Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants

• Sponsor: Allergan (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01785069
• Collaborator: (none)
• Enrollment: 355
• Locations: 29
• Arms: 4
• Actual Duration (Months): 35.6
• Patients Per Site: 12.2
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Augmentation; Breast Reconstruction; Breast Implant Revision	Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 355 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Dec 10, 2012
• Actual Primary Completion Date: Nov 30, 2015
• Actual Study Completion Date: Nov 30, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Augmentation Women who had breast augmentation with NATRELLE® 410 implants.	Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection; Surgical implant; Other Names: NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled Breast Implants
Experimental: Reconstruction Women who had breast reconstruction with NATRELLE® 410 implants.	Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection; Surgical implant; Other Names: NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled Breast Implants
Experimental: Revision-Augmentation Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.	Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection; Surgical implant; Other Names: NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled Breast Implants
Experimental: Revision-Reconstruction Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.	Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection; Surgical implant; Other Names: NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled Breast Implants

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants According to Investigator Satisfaction With Implants [3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)]

   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.

2. Percentage of Participants According to Participant Satisfaction With Implants [3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)]

   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.

Secondary Outcome Measures

1. Percentage of Participants With Local Complications [5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)]

   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).

2. Percentage of Participants With Reoperations [5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)]

   Kaplan-Meier risk rates (estimation of the percentage of participants) of reoperation is reported.

3. Percentage of Participants With Implant Removal With or Without Replacement [5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)]

   Kaplan-Meier risk rates (estimation of the percentage of participants) of implant removal with or without replacement

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, 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

• Female, age 18 or older

• Present with 1 or more of the following conditions:

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

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)

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

• Has adequate tissue available to cover implants

• 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)

Exclusion Criteria:

For 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

• Does not have advance 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., hemoglobin A1c (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	Laurence Berkowitz	Campbell	California	United States	95008
2	Roy Hong	Palo Alto	California	United States	94301
3	Eric Bachelor	Pleasanton	California	United States	94566
4	Gregory Liebscher	Colorado Springs	Colorado	United States	80919
5	Scott Spear	Washington	District of Columbia	United States	20007
6	Calvin Peters	Orlando	Florida	United States	32801
7	Walter Erhardt	Albany	Georgia	United States	31701
8	James Namnoum	Atlanta	Georgia	United States	30342
9	Janet Turkle	Carmel	Indiana	United States	46032
10	Julene Samuels	Louisville	Kentucky	United States	40205
11	Timothy Mickel	Monroe	Louisiana	United States	71201
12	John Renucci	Grand Rapids	Michigan	United States	49503
13	Steven Morris	Midland	Michigan	United States	48640
14	Charles Nathan	Chesterfield	Missouri	United States	63005
15	Herluf Jr. Lund	Chesterfield	Missouri	United States	63005
16	Patricia McGuire	Creve Coeur	Missouri	United States	63141
17	Perry Johnson	Omaha	Nebraska	United States	68118
18	Peter Hyans	Berkeley Heights	New Jersey	United States	07922
19	Peter Hetzler	Little Silver	New Jersey	United States	07739
20	Caroline Glicksman	Sea Girt	New Jersey	United States	08750
21	Tracy Pfeifer	Great Neck	New York	United States	10028
22	Lloyd Gayle	New York	New York	United States	10021
23	Raymond Isakov	Cleveland	Ohio	United States	44195
24	Craig Colville	Toledo	Ohio	United States	43615
25	Frank Barone	Toledo	Ohio	United States	43623
26	Mary Gingrass	Nashville	Tennessee	United States	37203
27	Patrick Maxwell	Nashville	Tennessee	United States	37212
28	Jeffrey Friedman	Houston	Texas	United States	77030
29	Thomas Blanchard	Newport News	Virginia	United States	23606

Sponsors and Collaborators

• Allergan

Investigators

• Study Chair: Andrew Schumacher, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01785069
• Other Study ID Numbers: 410XL-001
• First Posted: Feb 6, 2013
• Last Update Posted: Jun 25, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

Participant Flow

Arm/Group Title	Augmentation	Revision-Augmentation	Reconstruction	Revision-Reconstruction
Arm/Group Description	Women who had breast augmentation with NATRELLE® 410 implants.	Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.	Women who had breast reconstruction with NATRELLE® 410 implants.	Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
Period Title: Overall Study
STARTED	107	76	104	68
COMPLETED	95	64	91	54
NOT COMPLETED	12	12	13	14

Baseline Characteristics

Arm/Group Title	Augmentation	Revision-Augmentation	Reconstruction	Revision-Reconstruction	Total
Arm/Group Description	Women who had breast augmentation with NATRELLE® 410 implants.	Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.	Women who had breast reconstruction with NATRELLE® 410 implants.	Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.	Total of all reporting groups
Overall Participants	100	72	99	60	331
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	35.1	48.3	51.8	54.7	46.5
Sex: Female, Male (Count of Participants)
Female	100 100%	72 100%	99 100%	60 100%	331 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants According to Investigator Satisfaction With Implants
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.
Time Frame	3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Augmentation	Revision-Augmentation	Reconstruction	Revision-Reconstruction
Arm/Group Description	Women who had breast augmentation with NATRELLE® 410 implants.	Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.	Women who had breast reconstruction with NATRELLE® 410 implants.	Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
Measure Participants	100	66	95	49
Number [percentage of participants]	99.0 99%	97.0 134.7%	100.0 101%	95.9 159.8%

2. Primary Outcome

Title	Percentage of Participants According to Participant Satisfaction With Implants
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.
Time Frame	3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Augmentation	Revision-Augmentation	Reconstruction	Revision-Reconstruction
Arm/Group Description	Women who had breast augmentation with NATRELLE® 410 implants.	Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.	Women who had breast reconstruction with NATRELLE® 410 implants.	Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
Measure Participants	99	66	95	49
Number [percentage of participants]	99.0 99%	95.5 132.6%	94.9 95.9%	91.8 153%

3. Secondary Outcome

Title	Percentage of Participants With Local Complications
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).
Time Frame	5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Augmentation	Revision-Augmentation	Reconstruction	Revision-Reconstruction
Arm/Group Description	Women who had breast augmentation with NATRELLE® 410 implants.	Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.	Women who had breast reconstruction with NATRELLE® 410 implants.	Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
Measure Participants	100	72	99	60
Any complication	9.05 9.1%	15.71 21.8%	15.28 15.4%	3.77 6.3%
Asymmetry	1.00 1%	0.00 0%	3.03 3.1%	0.00 0%
Breast pain	2.00 2%	0.00 0%	1.01 1%	2.00 3.3%
Capsular contracture	3.05 3.1%	3.12 4.3%	4.40 4.4%	3.67 6.1%
Delayed wound healing	0.00 0%	1.39 1.9%	0.00 0%	0.00 0%
Fluid accumulation/seroma	0.00 0%	1.39 1.9%	0.00 0%	0.00 0%
Implant malposition	3.00 3%	4.17 5.8%	4.04 4.1%	1.67 2.8%
Implant palpability/visibility	0.00 0%	1.39 1.9%	0.00 0%	0.00 0%
Implant rupture	3.09 3.1%	12.64 17.6%	2.16 2.2%	5.91 9.9%
Infection	0.00 0%	1.39 1.9%	2.02 2%	0.00 0%
Ptosis	0.00 0%	1.39 1.9%	0.00 0%	0.00 0%
Redness	1.00 1%	0.00 0%	2.02 2%	0.00 0%
Swelling	1.05 1.1%	0.00 0%	0.00 0%	0.00 0%
Wrinkling/rippling	0.00 0%	2.78 3.9%	0.00 0%	1.67 2.8%
Other complications	1.00 1%	2.78 3.9%	2.12 2.1%	0.00 0%

4. Secondary Outcome

Title	Percentage of Participants With Reoperations
Description	Kaplan-Meier risk rates (estimation of the percentage of participants) of reoperation is reported.
Time Frame	5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Augmentation	Revision-Augmentation	Reconstruction	Revision-Reconstruction
Arm/Group Description	Women who had breast augmentation with NATRELLE® 410 implants.	Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.	Women who had breast reconstruction with NATRELLE® 410 implants.	Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
Measure Participants	100	72	99	60
Number (95% Confidence Interval) [percentage of participants]	9.07 9.1%	25.64 35.6%	39.84 40.2%	39.01 65%

5. Secondary Outcome

Title	Percentage of Participants With Implant Removal With or Without Replacement
Description	Kaplan-Meier risk rates (estimation of the percentage of participants) of implant removal with or without replacement
Time Frame	5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Augmentation	Revision-Augmentation	Reconstruction	Revision-Reconstruction
Arm/Group Description	Women who had breast augmentation with NATRELLE® 410 implants.	Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.	Women who had breast reconstruction with NATRELLE® 410 implants.	Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
Measure Participants	100	72	99	60
Number (95% Confidence Interval) [percentage of participants]	1.05 1.1%	12.42 17.3%	2.35 2.4%	6.13 10.2%

Adverse Events

Time Frame	5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Adverse Event Reporting 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.
Arm/Group Title	Augmentation		Reconstruction		Revision-Augmentation		Revision-Reconstruction
Arm/Group Description	Women who had breast augmentation with NATRELLE® 410 implants.		Women who had breast reconstruction with NATRELLE® 410 implants.		Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.		Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
All Cause Mortality
	Augmentation		Reconstruction		Revision-Augmentation		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		Reconstruction		Revision-Augmentation		Revision-Reconstruction
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		2/72 (2.8%)		0/99 (0%)		0/60 (0%)
Infections and infestations
Bacterial pneumonia	0/100 (0%)		1/72 (1.4%)		0/99 (0%)		0/60 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	0/100 (0%)		1/72 (1.4%)		0/99 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Augmentation		Reconstruction		Revision-Augmentation		Revision-Reconstruction
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

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.