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

Breast Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01870869
• Other study ID #: 410CAXL-001
• Status: Terminated
• Phase: N/A
• Start date: May 29, 2013
• 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1951
• 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 either been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study under the inclusion criteria below and received NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts; or be planning to be implanted with NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts and meet the inclusion criteria listed below:

• 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

Exclusion Criteria:

For entry in this study, participants must have either been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study and did not meet the exclusion criteria listed below or plan to undergo implantation with NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts and does not meet the exclusion criteria listed below:

• 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

Related Conditions & MeSH terms

• Breast Augmentation
• Breast Implant Revision
• Breast Reconstruction

Intervention

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

Locations

Country	Name	City	State
United States	James Namnoum	Atlanta	Georgia
United States	Gavin Dry	Bellevue	Washington
United States	Peter Hyans	Berkeley Heights	New Jersey
United States	Anthony Griffin	Beverly Hills	California
United States	Laurence Berkowitz	Campbell	California
United States	Janet Turkle	Carmel	Indiana
United States	Charles Nathan	Chesterfield	Missouri
United States	Herluf Lund Jr.	Chesterfield	Missouri
United States	Raymond Isakov	Cleveland	Ohio
United States	Tad Heinz	Colorado Springs	Colorado
United States	Patricia McGuire	Creve Coeur	Missouri
United States	William Carpenter	Dallas	Texas
United States	Gary Snider	Denver	Colorado
United States	Peter Johnson	Des Plaines	Illinois
United States	Stephen Madry	Elk Grove Village	Illinois
United States	Terrence Murphy	Englewood	Colorado
United States	Mark Jewell	Eugene	Oregon
United States	Orlando De Lucia	Farmington	Connecticut
United States	Isaac Starker	Florham Park	New Jersey
United States	Bradley Bengtson	Grand Rapids	Michigan
United States	John Renucci	Grand Rapids	Michigan
United States	Schuyler Meltis	Hannibal	Missouri
United States	Jeffrey Friedman	Houston	Texas
United States	Bruce Van Natta	Indianapolis	Indiana
United States	Christine Kelley-Patteson	Indianapolis	Indiana
United States	Peter Hetzler	Little Silver	New Jersey
United States	Mary Powers	Long Beach	California
United States	Julene Samuels	Louisville	Kentucky
United States	Gloria Duda	McLean	Virginia
United States	Steven Morris	Midland	Michigan
United States	Timothy Mickel	Monroe	Louisiana
United States	Kristina D. O'Shaughnessy	Nashville	Tennessee
United States	Patrick Maxwell	Nashville	Tennessee
United States	John Sherman	New York	New York
United States	Lloyd Gayle	New York	New York
United States	Tracy Pfeifer	New York	New York
United States	Derek Shadid	Oklahoma City	Oklahoma
United States	Robert Hein	Oklahoma City	Oklahoma
United States	Brad Storm	Olathe	Kansas
United States	Perry Johnson	Omaha	Nebraska
United States	Perry Johnson	Omaha	Nebraska
United States	Roy Hong	Palo Alto	California
United States	Natan Yaker	Plano	Texas
United States	Eric Bachelor	Pleasanton	California
United States	Robert Jacobs	Port Jefferson Station	New York
United States	Marc Alan Drimmer	Princeton	New Jersey
United States	Douglas Reavie	San Diego	California
United States	Steven Teitelbaum	Santa Monica	California
United States	Caroline Glicksman	Sea Girt	New Jersey
United States	Paul Davis	Shreveport	Louisiana
United States	John Lettieri	Spartanburg	South Carolina
United States	John Decorato	Staten Island	New York
United States	Gerard Mosiello	Tampa	Florida
United States	Lewis Berger	Tampa	Florida
United States	Craig Colville	Toledo	Ohio
United States	Frank Barone	Toledo	Ohio
United States	William Adams	University Park	Texas
United States	Allen Gabriel	Vancouver	Washington

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