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The Filshie Clip System
Female Surgical Contraception
Dispelling the Myths!! From IUD's to contraceptive pills, from IUS to injectables, from implants to sterilisation – when it comes to contraception, today's women are spoilt for choice.
Much has been written and debated on the merits of these different products and this brochure is designed to dispel the myths. .
Filshie Clip System versus Long Acting Reversible Contraception
How successful are modern day IUD's/IUS?
Whilst many companies claim that their product can be left in place for up to 5 years - this rarely happens. Statistical data shows that on average the Levonorgestrel Intrauterine System (LNG-IUS) on average only stays in place for 3.32 years(17). The most common reasons for removal are unacceptable vaginal bleeding and pain. Up to 60% of women stop using the LNG-IUS within 5 years(1) . Once Filshie Clips are applied the patient need never worry about contraception again. With a success rate of 99.76%
the Filshie Clip is a safe, simple and reliable method of surgical contraception(11).
What is the expulsion rate and continuation rate of the LNG-IUS?
The Faculty of Family Planning and Reproductive Health Care has published a comprehensive review of the LNG-IUS states that "the gross rate of expulsion increased from 4.5 per 100 users at 12 months to 5.2 per 100 users at 24 months and up to 5.9 per 100 users at 60 months"(3).
Over a 5-year period, approximately 5.9% of LNG-IUS's are expelled from the body spontaneously(6).
During the use of the LNG-IUS, the symptoms most strongly associated with its premature removal were excessive bleeding and spotting, infection and pain(4).
Long term continuation rates for copper IUD's and the LNG-IUS in clinical trials have been 33-53%(4). Is female sterilisation reversible?
Only 5% of patients regret sterilisation and only 1% of these regret it sufficiently to have the procedure reversed(7).
Reversal of Filshie Clip sterilisation is universally accepted as having an extremely high success rate of between 80%
- 100% via a relatively minor surgical procedure(8,13).
What are the ectopic pregnancy rates?
In the largest study of its type conducted in Finland, out of the 108 LNG-IUS failures reported, 44 were ectopic pregnancies. This equates to 40% of the failures reported in the study resulting in a potentially dangerous ectopic pregnancy(4).
In the rare event of a Filshie Clip failure, the ectopic pregnancy rate is just 4%(18).
What are the costs of surgical contraception versus LARC?
Analysis showed that at 15 years of contraceptive use, female and male sterilisation is more cost effective than all other methods of long-acting reversible contraception(10). When it comes to surgical contraception, women today have two options – laparoscopic or hysteroscopic sterilisation.
Laparoscopic sterilisation is the most common method of female surgical contraception. .
Filshie Clip System versus Hysteroscopic approach
The Filshie Clip, with over 25 years of proven success, has been applied more than 8 million times worldwide.
The latest method of hysteroscopic sterilisation has only been used for permanent sterilisation in approximately 50,000 patients(21).
Although the Filshie Clip should be regarded as permanent, successful reversal is achievable in over 90% of
patients(13).
Hysteroscopic sterilisation MUST be regarded as totally PERMANENT, as the latest method DOES NOT allow for reversibility.
Following the successful application of Filshie Clips there is usually no need for a follow-up procedure.
THREE MONTHS following hysteroscopic sterilisation (when using the ESSURE device) a HSG (hysterosalpingogram) is necessary to check for the successful placement of the implants. During this period the patient must rely on an alternative method of contraception. If the HSG shows a non-occluded fallopian tube the patient cannot rely on this hysteroscopic device for contraception and may require further surgery(19). Laparoscopic sterilisation using Filshie Clips is usually carried out as a day surgery procedure and can be performed
under local or general anaesthetic.
Hysteroscopic sterilisation can be carried out using local anaesthetic. However, a recent study has shown that up to 77% of patients would prefer to have a laparoscopic sterilisation versus a hysteroscopic sterilisation(2).
The application of Filshie Clips is possible immediately following child birth. Hysteroscopic methods of sterilisation
CANNOT be performed immediately following childbirth.
Unusual uterine shape or uterine pathology does not affect female surgical contraception using the Filshie Clip. For
hysteroscopic sterilisation uterine pathology or an unusual shaped uterus are contraindicated(20).
A clinical study has shown that the Filshie Clip was successfully implanted in 100% of all patients, in comparison to
only 81% of patients using the latest hysteroscopic method(14).
IVF is NOT contraindicated following the application of Filshie Clips.
The Filshie Clip System versus other methods of surgical contraception:
1. What are the failure rates for the different surgical contraception methods?
The Filshie Clip has demonstrated a success rate of 99.76%(11) making it an extremely effective method for female surgical
contraception. Studies from around the world have consistently demonstrated the low failure rate of the Filshie Clip. The table
below highlights the success of the Filshie Clip:
Failure Rate (%)
Yuzpe (Rioux et al) Puraviappan et al Kovacs & Krins (4) Although not available in the USA when the CREST study was conducted, the above long-term follow-up studies of the Filshie
Clip confirm its enviably low failure rate.
The CREST 10-year follow-up study indicates the following failure rates for comparative methods(9): Failure Rate (%)
2. Should a surgeon counsel patients based solely on the CREST study data?
In accordance with the Royal College of Obstetricians and Gynaecologists Clinical Guidelines, patients should be given full
information on the operation that they are having. This means that Filshie Clip data should be used when Filshie Clips are being
applied.
•
The CREST study highlighted higher than expected failure rates for sterilisation over a long period. However, the CREST
study did not feature the Filshie Clip as it was not available in the USA at the time the study was undertaken.
Clinical data clearly shows that the failure rate of the Filshie Clip is significantly lower than other methods of surgical
contraception.
Any surgeon counselling a patient on the Filshie Clip should not use the data from the CREST study, but should use the
clinical data readily available on the long term success of the Filshie Clip.
(1) NICE - Long-acting reversible contraception.
(7) Filshie GM, Helson K, Teper S.
(13) Nwagbara PN, Stibbe HM, Browning AJ, Tonks AM.
Clinical Guideline 30, October 2006 Day case sterilization with the Filshie Clip in Nottingham. Reversal of female sterilisation experience in a district (2) Baxter N, Hudson H, Rogerson L, Duffy S.
10-year follow-up study: the first 200 cases. general hospital. Hysteroscopic sterilisation: a study of women's attitudes to ISGE 7th Annual Meeting, March 1998.
Journal of Obstetrics and Gynaecology (1997), Vol. 17, No. a novel procedure. (8) Hulka JF, Noble AD, Letchworth AT, Lieberman B, Owen
BJOG March 2005, Vol. 112, p.360-362.
E, Gomel V, Taft RC, Haney AF, Wheeless CR, Imrie AH, (14) Duffy S, Marsh F, Rogerson L, Hudson H, Cooper K, Jack S,
(3) Faculty of Family Planning and Reproductive Heath Care
Winston RL, Loeffler FE. Hunter D, Philips G. Guidance (April 2004). Reversibility of clip sterilizations. Female sterilisation: a cohort controlled comparative study The Levonorgestrel-releasing Intrauterine System (LNG-IUS) Lancet 1982, Oct 23; 2(8304): 927 of ESSURE versus laparoscopic sterilisation. in contraception and reproductive health. (9) Peterson HB, Xia Z, Hughes JM, Wilcox LS, Ratliff Tylor L,
BJOG, Nov 2005, Vol. 112, p.1522-1528.
The Journal of Family Planning and Reproductive Health (15) Royal College of Obstetricians and Gynaecologists.
Care 2004; Vol 30, No 2, p.99-108.
The risk of pregnancy after tubal sterilization: Findings for Evidence-based Clinical Guideline Number 4, (4) Backman T, Huhtala S, Blom T, Luoto R, Rauramo I,
the US Collaborative Review of Sterilization. Male and Female Sterilisation. January 2004.
American Journal Obstetrics & Gynaecology, April 1996, (16) FDA Advisory Panel Meeting.
Length of use and symptoms associated with premature 174:1161-1170 (CREST Study).
Presentation made by Prof. Theodore King, 26 Feb 1996.
removal of the Levonorgestrel Intrauterine System: A nation- (10) O'Brien S, Gupta J, Najia S, Yehia M.
(17) NICE – National cost-impact report.
wide study of 17,360 users. Update on female sterilisation: report from an international Implementing the NICE clinical guideline on long-acting BJOG 2000; Vol. 107, p.335-339. symposium at the 6th International Scientific Meeting of reversible contraception. (5) Andersson K, Odlind V, Rybo G.
the Royal College of Obstetricians and Gynaecologists (to Clinical Guideline No. 30, December 2005.
Levonorgestrel-releasing and copper-releasing (Nova T) IUDs (18) Filshie GM.
during five years of use: A randomized comparative trial. (11) Kovacs GT, Krins AJ.
Long term experience with the Filshie Clip. Contraception, January 1994; 49, p.56-72.
Female sterilisations with Filshie Clips: what is the risk Gynaecology Forum, Vol. 7, Issue 3, 2002.
(6) Cox M, Tripp J, Blacksell S.
failure? A retrospective survey of 30,000 applications. (19) Conceptus / Essure Patient Information Brochure
Clinical performance of the Levonorgestrel Intrauterine The Journal of Family Planning & Reproductive Health Care (CC-0454-01. 14.03.03GB) System in routine use by the UK Family Planning and 2002; 28(1):34-5. Reproductive Health Research Network: 5-year report. (12) Peterson HB, Xia Z, Hughes JM, Wilcox LS, Ratliff Tylor L,
(20) Cooper JM, Carignan CS, Cher D, Kerin JF.
The Journal of Family Planning and Reproductive Health Microinsert non-incisional hysteroscopic sterilization. Care 2002; 28(2), p.73-77. The risk of Ectopic Pregnancy after Tubal Sterilization: for Obstetrics & Gynaecology 2003; 102(1):59-67.
The US Collaborative Review of Sterilization Working (21) Baxter AJ
New developments Advances in hysterorscopic sterilisation. The New England Journal of Medicine, 13 March 1997, Vol. The Obstetrician & Gynaecologist. 2006;8:103-106. Femcare-Nikomed Limited Stuart Court, Spursholt Place, Salisbury Road, Romsey, Hampshire SO51 6DJ, UK Brochure Re-order Code: Tel: +44 (0)1794 525100 Fax: +44 (0)1794 525101 BRO - 0029 (04/07) Email: [email protected] Web: www.femcare-nikomed.co.uk

Source: http://www.femcare-nikomed.co.uk/brochures/BRO-0029.pdf