Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that the mersilene tape caused and/or contributed to the preterm pre-labor rupture of membranes described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: best practice & research clinical obstetrics and gynaecology (2019);59:89-97.Https://doi.Org/10.1016/j.Bpobgyn.2019.06.001.
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Title: cervical cerclage in twin pregnancy.The aim of this study was to review the role of cervical cerclage in the prevention of preterm birth (ptb) in women with twin pregnancy.A total of 24 women [mean age of 31.5 ± 4.1 years (range 23-39 years)] who underwent a simplified laparoscopic cervical cerclage (lcc) were included in the study.Surgery was performed using a 5-mm mersilene tape (rs-22; ethicon, inc., somerville, nj, usa).Reported complications include second-trimester miscarriages (n=3), subsequent neonatal death due to extremely premature gestations (n=3), and preterm pre-labor rupture of membranes (n=1).In conclusion, lcc appears to be a safe, simple, and minimally invasive approach, which could potentially play an important role in women with established cervical incompetence and twin gestations who have had a failed tvc or a very short cervix that is not amenable to a tvc.The encouraging results presented in this review should be considered preliminary and confirmed in a larger cohort study.
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