%) in 2007 corresponded signif-

icantly with the increase in hysteroscopic sterilizationsfrom 0 (0.0%) to 42 (80.8%) (c2

5 73, df 5 5, p ,.001,

r 5 .558). Similarly, laparoscopic sterilizations at the Berry

Center decreased significantly from 159 (99.4%) in 2002 to

55 (46.6%) in 2007, and this decrease corresponded signifi-

cantly with the increase in hysteroscopic sterilizations from

0 (0.0%) to 63 (53.4%) (c25 177, df 5 5, p ,.001,

r 5 .391). Evaluation of hospital-to-hospital variation

revealed an increased rate of hysteroscopic sterilizations rel-

ative to laparoscopic sterilizations at Sinai-Grace Hospital

compared with Hutzel Women’s Hospital and the Berry

Center (c25 48, df 5 2, p ,.001).

Regarding postpartum tubal ligations, 3025 postpartumtubal ligations were performed at Hutzel Women’s Hospital

between January 1, 2002, and December 31, 2007. Of these

3025 postpartum sterilizations, 1469 tubal ligations were per-

formed at the time of cesarean section and 1556 minilaparot-

omy tubal ligations were performed after vaginal delivery.

From 2002 through 2007, a slight, but nonsignificant, de-

crease occurred in the percentage of postpartum tubal liga-

tions performed at the time of cesarean section, from

20.3% (232/1143) of cesarean sections in 2002 to 16.6%

(250/1502) in 2007 (c25 11, df 5 5, p5 .051, r 52.032)

(Table 2). However, a significant decrease occurred from

2002 through 2007 in the percentage of postpartum tuballigations performed after vaginal delivery, from 7.9%

Table 1

Interval sterilization procedures performed at the Detroit MedicalCenter by year

Year

Laparoscopic

tubal sterilization,

No. (%)a

Hysteroscopic

sterilization

(Essure), No. (%)a

Minilaparotomy

tubal ligation,

No. (%)a Total

2002 475 (97.9) 0 (0.0) 10 (2.1) 4852003 403 (87.8) 53 (11.5) 3 (0.7) 459

2004 335 (80.9) 75 (18.1) 4 (1.0) 414

2005 335 (82.1) 71 (17.4) 2 (0.5) 408

2006 247 (68.4) 114 (31.6) 0 (0.0) 361

2007 173 (48.5) 183 (51.3) 1 (0.3) 357

a Percent of all interval sterilization procedures performed that year.

Shavell et al. Trends in Sterilization 23

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(345/4383) of vaginal deliveries in 2002 to 3.3% (123/3708)

in 2007 (c25 88, df 5 5, p ,.001, r 52.048).

In the study period, the mean age of women who under-

went postpartum tubal ligation at the time of cesarean section

was significantly greater than the mean age of women whounderwent postpartum tubal ligation after vaginal delivery

(34.86 5.7 vs 32.96 5.2 years, p ,.001). In addition, for

those who underwent postpartum tubal ligation at the time

of cesarean section, a significant decrease occurred in mean

age from 37.36 5.5 years in 2002 to 32.7 6 5.7 years in

2007 (F5 32, df 5 5, 1463, p ,.001) (Table 3). Similarly,

for women who underwent tubal ligation after vaginal deliv-

ery, the mean age decreased significantly over time from

35.76 5.1 years in 2002 to 31.36 5.1 years in 2007

(F5 34, df 5 5, 1550, p ,.001). This trend in decreasing

mean age was not observed for those who underwent interval

sterilization procedures, in whom mean ages did not differ significantly from 2002 through 2007 for either laparoscopic

sterilizations (p 5.578) or hysteroscopic sterilizations

(p 5.108).

In the year 2003, when Essure hysteroscopic sterilization

was first performed at Hutzel Women’s Hospital, the mean

procedure time was 26.66 12.2 minutes, which was compa-

rable with the mean procedure time of 23.36 14.4 minutes in

2007 (p5 .226). In addition, the mean procedure time for

hysteroscopic sterilization in 2007 was significantly shorter

than the mean procedure time for laparoscopic sterilization

(23.36 14.4 vs 40.26 14.8 minutes, p ,.001).

Discussion

Since the introduction of the Essure permanent birth con-

trol device, this minimally invasive, nonincisional method of

sterilization has increased in popularity at the DMC. At the

DMC facilities that we included in our analysis, the percent-

age of Essure hysteroscopic sterilizations increased from

0.0% of all interval sterilizations in 2002 to 51.3% in 2007.

Conversely, the percentage of laparoscopic sterilizations

decreased from 97.9% in 2002 to 48.5% in 2007. Thus, a sig-

nificant proportion of laparoscopic sterilizations, the conv-

entional method of interval sterilization, were replaced byEssure hysteroscopic sterilizations. Of note, the total number

of sterilization procedures performed at the DMC facilities

analyzed decreased during the study period while the popula-

tion numbers served by these facilities remained stable.

The Essure procedure is an attractive alternative to laparo-

scopic tubal sterilization as the minimally invasive, noninci-sional nature of the procedure provides for fewer reported

complications. Based on findings from the US Collaborative

Review of Sterilization, the overall major complication rate

for laparoscopic tubal sterilization is 1.6/100 procedures

[1]. Major complications include unintended major surgery

because of bleeding from the fallopian tube or mesosalpinx,

bleeding from the laparoscopic puncture site, or stomach or

bowel perforation, rehospitalization because of pelvic infec-

tions, severe vaginal bleeding, or abdominal pain, and febrile

morbidity. Those with diabetes mellitus, earlier abdominal or

pelvic surgery, or obesity are at increased risk for complica-

tions [1].Potential risks of hysteroscopic sterilization include hy-

pervolemia, uterine perforation, and vasovagal response,

which occurred in 2.9%, 1.1%, and 1.0% of procedures in Es-

sure clinical trials, respectively [2,6]. Failed device place-

ment is another complication of Essure hysteroscopic

sterilization. In a multicenter phase-III trial, bilateral place-

ment of the Essure device could not be achieved in 8% of

women in whom placement was attempted [7]. Anatomic im-

pediments and tubal spasm accounted for most placement

failures. Perforation of the tubal lumen and device expulsion

also occurred. Postoperative complications are similar to

those experienced after diagnostic hysteroscopy: mild uterine

Fig. 1. Interval sterilization procedures by year.

Table 2

Postpartum sterilizations performed at Hutzel Women’s Hospital byyear

Year

Postpartum salpingectomy

at cesarean section, No. (%)a Postpartum salpingectomy

after vaginal delivery, No. (%)b

2002 232 (20.3) 345 (7.9)

2003 231 (19.4) 311 (7.3)

2004 237 (18.7) 258 (6.7)

2005 266 (19.9) 281 (7.7)

2006 253 (16.8) 238 (6.2)

2007 250 (16.6) 123 (3.3)

a Percent of all cesarean sections performed that year.b Percent of all vaginal deliveries performed that year.

24 Journal of Minimally Invasive Gynecology, Vol 16, No 1, January/February 2009

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cramping and light vaginal bleeding [7]. Although complica-

tions exist for both procedures, Essure hysteroscopic sterili-

zation appears to be a safer method of interval sterilization

when compared with laparoscopic sterilization. Furthermore,

Essure hysteroscopic sterilization may be performed under sedation or local anesthesia whereas laparoscopic steriliza-

tion is most commonly performed under general anesthesia.

Thus, the inherent risks of general anesthesia are avoided.

For these reasons, physicians and other health care providers

at the DMC are discussing Essure hysteroscopic sterilization

with women who desire permanent sterilization, particularly

women who have multiple medical comorbidities or who

have undergone abdominal or pelvic surgery.

Among experienced surgeons, Essure hysteroscopic ster-

ilization also requires less operating time than laparoscopic

sterilization. Based on operating department records from

Hutzel Women’s Hospital for the year 2007, the mean timeto complete hysteroscopic sterilization was 23.3 minutes,

which was significantly less than the 40.2 minutes needed

for laparoscopic sterilization. In a multicenter phase-II trial,

the mean time for Essure device placement was 18 minutes,

which is comparable to our findings [6]. Moreover, in an in-

stitutional setting, the Essure procedure has the added benefit

of being equivalent in cost, if not less expensive, when com-

pared with laparoscopic sterilization. In a retrospective cost

analysis comparing Essure hysteroscopic sterilization to lap-

aroscopic sterilization via bipolar coagulation, the Essure

procedure had an institutional savings of $108/patient when

performed in an operating department setting [8]. Of note,this cost savings included laparoscopic sterilization by Filshie

clips (Cooper Surgical, Trumbull, CT) if Essure placement

failed and the confirmatory hysterosalpingogram. When the

Essure procedure is performed in the office setting, the cost

savings are significantly greater. In one analysis, the institu-

tional cost for hysteroscopic sterilization was $1374 versus

$3449 for laparoscopic sterilization [9]. Although institutional

cost savings exist, no facility pressure existed to replace

laparoscopic sterilization with Essure hysteroscopic steriliza-

tion at the DMC. In fact, it was physicians trained in Essure,

not facility administration, who were the driving force behind

the implementation of hysteroscopic sterilization at our facility.

Aside from cost savings, in a cohort-controlled study of

Essure versus laparoscopic sterilization, a higher level of pa-

tient satisfaction and tolerance was reported by those who un-

derwent Essure sterilization [10]. Satisfaction with the Essure

procedure was rated as very good to excellent by 96% of women up to 24 months after sterilization [6]. Although the

data on the efficacy of the Essure procedure are preliminary,

no pregnancies were reported at 5 years of follow-up in

Essure clinical trials when tubal occlusion was established

[2]. However, several cases were reported of post-Essure

pregnancies in women in whom tubal occlusion was con-

firmed [11,12]. In a summary of pregnancies reported after

Essure hysteroscopic sterilization, 64 unintended pregnan-

cies were reported in more than 50,000 Essure procedures

[13]. Most pregnancies resulted from patient or physician

noncompliance with post-Essure follow-up, misinterpreta-

tion of the hysterosalpingogram or radiograph, or the pres-ence of an intrauterine pregnancy at the time of device

placement. Based on data from the Essure phase-II clinical

trial, the pregnancy rate for the Essure procedure after 5 years

of follow-up is estimated to be 2.6/1000 procedures [13].

Comparatively, the 5-year cumulative pregnancy rate for

women who underwent laparoscopic sterilization via bipolar

coagulation between 1985 and 1987 was 6.3/1000 proce-

dures with a lifetime failure rate for laparoscopic sterilization

quoted as 1 in 200 [14,15]. Essure hysteroscopic sterilization

may be a more effective method of permanent contraception

than laparoscopic sterilization. However, the data on preg-

nancy and complication rates associated with the Essure pro-cedure are based on clinical trials, whereas those for

laparoscopic sterilization are based on general practice.

Therefore, the data may not be comparable. The true preg-

nancy and complication rates for the Essure device are still

unknown.

From 2002 through 2007, a shift occurred toward Essure

hysteroscopic sterilization at the DMC while laparoscopic

sterilizations and postpartum minilaparotomy tubal ligations

declined. In analyzing the trends in postpartum tubal liga-

tions at Hutzel Women’s Hospital, the number of tubal liga-

tions performed at the time of cesarean section remained

steady whereas the number of minilaparotomy tubal ligationsafter vaginal delivery decreased. From 2002 through 2007,

Table 3

Mean age of women undergoing permanent sterilization at Hutzel Women’s Hospital

Mean age6 SD, y

Year

Laparoscopic

sterilization

Hysteroscopic

sterilization

Minilaparotomy

tubal ligation

Tubal ligation

at cesarean section

Tubal ligation

after vaginal delivery

2002 31.06 5.7 – 31.66 5.7 37.36 5.5 35.76 5.1

2003 30.86 6.0 34.16 6.3 31.36 0.6 36.56 5.3 35.56 5.1

2004 31.76 5.7 31.36 4.7 31.06 5.3 35.66 5.3 33.96 4.9

2005 31.46 6.1 32.56 6.6 28.56 4.9 33.96 5.6 33.06 4.4

2006 31.46 5.7 32.06 6.1 – 32.76 4.9 31.86 4.7

2007 33.06 5.3 31.36 5.4 33.06 0.0 32.76 5.7a 31.36 5.1a

a Significant decrease in mean age from 2002 through 2007 (p ,.001).


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a 64.3% reduction occurred in the number of tubal ligations

performed after vaginal delivery from 7.9% to 3.3% of all

vaginal deliveries. Although not confirmed, this decrease

may be a result of the increasing popularity of the Essure pro-

cedure. Given the nonincisional, minimally invasive nature

of Essure hysteroscopic sterilization, patients may prefer to

wait 6 weeks after their vaginal delivery to schedule an Es-sure procedure rather than undergo a minilaparotomy tubal

ligation the day after delivery. Physicians may also prefer Es-

sure hysteroscopic sterilization given the minimal amount of

complications associated with the procedure. Aside from the

necessary infraumbilical incision, the postpartum minilapar-

otomy tubal ligation has inherent risks that the Essure proce-

dure does not. In an analysis of 5095 women who underwent

postpartum minilaparotomy tubal ligations, 20 women expe-

rienced major complications including intraoperative blood

loss greater than 500 mL, unintended major surgery, febrile

morbidity, and pulmonary embolus [16]. Minor complica-

tions such as abdominal wall hematoma, wound dehiscence,uterine injury, and ileus also occurred. Essure hysteroscopic

sterilization, therefore, may be a more prudent option than

postpartum salpingectomy for morbidly obese women or

for those with earlier abdominal surgery or serious medical

comorbidities. Furthermore, the 5-year cumulative preg-

nancy rate for postpartum salpingectomy is 6.3/1000 proce-

dures, which is higher than the rate of 2.6/1000 for the

Essure procedure [13].

The decrease in postpartum tubal ligations performed after

vaginal delivery at Hutzel Women’s Hospital may also be

economically driven. However, physician reimbursement

for a postpartum tubal ligation is comparable with the reim-bursement for both Essure hysteroscopic sterilization and

laparoscopic sterilization. For example, physician reimburse-

ment from a Michigan preferred provider organization is cur-

rently $415.10 for a postpartum tubal ligation, $564.06 for

Essure hysteroscopic sterilization, and $457.80 for laparo-

scopic sterilization. Although reimbursements for the interval

sterilization procedures are higher, these values do not differ

dramatically. When Essure hysteroscopic sterilization is per-

formed in an office setting, however, physician reimburse-

ment tends to be considerably higher. Thus, it is possible

that physicians are replacing postpartum tubal ligations

with in-office Essure sterilizations. We did not analyze officesterilization procedures in this study.

It is important to note that postpartum salpingectomies are

elective procedures that do not take precedence over cesarean

sections or other obstetric emergencies at Hutzel Women’s

Hospital. At a busy inner-city hospital with more than 5000

deliveries a year, postpartum tubal ligations are often de-

layed, postponed to the following day, or cancelled alto-

gether. Thus, most private physicians at Hutzel Women’s

Hospital have abandoned postpartum tubal ligations for prac-

tical, not economic, reasons. Postpartum sterilizations are of-

fered to all of our clinic patients who desire permanent

sterilization and are older than 21 years; however, many of the procedures are cancelled at the patient’s request after

being counseled extensively about other methods of contra-

ception including interval sterilization.

Although Essure hysteroscopic sterilization is an excellent

alternative to conventional laparoscopic tubal sterilization

and minilaparotomy tubal ligation, several disadvantages

exist to this procedure. The main inconvenience of Essure

hysteroscopic sterilization is the need for a hysterosalpingo-gram 3 months after device placement to confirm bilateral

tubal occlusion and proper device placement. Until bilateral

tubal occlusion is confirmed, women must use an alternate

form of contraception. The requirement for post-Essure hys-

terosalpingography may lead to issues with compliance. For

example, the follow-up rate for confirmatory hysterosalpin-

gography in our clinic population was only 12.7% [17]. An-

other drawback to Essure hysteroscopic sterilization is the

permanence of the procedure. Unlike patients who have un-

dergone laparoscopic tubal sterilization or postpartum salpin-

gectomy, tubal reanastomosis is not an option for those who

have undergone successful Essure hysteroscopic sterilization[15]. Once tubal occlusion occurs, the procedure is irrevers-

ible. The successful placement of Essure microinserts,

furthermore, depends on the skill of the hysteroscopist and

the absence of anatomic impediments.

Overall, Essure hysteroscopic sterilization offers a mini-

mally invasive, effective, and well-tolerated method of per-

manent sterilization for women that provides an attractive

alternative to laparoscopic sterilization and postpartum mini-

laparotomy. Since the approval of the Essure permanent birth

control device in November 2002, the choice of approach to

sterilization was dramatically altered at the DMC.

Acknowledgment

The authors would like to thank Michael Kruger, statisti-

cal analyst, for his assistance.

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