Retrospective Study of Reoperation After Primary Augmentation With NATRELLE® INSPIRA® Breast Implants

This study will evaluate the incidence of reoperations associated with the use of smooth and textured NATRELLE® INSPIRA® TruForm® 1 and TruForm® 2 devices in patients who have undergone primary breast augmentation.

Inclusion Criteria:

• Primary breast augmentation (either bilateral or unilateral) operated on by the investigating surgeon with an infra-mammary approach smooth or textured NATRELLE® INSPIRA® TruForm® 1 or 2 device
• Primary breast augmentation 2 to 4 years (24-48 months) prior to data collection
• Subfascial, submuscular, dual plane or subglandular implant placement

Exclusion Criteria:

• Breast augmentation for Poland Syndrome or amastia
• Breast reconstruction following mastectomy
• Revision or secondary breast reconstruction
• Non NATRELLE® INSPIRA® device implanted at initial breast augmentation
• Women diagnosed with breast disease considered to be pre-malignant or malignant prior to or at the time of primary breast augmentation
• Surgical procedures of the breast not related to the primary breast augmentation (e.g. excision of significant skin lesions or a biopsy) occurring prior to or at the time of primary augmentation that may adversely affect the aesthetic outcome in the opinion of the investigator
• Axillary or peri-areolar approach
• Mastopexy augmentation