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Contraceptive failure after hysteroscopic sterilization: Analysis of clinical and demographic data from 103 unplanned pregnancies.

Sills ES, Li X, Jones CA, Wood SH - Obstet Gynecol Sci (2015)

Bottom Line: Patients age ≥30 years and BMI <25 reported conception after HS somewhat sooner than younger patients, although the differences in time to pregnancy were not significant (P=0.24 and 0.09, respectively).Age, BMI, or surgical history are unlikely to predict contraceptive failure with HS.Further follow-up studies are planned to capture additional data on this issue.

View Article: PubMed Central - PubMed

Affiliation: Reproductive Research Section, Center for Advanced Genetics, Carlsbad, CA, USA. ; Department of Molecular & Applied Biosciences, University of Westminster, London, UK.

ABSTRACT

Objective: This investigation examined data on unplanned pregnancies following hysteroscopic sterilization (HS).

Methods: A confidential questionnaire was used to collect data from women with medically confirmed pregnancy (n=103) registered after undergoing HS.

Results: Mean (±SD) patient age and body mass index (BMI) were 29.5±4.6 years and 27.7±6.1 kg/m(2), respectively. Peak pregnancy incidence was reported at 10 months after HS, although <3% of unplanned pregnancies occurred within the first three months following HS. Mean (±SD) interval between HS and pregnancy was 19.6±14.9 (range, 2 to 84) months. Patients age ≥30 years and BMI <25 reported conception after HS somewhat sooner than younger patients, although the differences in time to pregnancy were not significant (P=0.24 and 0.09, respectively). The recommended post-HS hysterosalpingogram (to confirm proper placement and bilateral tubal occlusion) was obtained by 66% (68/103) of respondents.

Conclusion: This report is the first to provide patient-derived data on contraceptive failures after HS. While adherence to backup contraception 3 months after HS can be poor, many unintended pregnancies with HS occur long after the interval when alternate contraceptive is required. Many patients who obtain HS appear to ignore the manufacturer's guidance regarding the post-procedure hysterosalpingogram to confirm proper device placement, although limited insurance coverage likely contributes to this problem. The greatest number of unplanned pregnancies occurred 10 months after HS, but some unplanned pregnancies were reported up to 7 years later. Age, BMI, or surgical history are unlikely to predict contraceptive failure with HS. Further follow-up studies are planned to capture additional data on this issue.

No MeSH data available.


Early (pre-contrast) hysterosalpingogram image performed three months after hysteroscopic sterilization. This radiograph illustrates placement of more than the recommended two Essure devices. Terminal markers are seen for five intact implants (1 to 5), and a fragment of a sixth device is also suggested (arrow).
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Figure 2: Early (pre-contrast) hysterosalpingogram image performed three months after hysteroscopic sterilization. This radiograph illustrates placement of more than the recommended two Essure devices. Terminal markers are seen for five intact implants (1 to 5), and a fragment of a sixth device is also suggested (arrow).

Mentions: Considering the patient data presented here, previous risk models [12] based on a relatively high first-year failure rate (i.e., pregnancy occurring within the first year after HS) appear valid but may still require some recalibration. Our analysis of contraceptive failure with HS did identify a peak unplanned pregnancy incidence within the first 12 months of device placement, but mean interval to pregnancy after HS was closer to 20 months. We may thus speculate that even if these patients had availed of an alternate method of contraception in the first three months following HS, many unplanned pregnancies would have still occurred. Since contraceptive efficacy for HS is often reported based on total number of HS devices sold during a reference period rather than the actual number of patients who undergo HS (Fig. 2), the published failure rate for HS may not be reliable [9]. Calculating contraceptive efficacy using absolute patient count instead of product inventory data may give a more accurate impression of actual or "realworld" HS experience, as described previously [12]. Additional research is needed to complete our understanding of outcomes following HS.


Contraceptive failure after hysteroscopic sterilization: Analysis of clinical and demographic data from 103 unplanned pregnancies.

Sills ES, Li X, Jones CA, Wood SH - Obstet Gynecol Sci (2015)

Early (pre-contrast) hysterosalpingogram image performed three months after hysteroscopic sterilization. This radiograph illustrates placement of more than the recommended two Essure devices. Terminal markers are seen for five intact implants (1 to 5), and a fragment of a sixth device is also suggested (arrow).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4663227&req=5

Figure 2: Early (pre-contrast) hysterosalpingogram image performed three months after hysteroscopic sterilization. This radiograph illustrates placement of more than the recommended two Essure devices. Terminal markers are seen for five intact implants (1 to 5), and a fragment of a sixth device is also suggested (arrow).
Mentions: Considering the patient data presented here, previous risk models [12] based on a relatively high first-year failure rate (i.e., pregnancy occurring within the first year after HS) appear valid but may still require some recalibration. Our analysis of contraceptive failure with HS did identify a peak unplanned pregnancy incidence within the first 12 months of device placement, but mean interval to pregnancy after HS was closer to 20 months. We may thus speculate that even if these patients had availed of an alternate method of contraception in the first three months following HS, many unplanned pregnancies would have still occurred. Since contraceptive efficacy for HS is often reported based on total number of HS devices sold during a reference period rather than the actual number of patients who undergo HS (Fig. 2), the published failure rate for HS may not be reliable [9]. Calculating contraceptive efficacy using absolute patient count instead of product inventory data may give a more accurate impression of actual or "realworld" HS experience, as described previously [12]. Additional research is needed to complete our understanding of outcomes following HS.

Bottom Line: Patients age ≥30 years and BMI <25 reported conception after HS somewhat sooner than younger patients, although the differences in time to pregnancy were not significant (P=0.24 and 0.09, respectively).Age, BMI, or surgical history are unlikely to predict contraceptive failure with HS.Further follow-up studies are planned to capture additional data on this issue.

View Article: PubMed Central - PubMed

Affiliation: Reproductive Research Section, Center for Advanced Genetics, Carlsbad, CA, USA. ; Department of Molecular & Applied Biosciences, University of Westminster, London, UK.

ABSTRACT

Objective: This investigation examined data on unplanned pregnancies following hysteroscopic sterilization (HS).

Methods: A confidential questionnaire was used to collect data from women with medically confirmed pregnancy (n=103) registered after undergoing HS.

Results: Mean (±SD) patient age and body mass index (BMI) were 29.5±4.6 years and 27.7±6.1 kg/m(2), respectively. Peak pregnancy incidence was reported at 10 months after HS, although <3% of unplanned pregnancies occurred within the first three months following HS. Mean (±SD) interval between HS and pregnancy was 19.6±14.9 (range, 2 to 84) months. Patients age ≥30 years and BMI <25 reported conception after HS somewhat sooner than younger patients, although the differences in time to pregnancy were not significant (P=0.24 and 0.09, respectively). The recommended post-HS hysterosalpingogram (to confirm proper placement and bilateral tubal occlusion) was obtained by 66% (68/103) of respondents.

Conclusion: This report is the first to provide patient-derived data on contraceptive failures after HS. While adherence to backup contraception 3 months after HS can be poor, many unintended pregnancies with HS occur long after the interval when alternate contraceptive is required. Many patients who obtain HS appear to ignore the manufacturer's guidance regarding the post-procedure hysterosalpingogram to confirm proper device placement, although limited insurance coverage likely contributes to this problem. The greatest number of unplanned pregnancies occurred 10 months after HS, but some unplanned pregnancies were reported up to 7 years later. Age, BMI, or surgical history are unlikely to predict contraceptive failure with HS. Further follow-up studies are planned to capture additional data on this issue.

No MeSH data available.