Predicting negligence in female sterilization failure using time interval to sterilization failure: analysis of 131 cases

Authors: Varma, Rajesh; Gupta, Janesh K.

Source: Human Reproduction, Volume 22, Number 9, 18 September 2007 , pp. 2437-2443(7)

Publisher: Oxford University Press

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Abstract:

BACKGROUND

Sterilization failure due to tubal non-occlusion or wrong structure sterilization is considered negligent, whereas spontaneous tubal recanalization or fistula formation is considered non-negligent. We examined whether interval to pregnancy failure was predictive of a negligent rather non-negligent failure mechanism. We aim to test this hypothesis in a selected population series of known mechanisms of sterilization failure and their time interval to failure.

METHODS

Analyses of 131 failed sterilizations pooled from UK (NHS Litigation Authority, Medical Protection Society and our hospital), Australia and a qualitative systematic review.

RESULTS

We identified 88 negligent and 43 non-negligent sterilization failures. Filshie and ring methods failed earlier than diathermy and Pomeroy methods. Sterilization failure occurred significantly earlier in negligent than non-negligent failure mechanisms [median failure intervals 7.0 versus 12.0 months; Hazard ratio (2.35 95% CI 1.314.21)]. Knowing that sterilization failure occurred early, increased the probability that the failure mechanism was likely to be negligent rather than non-negligent.

CONCLUSIONS

A short interval to failure is suggestive of a negligent failure mechanism. There is less certainty in the predictive value of longer time intervals on the mechanism of failure due to a paucity of cases. A national register of failed sterilizations that have been systematically investigated is needed to improve our understanding of negligent and non-negligent failure mechanisms.

Keywords: sterilization; tubal; treatment failure; survival analysis; Bayes theorem

Document Type: Research article

DOI: http://dx.doi.org/10.1093/humrep/dem188

Publication date: 2007-09-18

More about this publication?
  • Human Reproduction features full-length, peer-reviewed papers reporting original research, clinical case histories, as well as opinions and debates on topical issues. Papers published cover the scientific and medical aspects of reproductive physiology and pathology, endocrinology, andrology, gonad function, gametogenesis, fertilization, embryo development, implantation, pregnancy, genetics, genetic diagnosis, oncology, infectious disease, surgery, contraception, infertility treatment, psychology, ethics and social issues. The highest scientific and editorial standard is maintained throughout the journal along with a rapid rate of publication.
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