Filshie Clips Recall In 2023? A recently filed federal lawsuit claiming harm caused by the migration of Filshie clips implanted in the Plaintiffs alleges, “Women and their doctors depend on the defendants, the manufacturers, and distributors of products like Filshie Clips, to be forthcoming about the safety and risks of Filshie Clips. This reliance on the defendants was warranted. The regulatory scheme that governs Filshie Clips is premised on a system whereby the manufacturer is responsible for reporting relevant safety information to the public. The onus is on the manufacturer to come forward with any safety risks because the public and the FDA would otherwise have no insight of adverse events.”
“Filshie Clips pose significant health risk, and the product has subjected untold thousands of women to significant injuries. These injuries stem from the simple fact that Filshie Clips have a propensity to migrate after being placed on the fallopian tubes. Migration of the clips following a normal application is estimated to occur over 25% of the time. The pathophysiology is related to the speed at which peritoneal-like tissue forms over the clip anchoring it to the fallopian tube. The migration of the clip often requires surgical intervention to remove the Filshie Clips from the woman’s body. The defendants neither warned nor adequately informed the plaintiffs nor their healthcare providers how frequently these migrations occur or the severity and permanency of the potential injuries even though the defendants had received adverse reports and knew or should have known Filshie Clips had a significant propensity to migrate.”
“The plaintiffs have suffered as a result of the defendants’ failure to report adverse events involving the Filshie Clip. That failure violated requirements imposed by the FDA. However, the risk of clip migration was significantly higher and continued to increase since the initial PMA. Despite these increases, the defendants failed to address the Filshie Clips safety issues, even though adverse event reports did or should have alerted them to a product defect causing the device to cause injuries. Despite having knowledge of an approximately two-hundred-fold increased risk of migration over the reported .13%, and rather than inform of such risk, the defendants, CooperSurgical, Cooper Companies, Femcare, and Utah Medical tout the benefits of the Filshie Clip version of the bilateral tubal ligation procedure over other available procedures. As noted in the press release regarding the Femcare, Ltd. purchase, the Filshie Clip System was claimed to be “safer than electrocautery and the newer hysteroscopic devices” without mention of the risk of migration associated with the clips.”
“The defendants had a duty to act as reasonable manufacturers and distributors of medical devices. They had a duty to continually monitor their product, including, but not limited to, its design, manufacturing, performance, safety profile, and labeling. They had a duty to continually test their product and ensure it was safe and would perform as intended. Yet the defendants breached their duties and, as a result, the plaintiffs were injured. The knowledge defendants have regarding the migration issues involved with the Filshie Clip Systems not only triggers responsibility under Connecticut law for product liability, they also imposed parallel duties on the defendants pursuant to the Food, Drug, and Cosmetic Act (“FDCA”) to accurately report and update the FDA of the same. These duties, both under applicable Connecticut state law and the FDCA, are substantially similar. The Connecticut state law does not impose a higher standard than the FDCA. If the defendants had timely disclosed the propensity and severity of risks associated with use of the Filshie Clips, the plaintiffs’ injuries could have been avoided. Instead, the defendants did nothing, and for that, the plaintiffs here seek redress both to compensate them for their losses and to strongly deter future, similar misconduct.”
Medical Device Recalls: Corrections And Removals – 21 CFR 806
Under 21 CFR 806, Medical Devices; Reports of Corrections 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. A report must be made even if the event was caused by use error. A report is not required if the information has already been provided to FDA under Medical Device Reporting (21 CFR 803) or Repurchase, Repairs or Replacement of Electronic Products (21 CFR 1004) or if the corrective or removal action was initiated by an FDA order under Medical Device Recall Authority (21 CFR 810).
Manufacturers and importers must keep records of those corrections and removals that are not required to be reported to FDA. However, if a report is not required under 21 CFR 806, the firm may voluntarily report under 21 CFR 7.
The definition of “risk to health”‘ under 21 CFR 806 tracks the definitions of Class I and Class II recalls in 21 CFR 7.3(m). Therefore, reports of corrections and removals are required for Class I and Class II recalls. Under 21 CFR 806, manufacturers and importers need not report events categorized as Class III recalls under 21 CFR §7; only record keeping requirements would apply.
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.
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