Millions of women in the United States have had Filshie Clips implanted as a means of permanent sterilization. The vast majority of these women apparently have not suffered any complications or adverse events regarding their Filshie Clips. Nonetheless, we receive inquiries on nearly a daily basis from women throughout the United States who believe they have suffered harm that they associate with their Filshie Clips.
Are Filshie Clips Safe?
Despite the continuing widespread use of Filshie Clips for permanent sterilization in the United States, the question of whether Filshie Clips are safe for all women is an important question that needs further medical and scientific investigation to insure that women are not unnecessarily harmed by Filshie Clips.
CooperSurgical, which manufactures and distributes Filshie Clips in the United States, has published “Instructions For Use” for medical providers who implant Filshie Clips in women. The Instructions For Use (revised September 2016) is an interesting read: under the heading “Clip Expulsion, Foreign Body Reactions, and Asymptomatic Migration,” CooperSurgical reports “Instances of clip expulsion per urethra, vaginal cuff and bowel, as well as foreign body reactions have been reported (3 expulsions and 2 foreign body reactions were reported in 5,326 women). Three instances of apparently asymptomatic migration of the clip were observed as incidental findings, but the frequency of this event is not known.” However, the number of those reported complications is based on outdated data and do not appear to have been updated.
CooperSurgical reported Filshie Clip migration or expulsion as an adverse event at the rate of 0.13%. Once again, the rate of those reported adverse events is based on outdated data and do not appear to have been updated. If the Filshie Clips inquiries we continue to receive is an indicator, the incidence of migration of the Filshie Clip is significant and substantial, and CooperSurgical should be required to currently investigate and report the current and updated “frequency of this event.”
Under the heading “Patient Counseling,” the Instructions For Use states: “Prior to any sterilization procedure being performed, the patient should be fully informed about alternative methods of contraception, the possible side effects of the procedure, any complications which may arise during and following the procedure and the risks and benefits associated with sterilization in general and the Filshie Tubal Ligation System procedure in particular. The patient should be encouraged to discuss openly and fully any questions she may have concerning the Filshie Clip.”
Many of the women who have contacted us regarding serious problems they associate with their Filshie Clips claim that they were not told that Filshie Clips would be used during their sterilization procedures. Failure to disclose the use of Filshie Clips and related matters may very well be the basis for a claim of lack of informed consent for the procedure. However, it is essential to obtain and review all consent forms signed by the patient for the sterilization procedure to determine if the consent forms mention that Filshie Clips would be implanted and if the risks associated with Filshie Clips and the alternatives to Filshie Clips were properly disclosed and discussed with patients before their Filshie Clips procedure.
One aspect of the informed consent issue for Filshie Clips procedures is that medical providers who perform sterilization procedures on women may act paternalistically (i.e., making sterilization procedure decisions for their patients without full discussion and disclosures about the alternatives available to the patients) and they wrongly believe it is their decision, not the patients’ informed decision, which method of sterilization will be used on their patients.
Under the heading “Long Term Implantation and Sequelae,” the Instructions For Use state: “The silicone and titanium used in the manufacture of the Filshie Clip are generally regarded as safe materials for human implantation. Although no adverse toxic or tumorigenic effects due to the device or its materials have been reported, the effects of long term implantation are unknown. The long term effects of tubal sterilization on women are unclear. Several uncontrolled studies suggest that women undergoing tubal sterilization may be prone to gynecological problems. More recent controlled studies report that sterilization does not cause any long term effects. The rates of hospital referral for gynecological or psychiatric conditions appear to be similar for women undergoing tubal sterilization and women whose husbands underwent vasectomy.” Again, those statements as they apply to Filshie Clips appear to be based on old data from old studies that have not been updated based on new studies.
5,754 women were enrolled in the eleven prospective clinical trials reported in the pre-market approval application (PMA) for Filshie Clips and who were sterilized using the Filshie Tubal Ligation System.
If you or a loved one suffered injury or other harm from the use of Filshie clips in the United States, you should promptly find a medical malpractice lawyer in your state who may investigate your Filshie clip claim for you and represent you in a Filshie clip medical malpractice and/or product liability case, if appropriate.
Visit our website or call us toll-free in the United States at 800-295-3959 to find medical malpractice attorneys in your U.S. state who may assist you with your Filshie clip claim.
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