Filshie Clip Recall 2022?

The FDA uses the term “recall” when a manufacturer takes a correction or removal action to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, an artificial hip) is recalled, it does not always have to be explanted from patients. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place.

In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily). When a company learns that it has a product that violates FDA law, it does two things:

  • Initiates a recall (through correction or removal)
  • Notifies the FDA.

Legally, the FDA can require a company to recall a device. This could happen if a company refuses to recall a device that is associated with significant health problems or death. However, in practice, the FDA has rarely needed to require a medical device recall.

Source

When we last checked the FDA medical device database for Filshie clips on March 15, 2022, the result stated “No records were found with Productfilshie clips  Page Last Updated: 03/14/2022.”

Filshie Clip Migration Claims

Femcare Ltd., which applied with the FDA for premarket approval of the Filshie Clip System (Mark VI) in 1992, advised the FDA in 1996 in seeking approval to market the Filshie Clip in the United States that 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 

According to Utah Medical Products, Inc., as stated in its Form 10-K Annual Report filed with the SEC for the fiscal year ended December 31, 2018, “UTMD acquired the FILSHIE Clip System as part of its acquisition of Femcare in March 2011. In 2018, sales of FILSHIE Clips, applicators and accessories represented 35% of UTMD’s total U.S. Dollar denominated sales. The FILSHIE Clip is a female surgical contraception device used for tubal ligation, i.e., placed on the fallopian tubes, generally laparoscopically, but also postpartum during a C-Section procedure. The FILSHIE Clip, implanted in over six million women worldwide during the last 37 years, has empirically been proven to be the safest and most effective tubal occlusive device, is as easy or easier to achieve occlusion as any of the alternative surgical techniques, and has a substantially higher probability of reversibility when compared to all of the other approaches for women who later decide that they might like to get pregnant. Femcare has obtained numerous regulatory approvals for the FILSHIE Clip System, which in 2018 was sold directly by UTMD to medical facilities in Canada, Ireland, France, the UK and Australia, and through specialty distributors in many other countries including by CooperSurgical Inc. (CSI) in the U.S.  In February 2019, UTMD acquired the exclusive distribution rights from CSI, and will begin to sell the FILSHIE Clip System directly to medical facilities in the U.S.”

“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

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.

This entry was posted on Sunday, June 26th, 2022 at 5:24 am. Both comments and pings are currently closed.

placeholder

Easy Free Consultation

Fill out the form below for a free consultation or contact us directly at 800.295.3959.
  • Please enter the correct answer to this math problem.
  • This field is for validation purposes and should be left unchanged.

    Easy Free Consultation

    Fill out the form below for a free consultation or contact us directly at 800.295.3959