Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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).
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