For Immediate Release: September 1, 2016
Contact: Craig M. Sandberg, 312.263.7249, email@example.com
Chicago, IL – A fellow attorney recently asked me about a case I was handling in the State of Washington involving the use of Filshie clips as a means of permanent female sterilization. The case involved a F-37 who became pregnant shortly after her doctor applied bilateral Filshie clips to her fallopian tubes one-day postpartum. The attorney knew, through this website, that I had settled a similar case in 2008. Nevertheless, he could not find any other reported settlements through his web search.
The aforementioned attorney asked for a quick primer on the use, application, risks, and failure rates of the Filshie clips. At the time, I was able to quickly provide him with a general understanding of those areas. That conversation got me thinking that posting some more specific information might be helpful to readers of these blog posts, as well.
I hope what follows is a helpful starting point. This should not be considered exhaustive and I have attempted to provide citations for information when I can.
Description of Using Filshie Clips as an Occlusive Procedure
“[T]he Filshie clip (CooperSurgical, Lake Forest, CA) is a hinged device made of titanium lined with silicone rubber. After the fallopian tube has been identified, the Filshie clip is brought to an area of tube 2–3 cm distal to the uterotubal junction. The lower edge of the clip is then visualized through the mesosalpinx to confirm that, when closed, the clip will completely occlude the tubal lumen. The clip is then closed via the applicator, and when closed flattens the curved upper jaw of the clip, occluding the tube. The upper jaw of the clip has a leading edge that extends under the lip of the lower jaw. As necrosis occurs, the rubber expands to keep the lumen blocked. Over time the tube divides into two separate peritoneum-covered stumps. Unique to the Filshie clip, there are several points to remember:
Schmidt, E, Diedrich, J, et al, Glob. Libr. Women’s Med., (ISSN: 1756-2228) 2014; DOI 10.3843/GLOWM.10402 (internal citations omitted).
“Filshie clips are 12.7 mm long and 4 mm wide with jaws of titanium lined with silicone rubber. They effect sterilisation[sic] by causing avascular necrosis at the site of clip application. The tubes eventually divide leaving two healed and occluded stumps.” Emmanuel Kalu, et al., Migrating Filshie clip: an unmentioned complication of female sterilisation[sic], J. Fam. Plan. Reprod. Health Care 2006 32:188-189.
The applicable section of the Code of Federal Regulation regulating the U.S. Food and Drug Administration (“FDA”) states that "[a] contraceptive tubal occlusion device (TOD) and introducer is a device designed to close a fallopian tube with a mechanical structure, e.g., a band or clip on the outside of the fallopian tube or a plug or valve on the inside. The devices are used to prevent pregnancy." 21 C.F.R. 884.5380 (Contraceptive tubal occlusion device (TOD) and introducer). This section of the Code is for "medical devices", which would, apparently, include a Filshie clip.
The literature from CooperSurgical, Inc provides the following information:
“The Filshie Clip is manufactured from titanium and is lined on the inner surface with silicone rubber (both are implantable grade). At one end there is a hinge and at the other a latch, allowing for manipulation of the Fallopian tube. The Filshie Clip is applied across the entire diameter of the Fallopian tube. When the Clip is fully closed, the upper jaw is flattened and is securely latched under the front end of the lower jaw. This acts as a clasp, securing the upper jaw of the Clip. The silicone rubber is in direct contact with the tissues and both are compressed under the force applied by the titanium. When avascular necrosis of the Fallopian tube occurs the compressed silicone expands to maintain complete occlusion of the lumen. This prevents re-canalisation and destroys approximately 4mm of the Fallopian tube…The Filshie Clip is 13mm long, 3.5mm wide and when closed 4mm high.
Important: Before applying Filshie Clips, please carefully read the Filshie Clip Instructions For Use that is provided in all boxes of Filshie Clips, including the sections on Contraindications, Warnings, Precautions, Side Effects and Adverse Effects.”
Stated differently, Filshie clips can be thought of as clamps applied to the fallopian tubes, which are designed to prevent pregnancy by completely occluding the tubes. Occlusion refers to “[c]rushing the whole diameter of the tube leads to an effective closure of the lumen.” Frits B. Lammes, Spontaneous opening of the Filshie clip as a cause of sterilisation[sic] failure, Brit. J. of Obst. and Gynaecol. 2001; 657-658.
Post-Application Expulsion and Migration of Filshie Clips
Case reports of complications include migration of a clip and expulsion through the abdominal wall (Tan BL, et al., Migrating Filshie clip, Australian and N.Z. J. of Obst. and Gynaecol. 2004 44:583 – 584), via the anus (Pandit M., Early extrusion of bilateral Filshie clips after laparoscopic sterilization, Brit. J. of Obst. and Gynaecol. 2005 112:680), vagina (Kale A, et al., Spontaneous vaginal expulsion of a Filshie clip, Annals of the Acad. of Med., Sing. 2008 37:438 – 439), or urethra (Connolly D, et al., Migration of Filshie clips – report of two cases and review of the literature, Ulster Med. J. 2005 74:126 – 128; Gregory J. Kesby, et al., Migration of a Filshie clip into the urinary bladder seven years after laproscopic sterilization, BJOG: An Int’l J. of Obst. and Gynaecol. 1997 104(3):379-382).
Migrating clips have been described as presenting as chronic groin sinus (Kolias AG, et al., Chronic groin sinus: an unusual complication of sterilisation clips, Annals of the Royal C. of Surgeons of Eng. 2010 92:W13 – W14) chronic perianal sepsis (Dua RS, et al., Extruded Filshie clip presenting as an ischiorectal abscess, Annals of the Royal C. of Surgeons of Eng. 2007 89:808 – 809; Hasan A, et al., Filshie clip migration with recurrent perianal sepsis and low ﬁstula in ano formation, Brit. J. of Obstetrics & and Gynaecol. 2005 112:1581) adherent to the peritoneum (Kalu, et al., Migratiging Filshie clip: an unmentioned complication of female sterilisation[sic], J. Fam. Plan. Reprod. Health Care 2006 32: 188-189), within the right inguinal region (Allison Michelle Mumme, et al., Filshie clip migration with multiple groin hernias: a case report, J. of Med. Case Rep. 2015 9:187), upper vaginal wall (N.Y.A. Renard, et al., Filshie clip migration: A report of two cases, J. of Obst. and Gynaecol., July 2012; 32; 492-501), and lying against the right hemi-diaphragm (N.Y.A. Renard, et al., Filshie clip migration: A report of two cases, J. of Obst. and Gynaecol., July 2012; 32; 492-501).
The literature search did not demonstrate any description of a Filshie clip "slipping" from or along the fallopian tube after it had been properly applied. The only medical or legal writings I found describing a Filshie clip “slipping” is contained in the case of Catlin v. Hamburg, 56 A.3d 914 (Pa. 2012) and involves an intra-operative misapplication that was identified immediately. In Catlin, the court describes that the defendant “utilized ‘Filshie’ clips to occlude, or close off, [the plaintiff’s] fallopian tubes.” Catlin, 56 A.3d at 917. Intra-operatively, the Filshie clip slipped and a second procedure (modified Pomeroy tubal ligation) was performed, as opposed to a second Filshie clip being applied to the same tube. The decision does not describe whether additional clips were available.
Risks of Filshie Clip Failure (Postpartum vs. Interval)
The Practice Bulletin entitled “Benefits and Risks of Sterilization” that is published by the American College of Obstetricians and Gynecologists (“ACOG”) states that mechanical devices, like a Filshie clip, “are most likely to be effective when used to occlude a normal fallopian tube; tubal adhesions, thickened tubes, or dilated fallopian tubes may increase the risk of misapplication and subsequent failure.” ACOG Practice Bulletin, Benefits and Risks of Sterilization, No. 133, Feb. 2013. Importantly, when Filshie clips are applied postpartum, those clips will be applied to fallopian tubes that have been described as “dilated” or “swollen”. Stated differently, the clips will not be applied to a "normal" fallopian tube.
According the case studies cited by the manufacturer (CooperSurgical, Lake Forest, CA), there is a 600%+ increase in the chance of pregnancy when a Filshie clip is applied postpartum, rather than having the procedure done six to eight weeks later (“interval”). “The recognized failure rate for the Filshie Clip is 2.7/1000 [0.27%], but may be higher in women with certain pre-existing conditions (including pelvic inflammatory disease and obesity.” “Women sterilized postpartum or postabortion may be at increased risk of pregnancy. The pregnancy rate following tubal sterilization of postpartum patients is higher than that reported in interval patients. After two (2) years the annual pregnancy rate for patients sterilized with the Filshie Clip was 1.7% for postpartum patients.” CooperSurgical, Care, Maintenance and Sterilization Manual.