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

Not Applicable
Completed
Conditions
Breast Augmentation
Revision of Augmentation or Reconstruction
Breast Reconstruction
Interventions
Device: Natrelle(TM) Silicone-Filled Breast Implants
Registration Number
NCT00689871
Lead Sponsor
Allergan Medical
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
715
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
2Natrelle(TM) Silicone-Filled Breast ImplantsPrimary reconstruction
4Natrelle(TM) Silicone-Filled Breast ImplantsRevision-reconstruction
1Natrelle(TM) Silicone-Filled Breast ImplantsPrimary augmentation
3Natrelle(TM) Silicone-Filled Breast ImplantsRevision-augmentation
Primary Outcome Measures
NameTimeMethod
Local Complications10 years

By patient risk of complications occuring in at least 5% of patients in 1 or more cohorts

Secondary Outcome Measures
NameTimeMethod
Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale10 years

Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied

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