NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study

• Sponsor: Allergan (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01853605
• Collaborator: (none)
• Enrollment: 3,811
• Location: 1
• Arms: 4
• Duration (Months): 136
• Patients Per Site Per Month: 28

Study Details

Study Description

Brief Summary

Post-approval study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for breast augmentation, reconstruction, or revision

Condition or Disease	Intervention/Treatment	Phase
Breast Augmentation; Breast Reconstruction; Breast Implant Revision	Device: Anatomically shaped silicone gel-filled breast implants	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 3811 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 2003
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Augmentation Women undergoing breast augmentation.	Device: Anatomically shaped silicone gel-filled breast implants; Surgical implant; Other Names: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF)
Experimental: Reconstruction Women undergoing breast reconstruction.	Device: Anatomically shaped silicone gel-filled breast implants; Surgical implant; Other Names: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF)
Experimental: Revision-Augmentation Women undergoing revision of previous breast augmentation.	Device: Anatomically shaped silicone gel-filled breast implants; Surgical implant; Other Names: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF)
Experimental: Revision-Reconstruction Women undergoing revision of previous breast reconstruction.	Device: Anatomically shaped silicone gel-filled breast implants; Surgical implant; Other Names: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF)

Outcome Measures

Primary Outcome Measures

1. Subject Satisfaction With Breast Implants on a 5-Point Scale [5 years]

   Subject satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for subject's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the subject reports different responses for the left and right breasts.

2. Investigator Satisfaction With Breast Implants on a 5-Point Scale [5 years]

   Investigator satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for Investigator's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the Investigator reports different responses for the left and right breasts.

3. Local Complications [5 years]

   Local complications are the cumulative complications occurring in at least 5% of subjects in 1 or more cohorts over the duration of the study. The Kaplan-Meier risk rate is presented.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

For entry in this study, subjects must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study under the inclusion criteria listed below and received NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants Styles 410 FM, FF, MM, or MF in 1 (for unilateral breast reconstruction or revision) or both breasts.

• Female, age 18 or older

• Present with one or more of the following conditions:

• 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

• 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 permanent implants are placed in the reconstructed breast)

• 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

• Has adequate tissue available to cover implants

• Willing to undergo MRI at the specified follow-up visit for subjects at MRI designated sites and be eligible for MRI (e.g., no implanted metal or metal devices, no history of severe claustrophobia)

Exclusion Criteria:

For entry in this study, subjects must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study and met the exclusion criteria listed below but not received any NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled 410 X- or L-Style Breast Implants

• Does not have advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy

• Does not have existing carcinoma of the breast, without mastectomy

• Does not have abscess or infection in the body at the time of enrollment

• Is not pregnant or nursing

• Does not have any disease, including uncontrolled diabetes (e.g., HbA1c > 8%), that is clinically known to impact wound healing ability

• Does not show tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity, or ulceration

• Does not have or is under treatment for any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)

• 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)

• Is not willing to undergo further surgery for revision, if medically required

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Eugene	Oregon	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan Medical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01853605
• Other Study ID Numbers: 410CA-002
• First Posted: May 15, 2013
• Last Update Posted: Aug 11, 2015
• Last Verified: Jul 1, 2015

Study Results

Participant Flow

Recruitment Details	The study was discontinued following product approval.

Arm/Group Title	Augmentation	Revision-Augmentation	Reconstruction	Revision-Reconstruction
Arm/Group Description	Women undergoing breast augmentation.	Women undergoing revision of previous breast augmentation.	Women undergoing breast reconstruction.	Women undergoing revision of previous breast reconstruction.
Period Title: Overall Study
STARTED	1939	693	751	428
COMPLETED	1939	693	751	428
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Augmentation	Revision-Augmentation	Reconstruction	Revision-Reconstruction	Total
Arm/Group Description	Women undergoing breast augmentation.	Women undergoing revision of previous breast augmentation.	Women undergoing breast reconstruction.	Women undergoing revision of previous breast reconstruction.	Total of all reporting groups
Overall Participants	1939	693	751	428	3811
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	36.0 (8.65)	46.2 (9.96)	49.8 (10.03)	53.5 (9.11)	42.5 (11.52)
Sex: Female, Male (Count of Participants)
Female	1939 100%	693 100%	751 100%	428 100%	3811 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Subject Satisfaction With Breast Implants on a 5-Point Scale
Description	Subject satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for subject's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the subject reports different responses for the left and right breasts.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants, who completed the 5 year follow-up visit, and had data at the time point.

Arm/Group Title	Augmentation	Revision-Augmentation	Reconstruction	Revision-Reconstruction
Arm/Group Description	Women undergoing breast augmentation.	Women undergoing revision of previous breast augmentation.	Women undergoing breast reconstruction.	Women undergoing revision of previous breast reconstruction.
Measure Participants	1929	688	740	419
Definitely Satisfied	1772	559	542	295
Somewhat Satisfied	119	87	145	89

2. Primary Outcome

Title	Investigator Satisfaction With Breast Implants on a 5-Point Scale
Description	Investigator satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for Investigator's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the Investigator reports different responses for the left and right breasts.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants, who completed the 5 year follow-up visit, and had data at the time point.

Arm/Group Title	Augmentation	Revision-Augmentation	Reconstruction	Revision-Reconstruction
Arm/Group Description	Women undergoing breast augmentation.	Women undergoing revision of previous breast augmentation.	Women undergoing breast reconstruction.	Women undergoing revision of previous breast reconstruction.
Measure Participants	1922	689	745	418
Definitely Satisfied	1798	560	564	310
Somewhat Satisfied	97	83	141	83

3. Primary Outcome

Title	Local Complications
Description	Local complications are the cumulative complications occurring in at least 5% of subjects in 1 or more cohorts over the duration of the study. The Kaplan-Meier risk rate is presented.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants who completed the 5 year follow-up visit.

Arm/Group Title	Augmentation	Revision-Augmentation	Reconstruction	Revision-Reconstruction
Arm/Group Description	Women undergoing breast augmentation.	Women undergoing revision of previous breast augmentation.	Women undergoing breast reconstruction.	Women undergoing revision of previous breast reconstruction.
Measure Participants	1939	693	751	428
Capsular Contracture	3.27	6.33	6.48	7.29
Asymmetry	0.83	0.87	5.94	3.32

Adverse Events

Adverse Event Reporting Description	Adverse event (AE) data experienced by ≥5% of subjects are recorded as an outcome measure.
Arm/Group Title	Augmentation		Revision-Augmentation		Reconstruction		Revision-Reconstruction
Arm/Group Description	Women undergoing breast augmentation.		Women undergoing revision of previous breast augmentation.		Women undergoing breast reconstruction.		Women undergoing revision of previous breast reconstruction.
All Cause Mortality
	Augmentation		Revision-Augmentation		Reconstruction		Revision-Reconstruction
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Augmentation		Revision-Augmentation		Reconstruction		Revision-Reconstruction
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1939 (0%)		0/693 (0%)		0/751 (0%)		0/428 (0%)
Other (Not Including Serious) Adverse Events
	Augmentation		Revision-Augmentation		Reconstruction		Revision-Reconstruction
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1939 (0%)		0/693 (0%)		0/751 (0%)		0/428 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.