A Filshie clip is a silicone-lined, titanium occlusive device, originally designed for surgical contraception that was approved by the FDA in September 1996 for permanent contraception in women. The Filshie clip is placed with an applicator and designed to permanently occlude the mid-isthmic portion of the fallopian tube segment but also has the potential for occluding vascular structures during laparoscopic surgery.
A manufacturer of Filshie clips describes the medical device as a “small titanium clip with soft Silastic® lining [that] is an effective and immediate method of surgical sterilization. After the clip is applied, the silicone lining maintains pressure on the tube, resulting in complete tubal occlusion and eventual necrosis at the clip site. The Filshie Tubal Ligation System provides the most versatile and effective tubal ligation for either inpatient or outpatient procedures.”
Despite the wide-spread use of Filshie clips for tubal ligation (sterilization) procedures, many women have experienced unexpected problems, including migration of the Filshie clips. The MAUDE Adverse Event Reports in the FDA database describe many incidents of Filshie clip migration and resulting harm.
Some Background Information
Femcare Ltd., which applied with the FDA for premarket approval of the Filshie Clip System (Mark VI) in 1992, advised the FDA in seeking approval to market the Filshie Clip in the United States that reported Filshie Clip “migration or expulsion” (“adverse effect”) occurred at the rate of 0.13%. “Of the 5454 women who were enrolled in the ten prospective FHI clinical trials reported in the submission and who were sterilized using Filshie Clip tubal occlusion system, eight (0.1%) women were reported to have experienced instances of clip migration, clip expulsion, or foreign body reaction … Three instances of apparently asymptomatic migration of the clip were observed as incidental findings, but the frequency of this event is unknown.” Source
Hence, at the time the manufacturer of Filshie clips applied for FDA approval to sell the medical device in the United States, the FDA was provided with data from the manufacturer that stated that Filshie clip migration was an adverse effect that was highly unlikely and very unusual – Filshie clip migration was reported in only 8 out of 5,454 women who had been implanted with the Filshie clip.
Compare that representation with information provided to the SEC for the fiscal year ending in 2018 by Utah Medical Products, Inc., which acquired the FILSHIE Clip System as part of its acquisition of Femcare in March 2011:
Utah Medical Products, Inc. (“UTMD”) Annual Report for its fiscal year that ended on December 31, 2018 filed with the United States Securities and Exchange Commission “(SEC”) stated, in part: “A well-known and clinically reported potential side effect of FILSHIE Clip tubal ligation is clip migration. A clip occluded Fallopian tube eventually separates into two permanently closed stubs after tissue necrosis under a closed clip. Peritoneal tissue usually encapsulates an implanted clip while still in contact with the Fallopian tube. In some cases where tissue encapsulation is slow, migration of a clip occurs after sterilization has been achieved. Although the silicone lining of the clip helps prevent clip migration and reduces the risk of tubal regeneration, one clinical journal publication indicated migration occurs 6% of the time. Dr. FILSHIE, the inventor of the clip, expressed his opinion in 2002 that over 25% of patients will experience a migration of one or more clips, typically within the abdominal cavity. Once detached, the clip becomes encompassed in dense adhesive tissue normally without any symptoms, only rarely causing any complication. However, a low grade inflammatory response can occur. Because clips are biologically inert and relatively small, physicians generally have concluded that removing a migrated clip represents more risk to long term well-being than leaving it in the body. UTMD recently retained a clinical expert who in 2010 had published the results of a twenty-year retrospective review of all reported FILSHIE clip migration events in the English literature, in order to independently review all reported complaints contained in the US FDA MAUDE website and the Australia TGA DAEN website over the most recent ten years. His February 2019 written report generally observed that “There were no serious clinical or life-threatening complications that related directly or indirectly to the FILSHIE clips or their migration.”” Source
Hence, six years after the FDA approved the sale of Filshie clips in the United States based, in part, on the manufacturer’s representation of the extremely unlikely incidence of Filshie clip migration, the manufacturer was telling its shareholders that Dr. Filshie, who invented the device, stated in 2002 that over 25% of women who received the Filshie clip device could expect migration of one or more of the Filshie clips.
Most of the women who contact us regarding Filshie clips advise us that they were unaware that Filshie clips could migrate, which raise possible informed consent and other issues, and that they would not have agreed to Filshie clips had they been fully informed. Most of these women tell us that they suffer substantial pain and other harms due to Filshie clip migration.
If you or a loved one suffered injury or other harm from Filshie clip migration in the United States, you should promptly find a lawyer who may investigate your Filshie clip migration claim for you and represent you or your loved one in a Filshie clip migration 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 migration claim.
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