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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
355
Laurence Berkowitz
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: 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
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: 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
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, 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)
Percentage of Participants With Reoperations
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Campbell, California, United States
Roy Hong
Palo Alto, California, United States
Eric Bachelor
Pleasanton, California, United States
Gregory Liebscher
Colorado Springs, Colorado, United States
Scott Spear
Washington D.C., District of Columbia, United States
Calvin Peters
Orlando, Florida, United States
Walter Erhardt
Albany, Georgia, United States
James Namnoum
Atlanta, Georgia, United States
Janet Turkle
Carmel, Indiana, United States
Julene Samuels
Louisville, Kentucky, United States
...and 19 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 07 July 2009 and 01 January 2012)
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
Time frame: 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)