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Filshie Clip Q&A
Filshie Clip Recommended for Approval for Use in the United States
Filshie Clip Q&A
A: Filshie Clip is a small, hinged titanium clip lined with a soft silastic rubber. It is a little less than ½" long and approximately 1/8" wide when in the closed position.
Q: What is a Tubal Ligation using the Filshie Clip?
A: Tubal Ligation with the Filshie Clip is a permanent method of birth control. To achieve this, a small incision is made around the navel area so the scar is tiny and practically nonexistent. A laparoscope, a long thin instrument, is inserted through the incision and enables the doctor to view the fallopian tubes. Using a special Filshie Clip applicator the doctor will place a Filshie Clip on each fallopian tube. The Filshie Clip occludes the fallopian tube preventing eggs to travel from the ovaries to the uterus where they can become fertilized by sperm. The eggs are simply reabsorbed by the body. The soft silastic rubber lining of the Filshie Clip gently compresses the fallopian tubes as opposed to other permanent sterilization methods which burn, cut, or crush the tube.
Q: How long is the Filshie Clip procedure?
A: Procedure time is approximately 20 minutes.
Q: Will my period be affected by the surgery?
A: You will continue to have a menstrual cycle. Your period may change due to age or to the removal of your past contraceptive method (such as the pill) but changes in your cycle will not be due to the Filshie Clip.
Q: Will this decrease my sex drive?
A: No. Tubal Ligation does not inhibit the sex drive - all hormone reproduction will remain the same. Some women even say they feel an increase in their sex drive due to the convenience of not having to worry about birth control any longer.
Q: Will it cause or prevent menopause?
A: Tubal Ligations have no effect on menopause. Your body will experience its regular hormonal change.
Q: Is it reversible?
A: A tubal ligation should be thought of as a permanent method of birth control. Compared to other sterilization methods, the Filshie Clip affects the least amount of fallopian tube thus increasing the opportunity for a successful reversal.
Q: Does the Filshie Clip contain latex?
A: There is no latex used in the manufacturing of the Filshie Clip system.
Q: Does the Filshie Clip contain nickel?
A: There is no nickel used in the manufacturing of the Filshie Clip System.
Filshie Clip Recommended for Approval for Use
in the United States
Description and Application
The device is smaller than a penny and designed to occlude the tube with minimal destruction. It is made of titanium with a silicone rubber lining, which expands to keep the tube compressed as it flattens. Using a customized applicator, the surgeon half closes the upper jaw to insert the applicator and clip though a cannula or operating laparoscope. When the surgeon releases the finger bar, the applicator and clip reopen and can be used as soft-nosed forceps to pick up the tube and examine the placement site. Once satisfied that the clip is positioned correctly, the surgeon squeezes the finger bar to its full limit. The clip is released automatically from the applicator and locked onto the tube. Ideally, the clip is applied across the isthmus, leaving an equal amount of tube on either side.
The remaining tube is considered to be adequate for successful reanastomosis. Albert Yuzpe, MD, Professor Emeritus of Obstetrics and Gynecology at the University of West Ontario in London, Ontario, Canada, spoke about the results of Canadian studies that had successful reversal rates after Filshie clip sterilization of 90%. Dr. Yuzpe characterized the application technique as easy to learn and having few complications, primarily because the surgeon can be sure of correctly seating the clip before it is locked into place.
Safety and efficacy
The panel considered safety and efficacy data from studies conducted by Family Health International (FHI). In total, FHI conducted 11 studies of the Filshie clip at 43 sites in 10 countries. Over 6,000 women were sterilized with Filshie clips and almost 4,000 were sterilized with other methods, including the tubal ring and the Wolf clip.
Four of the studies were designated pivotal evaluations: all were prospective, comparative, randomized and multicenter investigations of interval sterilizations. The studies compared the tubal ring and Wolf clip to the Filshie clip, with over 400 women in each of the two comparison groups. In the two studies comparing the Filshie and Wolf clips, the pooled analysis yielded a 12-month cumulative pregnancy rate of 0.1 per 100 women for the Filshie clip group and 0.7 per 100 women for the Wolf clip group. In the two studies comparing the Filshie clip and the tubal ring, the pooled analysis yielded the same 12-month cumulative pregnancy rate for both methods0.2 per 100 women.
A subset of women from each of these studies was followed for 24 months after sterilization. In the Wolf clip comparison, the Filshie clip group had two pregnancies in 24 months, a cumulative rate of 0.7 per 100 women; the Wolf clip group had six pregnancies, a cumulative rate of 2.8 per 100 women. In the 24-month follow-up of the tubal ring comparison groups, the Filshie clip sample again had two pregnancies, a cumulative rate of 0.7 per 100 women; the tubal ring sample had one pregnancy, a 24-month cumulative rate of 0.3 per 100 women.
The panel also had requested data from the single postpartum study conducted by FHI. In that prospective study, the pregnancy rate for women who received the Filshie clip sterilization was significantly higher than those sterilized by the Pomeroy method: at 24 months, the Filshie clip rate was 1.7, and the Pomeroy method rate was 0.4 per 100 women. This study indicates that the Filshie clip may be less effective when used postpartum than when applied during interval sterilizations. It should be noted that all these efficacy data are based on 1 and 2 years of follow-up; long-term data, such as that obtained by CREST, are not available.
In safety studies, the Filshie clip compared positively with other devicesthe surgical injury rate was a low 1.6 for the entire population. The most common injury was a tubal mesosalpingeal injury, caused more often by the tubal ring than the Filshie clip. Only one ectopic pregnancy was reported among the more than 5,000 Filshie clip sterilizations in the overall population.
In five cases, the Filshie clip had migrated (was found in a place other than attached to the fallopian tube). The researchers explained that after necrosis of the occluded tube, the clip may drop into the abdominal cavity. In these five migrations, the tube was completely occluded and the clip was still closed when discovered. In two cases, the Filshie clip had provoked a foreign body reaction. The other three migrations were incidental findings and had caused no reactions or discomfort to the patient.
FDA Recommends Approval with Conditions
The panel's recommendation to approve had a short list of conditions: that the manufacturer clarify reuse guidelines for the device applicator and provide final results of toxicology testing, information on magnetic resonance compatibility, and further information about the timing of the postpartum study procedures. The panel also wished to review labeling prior to final approval, expressing particular interest in discussion of "migration" and its causes, and of the higher failure rates associated with postpartum versus interval applications of the Filshie clip.
Information in this report was drawn from transcripts of the
proceedings: Obstetrics and Gynecology Devices Panel of the
Department of Health and Human Services Public Health Service, Food
and Drug Administration meeting of February 26, 1996.