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

NCT01785069 | Terminated Results FDA Device

• 1 other identifier: 410XL-001
• Study Type: interventional
• Target: 355
• Locations: 1 country
• Sites: 29

Brief 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.

Conditions

Breast Augmentation; Breast Reconstruction; Breast Implant Revision

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (3)

• Percentage of Participants With Local Complications

  5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)

• Percentage of Participants With Reoperations

  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

  5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)

Study Arms (4)

Augmentation

EXPERIMENTAL

Women who had breast augmentation with NATRELLE® 410 implants.

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

Reconstruction

EXPERIMENTAL

Women who had breast reconstruction with NATRELLE® 410 implants.

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

Revision-Augmentation

EXPERIMENTAL

Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.

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

Revision-Reconstruction

EXPERIMENTAL

Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.

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

Interventions

Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection DEVICE

Surgical implant

Also known as: NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled Breast Implants

Augmentation; Reconstruction; Revision-Augmentation; Revision-Reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, age 18 or older
• Present with 1 or more of the following conditions:
• 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
• 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)
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (29)

Laurence Berkowitz

Campbell, California, 95008, United States

Location

Roy Hong

Palo Alto, California, 94301, United States

Location

Eric Bachelor

Pleasanton, California, 94566, United States

Location

Gregory Liebscher

Colorado Springs, Colorado, 80919, United States

Location

Scott Spear

Washington D.C., District of Columbia, 20007, United States

Location

Calvin Peters

Orlando, Florida, 32801, United States

Location

Walter Erhardt

Albany, Georgia, 31701, United States

Location

James Namnoum

Atlanta, Georgia, 30342, United States

Location

Janet Turkle

Carmel, Indiana, 46032, United States

Location

Julene Samuels

Louisville, Kentucky, 40205, United States

Location

Timothy Mickel

Monroe, Louisiana, 71201, United States

Location

John Renucci

Grand Rapids, Michigan, 49503, United States

Location

Steven Morris

Midland, Michigan, 48640, United States

Location

Charles Nathan

Chesterfield, Missouri, 63005, United States

Location

Herluf Jr. Lund

Chesterfield, Missouri, 63005, United States

Location

Patricia McGuire

Creve Coeur, Missouri, 63141, United States

Location

Perry Johnson

Omaha, Nebraska, 68118, United States

Location

Peter Hyans

Berkeley Heights, New Jersey, 07922, United States

Location

Peter Hetzler

Little Silver, New Jersey, 07739, United States

Location

Caroline Glicksman

Sea Girt, New Jersey, 08750, United States

Location

Tracy Pfeifer

Great Neck, New York, 10028, United States

Location

Lloyd Gayle

New York, New York, 10021, United States

Location

Raymond Isakov

Cleveland, Ohio, 44195, United States

Location

Craig Colville

Toledo, Ohio, 43615, United States

Location

Frank Barone

Toledo, Ohio, 43623, United States

Location

Mary Gingrass

Nashville, Tennessee, 37203, United States

Location

Patrick Maxwell

Nashville, Tennessee, 37212, United States

Location

Jeffrey Friedman

Houston, Texas, 77030, United States

Location

Thomas Blanchard

Newport News, Virginia, 23606, United States

Location

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Andrew Schumacher

  Allergan

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: February 6, 2013
• Study Start: December 10, 2012
• Primary Completion: November 30, 2015
• Study Completion: November 30, 2015
• Last Updated: June 25, 2020
• Results First Posted: June 25, 2020

Record last verified: 2020-06

Locations

US (29)