Can initial vaginal bleeding patterns in etonogestrel implant users predict subsequent bleeding in the first 2 years of use?

ObjectivesTo evaluate if a simple method for characterizing vaginal bleeding patterns in etonogestrel contraceptive implant users can predict subsequent patterns and bleeding-related discontinuation over the first 2 years of use.Study designWe reanalyzed phase 3 study bleeding data for non-breastfeeding participants from the United States, Europe, Russia and Chile during the first 2 years of implant use to characterize and correlate bleeding patterns. We used 90-day reference periods with period 1.1 starting at Day 29 and ending at Day 118. We dichotomized bleeding patterns as "favorable" (amenorrhea, infrequent bleeding and normal frequency bleeding without prolonged bleeding) or "unfavorable' (prolonged and/or frequent bleeding) and tracked user groups based on these bleeding patterns in reference period 1.1 through Year 1 and from Year 1 through Year 2, respectively.ResultsWe evaluated data from 537 and 428 women with up to 1 and 2 years use, respectively. Of the 325 (60.5%) women with favorable bleeding in reference period 1.1, 275 (84.6%) reported favorable bleeding also in reference period 2, 197 (60.6%) reported favorable bleeding throughout Year 1, and favorable bleeding in 75-85% of reference periods in Year 2. Among 212 (39.5%) women with unfavorable bleeding in reference period 1.1, 118 (55.7%) continued with unfavorable bleeding in reference period 2, while about 40%-50% reported favorable patterns in RP 2, 3 and/or 4. Initial favorable bleeding resulted in lower discontinuation rates than initial unfavorable bleeding in years 1 (3.7% vs 12.7%, p≪.0001) and 2 (2.5% vs 16.5%, p≪.0001).ConclusionImplant users with favorable bleeding in the first reference period are likely to continue with favorable bleeding over the next 2 years. Initial bleeding patterns predict overall continuation rates in years 1 and 2. Implications Statement When evaluating vaginal bleeding in any 90-day reference period over 2 years of etonogestrel implant use, approximately 80% of women with favorable and 40% with unfavorable bleeding patterns will have favorable bleeding in the next reference periods. These findings can facilitate counseling regarding bleeding for women using the etonogestrel implant

The US etonogestrel implant mandatory clinical training and active monitoring programs: 6-year experience

ObjectiveThe objective was to monitor the effectiveness of the etonogestrel implant clinical training program through a voluntary active monitoring program (AMP).Study designUS health care providers underwent mandatory training by the manufacturer on etonogestrel implant insertion, localization and removal. After training, health care providers could enroll in a voluntary AMP to provide outcome data to meet a postmarketing commitment of the manufacturer with the US Food and Drug Administration (FDA). Those who volunteered completed and faxed forms to the manufacturer after implant insertion and removal detailing the procedure and device-related outcomes, including insertion-, localization- or removal-associated events. Experts reviewed outcome data quarterly, which the Sponsor then reported to the FDA.ResultsAmong 42,337 health care providers completing the training program, 4294 (10.1%) volunteered to participate in the AMP. The 26,198 forms submitted over 6.4 years included more insertion (n=20,497) forms than removal forms (n=5701). The volunteers reported 646 events on 566 (2.2%) forms related to insertion (n=197), localization (n=34), removal (n=357) and "other" (n=58). Clinically important events included noninsertion (n=4), serum etonogestrel positive but implant not found (n=1), and possible nerve (n=66) or vascular (n=5) injury. The reports did not include any insertion-, localization- or removal-associated hospitalizations. Eight (0.14%) removal reports described referral for surgical implant removal.ConclusionEvents related to insertion, localization or removal of the etonogestrel implant are uncommon among US providers who received mandatory training in the use of the implant.ImplicationsThis report presents results from the first mandatory US contraceptive training program. Health care providers volunteered to report information about etonogestrel implant insertion, localization and removal. Although the data do not demonstrate whether a mandatory program improves outcomes, they elucidate the utility and real-life experience that clinical training programs can provide

The US etonogestrel implant mandatory clinical training and active monitoring programs: 6-year experience.

ObjectiveThe objective was to monitor the effectiveness of the etonogestrel implant clinical training program through a voluntary active monitoring program (AMP).Study designUS health care providers underwent mandatory training by the manufacturer on etonogestrel implant insertion, localization and removal. After training, health care providers could enroll in a voluntary AMP to provide outcome data to meet a postmarketing commitment of the manufacturer with the US Food and Drug Administration (FDA). Those who volunteered completed and faxed forms to the manufacturer after implant insertion and removal detailing the procedure and device-related outcomes, including insertion-, localization- or removal-associated events. Experts reviewed outcome data quarterly, which the Sponsor then reported to the FDA.ResultsAmong 42,337 health care providers completing the training program, 4294 (10.1%) volunteered to participate in the AMP. The 26,198 forms submitted over 6.4 years included more insertion (n=20,497) forms than removal forms (n=5701). The volunteers reported 646 events on 566 (2.2%) forms related to insertion (n=197), localization (n=34), removal (n=357) and "other" (n=58). Clinically important events included noninsertion (n=4), serum etonogestrel positive but implant not found (n=1), and possible nerve (n=66) or vascular (n=5) injury. The reports did not include any insertion-, localization- or removal-associated hospitalizations. Eight (0.14%) removal reports described referral for surgical implant removal.ConclusionEvents related to insertion, localization or removal of the etonogestrel implant are uncommon among US providers who received mandatory training in the use of the implant.ImplicationsThis report presents results from the first mandatory US contraceptive training program. Health care providers volunteered to report information about etonogestrel implant insertion, localization and removal. Although the data do not demonstrate whether a mandatory program improves outcomes, they elucidate the utility and real-life experience that clinical training programs can provide

The matching of experimental polymer processing flows to viscoelastic numerical simulation

International audienceThis paper describes work carried out in order to match experimental processing flows to numerical simulation. The work has brought together a consortium that has developed reliable experimental methods by which processing flows can be achieved in the laboratory and then ranked against numerical simulation. A full rheological characterisation of a selected range of polymers was made and the results compared from different laboratories. The data was fitted to a number of rheological models. Multi-mode parameter fitting was universal for the linear viscoelastic response. Particular attention was paid to the non linear response of the material. Prototype industrial flow experiments were carried out for a number of geometries in different laboratories and the flow birefringence technique was used to map out the experimentally observed stress fields for different polymers in a range of complex flows that contained both extensional and shear flow components. Numerical simulation was carried out using a number of algorithms and a range of constitutive equations. In order to make a quantitative comparison between experiment and simulation, an Advanced Rheological Tool (ART) module was developed that was able in some cases to quantify the level of fit between the numerically predicted and the experimentally observed stress patterns. In addition the ART module was able to optimise certain non-linear parameters in order to improve the quality of fit between experiment and simulation

The matching of experimental polymer processing flows to viscoelastic numerical simulation

International audienceThis paper describes work carried out in order to match experimental processing flows to numerical simulation. The work has brought together a consortium that has developed reliable experimental methods by which processing flows can be achieved in the laboratory and then ranked against numerical simulation. A full rheological characterisation of a selected range of polymers was made and the results compared from different laboratories. The data was fitted to a number of rheological models. Multi-mode parameter fitting was universal for the linear viscoelastic response. Particular attention was paid to the non linear response of the material. Prototype industrial flow experiments were carried out for a number of geometries in different laboratories and the flow birefringence technique was used to map out the experimentally observed stress fields for different polymers in a range of complex flows that contained both extensional and shear flow components. Numerical simulation was carried out using a number of algorithms and a range of constitutive equations. In order to make a quantitative comparison between experiment and simulation, an Advanced Rheological Tool (ART) module was developed that was able in some cases to quantify the level of fit between the numerically predicted and the experimentally observed stress patterns. In addition the ART module was able to optimise certain non-linear parameters in order to improve the quality of fit between experiment and simulation