NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01870869

Enrollment

1951

Registered

2013-06-06

Start date

2013-05-29

Completion date

2015-11-30

Last updated

2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Augmentation, Breast Implant Revision, Breast Reconstruction

Brief summary

This study is a prospective, multicenter, nonrandomized study to provide access to and evaluate the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X-Style and L-Style Breast Implants for breast augmentation, reconstruction, or revision.

Interventions

DEVICEAnatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection

Surgical implant

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

For entry in this study, participants must have either been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study under the inclusion criteria below and received NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts; or be planning to be implanted with NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts and meet the inclusion criteria listed below: * Female, age 18 or older (age 22 or older for breast augmentation participants who are implanted under Protocol 410CAXL-001) * Present with 1 or more of the following conditions: * Primary breast augmentation (i.e., no previous breast implant surgery) indicated for participant 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

Exclusion criteria

For entry in this study, participants must have either been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study and did not meet the

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants According to Investigator Satisfaction With Implants	5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)	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.
Percentage of Participants According to Participant Satisfaction With Implants	5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)	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

Measure	Time frame	Description
Percentage of Participants With Local Complications	5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)	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, Hematoma, Hypertrophic scarring/other abnormal scarring, Implant extrusion, Implant malposition, Implant palpability/visibility, Implant rupture, Infection, Redness, Skin rash, Swelling, Tissue/skin necrosis, Upper pole fullness, Wrinkling/rippling and Other complications .
Percentage of Participants With Reoperations	5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)	Kaplan-Meier risk rates (estimation of the percentage of participants) of reoperation is reported.
Percentage of Participants With Implant Removal With or Without Replacement	5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)	Kaplan-Meier risk rates (estimation of the percentage of participants) of implant removal with or without replacement is reported.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Augmentation Women who had breast augmentation with NATRELLE® 410 implants.	278
Revision-Augmentation Women who had revision of previous breast augmentation with NATRELLE® 410 implants.	201
Reconstruction Women who had breast reconstruction with NATRELLE® 410 implants.	1,180
Revision-Reconstruction Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.	225
Total	1,884

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Death	0	0	7	1
Overall Study	Implanted with nonstudy device	1	3	14	4
Overall Study	Lost to Follow-up	10	2	25	3
Overall Study	Not evaluable	10	5	42	10
Overall Study	Reason not Specified	1	2	20	4
Overall Study	Subject choice	6	2	22	8

Baseline characteristics

Characteristic	Augmentation	Revision-Augmentation	Reconstruction	Revision-Reconstruction	Total
Age, Continuous	34.5 years	47.3 years	50.3 years	54.4 years	48.1 years
Sex: Female, Male Female	278 Participants	201 Participants	1180 Participants	225 Participants	1884 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0	0 / 0	0 / 0
serious Total, serious adverse events	0 / 278	0 / 201	7 / 1,180	1 / 225

Outcome results

Primary

Percentage of Participants According to Investigator Satisfaction With Implants

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.