Clinical trial NCT01870869: NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study
Official title: NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Augmentation
Breast Reconstruction
Breast Implant Revision
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-06-06
Enrollment: 1951
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants According to Investigator Satisfaction With Implants
timeFrame: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
measure: Percentage of Participants According to Participant Satisfaction With Implants
timeFrame: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Secondary outcomes:
measure: Percentage of Participants With Local Complications
timeFrame: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
measure: Percentage of Participants With Reoperations
timeFrame: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
measure: Percentage of Participants With Implant Removal With or Without Replacement
timeFrame: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Anthony Griffin
state: California
city: Campbell
country: United States
facility: Laurence Berkowitz
state: California
city: Long Beach
country: United States
facility: Mary Powers
state: California
city: Palo Alto
country: United States
facility: Roy Hong
state: California
city: Pleasanton
country: United States
facility: Eric Bachelor
state: California
city: San Diego
country: United States
facility: Douglas Reavie
state: California
city: Santa Monica
country: United States
facility: Steven Teitelbaum
state: California
city: Colorado Springs
country: United States
facility: Tad Heinz
state: Colorado
city: Denver
country: United States
facility: Gary Snider
state: Colorado
city: Englewood
country: United States
facility: Terrence Murphy
state: Colorado
city: Farmington
country: United States
facility: Orlando De Lucia
state: Connecticut
city: Tampa
country: United States
facility: Lewis Berger
state: Florida
city: Tampa
country: United States
facility: Gerard Mosiello
state: Florida
city: Atlanta
country: United States
facility: James Namnoum
state: Georgia
city: Des Plaines
country: United States
facility: Peter Johnson
state: Illinois
city: Elk Grove Village
country: United States
facility: Stephen Madry
state: Illinois
city: Carmel
country: United States
facility: Janet Turkle
state: Indiana
city: Indianapolis
country: United States
facility: Bruce Van Natta
state: Indiana
city: Indianapolis
country: United States
facility: Christine Kelley-Patteson
state: Indiana
city: Olathe
country: United States
facility: Brad Storm
state: Kansas
city: Louisville
country: United States
facility: Julene Samuels
state: Kentucky
city: Monroe
country: United States
facility: Timothy Mickel
state: Louisiana
city: Shreveport
country: United States
facility: Paul Davis
state: Louisiana
city: Grand Rapids
country: United States
facility: Bradley Bengtson
state: Michigan
city: Grand Rapids
country: United States
facility: John Renucci
state: Michigan
city: Midland
country: United States
facility: Steven Morris
state: Michigan
city: Chesterfield
country: United States
facility: Charles Nathan
state: Missouri
city: Chesterfield
country: United States
facility: Herluf Lund Jr.
state: Missouri
city: Creve Coeur
country: United States
facility: Patricia McGuire
state: Missouri
city: Hannibal
country: United States
facility: Schuyler Meltis
state: Missouri
city: Omaha
country: United States
facility: Perry Johnson
state: Nebraska
city: Omaha
country: United States
facility: Perry Johnson
state: Nebraska
city: Berkeley Heights
country: United States
facility: Peter Hyans
state: New Jersey
city: Florham Park
country: United States
facility: Isaac Starker
state: New Jersey
city: Little Silver
country: United States
facility: Peter Hetzler
state: New Jersey
city: Princeton
country: United States
facility: Marc Alan Drimmer
state: New Jersey
city: Sea Girt
country: United States
facility: Caroline Glicksman
state: New Jersey
city: New York
country: United States
facility: Lloyd Gayle
state: New York
city: New York
country: United States
facility: John Sherman
state: New York
city: New York
country: United States
facility: Tracy Pfeifer
state: New York
city: Port Jefferson Station
country: United States
facility: Robert Jacobs
state: New York
city: Staten Island
country: United States
facility: John Decorato
state: New York
city: Cleveland
country: United States
facility: Raymond Isakov
state: Ohio
city: Toledo
country: United States
facility: Craig Colville
state: Ohio
city: Toledo
country: United States
facility: Frank Barone
state: Ohio
city: Oklahoma City
country: United States
facility: Derek Shadid
state: Oklahoma
city: Oklahoma City
country: United States
facility: Robert Hein
state: Oklahoma
city: Eugene
country: United States
facility: Mark Jewell
state: Oregon
city: Spartanburg
country: United States
facility: John Lettieri
state: South Carolina
city: Nashville
country: United States
facility: Kristina D. O'Shaughnessy
state: Tennessee
city: Nashville
country: United States
facility: Patrick Maxwell
state: Tennessee
city: Dallas
country: United States
facility: William Carpenter
state: Texas
city: Houston
country: United States
facility: Jeffrey Friedman
state: Texas
city: Plano
country: United States
facility: Natan Yaker
state: Texas
city: University Park
country: United States
facility: William Adams
state: Texas
city: McLean
country: United States
facility: Gloria Duda
state: Virginia
city: Bellevue
country: United States
facility: Gavin Dry
state: Washington
city: Vancouver
country: United States
facility: Allen Gabriel
state: Washington
Study officials:
affiliation: Allergan
name: Andrew Schumacher
role: STUDY_CHAIR
References: