PubMed · 15796080
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Medroxyprogesterone.. https://pubmed.ncbi.nlm.nih.gov/15796080/
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OBJECTIVES: FemCap is a silicone-rubber barrier contraceptive approved for marketing in the United States. To address reported problems with removal and dislodgment, the device's developer added a strap to the device and increased the height of the brim. This trial assessed whether the new design reduced removal difficulties and had any effects on dislodgment, genital pain/discomfort, safety, and acceptability. METHODS: Women used the strapped device for 8 weeks with follow-up visits at 2 and 8 weeks. Outcome measures were obtained through diary cards, questionnaires, and naked eye examination. Data from these 120 women were compared with data from 419 women who used the unstrapped FemCap in a previous contraceptive effectiveness study. RESULTS: The strapped device was not significantly easier for users to remove than the unstrapped device. Similar odds of dislodgment and cervical/vaginal irritation were seen with the two devices. Both female and male participants were significantly more likely to report pain/discomfort with use of the strapped device. Female users of the strapped device were significantly more likely to say they disliked their device. In six weeks, two pregnancies were observed, but pregnancy was not an endpoint in the study and no conclusions should be drawn regarding pregnancy rates. CONCLUSIONS: The modifications to the FemCap did not significantly improve the ease of device removal and appears to have resulted in significantly more female and male partner pain/discomfort and decreased acceptability, compared with the unstrapped device.
OBJECTIVE: To compare by electron microscopy the surface of vaginal contraceptive rings before and after use. METHODS: A single ring was worn for 28 days by a volunteer with normal vaginal flora. This worn ring was then cut in half, with one half placed directly into fixative and the other half rinsed to remove visible mucus prior to being placed into the fixative. Another ring was taken directly from the package and placed in fixative. The surfaces of the three ring samples were studied by scanning electron microscopy at varying magnifications to ascertain if there was penetration of bacteria into the vinyl polymer or if the ring surface was altered with 1 month of use. RESULTS: The ring half placed directly into fixative with visible mucus had cellular debris on its surface but no evidence of material penetration. The other half of the ring worn for 28 days and rinsed before fixation had a similar surface appearance to the unused ring. CONCLUSIONS: The surface of the ethylene vinyl acetate contraceptive vaginal ring is remarkably uniform and after 1 month of use was without visible evidence of erosion, embedded bacteria or structural changes compared to an unused ring.
OBJECTIVE: To evaluate the reliability of pelvic X-ray and transvaginal ultrasound to localize Essure microinserts (Conceptus, San Carlos, California) after successful placement in both fallopian tubes 3 months after placement. DESIGN: Prospective, observational study. SETTING: Gynecology departments at two teaching hospitals. PATIENT(S): One hundred eighty-two patients who underwent hysteroscopic sterilization by placement of Essure microinserts between August 2002 and August 2004. INTERVENTION(S): Transvaginal ultrasound, pelvic X-ray, and hysterosalpingography (HSG) 3 months after sterilization with Essure. MAIN OUTCOME MEASURE(S): Transvaginal ultrasound confirmation of correct localization of microinserts after a 3-month follow-up. RESULT(S): In 150 of 182 patients, confirmation of successful bilateral placement of two microinserts (300 devices) was possible. In 9 patients it was not possible to identify both devices with ultrasound, or there was doubt about the extension of the device through the uterotubal junction. The other 291 devices were identified as being in a good position. CONCLUSION(S): Hysterosalpingography at the 3-month follow-up after successful placement of Essure microinserts can be replaced by transvaginal ultrasonography. A 3-month follow-up with HSG after the Essure procedure is only required after unsatisfactory placements. In those patients in whom transvaginal ultrasonography cannot confirm satisfactory localization, a complementary pelvic X-ray should be performed.