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

NCT01870869 | Terminated Results FDA Device

• 1 other identifier: 410CAXL-001
• Study Type: interventional
• Target: 1,951
• Locations: 1 country
• Sites: 58

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.

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.

  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.

  5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)

Secondary Outcomes (3)

• Percentage of Participants With Local Complications

  5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)

• Percentage of Participants With Reoperations

  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

  5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)

Study Arms (4)

Augmentation

EXPERIMENTAL

Women who had breast augmentation with NATRELLE® 410 implants.

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

Revision-Augmentation

EXPERIMENTAL

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

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

Revision-Reconstruction

EXPERIMENTAL

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

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

Interventions

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

Surgical implant

Also known as: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles FX, MX, LX, FL, ML, LL, LM, and LF)

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 (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (58)

Anthony Griffin

Beverly Hills, California, 90211, United States

Location

Laurence Berkowitz

Campbell, California, 95008, United States

Location

Mary Powers

Long Beach, California, 90806, United States

Location

Roy Hong

Palo Alto, California, 94301, United States

Location

Eric Bachelor

Pleasanton, California, 94566, United States

Location

Douglas Reavie

San Diego, California, 92128, United States

Location

Steven Teitelbaum

Santa Monica, California, 90404, United States

Location

Tad Heinz

Colorado Springs, Colorado, 80909, United States

Location

Gary Snider

Denver, Colorado, 80218, United States

Location

Terrence Murphy

Englewood, Colorado, 80113, United States

Location

Orlando De Lucia

Farmington, Connecticut, 06032, United States

Location

Lewis Berger

Tampa, Florida, 33607, United States

Location

Gerard Mosiello

Tampa, Florida, 33647, United States

Location

James Namnoum

Atlanta, Georgia, 30342, United States

Location

Peter Johnson

Des Plaines, Illinois, 60016, United States

Location

Stephen Madry

Elk Grove Village, Illinois, 60007, United States

Location

Janet Turkle

Carmel, Indiana, 46290, United States

Location

Bruce Van Natta

Indianapolis, Indiana, 46290, United States

Location

Christine Kelley-Patteson

Indianapolis, Indiana, 46290, United States

Location

Brad Storm

Olathe, Kansas, 66061, United States

Location

Julene Samuels

Louisville, Kentucky, 40241, United States

Location

Timothy Mickel

Monroe, Louisiana, 71201, United States

Location

Paul Davis

Shreveport, Louisiana, 71105, United States

Location

Bradley Bengtson

Grand Rapids, Michigan, 49503, 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 Lund Jr.

Chesterfield, Missouri, 63005, United States

Location

Patricia McGuire

Creve Coeur, Missouri, 63141, United States

Location

Schuyler Meltis

Hannibal, Missouri, 63401, United States

Location

Perry Johnson

Omaha, Nebraska, 68102, United States

Location

Perry Johnson

Omaha, Nebraska, 68118, United States

Location

Peter Hyans

Berkeley Heights, New Jersey, 07922, United States

Location

Isaac Starker

Florham Park, New Jersey, 07932, United States

Location

Peter Hetzler

Little Silver, New Jersey, 07739, United States

Location

Marc Alan Drimmer

Princeton, New Jersey, 08540, United States

Location

Caroline Glicksman

Sea Girt, New Jersey, 08750, United States

Location

Lloyd Gayle

New York, New York, 10021, United States

Location

John Sherman

New York, New York, 10028, United States

Location

Tracy Pfeifer

New York, New York, 10028, United States

Location

Robert Jacobs

Port Jefferson Station, New York, 11776, United States

Location

John Decorato

Staten Island, New York, 10306, 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

Derek Shadid

Oklahoma City, Oklahoma, 73134, United States

Location

Robert Hein

Oklahoma City, Oklahoma, 73134, United States

Location

Mark Jewell

Eugene, Oregon, 97401, United States

Location

John Lettieri

Spartanburg, South Carolina, 29303, United States

Location

Kristina D. O'Shaughnessy

Nashville, Tennessee, 37203, United States

Location

Patrick Maxwell

Nashville, Tennessee, 37212, United States

Location

William Carpenter

Dallas, Texas, 75246, United States

Location

Jeffrey Friedman

Houston, Texas, 77030, United States

Location

Natan Yaker

Plano, Texas, 75093, United States

Location

William Adams

University Park, Texas, 75205, United States

Location

Gloria Duda

McLean, Virginia, 22101, United States

Location

Gavin Dry

Bellevue, Washington, 98005, United States

Location

Allen Gabriel

Vancouver, Washington, 98664, 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: June 4, 2013
• First Posted: June 6, 2013
• Study Start: May 29, 2013
• Primary Completion: November 30, 2015
• Study Completion: November 30, 2015
• Last Updated: June 22, 2020
• Results First Posted: June 22, 2020

Record last verified: 2020-06

Locations

US (58)