Should Filshie Clips Be Recalled In 2023? We have been receiving increasing calls and inquiries from women throughout the United States regarding their experiences with the Filshie clips implanted in them for birth control purposes. Some of the Filshie clip procedures were done immediately after delivering a baby by Cesarean section delivery, and others had their Filshie clips placed during a laparoscopic procedure specifically dedicated to applying Filshie clips to their fallopian tubes. Many of these women express their justified concern and anger after discovering that one or more of their Filshie clips have migrated from where they were placed on their fallopian tubes, causing them substantial pain and other serious harm.

What Are Filshie Clips?

Filshie Clips are part of the “Filshie® Tubal ligation System” for laparoscopic tubal ligation, which involves applying a titanium clip with silicone rubber lining around each of the fallopian tubes. The Filshie Clip works by exerting continued pressure on the fallopian tube, causing avascularization for the 3 to 5 mm area it encompasses. The silicone continues this pressure even after necrosis starts and the fallopian tube decreases in size. Fibrosis then occurs, and the clip is peritonealized if all goes as planned. The disposable delivery system consists of an applicator which allows insertion into the women’s body to allow the clip to be snapped onto the fallopian tube. A women’s choice of birth control is a deeply personal decision, particularly when choosing a long-acting form of birth control like a tubal ligation which should permanently alter a women’s body.

On September 5, 1996, Femcare, the manufacturer of the Filshie Clip, obtained Conditional Premarket Approval (“PMA”) by the Food and Drug Administration (“FDA”) (PMA number P920046). Filshie Clips are classified as a Class III medical device by the FDA. Class III medical devices are those that either “present a potential unreasonable risk of illness or injury or are for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health.” 21 U.S.C. § 360c (1)(c). Because they are a Class III medical device, the FDA evaluated Filshie Clips’ safety and effectiveness prior to granting the product conditional approval. At that time, the FDA authorized its commercial distribution. Such approval was contingent upon the FDA’s finding that there was “a reasonable assurance” of the device’s safety and effectiveness. However, the PMA imposed certain conditions on the sale of the product, including certain labeling and reporting requirements, and restrictions on false or misleading advertising.

Should There Be A Filshie Clip Recall?

A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective. 21 CFR 7 provides guidance so that responsible firms may conduct an effective recall.

Medical device recalls are usually conducted voluntarily by the manufacturer under 21 CFR 7. In rare instances, where the manufacturer or importer fails to voluntarily recall a device that is a risk to health, FDA may issue a recall order to the manufacturer under 21 CFR 810, Medical Device Recall Authority. 21 CFR 810 describes the procedures the FDA will follow in exercising its medical device recall authority under section 518(e) of the Federal Food, Drug, and Cosmetic Act (Act).

Under 21 CFR 806, Medical Device Correction and Removals, manufacturers and importers are required to make a report to FDA of any correction or removal of a medical device(s) if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk to health.

Mandatory Device Recalls – 21 CFR 810

Medical device recalls are usually conducted voluntarily by the manufacturer under 21 CFR 7. In rare instances, where the manufacturer or importer fails to voluntarily recall a device that is a risk to health, FDA may issue a recall order to the manufacturer under 21 CFR 810, Medical Device Recall Authority. 21 CFR 810 describes the procedures the FDA will follow in exercising its medical device recall authority under section 518(e) of the Federal Food, Drug, and Cosmetic Act (Act).

If, after providing the appropriate person with an opportunity to consult with the agency, FDA finds that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, the FDA may issue a cease distribution and notification order requiring the person named in the order to immediately:

  • cease distribution of the device;
  • notify health professionals and device user facilities of the order; and
  • instruct these professionals and device user facilities to cease use of the device.

The person named in the order will have an opportunity for a regulatory hearing or to provide a written request to FDA asking that the order be modified, vacated, or amended. FDA may later amend the order to require a recall of the device.

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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 who may 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.