Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT01785069
Status:
TERMINATED
Last Update Posted:
2020-06-25
First Post:
2013-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area, Head', 'organization': 'Allergan'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)', 'description': 'Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.', 'eventGroups': [{'id': 'EG000', 'title': 'Augmentation', 'description': 'Women who had breast augmentation with NATRELLE® 410 implants.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Reconstruction', 'description': 'Women who had breast reconstruction with NATRELLE® 410 implants.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 72, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Revision-Augmentation', 'description': 'Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 99, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Revision-Reconstruction', 'description': 'Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Pulmonary embolism', 'notes': 'Following knee surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacterial pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants According to Investigator Satisfaction With Implants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Augmentation', 'description': 'Women who had breast augmentation with NATRELLE® 410 implants.'}, {'id': 'OG001', 'title': 'Revision-Augmentation', 'description': 'Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.'}, {'id': 'OG002', 'title': 'Reconstruction', 'description': 'Women who had breast reconstruction with NATRELLE® 410 implants.'}, {'id': 'OG003', 'title': 'Revision-Reconstruction', 'description': 'Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.0', 'groupId': 'OG000'}, {'value': '97.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '95.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)', 'description': 'The investigator rated their satisfaction with the participant\'s breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied,3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants where the investigator responded: "Definitely satisfied" or "Somewhat satisfied" is reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Evaluable population, all screened participants who satisfied all eligibility criteria documented on the eligibility form, entered the study, and had a Year 3 office visit and MRI within the window, with data available for analysis.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants According to Participant Satisfaction With Implants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Augmentation', 'description': 'Women who had breast augmentation with NATRELLE® 410 implants.'}, {'id': 'OG001', 'title': 'Revision-Augmentation', 'description': 'Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.'}, {'id': 'OG002', 'title': 'Reconstruction', 'description': 'Women who had breast reconstruction with NATRELLE® 410 implants.'}, {'id': 'OG003', 'title': 'Revision-Reconstruction', 'description': 'Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.0', 'groupId': 'OG000'}, {'value': '95.5', 'groupId': 'OG001'}, {'value': '94.9', 'groupId': 'OG002'}, {'value': '91.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)', 'description': 'The participant rated their satisfaction with the breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied, 3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants who responded: "Definitely satisfied" or "Somewhat satisfied" is reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Evaluable population, all screened participants who satisfied all eligibility criteria documented on the eligibility form, entered the study, and had a Year 3 office visit and MRI within the window, with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Local Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Augmentation', 'description': 'Women who had breast augmentation with NATRELLE® 410 implants.'}, {'id': 'OG001', 'title': 'Revision-Augmentation', 'description': 'Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.'}, {'id': 'OG002', 'title': 'Reconstruction', 'description': 'Women who had breast reconstruction with NATRELLE® 410 implants.'}, {'id': 'OG003', 'title': 'Revision-Reconstruction', 'description': 'Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.'}], 'classes': [{'title': 'Any complication', 'categories': [{'measurements': [{'value': '9.05', 'groupId': 'OG000', 'lowerLimit': '4.81', 'upperLimit': '16.66'}, {'value': '15.71', 'groupId': 'OG001', 'lowerLimit': '9.03', 'upperLimit': '26.58'}, {'value': '15.28', 'groupId': 'OG002', 'lowerLimit': '9.34', 'upperLimit': '24.43'}, {'value': '3.77', 'groupId': 'OG003', 'lowerLimit': '0.95', 'upperLimit': '14.33'}]}]}, {'title': 'Asymmetry', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '6.89'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '3.03', 'groupId': 'OG002', 'lowerLimit': '0.99', 'upperLimit': '9.10'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': 'Breast pain', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '7.76'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '1.01', 'groupId': 'OG002', 'lowerLimit': '0.14', 'upperLimit': '6.95'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '0.28', 'upperLimit': '13.36'}]}]}, {'title': 'Capsular contracture', 'categories': [{'measurements': [{'value': '3.05', 'groupId': 'OG000', 'lowerLimit': '0.99', 'upperLimit': '9.17'}, {'value': '3.12', 'groupId': 'OG001', 'lowerLimit': '0.78', 'upperLimit': '12.01'}, {'value': '4.40', 'groupId': 'OG002', 'lowerLimit': '1.67', 'upperLimit': '11.34'}, {'value': '3.67', 'groupId': 'OG003', 'lowerLimit': '0.93', 'upperLimit': '13.99'}]}]}, {'title': 'Delayed wound healing', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '1.39', 'groupId': 'OG001', 'lowerLimit': '0.20', 'upperLimit': '9.45'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': 'Fluid accumulation/seroma', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '1.39', 'groupId': 'OG001', 'lowerLimit': '0.20', 'upperLimit': '9.45'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': 'Implant malposition', 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '0.98', 'upperLimit': '9.01'}, {'value': '4.17', 'groupId': 'OG001', 'lowerLimit': '1.36', 'upperLimit': '12.36'}, {'value': '4.04', 'groupId': 'OG002', 'lowerLimit': '1.54', 'upperLimit': '10.41'}, {'value': '1.67', 'groupId': 'OG003', 'lowerLimit': '0.24', 'upperLimit': '11.25'}]}]}, {'title': 'Implant palpability/visibility', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '1.39', 'groupId': 'OG001', 'lowerLimit': '0.20', 'upperLimit': '9.45'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': 'Implant rupture', 'categories': [{'measurements': [{'value': '3.09', 'groupId': 'OG000', 'lowerLimit': '1.01', 'upperLimit': '9.29'}, {'value': '12.64', 'groupId': 'OG001', 'lowerLimit': '5.12', 'upperLimit': '29.38'}, {'value': '2.16', 'groupId': 'OG002', 'lowerLimit': '0.55', 'upperLimit': '8.38'}, {'value': '5.91', 'groupId': 'OG003', 'lowerLimit': '1.91', 'upperLimit': '16.94'}]}]}, {'title': 'Infection', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '1.39', 'groupId': 'OG001', 'lowerLimit': '0.20', 'upperLimit': '9.45'}, {'value': '2.02', 'groupId': 'OG002', 'lowerLimit': '0.51', 'upperLimit': '7.84'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': 'Ptosis', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '1.39', 'groupId': 'OG001', 'lowerLimit': '0.20', 'upperLimit': '9.45'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': 'Redness', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '6.89'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '2.02', 'groupId': 'OG002', 'lowerLimit': '0.51', 'upperLimit': '7.84'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '1.05', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '7.24'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': 'Wrinkling/rippling', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '2.78', 'groupId': 'OG001', 'lowerLimit': '0.70', 'upperLimit': '10.65'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '1.67', 'groupId': 'OG003', 'lowerLimit': '0.24', 'upperLimit': '11.25'}]}]}, {'title': 'Other complications', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '6.89'}, {'value': '2.78', 'groupId': 'OG001', 'lowerLimit': '0.70', 'upperLimit': '10.65'}, {'value': '2.12', 'groupId': 'OG002', 'lowerLimit': '0.53', 'upperLimit': '8.22'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)', 'description': 'Kaplan-Meier risk rates (estimation of the percentage of participants) of developing local complications is presented. Local complications collected in the study were: Asymmetry, Breast Pain, Capsular contracture, Delayed wound healing, Fluid accumulation/seroma, Implant malposition, Implant palpability/visibility. Implant rupture, Infection, Ptosis, Redness, Swelling, Wrinkling/rippling and Other complications (calcifications on mammogram, thing of mastectomy flap, deformity and nipple stretching).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population was defined as all screened participants who satisfied all eligibility criteria documented on the eligibility form, entered the study, and had a Year 3 office visit and MRI within the window.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Reoperations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Augmentation', 'description': 'Women who had breast augmentation with NATRELLE® 410 implants.'}, {'id': 'OG001', 'title': 'Revision-Augmentation', 'description': 'Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.'}, {'id': 'OG002', 'title': 'Reconstruction', 'description': 'Women who had breast reconstruction with NATRELLE® 410 implants.'}, {'id': 'OG003', 'title': 'Revision-Reconstruction', 'description': 'Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.07', 'groupId': 'OG000', 'lowerLimit': '4.82', 'upperLimit': '16.71'}, {'value': '25.64', 'groupId': 'OG001', 'lowerLimit': '16.44', 'upperLimit': '38.66'}, {'value': '39.84', 'groupId': 'OG002', 'lowerLimit': '30.88', 'upperLimit': '50.30'}, {'value': '39.01', 'groupId': 'OG003', 'lowerLimit': '27.81', 'upperLimit': '52.78'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)', 'description': 'Kaplan-Meier risk rates (estimation of the percentage of participants) of reoperation is reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population was defined as all screened participants who satisfied all eligibility criteria documented on the eligibility form, entered the study, and had a Year 3 office visit and MRI within the window.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Implant Removal With or Without Replacement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Augmentation', 'description': 'Women who had breast augmentation with NATRELLE® 410 implants.'}, {'id': 'OG001', 'title': 'Revision-Augmentation', 'description': 'Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.'}, {'id': 'OG002', 'title': 'Reconstruction', 'description': 'Women who had breast reconstruction with NATRELLE® 410 implants.'}, {'id': 'OG003', 'title': 'Revision-Reconstruction', 'description': 'Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.05', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '7.24'}, {'value': '12.42', 'groupId': 'OG001', 'lowerLimit': '4.43', 'upperLimit': '32.13'}, {'value': '2.35', 'groupId': 'OG002', 'lowerLimit': '0.59', 'upperLimit': '9.08'}, {'value': '6.13', 'groupId': 'OG003', 'lowerLimit': '1.98', 'upperLimit': '18.16'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)', 'description': 'Kaplan-Meier risk rates (estimation of the percentage of participants) of implant removal with or without replacement', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population was defined as all screened participants who satisfied all eligibility criteria documented on the eligibility form, entered the study, and had a Year 3 office visit and MRI within the window.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Augmentation', 'description': 'Women who had breast augmentation with NATRELLE® 410 implants.'}, {'id': 'FG001', 'title': 'Revision-Augmentation', 'description': 'Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.'}, {'id': 'FG002', 'title': 'Reconstruction', 'description': 'Women who had breast reconstruction with NATRELLE® 410 implants.'}, {'id': 'FG003', 'title': 'Revision-Reconstruction', 'description': 'Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '76'}, {'groupId': 'FG002', 'numSubjects': '104'}, {'groupId': 'FG003', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '91'}, {'groupId': 'FG003', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Implanted with nonstudy device', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Subject choice', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Not evaluable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '331', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Augmentation', 'description': 'Women who had breast augmentation with NATRELLE® 410 implants.'}, {'id': 'BG001', 'title': 'Revision-Augmentation', 'description': 'Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.'}, {'id': 'BG002', 'title': 'Reconstruction', 'description': 'Women who had breast reconstruction with NATRELLE® 410 implants.'}, {'id': 'BG003', 'title': 'Revision-Reconstruction', 'description': 'Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.1', 'groupId': 'BG000', 'lowerLimit': '19.0', 'upperLimit': '60.0'}, {'value': '48.3', 'groupId': 'BG001', 'lowerLimit': '26.0', 'upperLimit': '68.0'}, {'value': '51.8', 'groupId': 'BG002', 'lowerLimit': '28.0', 'upperLimit': '69.0'}, {'value': '54.7', 'groupId': 'BG003', 'lowerLimit': '25.0', 'upperLimit': '71.0'}, {'value': '46.5', 'groupId': 'BG004', 'lowerLimit': '19.0', 'upperLimit': '71.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '331', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Evaluable population was defined as all screened participants who satisfied all eligibility criteria documented on the eligibility form, entered the study, and had a Year 3 office visit and magnetic resonance imaging (MRI) within the window.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 355}}, 'statusModule': {'whyStopped': 'There was no indication that long-term follow-up would differ between any of the studies that have evaluated devices within the 410 Style Matrix.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2015-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-23', 'studyFirstSubmitDate': '2013-01-14', 'resultsFirstSubmitDate': '2020-05-13', 'studyFirstSubmitQcDate': '2013-02-04', 'lastUpdatePostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-23', 'studyFirstPostDateStruct': {'date': '2013-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants According to Investigator Satisfaction With Implants', 'timeFrame': '3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)', 'description': 'The investigator rated their satisfaction with the participant\'s breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied,3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants where the investigator responded: "Definitely satisfied" or "Somewhat satisfied" is reported.'}, {'measure': 'Percentage of Participants According to Participant Satisfaction With Implants', 'timeFrame': '3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)', 'description': 'The participant rated their satisfaction with the breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied, 3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants who responded: "Definitely satisfied" or "Somewhat satisfied" is reported.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Local Complications', 'timeFrame': '5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)', 'description': 'Kaplan-Meier risk rates (estimation of the percentage of participants) of developing local complications is presented. Local complications collected in the study were: Asymmetry, Breast Pain, Capsular contracture, Delayed wound healing, Fluid accumulation/seroma, Implant malposition, Implant palpability/visibility. Implant rupture, Infection, Ptosis, Redness, Swelling, Wrinkling/rippling and Other complications (calcifications on mammogram, thing of mastectomy flap, deformity and nipple stretching).'}, {'measure': 'Percentage of Participants With Reoperations', 'timeFrame': '5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)', 'description': 'Kaplan-Meier risk rates (estimation of the percentage of participants) of reoperation is reported.'}, {'measure': 'Percentage of Participants With Implant Removal With or Without Replacement', 'timeFrame': '5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)', 'description': 'Kaplan-Meier risk rates (estimation of the percentage of participants) of implant removal with or without replacement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Augmentation', 'Breast Reconstruction', 'Breast Implant Revision']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Style and L-Style Breast Implants.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor entry in this study, participants must have been enrolled in the 410 Continued Access (CA) Clinical Study or 410 Continued Access Reconstruction/Revision Expansion (CARE) Clinical Study under the inclusion criteria listed below and received NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Styles or L-Styles breast implants\n\n* Female, age 18 or older\n* Present with 1 or more of the following conditions:\n\n 1. Primary breast augmentation (i.e., no previous breast implant surgery) indicated for subject dissatisfaction with size or shape of breast (e.g., mammary hypoplasia), asymmetry, ptosis, or aplasia\n 2. Primary breast reconstruction (i.e., no previous breast implant surgery other than implantation of tissue expanders or contralateral augmentation for asymmetry) indicated, in the affected breast, for mastectomy for cancer, prophylactic mastectomy, or breast trauma (resulting in mastectomy) and for the unaffected breast, contralateral asymmetry (may be performed on the date of the mastectomy or the date when the permanent implants are placed in the reconstructed breast)\n 3. Breast implant revision surgery (i.e., removal and replacement of breast implants) indicated for previous augmentation or reconstruction with silicone-filled or saline-filled breast implants\n* Has adequate tissue available to cover implants\n* Willing to undergo magnetic resonance imaging (MRI) at the specified follow-up visits for subjects at MRI designated sites and be eligible for MRI (e.g., no implanted metal or metal devices, no history of severe claustrophobia)\n\nExclusion Criteria:\n\nFor entry in this study, participants must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study, meeting the exclusion criteria listed below, did not receive any NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled FM, FF, MM, or MF Style Breast Implants, and have not undergone implant removal with or without replacement surgery\n\n* Does not have advance fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy\n* Does not have existing carcinoma of the breast, without mastectomy\n* Does not have abscess or infection in the body at the time of enrollment\n* Is not pregnant or nursing\n* Does not have any disease, including uncontrolled diabetes (e.g., hemoglobin A1c (HbA1c) \\> 8%), that is clinically known to impact wound healing ability\n* Does not show tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation inadequate tissue, compromised vascularity, or ulceration\n* Does not have or is under treatment for any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)\n* Does not show psychological characteristics that may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation (e.g., body dysmorphic disorder)\n* Is not willing to undergo further surgery for revision, if medically required'}, 'identificationModule': {'nctId': 'NCT01785069', 'briefTitle': 'Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'A Prospective Multicenter Study of the Safety and Effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-filled X-style and L-style Breast Implants', 'orgStudyIdInfo': {'id': '410XL-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Augmentation', 'description': 'Women who had breast augmentation with NATRELLE® 410 implants.', 'interventionNames': ['Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection']}, {'type': 'EXPERIMENTAL', 'label': 'Reconstruction', 'description': 'Women who had breast reconstruction with NATRELLE® 410 implants.', 'interventionNames': ['Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection']}, {'type': 'EXPERIMENTAL', 'label': 'Revision-Augmentation', 'description': 'Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.', 'interventionNames': ['Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection']}, {'type': 'EXPERIMENTAL', 'label': 'Revision-Reconstruction', 'description': 'Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.', 'interventionNames': ['Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection']}], 'interventions': [{'name': 'Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection', 'type': 'DEVICE', 'otherNames': ['NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled Breast Implants'], 'description': 'Surgical implant', 'armGroupLabels': ['Augmentation', 'Reconstruction', 'Revision-Augmentation', 'Revision-Reconstruction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95008', 'city': 'Campbell', 'state': 'California', 'country': 'United States', 'facility': 'Laurence Berkowitz', 'geoPoint': {'lat': 37.28717, 'lon': -121.94996}}, {'zip': '94301', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Roy Hong', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94566', 'city': 'Pleasanton', 'state': 'California', 'country': 'United States', 'facility': 'Eric Bachelor', 'geoPoint': {'lat': 37.66243, 'lon': -121.87468}}, {'zip': '80919', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Gregory Liebscher', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Scott Spear', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Calvin Peters', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '31701', 'city': 'Albany', 'state': 'Georgia', 'country': 'United States', 'facility': 'Walter Erhardt', 'geoPoint': {'lat': 31.57851, 'lon': -84.15574}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'James Namnoum', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46032', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'Janet Turkle', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'zip': '40205', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Julene Samuels', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '71201', 'city': 'Monroe', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Timothy Mickel', 'geoPoint': {'lat': 32.50931, 'lon': -92.1193}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'John Renucci', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '48640', 'city': 'Midland', 'state': 'Michigan', 'country': 'United States', 'facility': 'Steven Morris', 'geoPoint': {'lat': 43.61558, 'lon': -84.24721}}, {'zip': '63005', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Charles Nathan', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '63005', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Herluf Jr. Lund', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '63141', 'city': 'Creve Coeur', 'state': 'Missouri', 'country': 'United States', 'facility': 'Patricia McGuire', 'geoPoint': {'lat': 38.66089, 'lon': -90.42262}}, {'zip': '68118', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Perry Johnson', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07922', 'city': 'Berkeley Heights', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Peter Hyans', 'geoPoint': {'lat': 40.68343, 'lon': -74.44265}}, {'zip': '07739', 'city': 'Little Silver', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Peter Hetzler', 'geoPoint': {'lat': 40.33678, 'lon': -74.04708}}, {'zip': '08750', 'city': 'Sea Girt', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Caroline Glicksman', 'geoPoint': {'lat': 40.13206, 'lon': -74.03458}}, {'zip': '10028', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'Tracy Pfeifer', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Lloyd Gayle', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Raymond Isakov', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43615', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Craig Colville', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '43623', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Frank Barone', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Mary Gingrass', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Patrick Maxwell', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Jeffrey Friedman', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23606', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'facility': 'Thomas Blanchard', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}], 'overallOfficials': [{'name': 'Andrew Schumacher', 'role': 'STUDY_CHAIR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}