Clinical trial NCT01785069: Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Augmentation
Breast Reconstruction
Breast Implant Revision
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-02-06
Enrollment: 355
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants According to Investigator Satisfaction With Implants
timeFrame: 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
measure: Percentage of Participants According to Participant Satisfaction With Implants
timeFrame: 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Secondary outcomes:
measure: Percentage of Participants With Local Complications
timeFrame: 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
measure: Percentage of Participants With Reoperations
timeFrame: 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
measure: Percentage of Participants With Implant Removal With or Without Replacement
timeFrame: 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Other outcomes:
Locations:
city: Campbell
country: United States
facility: Laurence Berkowitz
state: California
city: Palo Alto
country: United States
facility: Roy Hong
state: California
city: Pleasanton
country: United States
facility: Eric Bachelor
state: California
city: Colorado Springs
country: United States
facility: Gregory Liebscher
state: Colorado
city: Washington
country: United States
facility: Scott Spear
state: District of Columbia
city: Orlando
country: United States
facility: Calvin Peters
state: Florida
city: Albany
country: United States
facility: Walter Erhardt
state: Georgia
city: Atlanta
country: United States
facility: James Namnoum
state: Georgia
city: Carmel
country: United States
facility: Janet Turkle
state: Indiana
city: Louisville
country: United States
facility: Julene Samuels
state: Kentucky
city: Monroe
country: United States
facility: Timothy Mickel
state: Louisiana
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 Jr. Lund
state: Missouri
city: Creve Coeur
country: United States
facility: Patricia McGuire
state: Missouri
city: Omaha
country: United States
facility: Perry Johnson
state: Nebraska
city: Berkeley Heights
country: United States
facility: Peter Hyans
state: New Jersey
city: Little Silver
country: United States
facility: Peter Hetzler
state: New Jersey
city: Sea Girt
country: United States
facility: Caroline Glicksman
state: New Jersey
city: Great Neck
country: United States
facility: Tracy Pfeifer
state: New York
city: New York
country: United States
facility: Lloyd Gayle
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: Nashville
country: United States
facility: Mary Gingrass
state: Tennessee
city: Nashville
country: United States
facility: Patrick Maxwell
state: Tennessee
city: Houston
country: United States
facility: Jeffrey Friedman
state: Texas
city: Newport News
country: United States
facility: Thomas Blanchard
state: Virginia
Study officials:
affiliation: Allergan
name: Andrew Schumacher
role: STUDY_CHAIR
References: