How Often Do Filshie Clips Migrate? — In applying for premarket approval of the Filshie Clip System in 1993, the applicant reported clip migration or expulsion as an adverse event at the rate of 0.13%. (See pages 11 and 49 of 85). “Of the 5454 women who were enrolled in the ten prospective FHI [Family Health International] clinical trials reported in this submission and who were sterilized using the Filshie clip tubal occlusion system, eight (0.1%) women were reported to have experienced instances of clip migration, clip expulsion, or foreign body reaction … seven of the eight women underwent a surgical procedure for diagnosis or treatment of associated symptoms.” (page 22) “[M]ost women [in the clinical trials] were scheduled to be followed up for 12 months, and the maximum specified follow-up period was 24 months … data from a retrospective study, which attempted to evaluate women up to 60 months after the sterilization, were also included.” (page 16)
A medical journal article from 2007 states “A comprehensive literature review was performed which has demonstrated that clip migration is estimated to occur in 0.6 per 1000 cases. Dislodged clips are most commonly found within the peritoneal cavity, typically within the pouch of Douglas or paracolic gutters. Rarely, tubal clips may migrate into the urinary bladder, vagina or through the anterior abdominal wall.”
A medical journal article from 2020 states “Migration of Filshie clips used during TL [tubal ligation] is estimated to occur in 25% of all patients; 0.1-0.6% of these patients subsequently experience symptoms or extrusion of the clip from anatomical sites such as the anus, vagina, urethra, or abdominal wall. Migrated clips may present as chronic groin sinus, perianal sepsis, or chronic abdominal pain. These symptoms can occur as early as 6 weeks or as late as 21 years after application.”
The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers. Our cursory review of some of the MAUDE reports regarding Filshie clips indicates that hundreds of women and their health care providers have reported instances of Filshie clip migration and other adverse events involving their Filshie clips.
Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides the Food and Drug Administration (FDA) with the authority to require manufacturers to conduct postmarket surveillance at the time of approval or clearance or at any time thereafter of certain class II or class III devices. Postmarket surveillance is the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device. The data collected under a surveillance order help to address important public health questions on the safety and effectiveness of a device.
What Is Being Done For Women Who Have Experienced Filshie Clip Migration Problems?
WE ARE CURRENTLY INVESTIGATING FILSHIE CLIP MIGRATION CLAIMS THROUGHOUT THE UNITED STATES.
If you or a loved one suffered injury or other harm from Filshie clip migration, or other Filshie clip issues, in the United States, you should promptly find a lawyer who may investigate your Filshie clip claim for you and represent you or your loved one in a Filshie clip case, if appropriate.
Visit our website or call us toll-free in the United States at 800-295-3959 to find Filshie clip attorneys who may assist you with your Filshie clip claim.
Turn to us when you don’t know where to turn.