Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Allergan
Age
18–any
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants
