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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,951
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.
Time frame: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Percentage of Participants According to Participant Satisfaction With Implants
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: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Percentage of Participants With Local Complications
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 .
Time frame: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Percentage of Participants With Reoperations
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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
...and 48 more locations
Kaplan-Meier risk rates (estimation of the percentage of participants) of reoperation is reported.
Time frame: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Percentage of Participants With Implant Removal With or Without Replacement
Kaplan-Meier risk rates (estimation of the percentage of participants) of implant removal with or without replacement is reported.
Time frame: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)