Fact, fallacies and Filshie Clips
M. Filshie
University Hospital, Queen’s Medical Centre, Nottingham, UK
Introduction: Female sterilisation is the most popular method of
contraception worldwide when a woman has completed her family1. In
1996, the CREST long-term follow up study of different methods of female
sterilisation was published in the USA. This showed a higher than anticipated
failure rate and ectopic pregnancy rate than had been otherwise expected. This
study did not include the Filshie Clip, as it was not available in the USA at
that time. Present studies have shown that the Filshie Clip has a comparatively
lower long-term failure rate and ectopic pregnancy rate. However, senior
clinicians still quote the Crest Study figures for counselling purposes despite
the fact that the Filshie Clip is being used in their units2&3.
Fact 1. The overall long-term failure rate of the Crest Study is 36.5/10004
compared with the Filshie Clip, which is 2.7/10005.
Fact 2. The ectopic pregnancy rate quoted in the Crest Study is 1/3 of
failures i.e. 1% whereas the ectopic pregnancy rate of the Filshie Clip is 1 in
10,000 (4% of 2.7/ 1000)6, which actually equates to just 0.000108%!
Fact 3. The regret rate of the Crest Study is up to 20%7 compared
to just 5% with the Filshie Clip8.
Fact 4. The Mirena IUS has been quoted as having a failure rate equivalent to
the failure rate of female sterilisation with Filshie Clips. Where as this may
be the case, the definitive study of the IUS compared to the Filshie Clip with
intention to treat has not yet been undertaken. Pregnancies associated with
patients who have had their IUS removed for pain, bleeding and side effects have
not been included in the overall failure rate. The five year ectopic pregnancies
with LNG-IUD-20 is reported to be 1 in 50009
Conclusion: In units where the Filshie Clip is used for female
sterilisation; Filshie Clip data should be used for counselling purposes not
the Crest Study.
1. Rioux JE, Daris M. Curr Opin
Obstet Gynecol 2000;13:377–381
2. Mattinson A, Mansour D. J Fam
Planning Reprod Health 2003;29:136–139;
3. Killick S. Gynaecol Forum 2002;7:3–6
4. Peterson HB et al. Am J Obstet
Gynecol 1996;174:1161–1168
5. RCOG Guidelines. Male & Female
Sterilisation: Evidenced-Based Clinical Guidelines No.4, 2004
6. King T et al. The Filshie Clip: a
summary of clinical studies sponsored by FHI, FDA Approval submission, 1996,
p.36
7. Hills SD, Marchbanks PA, Tylor LR
et al. Obstet Gynecol 1996;93:889–895
8. Filshie M Helson K, Teper S. 7th
Annual Meeting of ISGE, 1998:14155
9. Anderson K, Odlind V, Rybo G.
Contraception 1994;49:56–72.
Competing interest: Marcus Filshie is
also the Medical Director of Femcare Limited.
