Australia Filshie Clip Recall: The Australian Government Department of Health and Aged Care Therapeutic Goods Administration states on its website that there was a recall commenced on July 1, 2020 for Filshie clips, inter alia, for “Product Defect Correction” for the following stated reason:
“Femcare Australia is providing updated “Instructions For Use” (IFUs) for the Filshie tubal ligation clips, Sterishot kits and Minilap Kit.
The purpose of the IFU update is to provide the following new additions to the “Precautions” and “Adverse Effects” sections of all of the IFUs:
“Migration of Filshie Clips may occur in up to 25% of patients with no clinical consequences in the majority of cases. Long term chronic pain has been reported that may be associated with clip migration and expulsion. Other adverse experiences which have been reported, but are not necessarily related to the use of the Filshie Clip, include suspected allergic and/or autoimmune reaction; weight gain; abdominal swelling; headache; and missed, heavy or irregular periods.
The patient should be counselled to consult with her allergist prior to implantation if hypersensitivity to nickel is suspected”.”
. . . .
Femcare Australia will provide customers a pdf copy of the amended IFU[s] which can be copied and inserted into each box after removal of the existing IFU.
This action has been closed out on 09/11/2020.”
Source TGA Recall Reference RC-2020-RN-00001-1.
Femcare Australia states on its website:
“The Filshie Clip System has become accepted as the “Gold Standard” of female surgical contraception by leading surgeons around the world.
A History of Success…
Over 30 years of proven clinical excellence:
• About 12 million clips have been successfully applied worldwide.
• Clinically proven success rate of 99.76%.
• Extremely low failure rate of only 2.4 failures per 1,000.
• Lowest incidence of ectopic pregnancy only 4% of the 2.4 per 1,000 failures resulting in ectopic pregnancies.
• Reversibility over 90% successful.
• Extremely effective for larger tubes (post partum).
• MRI compatible to 3T.
• Recommended by the UK Royal College of Obstetricians and Gynaecologists.
Sterishot II is designed for accurate Filshie Clip application for every patient.
Benefits:
• Fully calibrated and sterile for immediate single patient use.
• Key functionality consistent with the Filshie brand.
• Ergonomically designed handle to suit all hand sizes.
• Non-Slip Grip.
• Handle design allows greater surgeon control during Clip application.
• Reduced closure force.
• Non-touch Filshie Clip loading technique identical to existing system.”
Femcare’s brochure for the Filshie Clip Tubal Ligation System states:
“There are no known serious clinical or life-threatening complications that relate directly or indirectly to the Filshie Clips or their migration,” citing to a 2010 case report/review that stated, in part: “Symptomatic presentation secondary to migration of Filshie clips is rare but recognized complication of sterilisation by this method. It was estimated by Filshie that migration of one or more clips would occur in 25% of women. It is likely that not all loose clips cause symptoms, hence a proportion go undetected. When the Filshie clip was assessed for approval by the United States FDA in 1996, only 6 cases of migration or expulsion were reported amongst 5454 women involved in trials; there were three cases of spontaneous expulsion and three cases of incidentally discovered asymptomatic migration observed …
It is reassuring that none of the reported cases of Filshie clip migration have resulted in mortality prior to their removal or chronic morbidity subsequent to their removal. Nevertheless, the clinical presentations necessitated radiological interventions and invasive surgery in most to identify and retrieve the clip(s). As such, the authors recommend that clip migration and its possible sequelae should be carefully explained to patients to ensure they are aware of this potential complication, that it may occur from weeks to years after occlusion and has varied presentations.”
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.