Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants

Breast Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01785069
• Other study ID #: 410XL-001
• Status: Terminated
• Phase: N/A
• Start date: December 10, 2012
• Est. completion date: November 30, 2015

Study information

• Verified date: June 2020
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 355
• Est. completion date: November 30, 2015
• Est. primary completion date: November 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

For entry in this study, participants must have been enrolled in the 410 Continued Access (CA) Clinical Study or 410 Continued Access Reconstruction/Revision Expansion (CARE) Clinical Study under the inclusion criteria listed below and received NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Styles or L-Styles breast implants

• Female, age 18 or older

• Present with 1 or more of the following conditions:

1. Primary breast augmentation (i.e., no previous breast implant surgery) indicated for subject dissatisfaction with size or shape of breast (e.g., mammary hypoplasia), asymmetry, ptosis, or aplasia

2. 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 the permanent implants are placed in the reconstructed breast)

3. 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

• Willing to undergo magnetic resonance imaging (MRI) at the specified follow-up visits for subjects at MRI designated sites and be eligible for MRI (e.g., no implanted metal or metal devices, no history of severe claustrophobia)

Exclusion Criteria:

For entry in this study, participants must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study, meeting the exclusion criteria listed below, did not receive any NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled FM, FF, MM, or MF Style Breast Implants, and have not undergone implant removal with or without replacement surgery

• Does not have advance fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy

• Does not have existing carcinoma of the breast, without mastectomy

• Does not have abscess or infection in the body at the time of enrollment

• Is not pregnant or nursing

• Does not have any disease, including uncontrolled diabetes (e.g., hemoglobin A1c (HbA1c) > 8%), that is clinically known to impact wound healing ability

• Does not show tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation inadequate tissue, compromised vascularity, or ulceration

• Does not have or is under treatment for any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)

• Does not show 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

Related Conditions & MeSH terms

• Breast Augmentation
• Breast Implant Revision
• Breast Reconstruction

Intervention

Device:
• Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
Surgical implant

Locations

Country	Name	City	State
United States	Walter Erhardt	Albany	Georgia
United States	James Namnoum	Atlanta	Georgia
United States	Peter Hyans	Berkeley Heights	New Jersey
United States	Laurence Berkowitz	Campbell	California
United States	Janet Turkle	Carmel	Indiana
United States	Charles Nathan	Chesterfield	Missouri
United States	Herluf Jr. Lund	Chesterfield	Missouri
United States	Raymond Isakov	Cleveland	Ohio
United States	Gregory Liebscher	Colorado Springs	Colorado
United States	Patricia McGuire	Creve Coeur	Missouri
United States	John Renucci	Grand Rapids	Michigan
United States	Tracy Pfeifer	Great Neck	New York
United States	Jeffrey Friedman	Houston	Texas
United States	Peter Hetzler	Little Silver	New Jersey
United States	Julene Samuels	Louisville	Kentucky
United States	Steven Morris	Midland	Michigan
United States	Timothy Mickel	Monroe	Louisiana
United States	Mary Gingrass	Nashville	Tennessee
United States	Patrick Maxwell	Nashville	Tennessee
United States	Lloyd Gayle	New York	New York
United States	Thomas Blanchard	Newport News	Virginia
United States	Perry Johnson	Omaha	Nebraska
United States	Calvin Peters	Orlando	Florida
United States	Roy Hong	Palo Alto	California
United States	Eric Bachelor	Pleasanton	California
United States	Caroline Glicksman	Sea Girt	New Jersey
United States	Craig Colville	Toledo	Ohio
United States	Frank Barone	Toledo	Ohio
United States	Scott Spear	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Primary	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.	3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Secondary	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).	5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Secondary	Percentage of Participants With Reoperations	Kaplan-Meier risk rates (estimation of the percentage of participants) of reoperation is reported.	5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Secondary	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	5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)