Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants - Full Text View

Sponsor:	Allergan Medical
Information provided by (Responsible Party):	Allergan Medical
ClinicalTrials.gov Identifier:	NCT00689871

Purpose

Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.

Condition	Intervention
Breast Augmentation Breast Reconstruction Revision of Augmentation or Reconstruction	Device: Natrelle(TM) Silicone-Filled Breast Implants

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label

Resource links provided by NLM:

MedlinePlus related topics: Breast Reconstruction

U.S. FDA Resources

Further study details as provided by Allergan Medical:

Primary Outcome Measures:

Local Complications [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
By patient risk of complications occuring in at least 5% of patients in 1 or more cohorts

Secondary Outcome Measures:

Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied

Enrollment:	715
Study Start Date:	January 1999
Study Completion Date:	August 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Primary augmentation	Device: Natrelle(TM) Silicone-Filled Breast Implants Breast implant surgery
Experimental: 2 Primary reconstruction	Device: Natrelle(TM) Silicone-Filled Breast Implants Breast implant surgery
Experimental: 3 Revision-augmentation	Device: Natrelle(TM) Silicone-Filled Breast Implants Breast implant surgery
Experimental: 4 Revision-reconstruction	Device: Natrelle(TM) Silicone-Filled Breast Implants Breast implant surgery

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Female, age 18 years or older
Seeking primary breast augmentation (i.e., no previous breast implant surgery) indicated for the following: patient dissatisfaction with size or shape of breast (e.g., mammary hypoplasia, asymmetry, ptosis, or aplasia
Seeking primary breast reconstruction
Seeking breast revision-augmentation
Seeking breast revision-reconstruction
Adequate tissue available to cover implants
Patients at MRI designated sites must be willing to undergo MRI at their 1,3, 5, 7 and 9-year follow-up visits (serial MRI). The patient must be eligible for MRI (for example, no implanted metal or metal devices and no history of severe claustrophobia that may make her ineligible for MRI).

Exclusion Criteria:

Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
Existing carcinoma of the breast, without mastectomy
Abscess or infection in the body at the time of enrollment
Pregnant or nursing
Have any disease, including uncontrolled diabetes (e.g., HbAIc > 8%), that is clinically known to impact wound healing ability
Show tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration
Have, or under treatment for, any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)
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)
Are not willing to undergo further surgery for revision, if medically required

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689871

Locations

United States, District of Columbia

Washington, District of Columbia, United States

Sponsors and Collaborators

Allergan Medical

More Information

No publications provided

Responsible Party:	Allergan Medical
ClinicalTrials.gov Identifier:	NCT00689871 History of Changes
Other Study ID Numbers:	020056
Study First Received:	June 2, 2008
Results First Received:	December 19, 2011
Last Updated:	February 13, 2012
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 17, 2012