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

Not Applicable

Terminated

Conditions: Breast Reconstruction
Breast Implant Revision
Breast Augmentation

Registration Number: NCT01870869

Lead Sponsor: Allergan

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 1951

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 exclusion criteria listed below or plan to undergo implantation with NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts and does not meet the exclusion criteria listed below:

Has an advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
Has an existing carcinoma of the breast, without mastectomy
Has an abscess or infection in the body at the time of enrollment
Is pregnant or nursing
Has any disease, including uncontrolled diabetes (e.g., hemoglobin A1c (HbA1c) > 8%), that is clinically known to impact wound healing ability
Shows tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity, or ulceration
Has or is under treatment for any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)
Shows 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (57): Anthony Griffin
🇺🇸
Beverly Hills, California, United States
Laurence Berkowitz
🇺🇸
Campbell, California, United States
Mary Powers
🇺🇸
Long Beach, California, United States
Roy Hong
🇺🇸
Palo Alto, California, United States
Eric Bachelor
🇺🇸
Pleasanton, California, United States
Douglas Reavie
🇺🇸
San Diego, California, United States
Steven Teitelbaum
🇺🇸
Santa Monica, California, United States
Tad Heinz
🇺🇸
Colorado Springs, Colorado, United States
Gary Snider
🇺🇸
Denver, Colorado, United States
Terrence Murphy
🇺🇸
Englewood, Colorado, United States
Scroll for more (47 remaining)
Anthony Griffin
🇺🇸Beverly Hills, California, United States