Permanent Female Contraception

Permanent female contraception may be achieved by the occlusion or interruption of the fallopian tubes, thus preventing fertilization and providing highly effective long-term sterilization with limited complications using the Filshie® Tubal Ligation System featuring the Sterishot® II Applicator.

Excellent and Well Known Long Term Effectiveness In hundreds of published studies, the Filshie System demonstrates an exemplary “typical use” success rate that is superior to all methods studied in the CREST trials (1). Filshie Clips also have a very low rate of ectopic pregnancy.

Since introduction in 1982, with over 12 million clips applied, knowledgeable gynecologists have relied on the Filshie Clip System for high effectiveness and limited complications, whereas numerous studies and even professional recommendations confirm that the long-term benefits versus complications of prophylactic salpingectomy are not established. (2-4) “The risks of decreased ovarian function and/or premature surgical menopause [due to prophylactic salpingectomy] may outweigh the benefit of decreased ovarian cancer incidence.” (5) “Studies investigating patient-based outcomes [of prophylactic salpingectomy] are lacking.” (6)

As with salpingectomy, the occlusive nature of the Filshie Clip has been shown to reduce the incidence of ovarian cancer (7-9). However, the Filshie Clip System has significant advantages when compared to salpingectomy: Filshie Clip placement involves no electrocautery, sharp dissection or permanent excision of tissue. A well-known and clinically reported potential side effect of Filshie Clip tubal ligation is clip migration. There are no known serious clinical or life-threatening complications that relate directly or indirectly to the Filshie Clips or their migration. (10)

Quick and Easy to Apply Laparoscopic application of Filshie Clips requires basic laparoscopic skills and takes just a few minutes. Compared to salpingectomy, the surgery is easier. In a recent postpartum study, bilateral salpingectomy was successfully completed in only 68% of cases vs 95% successful completion of tubal ligation. Tubal ligation also had a 15 minutes shorter operative time than bilateral salpingectomy. (11) In certain women salpingectomy may technically be very difficult, increase intraoperative complication rate or even impossible such as women with abnormal anatomy and women with severe adhesions due to pelvic inflammatory disease or endometriosis. (12) There is no sharp dissection or excision of tissue that increases surgical risks, and operating room costs are lower.

Patient Satisfaction Many women prefer the least invasive approach when it involves removal of anatomy.

Permanent, Yet Reversible Because Filshie Clips preserve almost the entire fallopian tube, reversal via reanastomosis has been shown to be highly successful. (13)

Minimal Laparoscopic Ports Required Only a single central instrument port is required for placement. Multiple lateral instrumentation ports that are necessary for salpingectomy are not needed. Therefore risk of epigastric vessel injury is mitigated (14) and port site infection, irritation and herniation is potentially reduced.

Non-Hormonal, Permanent Device Filshie Clips maintain high effectiveness without replacement or maintenance. Clips do not leach copper or hormones and do not need replacement. Filshie Clips are less worrisome than IUDs for women who have completed their families.

Effective for Postpartum Application The Filshie Clip’s special silicone profile and clip length allows it to be placed onto edematous postpartum Fallopian tubes. The length is able to encompass a swollen tube, and the silicone maintains pressure on the clipped tube as the tube gradually compresses.

Globally Recognized and Recommended The proven success of the Filshie Clip is the reason that the UK Royal College of Obstetricians and Gynaecologists, in conjunction with the National Health Service, continues to recommend Filshie Clips as the preferred method for laparoscopic female sterilization. (15) The Filshie System is the most common tubal occlusion method in Australia and New Zealand (16), and is one of the most popular permanent sterilization methods in the United States, Canada, and a significant number of other countries worldwide.

Achieving consistent Filshie Clip application: The Sterishot II series of single patient use applicators provide consistently effective results with a calibrated Filshie Clip closure mechanism confirmed for each application. Since 2008, the patented (17) Sterishot II single patient use Filshie Clip applicator has been providing precise closure pressure and reliable locking of the clip. Compared to a reusable applicator, Sterishot II applicators
• eliminate potential for patient infection due to cross-contamination,
• eliminate annual calibration requirements,
• eliminate the risk of damage from handling and storage, and
• eliminate resources required for post-surgical cleaning, sterile processing and tracking between procedures.

CLINICAL REFERENCE

(1) Peterson HB, Xia Z, Hughes JM, et al. The risk of pregnancy after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Am J Obstet Gynecol 1996;174(4):1161–1170.
(2) Szender J, Lele S, Fallopian tube ligation or salpingectomy as means for reducing risk of ovarian cancer, AMA J Ethics. 2015 Sep 1;17(9):843-8.
(3) Salpingectomy for ovarian cancer prevention. Committee Opinion 620, ACOG. Obset Gynecol 2015;125:279-81.
(4) Venkatesh K K, Clark L H, Stamilio D M. Cost-effectiveness of opportunistic salpingectomy vs tubal ligation at the time of cesarean delivery. Am J ObstetGynecol 2019;220:106.e1-10.
(5) Backes FJ, Salpingectomy, why not? Am J Obstet Gynecol 2014;210(5):385-386
(6) Castellano T, Zerden M, March L, et al. Risks and benefits of salpingectomy at the time of sterilization. Obstet Gynecol Surv 2017;72(11):663-668
(7) Benefits and risks of sterilization. Practice Bulletin No. 208. American College of Obstetricians and Gynecologists. Obstet Gynecol 2019;133(3):e194-e207.
(8) Rice M, Hankinson S, Tworoger S, Tubal ligation, hysterectomy, unilateral oophorectomy, and risk of ovarian cancer in the Nurses’ Health Studies, Fertil Steril 2014;102:192-8.
(9) Gaitskell K, Green J, Pirie K, et al, Tubal ligation and ovarian cancer risk in a large cohort: Substantial variation by histological type, Int J Cancer 2016;138:1076-84.
(10) Gad N, Aziz R, Siwicki K, Filshie clip migration into wall of urinary bladder presenting with acute abdominal pain. Case report and review of English literature: from 1990 to April 2009, Pelviperineology 2010;29:84-7
(11) Subramaniam A, Blanchard CT, Erickson BK, et al. Feasibility of complete salpingectomy compared with standard postpartum tubal ligation at cesarean delivery: a randomized controlled trial. Obstet Gynecol 2018;132:20-7
(12) Braaten K, Dutton C, Laparoscopic female sterilization. UpToDate. Dec 2018
(13) Jayakrishnan K, Baheti SN. Laparoscopic tubal sterilization reversal and fertility outcomes. J Hum Reprod Sci 2011;4:125-9
(14) Bhoyrul S, Vierra MA, Nezhat CR, et al. Trocar injuries in laparoscopic surgery. J Am Coll Surg 2001;192(6):677-683.
(15) Faculty of Sexual & Reproductive Healthcare, Royal College of Obstetricians & Gynaecologists, Male and Female Sterilisation, 2014 Sep.
(16) The Royal Australian and New Zealand College of Obstetricians and Gynaecologists, Female sterilisation by Filshie clip tubal occlusion (C-Gyn 22), 2014 Nov.
(17) U.S. Patents 9,451,966, 10,092,296

PRODUCT DESCRIPTION

The Filshie® Tubal Ligation System with Filshie® Clips and the Sterishot® II applicator is a contraceptive tubal occlusion device indicated for permanent female sterilization by occlusion of the Fallopian tubes.

FEATURES

• Excellent Immediate and Long Term Clinical Effectiveness.
• Quick & easy to apply.
• Requires minimal laparoscopic ports.
• Can be applied immediately following childbirth.
• Non-hormonal, does not contain copper.
• MRI compatible.
• Permanent, yet has been shown to allow high reversal success.
• Consistent, highly effective results with a precalibrated Sterishot® II Filshie® Clip closure mechanism for each patient.
• No post-surgical cleaning, sterile processing, tracking between procedures or service required.

INDICATIONS

• The Filshie® Clip and Sterishot® II Applicator are intended to achieve occlusion of fallopian tubes for permanent female contraception.

CONTRAINDICATIONS

The Filshie® Clip must not be applied if any of the following conditions are present in the patient:

• Existing (current) or suspected pregnancy.
• Significant peritubular adhesions obscuring the portion of the Fallopian Tube to be occluded.
• Acute pelvic inflammatory disease (PID).
• Salpingitis isthmica nodosa or chronic isthmic induration.
• Any conditions contraindicating the use of surgery, or local or general anaesthetic.

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