Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Allergan Medical

ClinicalTrials.gov Identifier:

NCT00689871

First received: June 2, 2008

Last updated: February 13, 2012

Last verified: February 2012

History of Changes

Results First Received: December 19, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label
Conditions:	Breast Augmentation Breast Reconstruction Revision of Augmentation or Reconstruction
Intervention:	Device: Natrelle(TM) Silicone-Filled Breast Implants

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment: January 6, 1999-June 30, 2000 at multiple US sites

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Primary Augmentation	All women implanted for an indication of primary breast augmentation
Primary Reconstruction	All women implanted for an indication of primary breast reconstruction
Revision-augmentation	All women implanted for revision of a breast augmentation
Revision-reconstruction	All women implanted for revision of a breast reconstruction

Participant Flow: Overall Study

	Primary Augmentation	Primary Reconstruction	Revision-augmentation	Revision-reconstruction
STARTED	455 ^[1]	98 ^[2]	147 ^[3]	15 ^[4]
COMPLETED	280 ^[5]	46 ^[5]	74 ^[6]	8 ^[7]
NOT COMPLETED	175	52	73	7
Lost to Follow-up	123	13	37	1
Explanted of All Study Devices	36	25	29	3
Withdrawal by Subject	13	3	4	1
Death	1	10	2	2
Physician Decision	2	1	1	0

[1]	908 Implants
[2]	127 Implants
[3]	288 Implants
[4]	25 Implants
[5]	35 Patients discontinued
[6]	28 Patients discontinued
[7]	4 Patients discontinued

Baseline Characteristics

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Reporting Groups

	Description
Primary Augmentation	All women implanted for an indication of primary breast augmentation
Primary Reconstruction	All women implanted for an indication of primary breast reconstruction
Revision-augmentation	All women implanted for revision of a breast augmentation
Revision-reconstruction	All women implanted for revision of a breast reconstruction
Total	Total of all reporting groups

Baseline Measures

	Primary Augmentation	Primary Reconstruction	Revision-augmentation	Revision-reconstruction	Total
Number of Participants [units: participants]	455	98	147	15	715
Age, Customized [units: participants]
<=40 years	319	10	61	0	390
Between 40 and 60 years	136	73	84	9	302
>=60 years	0	15	2	6	23
Gender [units: participants]
Female	455	98	147	15	715
Male	0	0	0	0	0

Outcome Measures

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1. Primary:

Local Complications [ Time Frame: 10 years ]

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Measure Type	Primary
Measure Title	Local Complications
Measure Description	By patient risk of complications occuring in at least 5% of patients in 1 or more cohorts
Time Frame	10 years
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
all enrolled patients

Reporting Groups

	Description
Primary Augmentation	All women implanted for an indication of primary breast augmentation
Primary Reconstruction	All women implanted for an indication of primary breast reconstruction
Revision-augmentation	All women implanted for revision of a breast augmentation
Revision-reconstruction	All women implanted for revision of a breast reconstruction

Measured Values

	Primary Augmentation	Primary Reconstruction	Revision-augmentation	Revision-reconstruction
Number of Participants Analyzed [units: participants]	455	98	147	15
Local Complications [units: percentage by patient] Number ( 95% Confidence Interval )
Capsular Contracture	18.9 ( 15.4 to 23.1 )	24.6 ( 16.2 to 36.2 )	28.7 ( 21.3 to 37.9 )	6.7 ( 0.2 to 31.9 )
Breast Pain	11.5 ( 8.7 to 15.0 )	6.8 ( 2.8 to 16.1 )	11.7 ( 7.1 to 18.8 )	0 ( 0 to 0 )
Swelling	9.2 ( 6.8 to 12.4 )	7.1 ( 3.5 to 14.4 )	8.2 ( 4.6 to 14.5 )	0 ( 0 to 0 )
Implant Malposition	6.9 ( 4.8 to 9.7 )	2.3 ( 0.6 to 8.9 )	6.0 ( 3.1 to 11.7 )	13.3 ( 1.7 to 40.5 )
Nipple Complications	6.3 ( 4.3 to 9.1 )	3.3 ( 1.1 to 9.8 )	1.4 ( 0.3 to 5.4 )	0 ( 0 to 0 )
Hypertrophic/Other Abnormal Scarring	4.2 ( 2.6 to 6.5 )	5.5 ( 2.3 to 12.7 )	6.6 ( 3.5 to 12.3 )	0 ( 0 to 0 )
Asymmetry	3.3 ( 2.0 to 5.6 )	23.2 ( 15.4 to 33.9 )	6.5 ( 3.2 to 12.8 )	6.7 ( 0.2 to 31.9 )
Wrinkling	1.8 ( 0.8 to 3.7 )	10.2 ( 5.2 to 19.6 )	5.4 ( 2.6 to 11.0 )	0 ( 0 to 0 )
Implant Palpability/Visibility	1.6 ( 0.8 to 3.4 )	6.4 ( 2.3 to 12.7 )	6.0 ( 3.0 to 11.6 )	6.7 ( 0.2 to 31.9 )
Seroma/Fluid Accumulation	1.8 ( 0.9 to 3.4 )	2.3 ( 0.3 to 15.4 )	6.0 ( 3.0 to 11.6 )	6.7 ( 0.2 to 31.9 )
Bruising	0.4 ( 0.1 to 1.8 )	1.0 ( 0.1 to 7.1 )	3.0 ( 1.1 to 7.8 )	6.7 ( 0.2 to 31.9 )
Skin Rash	0.9 ( 0.3 to 2.3 )	2.0 ( 0.5 to 7.9 )	0.7 ( 0.1 to 4.9 )	6.7 ( 0.2 to 31.9 )

No statistical analysis provided for Local Complications

2. Secondary:

Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale [ Time Frame: 10 years ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only 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 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The timing of separate presentation or publication of the study by the PI is subject to mutual agreement in advance between the Sponsor and PI.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The Revision-reconstruction arm only had 15 patients enrolled, which makes the data for that arm difficult to interpret.

Results Point of Contact:

Name/Title: Medical Monitor
Organization: Allergan Medical
phone: (805) 961-5000
e-mail: devicetrials@allergan.com

No publications provided

Responsible Party:	Allergan Medical
ClinicalTrials.gov Identifier:	NCT00689871 History of Changes
Other Study ID Numbers:	020056
Study First Received:	June 2, 2008
Results First Received:	December 19, 2011
Last Updated:	February 13, 2012
Health Authority:	United States: Food and Drug Administration

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